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Publications2019-01-11T21:33:34+00:00

Assessing the real-world cost of care in patients with metastatic triple negative breast cancer (mTNBC) in the United States.

–  Skinner KE, Dufour R, Haiderali A, Huang M, Schwartzberg LS.

In: ISPOR Europe; 2018 November 10-14; Barcelona, Spain; 2018.

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Understanding health-related quality of life (HRQoL) in unresected stage III non-small cell lung cancer (NSCLC).

–  Ryan KJ, Skinner KE, Fernandes AW, Walker MS, Pavilack M, Punekar RS, VanderWalde NA.

In: ASCO Quality Care Symposium; 2018 September 28-29; Phoenix, AZ; 2018.

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Treatment outcomes in patients with metastatic neuroendocrine tumors: a retrospective analysis of a community oncology database.

–  Fisher MD, Pulgar S, Kulke MH, Mirakhur B, Miller PJ, Walker MS, Schwartzberg LS.

In: Journal of Gastrointestinal Cancer 2018 August 18; https://doi.org/10.1007/s12029-018-0160-x.

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Purpose: Metastatic neuroendocrine tumors (mNETs) are rare, heterogeneous tumors that present diagnostic and treatment challenges, with limited data on the management of mNETs in clinical practice. The present study was designed to identify current diagnostic and treatment patterns in mNET patients treated in the US community oncology setting. Methods: Patient-level data was collected from medical records of adults with mNETs from the Vector Oncology Data Warehouse, a comprehensive US community oncology network database.

Results: Of the 263 patients included (median follow-up, 22 months; range, 0.1–193.9), 30.4% (80/263) had intestinal tumors, 11.0% (29/263) had pancreatic, and 58.6% (154/263) had tumors of other or unknown location. Progression-free survival (PFS) from the start of first-line therapy differed significantly by tumor grade (log rank P = 0.0016) and location (P = 0.0044), as did overall survival (OS) (grade, P < 0.0001; location, P = 0.0068). Median PFS and OS for patients with undocumented tumor grade were shorter than for patients with G1/G2 tumors and longer than patients with G3 tumors. Median PFS and OS for patients with other or unknown tumors were shorter than for patients with intestinal tumors.

Conclusions: While potentially confounded by the high number of patients with other or unknown tumor locations, this retrospective study of patients in a US community oncology setting identified the importance of awareness of tumor grade and tumor location at diagnosis, as these were direct correlates of PFS and OS.

Treatment patterns and outcomes in stage IV bladder cancer in a community oncology setting: 2008-2015.

–  Fisher MD, Shenolikar R, Miller PJ, Fenton M, Walker MS.

In: Clinical Genitourinary Cancer 2018 August 10, https://doi.org/10.1016/j.clgc.2018.07.025.

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Introduction: Current real-world data regarding treatment patterns in advanced bladder cancer in the community setting are limited. This study describes patient characteristics, treatment patterns, and effectiveness outcomes for stage IV bladder cancer in the community setting. Methods: Medical records data of adults diagnosed with stage IV bladder cancer between January 1, 2008 and June 1, 2015 were retrospectively collected from a network of United States community oncology practices. Patient characteristics, treatment patterns, and efficacy outcomes were assessed. Across-group comparisons were conducted using bivariate analyses. Kaplan-Meier and Cox regression analyses of progression-free survival and overall survival (OS) were conducted.

Results: Of 508 patients (mean age, 70 ± 11 years), 75.2% were male, 79.1% white, 15.4% black, and 71.5% were ≥ 65 years. The most prevalent comorbidities were diabetes (23.4%) and renal disease (16.5%). Overall, 56% of patients received first-line platinum-based chemotherapy; the most common regimen was gemcitabine/carboplatin (23.6%), followed by gemcitabine/cisplatin (17%). The median OS was 9.4 months from stage IV bladder cancer diagnosis and 8.4 months from start of first-line therapy. Cox regression analysis of OS from diagnosis showed a higher risk of death for patients with no treatment (hazard ratio [HR], 2.06; P < .0001) or other treatment (HR, 1.83; P = .002) versus cisplatin and for patients with impaired performance (HR, 2.05; P < .0001).

Conclusion: Platinum-based chemotherapy was the most prescribed treatment for stage IV bladder cancer in the community setting. Several patients were not treated with any chemotherapy, although we did not observe the reason for no treatment. This study highlights an unmet need in this population, particularly in a relapsed/refractory setting, and the need for improvement in outcomes.

Pretreatment costs of care and time to initial treatment for patients with cancer of unknown primary.

–  Walker MS, Weinstein L, Luo R, Marino I.

In: Journal of Comparative Effectiveness Research 2018; 7(6):523-533.

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Aim: Time to treatment and pretreatment costs may be affected by unknown primary tumor site.

Methods: This retrospective study used electronic medical record data from patients in ten US community oncology practices. Eligible patients were ≥18 years, diagnosed with cancer of unknown primary (CUP) or known metastatic solid tumor, and presented between 1 January 2012 and 30 June 2014.

Results: Patients with CUP (n = 294) had a longer interval than non-CUP patients (n = 92) from presentation to treatment initiation (1.18 vs 0.49 months, p < 0.0001), and had higher pretreatment costs (US$27,882 vs US$20,449, p = 0.0075). When analyzed as monthly cost, the difference between groups in log-cost per month was nonsignificant.

Conclusion: Higher pretreatment costs in CUP patients appeared attributable to significantly longer time to initiation of therapy.

Patient reported outcomes in metastatic renal cell carcinoma patients receiving pazopanib in a community oncology setting.

–  Fisher MD, Ghate SR, Miller PJ, Walker MS, Ferrusi IL, Agarwal N.

In: ISPOR 23rd Annual International Meeting; 2018 May 19-23; Baltimore, MD; 2018.

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Impacts of time spent on rituximab infusion on patient satisfaction, stress, employment, and caregiver burden.

–  Fisher MD, Wallick CJ, Miller PJ, Walker MS, Lash S, Dawson KL, Reyes CM.

In: ISPOR 23rd Annual International Meeting; 2018 May 19-23; Baltimore, MD; 2018.

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Time spent on rituximab infusion and its impact on patient and caregiver burden

–  Fisher MD, Wallick CJ, Miller PJ, Walker MS, Lash S, Dawson KL, Reyes CM.

In: AMCP Managed Care and Specialty Pharmacy Annual Meeting; 2018 April 23-26; Boston, MA; 2018.

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Patient characteristics and costs in recurrent or refractory head and neck cancer: retrospective analysis of a community oncology database.

–  Fisher MD, Fernandes AW, Olufade TO, Miller PJ, Walker MS, Fenton M.

In: Clinical Therapeutics 2018; 40(4):562-573.

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Purpose: The goal of this study was to describe patient characteristics, health resource utilization (HRU), and costs associated with treating recurrent or refractory head and neck cancer (HNC) among patients with disease progression in the community oncology setting.

Methods: This retrospective observational study was conducted by using data from the Vector Oncology Data Warehouse. Patients had been diagnosed with locally advanced or metastatic (stage III–IVc) HNC between January 1, 2007, and October 1, 2015. Patients also had evidence of at least 1 systemic anticancer therapy regimen following the diagnosis of advanced HNC, with at least 1 disease progression. Costs, treatment patterns, and HRU were evaluated beginning with diagnosis of advanced HNC through 3 lines of therapy. Costs of surgery or radiation were not available for inclusion in the analysis. Total cost for the study period and cost per month were analyzed by using a generalized linear regression model.

Findings: The study included 462 patients (median age, 61 years; range, 26–99 years); of these, 81% were male, 77% were white, and 21% were black. At initial diagnosis, the most frequent tumor locations were the hypopharynx/larynx (31%) and the oropharynx (31%). Human papilloma virus testing was most frequent among the oropharynx group (22% tested, 52% positive). Overall, 42% were current tobacco users and 22% were current or past alcohol abusers/excessive users. Platinum-based combination therapies were the most frequently administered chemotherapy in both first (42%) and second (40%) lines of treatment. Through the overall study period (mean, 20.5 months), 74% of patients were hospitalized, 19% had an emergency department visit, and 100% had an office visit. The overall mean (SD) duration of hospital stay was 12.6 days, and the median number of office visits per patient was 35. The mean monthly health care cost for the overall study period was $14,391 (95% CI, 12,739–16,044). Hospitalization costs represented ~57% of the total expenditures. Statistically significant predictors of higher overall cost included primary tumor location in the oral cavity, history of alcohol abuse/excess use, use of cetuximab, and higher comorbidity index. Older age and being stage IV versus other stages of disease at diagnosis were associated with lower overall cost.

Implications: These data suggest that costs of care in patients with recurrent or refractory HNC are related to patient characteristics and treatment patterns. Identification of factors contributing to the costs of care in HNC may provide a useful foundation for developing strategies to control rising costs.

Effectiveness outcomes in patients with recurrent or refractory head and neck cancers: retrospective analysis of data from a community oncology database.

–  Fisher MD, Fernandes AW, Olufade TO, Miller PJ, Walker MS, Fenton M.

In: Clinical Therapeutics 2018; 40(9):1522-1537.

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Purpose: The purpose of this study was to provide an understanding of the effectiveness of existing therapies in patients with advanced head and neck cancer (HNC), particularly in clinical practice.

Methods: Data from the electronic medical records of adult patients diagnosed with locally advanced or metastatic (Stage III-IVc) HNC between January 1, 2007, and October 1, 2015, were retrospectively collected from a network of community oncology practices in the United States. Eligible patients experienced disease progression despite having received prior systemic therapy. Kaplan-Meier and Cox regression analyses of progression-free survival (PFS) and overall survival (OS) were conducted. Patient-reported outcomes were also collected.

Findings: The study included 462 patients (median age 61.0 years; 80.7% male; 77.1% white). Most patients had a history of tobacco use (41.8% current, 41.8% past), and human papillomavirus testing was infrequent overall (11.0%). The median overall duration of follow-up was 16.4 months (range, 2.3-85.2 months). Median PFS values were 8.45 months with first-line treatment and 5.33 months with second-line treatment. PFS with first-line treatment was significantly associated with primary tumor location, performance status, and tobacco use. Performance status was a predictor of PFS in second-line treatment. Median OS values were 21.04 and 9.53 months from the start of the first and second lines of therapy, respectively. Abuse/excessive use of alcohol, older age, and impaired performance status were associated with a significantly increased risk for death in outcomes analyses. Outcomes were worse among patients initially diagnosed with Stage IVc disease versus those who progressed to Stage IVc. Past tobacco use and alcohol abuse were associated with worse patient-reported symptoms such as dry mouth and sore throat (smoking) and trouble swallowing (alcohol).

Implications: This study of data from clinical practice shows that there remains a large unmet need for effective therapeutic options in advanced HNC. Patients’ characteristics such as alcohol use and performance status were statistically significant predictors of PFS and OS in Stage III-IVc HNC.

Healthcare costs in patients with advanced non-small cell lung cancer and disease progression during targeted therapy: a real-world observational study.

–  Skinner KE, Fernandes AW, Walker MS, Pavilack M, VanderWalde A.

In: Journal of Medical Economics 2018; 21(2): 192-200.

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Aims: To assess healthcare costs during treatment with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) and following disease progression in patients with advanced non-small cell lung cancer (NSCLC).

Methods: A retrospective analysis of medical records of US community oncology practices was conducted. Eligible patients had advanced NSCLC (stage IIIB/IV) diagnosed between January 1, 2008 and January 1, 2015, initiated treatment with erlotinib or afatinib (first-line or second-line), and had disease progression. Monthly Medicare-paid costs were evaluated during the TKI therapy period and following progression.

Results: The study included 364 patients. The total mean monthly cost during TKI therapy was $20,106 (95% confidence interval [CI] ¼ $16,836–$23,376), of which 47.0% and 42.4% represented hospitalization costs and anti-cancer therapy costs, respectively. Following progression on TKI therapy (data available for 316 patients), total mean monthly cost was $19,274 (95% CI ¼ $15,329–$23,218), and was higher in the 76.3% of patients who received anti-cancer therapy following progression than in the 23.7% of those who did not ($20,490 vs $15,364; p < .001). Among patients who received it, anticancer therapy ($11,198; 95% CI ¼ $7,102–$15,295) represented 54.7% of total mean monthly cost. Among patients who did not receive anti-cancer therapy, hospitalization ($13,829; 95% CI ¼ $4,922–$22,736) represented 90.0% of total mean monthly cost. Impaired performance status and brain metastases were significant predictors of increased cost during TKI therapy.

Limitations: The study design may limit the generalizability of findings.

Conclusions: Healthcare costs during TKI treatment and following progression appeared to be similar and were largely attributed to hospitalization and anti-cancer therapy. Notably, almost one-quarter of patients did not receive anti-cancer therapy following progression, potentially indicating an unmet need; hospitalization was the largest cost contributor for these patients. Additional effective targeted therapies are needed that could prolong progression-free survival, leading to fewer hospitalizations for EGFR mutation-positive patients.

Real-world clinical outcomes in BRCA-positive metastatic breast cancer patients treated in the community oncology setting.

–  Houts AC, Olufade T, Shenolikar R, Walker MS.

In: San Antonio Breast Cancer Symposium; 2017 December 5-9; San Antonio, TX; 2017.

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Treatment patterns and outcomes in patients with KRAS wild-type metastatic colorectal cancer treated in first line with bevacizumab- or cetuximab-containing regimens.

–  Houts AC, Ogale S, Sommer N, Satram-Hoang S, Walker MS.

In: Journal of Gastrointestinal Cancer 2017 Nov 22; https://doi.org/10.1007/s12029-017-0027-6.

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Purpose: Patients with Kirsten rat sarcoma viral oncogene wild-type (KRAS WT) metastatic colorectal cancer (mCRC) treated in first line with bevacizumab (B) or cetuximab (C) plus standard chemo backbones had comparable outcomes in phase III Cancer and Leukemia Group B (CALGB) 80405. We examined comparative effectiveness of B and C regimens in real-world community settings.

Methods: This retrospective study examined progression-free survival (PFS) and OS in a US community sample of KRAS WT mCRC patients treated with first-line B (n = 254) or C (n = 146) regimens. Medical records from the Vector Oncology Data Warehouse were used. Disease progression was determined from patient charts. OS was measured from the start of first-line treatment until death.

Results: There were no significant difference in either PFS or OS respectively between B-treated compared to C-treated patients (HR = 1.324, 95% CI 0.901, 1.947; HR = 1.080, 95% CI 0.721, 1.617). More B patients received oxaliplatin backbones (74.8 vs. 36.3%), and more C patients received irinotecan backbones (51.4 vs. 20.1%), p’s < 0.001. Multivariate survival analyses showed a significant difference indicating a greater risk for death among C-treated patients with right-sided tumors vs. left-sided tumors (HR = 2.263, 95% CI 1.394, 3.673, p = 0.0009), but not for B-treated patients (HR = 1.209, 95% CI 0.825, 1.771, p = 0.3297).

Conclusions: Consistent with CALGB 80405, median PFS and OS for these community oncology KRAS WT mCRC patients treated with first-line B or C regimens did not differ significantly

Progression-free survival in patients receiving chemotherapy alone (C) or chemotherapy with bevacizumab (CB) for first-line treatment of KRAS mutant metastatic colorectal cancer in community oncology settings.

–  Houts AC, Ogale S, Zafar Y, Hubbard JM, Satram-Hoang S, Sommer N, Walker MS.

In: Journal of Gastrointestinal Cancer 2017 Oct 23; https://doi.org/10.1007/s12029-017-0017-8.

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Purpose: Bevacizumab is a standard first line (L1) treatment for metastatic colorectal cancer (mCRC) patients regardless of RAS status. This retrospective study examined treatment patterns and outcomes in a community oncology sample of KRAS mutant mCRC patients treated with chemotherapy (C) or C plus bevacizumab (CB) in L1.

Methods: This study used medical records from the Vector Oncology Data Warehouse. Eligible patients were confirmed KRAS mutant mCRC and received L1 C or CB. Kaplan-Meier analysis assessed L1 progression free survival (PFS) and overall survival (OS). Cox regression models examined the interaction of tumor location (R/L) with treatment.

Results: CB (n = 264) compared to C (n = 109) patients were younger, less likely performance status (PS) impaired, and more likely with liver metastases. Median unadjusted PFS was 10.41 months (95% CI: 9.0-11.3) in CB and 7.66 months (95% CI: 6.5-9.1) in C patients (p = 0.174). Median unadjusted OS was 26.91 months (95% CI: 24.3-29.3) in CB and 23.33 months (95% CI: 19.7-29.2) in C patients (p = 0.571). For patients with right- vs. left-sided tumors, C (but not CB) treated patients had higher adjusted risk for progression (HR = 1.715, 95% CI 1.108, 2.653, p = 0.015).

Conclusions: CB- vs. C-treated KRAS mutant mCRC patients may have a meaningful PFS benefit. Patients with right-sided tumors treated with C were at higher risk for disease progression than patients with left-sided tumors. Tumor location had no significant effect on outcomes in the CB cohort.

Health care cost in patients with advanced non-small cell lung cancer and disease progression on targeted treatment in a real-world setting.

–  Skinner KE, Fernandes AW, Walker MS, Pavilack M, VanderWalde A.

In: Academy of Managed Care Pharmacy (AMCP) Nexus; 2017 October 16-19; Dallas, TX; 2017.

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Real-world treatment patterns and effectiveness among patients with metastatic colorectal cancer treated with ziv-aflibercept in community oncology practices in the USA.

–  Ivanova JI, Saverno KR, Sung J, Duh MS, Zhao C, Cai S, Vekeman F, Peevyhouse A, Dhawan R, Fuchs CS.

In: Medical Oncology 2017;34:193.

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Routine clinical practice data often differ from clinical trials. This study describes real-world treatment patterns and effectiveness among patients with metastatic colorectal cancer (mCRC) receiving ziv-aflibercept in non-academic, community oncology practices in the USA. De-identified electronic medical records from Vector Oncology and Altos Solutions databases were analysed. We identified 218 patients diagnosed with mCRC who had received prior oxaliplatin therapy and initiated ziv-aflibercept as part of second-line or later-line therapy. Overall survival (OS) and progression-free survival (PFS) were estimated using Kaplan–Meier analysis. Mean age was 62.8 years at ziv-aflibercept initiation. Most patients (91.7%) received bevacizumab before ziv-aflibercept, 95.4% initiated ziv-aflibercept with FOLFIRI or another irinotecan-based regimen, and 59.6% had received prior irinotecan. Overall, 24.8% of patients initiated ziv-aflibercept in second line, 31.7% in third line, 21.6% in fourth line and 22.0% in later lines of therapy. Mean duration of ziv-aflibercept treatment was 5.3 months. For patients initiating ziv-aflibercept in second-, third- and fourth-line therapy, median OS was 11.9 (95% confidence interval 5.1–16.2), 11.1 (6.9–16.7) and 8.1 (5.2–11.4) months, respectively, and median PFS was 4.4 (2.8–6.5), 4.3 (2.9–6.3) and 3.4 (2.2–5.2) months, respectively. Common adverse events (AEs) (any grade) included gastrointestinal disorders (64.7%) and asthenia/fatigue (63.3%). In routine clinical practice, ziv-aflibercept was frequently initiated in third line or later lines of therapy. Although patients receiving ziv-aflibercept were more heavily pretreated and potentially less robust compared with the VELOUR trial, median OS for patients receiving second-line ziv-aflibercept was comparable. AE rates were similar to or lower than the VELOUR trial.

Analysis of the psychological impact of cancer-related symptoms on patients with non-small cell lung cancer.

–  Walker MS, Pohl GM, Houts AC, Peltz G, Miller PJE, Schwartzberg LS, Stepanski EJ, Marciniak M.

In: Psycho-Oncology 2017; 26(6): 755-762.

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Background: Patients with non-small cell lung cancer (NSCLC) experience adverse physical symptoms because of cancer, cancer treatment, and comorbidities. The relations among Cancer-Related Symptoms, Functional Impairment, and Psychological Symptoms in patients with NSCLC is not well understood.

Methods: Retrospective analysis of patient-reported symptoms with the 38-item Patient Care Monitor survey, collected in routine clinical care for 1138 patients with NSCLC at eight US community oncology practices. Study sample was randomly split, and structural equation models examined the direct and mediated effects of Cancer-Related Symptoms and Functional Impairment on symptoms of acute distress (Distress) and depression (Despair) in the training sample. The training model was cross validated in testing sample. Results are presented for the full model using the entire sample.

Results: Patients were 48.3% female, with mean age of 66.0 years. The most common comorbidities were anemia (60.8%) and respiratory disease (24.5%). Severity of Cancer-Related Symptoms was strongly and positively related to Functional Impairment and Psychological Symptoms in both training and testing models. The modeled effect of Functional Impairment on Distress and Despair was significant in the overall model using the total sample, and significant or near-significant in the training and testing models. The mediated effect of Cancer-Related Symptoms by Functional Impairment tended to be weaker than its direct modeled effect on Distress and Despair.

Conclusions: Despite prior research suggesting that Functional Impairment plays a larger role than symptom burden in depression in NSCLC, the independent modeled effects of Functional Impairment were no greater than the direct modeled effects of Cancer-Related Symptoms.

Effectiveness outcomes and health related quality of life impact of disease progression in patients with advanced nonsquamous NSCLC treated in real-world community oncology settings: results from a prospective medical record registry study.

–  Walker MS, Wong W, Ravelo A, Miller PJE, Schwartzberg LS.

In: Health and Quality of Life Outcomes 2017; 15:160.

Background: Treatment options for advanced nonsquamous non-small cell lung cancer (NSCLC) in the first line include platinum-based doublet therapy with or without bevacizumab. This study examined efficacy outcomes and patient reported outcomes (PROs) in a community oncology patient sample.

Methods: Advanced nonsquamous NSCLC patients from 34 U.S. community oncology practices treated in first line with bevacizumab regimens (A platinum doublet; gemcitabine doublet; pemetrexed with platinum) or non-bevacizumab regimens (B platinum doublet; gemcitabine doublet; C pemetrexed with platinum) were recruited for this prospective study. Patient characteristics and clinical outcomes were accessed from routine care records. Three validated and widely used PRO measures of health related quality of life (HRQOL) and symptom burden were collected prospectively at each visit and up to one-year follow-up. Effectiveness outcomes were progression free survival (PFS) and overall survival (OS) assessed by Kaplan-Meier and Cox regression methods. PROs were analyzed with linear mixed model regression to examine changes over time, and the effect of disease progression.

Results: Of 147 patients in the study, 145 provided PRO data. Patients in treatment groups were: A (n = 66, 44.9%); B (n = 25, 17.0%); C (n = 56, 38.1%). A was associated with significantly longer OS than B (HR = 0.341, p =0.0012), and significantly longer than C (HR = 0.602, p = 0.0354). PFS results were similar. Irrespective of regimen group and on 12/32 measures, patients showed significant and clinically meaningful worsening of symptoms and HRQOL at disease progression. After disease progression, the pattern of symptom and HRQOL change showed continued worsening.

Conclusions: Bevacizumab-containing regimens were associated with longer PFS and OS compared with non-bevacizumab regimens. PRO measures show disease progression is associated with worsening HRQOL. Delaying disease progression can sustain better HRQL and reduce symptom burden.

Patient characteristics and costs in advanced head and neck cancer: retrospective analysis of a community oncology database.

–  Fisher MD, Fernandes AW, Miller PJ, Walker MS, Fenton M.

In: Academy of Managed Care Pharmacy (AMCP) Nexus; 2016 October 3-6; National Harbor, MD; 2016.

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Real-world treatment patterns and effectiveness among patients with metastatic colorectal cancer treated with ziv-aflibercept in community oncology practices in the USA.

–  Ivanova JI, Saverno KR, Sung J, Duh MS, Zhao C, Cai S, Vekeman F, Peevyhouse A, Dhawan R, Fuchs CS.

In: Medical Oncology 2017;34:193.

Read the full text here >>

Routine clinical practice data often differ from clinical trials. This study describes real-world treatment patterns and effectiveness among patients with metastatic colorectal cancer (mCRC) receiving ziv-aflibercept in non-academic, community oncology practices in the USA. De-identified electronic medical records from Vector Oncology and Altos Solutions databases were analysed. We identified 218 patients diagnosed with mCRC who had received prior oxaliplatin therapy and initiated ziv-aflibercept as part of second-line or later-line therapy. Overall survival (OS) and progression-free survival (PFS) were estimated using Kaplan–Meier analysis. Mean age was 62.8 years at ziv-aflibercept initiation. Most patients (91.7%) received bevacizumab before ziv-aflibercept, 95.4% initiated ziv-aflibercept with FOLFIRI or another irinotecan-based regimen, and 59.6% had received prior irinotecan. Overall, 24.8% of patients initiated ziv-aflibercept in second line, 31.7% in third line, 21.6% in fourth line and 22.0% in later lines of therapy. Mean duration of ziv-aflibercept treatment was 5.3 months. For patients initiating ziv-aflibercept in second-, third- and fourth-line therapy, median OS was 11.9 (95% confidence interval 5.1–16.2), 11.1 (6.9–16.7) and 8.1 (5.2–11.4) months, respectively, and median PFS was 4.4 (2.8–6.5), 4.3 (2.9–6.3) and 3.4 (2.2–5.2) months, respectively. Common adverse events (AEs) (any grade) included gastrointestinal disorders (64.7%) and asthenia/fatigue (63.3%). In routine clinical practice, ziv-aflibercept was frequently initiated in third line or later lines of therapy. Although patients receiving ziv-aflibercept were more heavily pretreated and potentially less robust compared with the VELOUR trial, median OS for patients receiving second-line ziv-aflibercept was comparable. AE rates were similar to or lower than the VELOUR trial.

Analysis of the psychological impact of cancer-related symptoms on patients with non-small cell lung cancer.

–  Walker MS, Pohl GM, Houts AC, Peltz G, Miller PJE, Schwartzberg LS, Stepanski EJ, Marciniak M.

In: Psycho-Oncology 2017; 26(6): 755-762.

Read the full text here >>

Background: Patients with non-small cell lung cancer (NSCLC) experience adverse physical symptoms because of cancer, cancer treatment, and comorbidities. The relations among Cancer-Related Symptoms, Functional Impairment, and Psychological Symptoms in patients with NSCLC is not well understood.

Methods: Retrospective analysis of patient-reported symptoms with the 38-item Patient Care Monitor survey, collected in routine clinical care for 1138 patients with NSCLC at eight US community oncology practices. Study sample was randomly split, and structural equation models examined the direct and mediated effects of Cancer-Related Symptoms and Functional Impairment on symptoms of acute distress (Distress) and depression (Despair) in the training sample. The training model was cross validated in testing sample. Results are presented for the full model using the entire sample.

Results: Patients were 48.3% female, with mean age of 66.0 years. The most common comorbidities were anemia (60.8%) and respiratory disease (24.5%). Severity of Cancer-Related Symptoms was strongly and positively related to Functional Impairment and Psychological Symptoms in both training and testing models. The modeled effect of Functional Impairment on Distress and Despair was significant in the overall model using the total sample, and significant or near-significant in the training and testing models. The mediated effect of Cancer-Related Symptoms by Functional Impairment tended to be weaker than its direct modeled effect on Distress and Despair.

Conclusions: Despite prior research suggesting that Functional Impairment plays a larger role than symptom burden in depression in NSCLC, the independent modeled effects of Functional Impairment were no greater than the direct modeled effects of Cancer-Related Symptoms.

Effectiveness outcomes and health related quality of life impact of disease progression in patients with advanced nonsquamous NSCLC treated in real-world community oncology settings: results from a prospective medical record registry study.

–  Walker MS, Wong W, Ravelo A, Miller PJE, Schwartzberg LS.

In: Health and Quality of Life Outcomes 2017; 15:160.

Read the full text here >>

Background: Treatment options for advanced nonsquamous non-small cell lung cancer (NSCLC) in the first line include platinum-based doublet therapy with or without bevacizumab. This study examined efficacy outcomes and patient reported outcomes (PROs) in a community oncology patient sample.

Methods: Advanced nonsquamous NSCLC patients from 34 U.S. community oncology practices treated in first line with bevacizumab regimens (A platinum doublet; gemcitabine doublet; pemetrexed with platinum) or non-bevacizumab regimens (B platinum doublet; gemcitabine doublet; C pemetrexed with platinum) were recruited for this prospective study. Patient characteristics and clinical outcomes were accessed from routine care records. Three validated and widely used PRO measures of health related quality of life (HRQOL) and symptom burden were collected prospectively at each visit and up to one-year follow-up. Effectiveness outcomes were progression free survival (PFS) and overall survival (OS) assessed by Kaplan-Meier and Cox regression methods. PROs were analyzed with linear mixed model regression to examine changes over time, and the effect of disease progression.


Results: Of 147 patients in the study, 145 provided PRO data. Patients in treatment groups were: A (n = 66, 44.9%); B (n = 25, 17.0%); C (n = 56, 38.1%). A was associated with significantly longer OS than B (HR = 0.341, p =0.0012), and significantly longer than C (HR = 0.602, p = 0.0354). PFS results were similar. Irrespective of regimen group and on 12/32 measures, patients showed significant and clinically meaningful worsening of symptoms and HRQOL at disease progression. After disease progression, the pattern of symptom and HRQOL change showed continued worsening.

Conclusions: Bevacizumab-containing regimens were associated with longer PFS and OS compared with non-bevacizumab regimens. PRO measures show disease progression is associated with worsening HRQOL. Delaying disease progression can sustain better HRQL and reduce symptom burden.

Maximizing the utility of real-world evidence: integration of structured electronic medical record (EMR) data, unstructured EMR data, and billing data for economics and outcomes research in oncology.

–  Walker MS, Ravelo A, Schulman K, Saverno K.

In: Value & Outcomes Spotlight 2017;3(5):11-13.

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Medical claims, disease registries, and other administrative databases have long served as source information for health economics and outcomes research (HEOR), particularly in U.S.-based research. In the last decade, however, the availability of patient medical records in electronic form has made it possible to include more clinical information in this type of research. Electronic medical record systems (EMRs) digitize the information that formerly existed solely as paper medical charts. This permits clinical characteristics, like disease severity, to be electronically extracted in the hope of providing more nuanced answers to research questions. In addition to increasing the depth of available clinical information, EMRs also broaden the choices available to HEOR researchers. This article addresses several key issues for consideration in the possible use of EMR data for research in oncology. These include how to evaluate potential data sources for your research, what EMR data provides beyond what is available in more traditional data sources, and the extent to which oncology EMR data support cost analyses.

Treatment patterns and outcomes in metastatic bladder cancer in community oncology settings.

-  Fisher MD, Shenolikar R, Miller PJ, Walker MS, Fenton M.

In: American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU); 2017 February 16-18; Orlando, FL; 2017.

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Patient characteristics and costs in advanced head and neck cancer: retrospective analysis of a community oncology database.

-  Fisher MD, Fernandes AW, Miller PJ, Walker MS, Fenton M.

In: Academy of Managed Care Pharmacy (AMCP) Nexus; 2016 October 3-6; National Harbor, MD; 2016.

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Burden of symptoms associated with development of metastatic bone disease in patients with breast cancer.

-  Cleeland C, von Moos R, Walker MS, Wang Y, Gao J, Chavez-MacGregor M, Liede A, Arellano J, Balakumaran A, Qian Y.

In: Burden of symptoms associated with development of metastatic bone disease in patients with breast cancer. Supportive Care in Cancer 2016;24(8):3557-3565.

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Purpose: Women with breast cancer frequently develop painful bone metastases. This retrospective study was designed to longitudinally characterize patterns of patient-reported symptoms among patients with breast cancer relative to the diagnosis of bone metastases.

Methods: Patient records were identified from the Oncology Services Comprehensive Electronic Records (OSCER) database which includes outpatient oncology practices across the USA. Symptom burden was assessed by Patient Care Monitor (PCM) assessments, which are administered as part of routine care in a subset of these practices. Eligible patients were women diagnosed with breast cancer (ICD-9-CM 174.xx) who developed bone metastases (ICD-9-CM 198.5) and had ≥1 PCM assessment between January 2007 and December 2012. The pre-specified endpoint was the occurrence of moderate to severe symptom burden, defined as PCM score ≥4 (0-10 scale).

Results: One thousand one hundred five women (median age, 61) met the eligibility criteria. Worsening of symptoms, particularly fatigue and pain, occurred in the months leading up to the diagnosis of bone metastases. After bone metastases diagnosis, the rate of increase in the proportion of patients experiencing moderate/severe symptoms slowed, but continued to climb during follow-up. Median time to moderate/severe symptoms was 0.9 month for fatigue, 1 month for pain, 2.9 months for trouble sleeping, and 7.7 months for numbness/tingling. Half of the patients received bone-targeted agents after diagnosis of bone metastases.

Conclusions: Symptom burden, especially pain and fatigue, increased both before and after the diagnosis of bone metastases, highlighting the need for proactive monitoring and management of symptoms in breast cancer patients.

Effect of brain metastasis on patient reported outcomes in advanced NSCLC treated in real world community oncology settings.

-  Walker MS, Wong W, Ravelo A, Miller PJE, Schwartzberg LS.

In: International Society for Pharmacoeconomics and Outcomes Research; 2016 May 21-25; Washington, DC; 2016.

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Impact of disease progression on patient reported outcomes in advanced NSCLC: evidence from patients treated in real world community oncology settings

-  Walker MS, Wong W, Ravelo A, Hazard S, Miller PJE, Schwartzberg LS.

In: International Society for Pharmacoeconomics and Outcomes Research; 2016 May 21-25; Washington, DC; 2016.

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Effectiveness outcomes in patients with advanced NSCLC treated in real world community oncology settings: results from a prospective medical record registry study.

-  Walker MS, Wong W, Ravelo A, Hazard S, Miller PJE, Schwartzberg LS.

In: International Society for Pharmacoeconomics and Outcomes Research; 2016 May 21-25; Washington, DC; 2016.

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Treatment outcomes in patients with metastatic neuroendocrine tumors: retrospective analysis of a community oncology database.

-  Fisher MD, Pulgar S, Kulke MH, Pitmann-Lowenthal S, Cox D, Miller PJ, et al.

In: National Comprehensive Cancer Network; 2016 March 31 - April 2; Hollywood, FL; 2016.

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Treatment patterns and outcomes in patients with KRAS wild type metastatic colorectal cancer (WTMCRC) treated in first line with bevacizumab (B) or cetuximab (C) containing regimens.

-  Houts AC, Ogale S, Walker MS, Sommer N.

In: American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI); 2016 January 21 - 23; San Francisco, CA; 2016.

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The impact of extended endocrine therapy on symptom burden and health-related quality of life in patients with early-stage breast cancer (ESBC).

-  Fisher MD, Schroeder BE, Miller PJE, Schnabel CA, Schwartzberg L, Walker MS.

In: San Antonio Breast Cancer Symposium; 2015 December 8 - 12; San Antonio, TX; 2015.

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Treatment patterns and outcomes in metastatic neuroendocrine tumors: results from a retrospective community oncology database.

-  Fisher MD, Pulgar S, Kulke MH, Pitmann-Lowenthal S, Cox D, Miller PJ, et al.

In: North American Neuroendocrine Tumor Society Symposium; 2015 October 15 - 17; Austin, TX; 2015.

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Clinical trial participants with metastatic renal cell carcinoma differ from patients treated in real-world practice.

-  Mitchell AP, Harrison MR, Walker MS, George DJ, Abernethy AP, Hirsch BR.

In: Journal of Oncology Practice 2015;11(6): 491-497.

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Purpose: Although narrow eligibility criteria improve the internal validity of clinical trials, they may result in differences between study populations and real-world patients, threatening generalizability. Therefore, we evaluated whether patients treated for metastatic renal cell cancer (mRCC) in routine clinical practice are similar to those enrolled onto clinical trials.

Patients and Methods: In this cohort study, we compared baseline characteristics of patients with mRCC in phase III clinical trials of new targeted therapies and those in a retrospective registry composed of academic (Duke) and community (ACORN Network) practices.

Results: A total of 438 registry patients received sunitinib, sorafenib, temsirolimus, or pazopanib (most commonly used agents) in first-line treatment. Registry patients receiving tyrosine kinase inhibitors (sunitinib, sorafenib, or pazopanib) were more likely to have poor-risk disease by Memorial Sloan Kettering Cancer Center criteria (poor, 7.4% v 2.9%; P < .001; favorable, 30.1% v 43.8%; P < .001) and to have impaired performance status (Eastern Cooperative Oncology Group > 1, 11.1% v 0.6%; P < .001). However, registry patients receiving temsirolimus were less likely to have poor-risk disease (poor, 10.2% v 69.4%; P < .001; favorable, 16.9% v 0%; P < .001). Thus, 39.0% of registry patients would have been excluded from the phase III clinical trial testing the drug they received.

Conclusion: Patients with mRCC treated with tyrosine kinase inhibitors in real-world clinical practice are sicker than those enrolled onto pivotal clinical trials, and more than one third are trial ineligible. Application of clinical trial findings to dissimilar populations may result in patient harm. Clinical research with more inclusive eligibility criteria is needed to appropriately guide real-world practice.

Real-world impact of treatment-induced peripheral neuropathy of patient-reported outcomes in patients with multiple myeloma in the United States.

-  Walker MS, Cong Z, Knopf KB, Aggarwal S, Kerr J, Houts AC.

In: Multinational Association of Supportive Care in Cancer; 2015 June 25-27; Copenhagen, Denmark; 2015.

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Treatment patterns and health resource utilization among patients diagnosed with early stage resected non-small cell lung cancer at US community oncology practices.

-  Buck PO, Saverno KR, Miller PJE, Arondekar B, Walker MS.

In: Clinical Lung Cancer 2015;16(6):486 - 495.

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Data on adjuvant therapy in resected non-small cell lung cancer (NSCLC) in routine practice are lacking in the United States. This retrospective observational database study included 609 community oncology patients with resected stage IB to IIIA NSCLC. Use of adjuvant therapy was 39.1% at disease stage IB and 64.9% to 68.2% at stage II to IIIA. The most common regimen at all stages was carboplatin and paclitaxel.

Background: Platin-based adjuvant chemotherapy has extended survival in clinical trials in patients with completely resected non-small cell lung cancer (NSCLC). There are few data on the use of adjuvant therapy in community-based clinical practice in the United States.

Materials and Methods: This was a retrospective observational study using electronic medical record and billing data collected during routine care at US community oncology sites in the Vector Oncology Data Warehouse between January 2007 and January 2014. Patients aged 18 years with a primary diagnosis of stage IB to IIIA NSCLC were eligible if they had undergone surgical resection. Treatment patterns, health care resource use, and cost were recorded, stratified by stage at diagnosis.

Results: The study included 609 patients (mean age, 64.8 years, 52.9% male), of whom 215 had stage IB disease, 130 stage IIA/II, 110 stage IIB, and 154 stage IIIA. Adjuvant systemic therapy after resection was provided to 345 (56.7%) of 609 patients, with lower use in patients with stage IB disease (39.1%) than stage II to IIIA disease (64.9-68.2%) (P < .0001). The most common adjuvant regimen at all stages was the combination of carboplatin and paclitaxel. There were no statistically significant differences in office visits or incidence of hospitalization by disease stage. During adjuvant treatment, the total monthly median cost per patient was $17,389.75 (interquartile range, $8,815.61 to $23,360.85).

Conclusion: Adjuvant systemic therapy was used in some patients with stage IB NSCLC and in the majority of patients with stage IIA to IIIA disease. There were few differences in regimen or health care resource use by disease stage.

US burden of illness associated with adjuvant therapy for stage I-III melanoma.

-  Houts AC, Ward MA, Oglesby A, Walker MS, Saverno K.

In: International Society for Pharmacoeconomic and Outcomes Research; 2015 May 16 - 20; Philadelphia, PA; 2015.

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Maximizing the utility of real world evidence: integration of structured EMR data, unstructured EMR data, and billing data for economics and outcomes research in oncology.

-  Walker MS, Schulman K, Ravelo A, Saverno K.

In: International Society for Pharmacoeconomic and Outcomes Research; 2015 May 16 - 20; Philadelphia, PA; 2015.

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Treatment outcomes in patients with metastatic neuroendocrine tumors: a retrospective analysis of a community oncology database.

-  Houts AC, Hennessy D, Walker MS, Nicacio L, Thompson S, Miller PJE, Somer B.

In: Journal of Community & Supportive Oncology 2014;12(9):321-328.

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Background. Treatment for metastatic castrate resistant prostate cancer in community settings is not well understood.

Objective. To examine treatment patterns, sequencing, and outcomes in patients receiving second- and third-line treatment after first-line docetaxel.

Methods. We used a community oncology database to identify patients who progressed after line 1 docetaxel (D) and received line 2 cabazitaxel (DC), abiraterone (DA), or other therapy (DO). Progression-free survival (PFS) and overall survival (OS) were assessed using Kaplan-Meier and Cox regression models. Line 3 included subsets DCA and DAC.

Results. Line 2 groups (DC = 60 patients; DA = 71; DO = 153) did not differ significantly on demographic and clinical characteristics or median PFS on docetaxel therapy. Cox regression for OS by line 2 groups showed increased risk for DA compared with DC (HR = 1.69, p = 0.026) when 24 untreated DO patients were excluded. A similar nonsignificant pattern was observed when the 24 untreated patients were included. Of patients receiving DC in line 2, a nominally greater proportion received A in line 3 (57%, 34 of 60 patients) than did patients who received DA in line 2 followed by C in line 3 (25%, 18 of 71).

Limitations. There was a small sample for line 3 and unexamined confounds and selection biases in observational research.

Conclusions. Treatment patterns in community settings following docetaxel are complex and may involve multiple hormonal agents prior to disease progression. Cabazitaxel may not be optimally used in advanced disease. Although Cox regression showed increased risk of death for DA compared with DC, results need to be validated prospectively.

Real-world outcomes in metastatic renal cell carcinoma: insights from a joint community-academic registry.

-  Harrison MR, Hirsch BR, George DJ, Walker MS, Chen C, Korytowsky B, Stepanski EJ, Abernethy AP.

In: Journal of Oncology Practice 2014;10(2):e63-72.

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Introduction: As new therapeutics for metastatic renal cell carcinoma (mRCC) are quickly introduced to market, comparative randomized trial evidence guiding treatment decisions is lacking, especially in the second treatment exposure and beyond. As a demonstration case, we studied mRCC in real-world clinical settings by creating a joint community-academic retrospective mRCC registry to assess outcomes.

Materials and Methods: For this overall survival (OS) analysis, the analytic cohort included all patients in the registry diagnosed between January 1, 2007, to May 31, 2011 (N = 384). Patients were grouped by up to three treatment exposures according to each drug’s mechanism of action: vascular endothelial growth factor tyrosine kinase inhibitor (VEGFR TKI), mammalian target of rapamicin inhibitor (mTOR), or no systemic treatment (NSTx, which could include radiation or surgery). OS by exposure sequence was evaluated using Kaplan-Meier, pairwise comparison, and Cox regression analyses.

Results: Median OS was 17.2 months. OS (months) for one exposure was: mTOR 5.4, TKI 18.2, NSTx 18.4; for two exposures: mTOR/TKI 9.3, TKI/mTOR 13.9, TKI/TKI 35.2; and for three exposures: TKI/mTOR/TKI 20.9, TKI/TKI/mTOR 33.1. By pairwise comparison, OS for TKI, mTOR/TKI, TKI/mTOR, TKI/ TKI, TKI/mTOR/TKI and TKI/TKI/mTOR sequences was greater than mTOR (all P _ .04); demographics confirmed that individuals treated with early mTOR inhibition more commonly had adverse prognostic features. In Cox regression analysis, compared with the referent (TKI), TKI/TKI (hazard ratio _ 0.53; P _ .03) had a lower risk of death, and mTOR (hazard ratio _ 2.16; P _ .002) had a higher risk of death.

Results. Line 2 groups (DC = 60 patients; DA = 71; DO = 153) did not differ significantly on demographic and clinical characteristics or median PFS on docetaxel therapy. Cox regression for OS by line 2 groups showed increased risk for DA compared with DC (HR = 1.69, p = 0.026) when 24 untreated DO patients were excluded. A similar nonsignificant pattern was observed when the 24 untreated patients were included. Of patients receiving DC in line 2, a nominally greater proportion received A in line 3 (57%, 34 of 60 patients) than did patients who received DA in line 2 followed by C in line 3 (25%, 18 of 71).

Conclusions: mRCC survival outcomes are different by pattern, with general findings consistent with trial-based expectations in similar patient populations. Real-world data can provide context around patterns of care and impact when experimental trial data are lacking.

Use of “Real world” data to describe adverse events for the treatment of metastatic renal cell carcinoma in routine clinical practice.

-  Hirsch BR, Harrison MR, George DJ, Walker MS, Chen C, Korytowsky B, Stepanski E, Abernethy AP.

In: Medical Oncology 2014;31(9).

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Insights into the experience of metastatic renal cell carcinoma (mRCC) patients are needed to optimize patient care. A retrospective, multicenter registry of mRCC patients treated at academic (Duke) and community (ACORN) practices was developed to fill this need. Treatment data was collected on 466 patients who received 1st line therapy from 2007-2011. Clinically significant adverse events (AEs) were abstracted from medical records and compared to clinical trials. 270 patients received 1st line therapy with sunitinib, 60 temsirolimus, 53 sorafenib, 25 pazopanib, and 58 “other.” 85.8% of all patients experienced at least one AE: fatigue (56.7%), vomiting (40.1%), diarrhea (33.7%), asthenia (32.8%) and mucosal inflammation (20.8%). When comparisons were made between patients >65 vs < 65 years old, rates of AEs were higher in the younger group. Dosing approaches and timing of AEs during therapy were varied. These data shine light on the patient experience in routine practice vs structured clinical trials. Real world AE frequency and severity differ from pivotal trials demonstrating the need to monitor patients closely and manage their AEs to optimize outcomes. As the number of treatment options with similar effectiveness grows, it is imperative to understand the real world patient experience.

Real-world treatment patterns and health resource utilization among patients diagnosed with early stage resected non-small cell lung cancer (NSCLC) at community oncology practices in the US.

-  Buck PO, Walker MS, Saverno KR, Miller PJE, Arondekar B.

In: Association of Managed Care Pharmacy Nexus Meeting; 2014 October 8 - 9; Boston, MA; 2014.

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Early treatment discontinuation and switching in first-line metastatic breast cancer: the role of patient reported symptom burden.

-  Walker MS, Masaquel AS, Kerr J, Lalla D, Abidoye O, Houts AC, Schwartzberg LS.

In: Breast Cancer Research and Treatment 2014;144(3):673-681.

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Treatment options for metastatic breast cancer (MBC) are complex, and some patients experience early discontinuation or switching of treatment (ETDS). We examined the relationship between ETDS and patient reported symptom burden among patients receiving first-line treatment of MBC in community oncology settings. This retrospective observational study used the ACORN Data Warehouse, a comprehensive community oncology repository of medical records and patient reported outcomes. Patients with first-line treatment for MBC who had Patient Care Monitor (PCM) surveys were eligible. ETDS was defined as: record stating ETDS, treatment duration < planned, and planned therapy < 6 weeks. Symptom burden was measured by two PCM Composite scores (Continuous [0-22] and Categorical [absent, mild, moderate, severe]) computed from 22 PCM items with varying cut points to assess symptom burden over time. Cox regression with time varying covariates was used to assess risk for ETDS controlling for patient characteristics and treatment type: Chemo (chemotherapy without targeted therapy (+ hormone therapy); Targeted (chemotherapy plus targeted therapy (+ hormone therapy); Hormone (hormone therapy only). Overall, 197 (24.7%) of a total sample of 797 patients had an ETDS event, of which 109 (55.3%) were switches rather than early discontinuation. ETDS rate was nominally lower in the Hormone group (11.1%) vs. Chemo (27.6%) or Targeted (26.1%). PCM Continuous Composite Score predicted ETDS, controlling for other variables (HR = 1.132, p <0.0001). ETDS was predicted by moderate and severe levels of PCM Categorical Composite Score (HR = 4.135, and HR = 5.287 vs. absent, respectively, both p <0.0001), with the pattern suggesting a threshold effect. Moderate or severe levels of a wide range of patient reported symptoms and the accumulation of symptoms over time significantly predicted ETDS. Providers may better maintain patients on planned therapy if they attend to overall symptom burden patients experience over time.

Treatment patterns and outcomes among patients with metastatic melanoma treated in community practice.

-  Walker MS, Reyes C, Kerr J, Satram-Hoang S, Stepanski EJ.

In: International Journal of Dermatology 2014;53(11):e499 - e506.

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Background: We conducted a retrospective observational study to characterize treatment patterns and outcomes among patients treated for metastatic melanoma in community settings. This picture of the treatment landscape (2006-2010) provides background for understanding new treatments now coming online.

Methods: Records were reviewed for 202 patients diagnosed from January 1, 2006 to September 1, 2010. Patients were ≥18 years old at metastatic diagnosis with no treatment of other cancers within 5 years. Treatment regimens, clinical characteristics, and outcomes were evaluated. Kaplan-Meier analysis and Cox regression compared progression free survival (PFS) and overall survival (OS) across regimen or other subgroups.

Results: Among patients treated systemically, PFS was 3.25 months in first line, 2.3 months in second line, and 1.84 months in third line. PFS did not vary significantly across regimens. Impaired performance status and brain metastasis were associated with shorter first line PFS. Response rate was 6% or less in first through third lines. At metastatic diagnosis, 51% of patients received systemic therapy. Following first through third disease progressions: 46%, 43%, and 29% of patients, respectively, received systemic therapy. Median survival was 7.66 months. Shorter survival was associated with presence of brain and liver metastasis (hazard ratio [HR]=1.98, p=0.0002; HR=1.49, p=0.031, respectively), and impaired performance status (HR=2.23, p=0.001); longer survival was associated with prior interferon (HR=0.57, p=0.014).

Conclusions: Metastatic melanoma patients treated in the community setting had limited response with little evidence of differential efficacy among regimens. New approved agents for melanoma will help to address the unmet need for treatment.

Clinical trial subjects compared to patients treated in "real world" practice: generalizability of renal cell carcinoma trials.

-  Mitchell AP, Harrison MR, Walker MS, George DJ, Abernethy AP, Hirsch BR.

In: Annual Meeting of the American Society of Clinical Oncology; 2014 May 30 - June 3; Chicago, IL; 2014.

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Treatment patterns and baseline characteristics of a prospective cohort of patients with advanced NSCLC treated in real world community oncology settings.

-  Walker MS, Ravelo A, Miller PJE.

In: International Society for Pharmacoeconomic and Outcomes Research; 2014 May 31 – June 4; Montreal, Quebec, Canada; 2014.

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Association of treatment induced peripheral neuropathy with treatment patterns and outcomes in patients with newly diagnosed multiple myeloma.

-  Walker MS, Kerr J, Martin MG, Panjabi S, T.G. Martin III.

In: Annual Meeting of the Association of Managed Care Pharmacy; 2014 April 1 - 4; Tampa, Florida; 2014.

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Burden of symptoms associated with development of metastatic bone disease in patients with breast cancer.

-  Cleeland C, Moos Rv, Walker M, Wang Y, Gao J, Liede A, Arellano J, Balakumaran A, Qian Y.

In: San Antonio Breast Cancer Symposium; 2013 December 10-14; San Antonio, TX; 2013.

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“Real world” treatment of metastatic renal cell carcinoma in a joint community- academic cohort: progression-free survival over three lines of therapy.

-  Harrison MR, George DJ, Walker MS, Chen C, Korytowsky B, Kirkendall DT, Stepanski EJ, Abernethy AP.

In: Clinical Genitourinary Cancer 2013;11(4):441-50.

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Background: New targeted therapeutics approved for metastatic renal cell carcinoma (mRCC) offer multiple options in each line of therapy; however, there is little prospective data beyond the first -line settings and overall comparative effectiveness data is limited. In the targeted therapy era, progression-free survival (PFS) has been the most common regulatory endpoint for demonstrating the benefit of new therapies.

Patients and Methods: Using a joint community-academic retrospective mRCC registry, we analyzed all patients in the registry that had undergone at least one line of systemic therapy (N=325) for PFS. Patients were grouped according to treatment choice (sorafenib, sunitinib, temsirolimus, everolimus, and other) for up to three lines of therapy. PFS by treatment choice and line of therapy was evaluated using Kaplan Meier and Cox regression analyses.

Results: PFS was longest in patients treated with sunitinib in the first and second lines of therapy. First line PFS for sorafenib, sunitinib, temsirolimus, everolimus and other was 6.9, 8.9, 4.2, not analyzed (too few patients), and 10.8 months respectively. Second line PFS was 4.6, 7.0, 3.2, 3.8, and 4.1 months respectively. Third line PFS was 4.5, 4.6, 9.9, 4.2, and 2.9 months respectively. The risk of progression in patients treated with temsirolimus was about twice that of patients treated with sunitinib.

Conclusion: Patients treated with sunitinib had the longest PFS in the first and second therapy lines. PFS from practice-based data appear consistent with trial-based expectations however, practice variation was still evident.

Association of treatment induced peripheral neuropathy (TIPN) with treatment patterns and outcomes in patients with newly diagnosed multiple myeloma.

-  Martin TG, Panjabi S, Kerr J, Martin MG, Walker MS.

In: Annual Meeting of the American Society of Hematology; 2013 December 7 - 10; New Orleans, LA; 2013.

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Community oncology treatment patterns and clinical effectiveness in metastatic castration-resistant prostate cancer (mCRPC) patients who progressed after docetaxel.

-  Houts AC, Hennessy D, Walker MS, Nicacio L, Thompson S, Miller PJE, Somer B.

In: American Society of Clinical Oncology Quality Care Symposium; 2013 November 1 - 2; San Diego, CA; 2013.

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Treatment patterns and clinical characteristics of patients with advanced basal cell carcinoma in the community oncology setting.

-  Walker MS, Schwartzberg LS, Chen DM, Ramanan DD, Houts AC, Reyes C.

In: Journal of Cancer Therapy 2013;4:24-31.

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Advanced basal cell carcinoma (aBCC) includes metastatic and locally advanced BCC that is inoperable (or with surgery contraindicated). We describe patient characteristics and treatment history for aBCC cases from community oncology.
Nine cases of aBCC were found within the ACORN Data Warehouse, a community oncology database of >180,000 cancer patients. Data were summarized descriptively. Three illustrative case histories are presented.
Patients were predominantly Caucasian (8/9), male (6/9), and over 60 (6/9). Four had metastatic disease; five had aBCC without metastasis. Five had a history of treatment for early stage BCC, including surgery (5/5), radiation (1/5), and none had chemotherapy. Those with history of early stage BCC had periods of apparent lack of follow-up and treatment. One had chemotherapy for aBCC (platinum based with radiation) and eight had radiation without chemotherapy. Patients had multiple comorbid serious medical conditions. Six were deceased, but only one was documented to have aBCC as cause of death.
Advanced BCC is rare in community oncology settings. There appear to be gaps in the care and follow-up of patients with initial early stage BCC. More data and larger samples are needed from multi-specialty databases such as dermatology and head and neck surgery.

Early treatment discontinuation and switching in 1st line metastatic breast cancer: impact of symptom burden in a real world sample.

-  Walker MS, Masaquel AS, Kerr J, Lalla D, Abidoye O, Schwartzberg LS.

In: ESMO European Cancer Congress 2013; 2013 September 27 - October 1; Amsterdam, Netherlands; 2013.

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Adverse events (AEs) by age: data from a real world, multicenter registry of patients treated for metastatic renal cell carcinoma (mRCC).

-  Harrison MR, Hirsch BR, Walker MS, Roe L, Chen C, Korytowsky B, Stepanski E, George DJ, Abernethy AP.

In: ESMO European Cancer Congress 2013; 2013 September 27 - October 1; Amsterdam, Netherlands; 2013.

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Real world symptom burden and early treatment discontinuation in 1st line metastatic breast cancer.

-  Walker MS, Masaquel AS, Kerr J, Lalla D, Abidoye O, Ogbata O, Schwartzberg LS.

In: Annual Meeting of the American Society of Clinical Oncology; 2013 May 31 - June 4; Chicago, IL; 2013

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Anemia-related costs and adverse event rates in cancer patients who do not respond to erythropoietin stimulating agents.

-  Landsman-Blumberg P, Shi N, Varker H, Juneau P, Girvan A, Pohl G, Lau J, Bowman L.zberg LS.

In: Annual Meeting of the Association for Value-Based Cancer Care Conference; 2013 May 2 - 5; Hollywood, FL; 2013.

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Use of a validated assessment tool demonstrates the frequency of patient-experienced, regimen-related side effects associated with the treatment of common solid tumors.

-  Miles K, Weidner SM, Sonis ST, Walker M, Chandler J.

In: Oncology Nursing Society 38th Annual Congress; 2013 April 25-28; Washington, DC; 2013.

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The association of skin rash severity with overall survival: findings from patients receiving erlotinib for pancreatic cancer in the community setting.

-  Stepanski EJ, Reyes C, Walker MS, Hoang SS, Leon L, Wojtowicz-Praga S, Miller PJE, Houts AC, Schwartzberg LS.

In: Pancreas 2013;42(1):32-6.

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OBJECTIVES: This retrospective study examined pancreatic cancer patients who received combination gemcitabine and erlotinib to determine if the association between rash and outcomes observed in clinical trials would be observed in 'real-world' community oncology settings. METHODS: Medical records from 10 community oncology practices were used to identify eligible patients. Rash severity was classified as High (moderate/severe) versus Low (absent/mild) based on medical record review. Kaplan-Meier analysis assessed progression-free survival (PFS) and overall survival (OS) by rash status from a landmark of 42 days after treatment initiation. Cox regression with time-varying covariates tested whether high-severity rash predicted longer OS and PFS. RESULTS: The High Severity group (n = 34) had longer median OS from the landmark than the Low Severity group (n = 134; 7.58 months vs 5.03 months, P = 0.0339). Cox regression analysis (n = 174) confirmed a reduced risk of death with High Rash Severity (hazard ratio [HR] = 0.67, P = 0.0389). Progression-free survival results showed a similar pattern (median PFS 2.37 months from landmark vs 2.04 months for High vs Low Severity groups, P = 0.0485). CONCLUSIONS: Results from this community sample were consistent with findings from randomized clinical trials, showing that longer OS is predicted by high-severity rash in erlotinib-treated pancreatic cancer patients.

Relationship between incidence of fracture and health-related quality-of-life in metastatic breast cancer patients with bone metastases.

-  Walker MS, Miller PJE, Namjoshi M, Houts AC, Stepanski EJ, Schwartzberg LS.

In: Journal of Medical Economics 2013;16(1):179-189.

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OBJECTIVE: This retrospective observational study describes treatment patterns and longitudinal health-related quality-of-life (HRQoL) among metastatic breast cancer patients with bone metastasis from nine community oncology clinics. METHODS: For description of treatment patterns, patients were classified as treated if they started zoledronic acid within 60 days of diagnosis of bone metastasis, were considered untreated if they had not, and were considered unclassified if they died or experienced fracture before 60 days had elapsed. Medical record review provided demographic and disease characteristics as well as history of treatment. Patients completed Patient Care Monitor (PCM) assessments of patient reported outcomes during routine care for up to 2 years from the date of bone metastasis diagnosis. RESULTS: The overall rate of fracture in the sample was 17.4%. Of the 321 patients enrolled, 160 were treated as of 60 days after diagnosis of bone metastasis, 147 were untreated, and 14 were unclassified. Of the 147 untreated as of 60 days, 82 did eventually receive zoledronic acid. More than half of all patients treated with zoledronic acid delayed the start of treatment by more than 30 days after diagnosis of bone metastasis. Patients who had a fracture showed decreased mobility and increased pain and anxiety at fracture, with recovery taking ~16 months. LIMITATIONS: Key limitations included: convenience sample with information limited to medical record content, low rate of observed fractures possibly due to limited 2-year follow-up, and exclusion of non-zoledronic acid bisphosphonate use. CONCLUSIONS: Whereas the proportion of patients experiencing a fracture was small, the impact of fracture on HRQoL was significant and was more prominently seen to impact specific dimensions of HRQoL.

Predicting risk of chemotherapy-induced side effects in patients with colon cancer with single-nucleotide polymorphism (SNP) Bayesian networks (BNs).

-  Sonis ST, Schwartzberg LS, Walker MS, Weidner SM, Alterovitz G.

In: American Society of Clinical Oncology, Gastrointestinal Cancers Symposium; 2013 January 24 - 26; San Francisco, CA; 2013.

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KRAS testing of mCRC patients in a community-based oncology setting.

-  Carter GC, Landsman-Blumberg PB, Johnson BH, Sedgley R, Shankaran V.

In: American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO-GI); 2013 January 24 - 26; San Francisco, CA; 2013.

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Symptom burden & quality of life among patients receiving second-line treatment of metastatic colorectal cancer.

-  Walker MS, Yu E, Kerr J, Yim YM, Stepanski EJ, Schwartzberg LS.

In: BMC Research Notes 2012;5:314.

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Introduction: Bevacizumab (B) and cetuximab (C) are both approved for use in the treatment of metastatic colorectal cancer (mCRC) in the second-line. We examined self reported symptom burden during second-line treatment of mCRC.

Methods: Adult mCRC patients treated in the second-line setting with a regimen that included B, C, or chemotherapy only (O) and who had completed ≥ 1 Patient Care Monitor (PCM) surveys as part of routine clinical care were drawn from the ACORN Data Warehouse. Primary endpoints were rash, dry skin, itching, nail changes, nausea, vomiting, fatigue, burning in hands/feet, and diarrhea. Linear mixed models examined change in PCM scores across B, C and O (B = reference).

Results: 182 patients were enrolled (B: n=106, C: n=38, O: n=38). Patients were 51% female, 67% Caucasian, with mean age of 62.0 (SD=12.6). Groups did not differ on demographic or clinical characteristics. The most common second-line regimens were FOLFIRI ± B or C (23.1%) and FOLFOX ± B or C (22.5%). Results showed baseline scores to be strongly predictive of second-line symptoms across all PCM items (all p < .0001 except for Rash, p = .0013). Controlling for baseline, patients on B tended to have more stable and less severe symptoms. Patients on C had more severe rash, dry skin, and itching and had nail change scores that worsened faster than did B patients.

Conclusions: Patients receiving second-line treatment for mCRC with B report less symptom burden, especially dermatologic, compared to patients treated with C.

Using text mining of electronic medical records to identify KRAS testing status in mCRC patients.

-  Miller PJE, Walker MS, Landsman-Blumberg PB, Carter GC.

In: International Society for Pharmacoeconomic and Outcomes Research; 2013 May 18-22; New Orleans, LA; 2013

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Treatment patterns and clinical characteristics of patients with advanced basal cell carcinoma (aBCC) in the community oncology setting.

-  Walker MS, Schwartzberg LS, Chen DM, Ramanan D.

In: American Academy of Dermatology; 2012 March 6 - 20; San Diego, CA; 2012.

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Treatment patterns among patients with metastatic melanoma treated in the community oncology setting.

-  Walker MS, Reyes C, Kerr J, Satram-Hoang S, Stepanski EJ.

In: The 8th International Congress of The Society for Melanoma Research; 2011 November 9 - 11; Tampa, FL; 2011.

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“Real world” treatment of metastatic renal cell carcinoma (mRCC) in community and academic settings.

-  George DJ, Walker MS, Hudson LL, Chen C, Korytowsky B, Harrison MR, Stepanski E, Abernethy AP.

In: Annual Meeting of the Kidney Cancer Association; 2011 October 14 - 15; Chicago, IL; 2011.

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Symptom burden and quality of life in patients with follicular lymphoma undergoing maintenance treatment with rituximab compared with observation.

-  Walker MS, Stepanski EJ, Reyes C, Satram-Hoang S, Houts AC, Schwartzberg LS.

In: Therapeutic Advances in Hematology 2011;2(3):129-139.

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BACKGROUND: The impact on health related quality of life (HRQoL) of rituximab maintenance (R-M) versus observation (OBS) after induction for treatment of follicular lymphoma (FL) is unclear. METHODS: We reviewed the charts of 137 patients (53% female, 87% White, age 61.0 +/- 12.4 years) who received either R-M (n = 53) or OBS (n = 84) after chemotherapy induction for newly diagnosed FL at community oncology practices within the US. Patients (65% with advanced disease; 48% with a high FLIPI score [3-5]) had completed >/=1 Patient Care Monitor HRQoL survey in the period following front-line therapy, and were excluded if they had progressed during front-line therapy. RESULTS: Linear mixed models showed that postinduction, most symptoms were stable, with patients on R-M reporting HRQoL that was equal to that reported by OBS patients. CONCLUSIONS: Among R-M patients, receipt of rituximab was associated with improved psychological symptoms.

Treatment patterns, medical resource use, and costs associated with second line treatment of non small cell lung cancer.

-  Walker MS, Pohl GM, Peltz G, Stepanski EJ, Faries D, Marciniak MD, Schwartzberg LS.

In: Chicago Multidisciplinary Symposium in Thoracic Oncology; 2010 December 9-11, 2010; Chicago, IL; 2010.

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Use of the Patient Care Monitor to screen for depression in adult cancer patients interviewed with the structured clinical interview for DSM-IV.

-  Houts AC, Lipinski D, Olsen JP, Baldwin S, Hasan M.

In: Psycho-Oncology 2010;19(4):399-407.

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OBJECTIVE: To evaluate the Patient Care Monitor (PCM1.0) Acute Distress and Despair normalized T scores as indicators of a diagnosis of Major Depression according to the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID). METHODS: Subjects were 21 adult cancer patients identified by treating community oncologists as having significant emotional distress matched on age, cancer type, treatment history, and sex to 21 patients not having significant distress. All completed e/tablet PCM 1.0 and SCID administered by trained interviewers. Unweighted kappa and receiver operating characteristics (ROC) analyses were used to assess scale properties. RESULTS: Agreement between SCID Major Depression and Acute Distress and Despair (T> or =65) were kappa=0.751 and 0.755, respectively. ROC area under the curve values for these two scales were 0.967 (SE+/-0.03) and 0.942 (SE+/-0.03), respectively, with optimal cut points of T=61 and 63, respectively. CONCLUSIONS: Under conditions of preselected extreme groups, PCM 1.0 Acute Distress and Despair T scores are reasonable screening indicators of clinical depression in cancer patients. PCM 1.0 provides an efficient method for point-of-care screening of depression in community oncology clinics.

Validation of the Patient Care Monitor (Version 2.0): a review of system assessment instrument for cancer patients.

-  Abernethy AP, Zafar SY, Uronis H, Wheeler JL, Coan A, Rowe K, et al.

In: Journal of Pain and Symptom Management 2010;40(4):545-58.

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The effect of disease progression on patient reported outcomes in HER-2 negative metastatic breast cancer patients.

-  Hasan M, Walker M, Yim YM, Yu E, Stepanski E, Schwartzberg L.

In: San Antonio Breast Cancer Symposium; 2009 December 9 - 13; San Antonio, TX; 2009.

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Symptom burden in patients with follicular lymphoma undergoing maintenance treatment with Rituxan compared with observation.

-  Walker M, Stepanski E, Reyes C, Hasan M, Schwartzberg L.

In: Annual Meeting of the American Society of Hematology; 2009 December 5 - 9; New Orleans, LA; 2009.

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Initial treatment and changes in adjuvant endocrine therapy for early stage breast cancer.

-  Schwartzberg LS, Cobb P, Senecal F, Henry D, Kulig K, Walker MS, Houts AC, Stepanski EJ.

In: The Breast 2009;18(2):78-83.

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Aromatase inhibitors (AI) represent an important alternative to tamoxifen in both advanced breast cancer and adjuvant hormonal therapy (AHT), and have been extensively studied in clinical trials. However, the translation of these clinical trial results to the real world has not been extensively explored. This paper reports findings from a retrospective chart review conducted at four community oncology sites in the USA to examine practice patterns among patients receiving AHT for early stage breast cancer. Two-hundred patients with confirmed diagnosis of stage I - IIIA breast cancer were enrolled. Fifty-one patients were selected for a structured telephone interview regarding symptom burden while on AHT. Patients were 87.5% Caucasian, with mean age of 63 years, and 92.5% had stage I or II disease. Time to discontinuation or switching from first line AHT did not vary by AHT drug class (tamoxifen vs. AI) or by other treatment characteristics. However, AI patients were observed over a shorter period, with more cases censored as a result. Findings show that 20% of AI patients discontinued or switched within the first year, and musculoskeletal symptoms predicted time to discontinuation or switching among patients on anastrozole. In contrast, tamoxifen patients who switched to AIs tended to do so following clinical guidelines for use of AIs. Interview results showed that a greater proportion of anastrozole than tamoxifen patients cited side effects as the reason for switching. Findings from this study show that community oncologists quickly translate clinical trials data into practice, and appear to follow clinical guidelines regarding switching of first-line tamoxifen therapy to AIs.

A retrospective study of quality of life in a community sample of patients with early stage breast cancer.

-  Walker MS, Schwartzberg LS, Stepanski EJ, Fortner BV.

In: Breast Cancer Research and Treatment 2009;115(2):415-422.

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Few studies have examined the pattern of change in quality of life (QoL) over time among patients with breast cancer, or the impact of disease recurrence on QoL. This retrospective study examined QoL among patients with stage I-IIIB breast cancer. Individual, disease, and treatment characteristics were abstracted from the medical record, and linked with QoL data collected as a routine part of patient care. The sample included patients with nonrecurrent (N=100) and recurrent (N=19) disease who completed 1,449 QoL assessments. Linear mixed model analysis showed that disease recurrence significantly and adversely affected QoL across all domains. QoL did not appear to deteriorate in advance of recurrence. The pattern of adjustment after recurrence varied across QoL domains in theoretically consistent ways. Study findings suggest that patients show improvement in some areas after recurrence, but generally do not recover previous levels of QoL.

The relation of trouble sleeping, depressed mood, pain and fatigue in patients with cancer.

-  Stepanski EJ, Walker MS, Schwartzberg LS, Blakely LJ, Ong J, Houts AC.

In: Journal of Clinical Sleep Medicine 2009;5(2):132-136.

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STUDY OBJECTIVES: To evaluate the relation among several symptoms that occur commonly in cancer patients: trouble sleeping, fatigue/sleepiness, depressed mood, and pain in a large cohort of cancer patients undergoing treatment in a community oncology practice. METHODS: Demographic, clinical, and patient reported outcomes data from 11,445 cancer patients undergoing treatment in a large community oncology practice were analyzed using structural equation modeling. The data were split so that a model was constructed using half of the patients; this model was then cross-validated on the remaining patients. RESULTS: Fatigue was best represented as a latent variable, and significant direct effects were found for trouble sleeping, depressed mood, and pain. Also, there were significant indirect effects of these variables on fatigue. The effect of depressed mood on fatigue and pain was mediated by trouble sleeping, and the effect of trouble sleeping on fatigue was mediated by pain. CONCLUSIONS: These results predict that interventions aimed at treatment of trouble sleeping, depressed mood, and pain will improve fatigue in patients with cancer. Further, these data predict that treatment of trouble sleeping will improve pain management in this population.

Psychosocial impact of cancer related symptoms among patients with lung cancer.

-  Walker M, Peltz G, Houts A, Pohl G, Schwartzberg L, Stepanski E, Marciniak M.

In: Annual Meeting of the American Society of Clinical Oncology; 2009 May 29 - June 2; Orlando, FL; 2009.

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Psychosocial impact of cancer related symptoms among patients with lung cancer.

-  Walker M, Peltz G, Houts A, Pohl G, Schwartzberg L, Stepanski E, Marciniak M.

In: Annual Meeting of the American Society of Clinical Oncology; 2009 May 29 - June 2; Orlando, FL; 2009.

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Psychosocial impact of cancer related symptoms among patients with lung cancer.

-  Walker M, Peltz G, Houts A, Pohl G, Schwartzberg L, Stepanski E, Marciniak M.

In: Annual Meeting of the American Society of Clinical Oncology; 2009 May 29 - June 2; Orlando, FL; 2009.

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Feasibility and acceptability to patients of a longitudinal system for evaluating cancer-related symptoms and quality of life: pilot study of an e/Tablet data-collection system in academic oncology.

-  Abernethy AP, Herndon JE, 2nd, Wheeler JL, Day JM, Hood L, Patwardhan M, Shaw H, Lyerly HK.

In: Journal of Pain and Symptom Management 2009;37(6):1027-38.

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Retrospective chart review of severe infusion reactions with rituximab, cetuximab, and bevacizumab in community oncology practices: Assessment of clinical consequences.

-  Schwartzberg LS, Stepanski EJ, Fortner BV, Houts AC.

In: Supportive Care in Cancer 2008;16(4):393-398.

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GOALS OF WORK: Monoclonal antibody (MoAb) treatments can result in severe infusion reactions. Managing infusion reactions in the outpatient setting introduces clinical and resource challenges for patients and providers, but there is little information regarding prevention, management, or outcomes of severe infusion reactions. This study represents one of the first attempts to describe the clinical consequences of severe infusion reactions associated with MoAb treatment. MATERIALS AND METHODS: Clinic staff identified adults treated with rituximab, cetuximab, or bevacizumab who experienced a grade 3 or higher (severe) infusion reaction. Chart reviews from 19 oncology practice sites across the USA captured patient demographics, infusion reaction management procedures, and clinical outcomes. MAIN RESULTS: With an average age of 62 years, the sample comprised of 76 patients who experienced a severe infusion reaction while receiving rituximab (n = 47), cetuximab (n = 24), and bevacizumab (n = 5). The most common pretreatment medications were acetaminophen and antihistamine in the rituximab group and corticosteroids (42%) in the cetuximab group. All cetuximab and the majority of rituximab severe infusion reactions occurred during the first cycle of therapy. Post infusion reaction management typically included corticosteroids, oxygen, and intravenous fluids. Overall, 22% were hospitalized for a mean of 4 days (range = 2.0 to 6.0 days). Permanent discontinuation of MoAb therapy occurred after the majority of cetuximab (79 to 100%) related severe infusion reactions. CONCLUSIONS: Severe infusion reactions are intensive events that present a serious challenge to patients and oncology practices. Efforts to prevent or reduce such reactions could be of great benefit.

Feasibility and acceptability to patients of a longitudinal system for evaluating cancer-related symptoms and quality of life: pilot study of an e/Tablet data-collection system in academic oncology.

-  Abernethy AP, Herndon JE, 2nd, Wheeler JL, Day JM, Hood L, Patwardhan M, Shaw H, Lyerly HK.

In: Journal of Pain and Symptom Management 2009;37(6):1027-38.

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Improving health care efficiency and quality using tablet personal computers to collect research-quality, patient-reported data.

-  Abernethy AP, Herndon JE, 2nd, Wheeler JL, Patwardhan M, Shaw H, Lyerly HK, Weinfurt K.

In: Health Services Research 2008;43(6):1975-91.

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Relation of sleep disturbance, depression, pain, and fatigue in patients with cancer.

-  Stepanski EJ, Walker MS, Schwartzberg LS, Blakely LJ.

In: Mechanisms and Treatment of Cancer-Related Symptoms Conference, MD Anderson Cancer Center; 2008 January 24 - 26; Houston, TX; 2008.

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Relation of sleep disturbance, depression, pain, and fatigue in patients with cancer.

-  Stepanski EJ, Walker MS, Schwartzberg LS, Blakely LJ.

In: Mechanisms and Treatment of Cancer-Related Symptoms Conference, MD Anderson Cancer Center; 2008 January 24 - 26; Houston, TX; 2008.

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Symptom burden for patients with metastatic colorectal cancer treated with first-line FOLFOX or FOLFIRI with and without bevacizumab in the community setting.

-  Fortner BV, Schwartzberg LS, Stepanski EJ, Houts AC.

In: Supportive Cancer Therapy 2007;4(4):233-240.

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Background: FOLFOX (oxaliplatin/leucovorin/5-fluorouracil) and FOLFIRI (irinotecan/leucovorin/5-fluorouracil) with or without bevacizumab have become standard-of-care regimens in first-line treatment of metastatic colorectal cancer. However, there is a paucity of symptom burden information regarding these regimens from the patient perspective in community oncology. Patients and Methods: This retrospective chart review and telephone interview study examined patients with first-line metastatic colorectal cancer from 5 community oncology centers treated with FOLFOX or FOLFIRI with and without bevacizumab. Patient reported outcomes were taken from the Patient Care Monitor 1.0 Revised, a validated tablet computer-based questionnaire that measures symptom burden and several scales of functioning and quality of life. A subset of patients completed structured telephone interviews about the impact of treatment on practical activities and income. Results: Eighty-eight patients with an average age of 62 years were included. Patients completed a median of 8 cycles of treatment. The most common moderate to severe symptom complaint was fatigue. Gastrointestinal symptoms were common but did not cluster in one regimen versus another. Neuropathy related symptoms were also common across all regimens except FOLFIRI without bevacizumab. Nausea and neutropenia were common indications for concomitant medications. One third reported work and other activity interference, and care produced out of- pocket expenditures in excess of $1000. Conclusion: Although sample size was small in the FOLFIRI-based regimens, patient reports and chart records suggested that there was not a systematic difference between FOLFOX and FOLFIRI regimens in type of symptom. The addition of bevacizumab did not appear to increase symptom burden.

Practice patterns of community based adjuvant hormonal therapy (AHT) in early stage breast cancer (ESBC).

-  Schwartzberg LS, Cobb P, Kulig K, Walker MS, Stepanski EJ, Fortner BV.

In: ASCO Breast Cancer Symposium; 2007 September 7-8; San Francisco, CA; 2007.

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Willingness to pay to prevent chemotherapy induced nausea and vomiting.

-  Miller PJE, Balu S, Buchner D, Walker MS, Stepanski EJ, Schwartzberg LS.

In: Annual Meeting of the American Society of Clinical Oncology; 2011 June 3 - 7; Chicago, IL; 2011.

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Prevalence of insomnia and associated symptoms in patients with cancer.

-  Stepanski EJ, Walker MS, Schwartzberg LS, Blakely LJ, Fu D, Fortner BV.

In: Annual Meeting of the American Society of Clinical Oncology; 2007 June 1 - 5; Chicago, IL; 2007.

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Validation of the Cancer Care Monitor items for physical symptoms and treatment side effects using expert oncology nurse evaluation.

-  Fortner B, Baldwin S, Schwartzberg L, Houts AC.

In: Journal of Pain and Symptom Management 2006;31(3):207-14.

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Psychometric content evaluation and pilot testing of a computer administered system for symptom screening and quality of life in adult cancer patients.

-  Fortner B, Okon T, Schwartzberg L, Tauer K, Houts AC.

In: Journal of Pain and Symptom Management 2003;26(6):1077-92.

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