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Publications 2018-12-28T22:08:34+00:00

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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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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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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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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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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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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Cancer patient preferences and willingness to pay for preventing chemotherapy induced nausea and vomiting in the U.S.

-Miller PJE, Balu S, Buchner D, Walker MS, Stepanski EJ, Schwartzberg LS.
In: International Society for Pharmacoeconomic and Outcomes Research; 2011 May 21 – 25; Baltimore, MD; 2011.

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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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“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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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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Outcomes of “real world” treatment for metastatic renal cell carcinoma (mRCC).

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

In: American Society of Clinical Oncology 2012 Genitourinary Cancers Symposium; 2012 February 2 – 4; San Francisco, CA; 2012.

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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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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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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.

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

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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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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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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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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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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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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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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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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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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 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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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 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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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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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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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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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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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 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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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 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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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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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. A

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

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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. S

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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

Health and Quality of Life Outcomes 2011;9:46.

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BACKGROUND: This retrospective study evaluated the impact of disease progression and of specific sites of metastasis on patient reported outcomes (PROs) that assess symptom burden and health related quality of life (HRQoL) in women with metastatic breast cancer (mBC).

METHODS: HER-2 negative mBC patients (n = 102) were enrolled from 7 U.S. community oncology practices. Demographic, disease and treatment characteristics were abstracted from electronic medical records and linked to archived Patient Care Monitor (PCM) assessments. The PCM is a self-report measure of symptom burden and HRQoL administered as part of routine care in participating practices. Linear mixed models were used to examine change in PCM scores over time.

RESULTS: Mean age was 57 years, with 72% of patients Caucasian, and 25% African American. Median time from mBC diagnosis to first disease progression was 8.8 months. Metastasis to bone (60%), lung (28%) and liver (26%) predominated at initial metastatic diagnosis. Results showed that PCM items assessing fatigue, physical pain and trouble sleeping were sensitive to either general effects of disease progression or to effects associated with specific sites of metastasis. Progression of disease was also associated with modest but significant worsening of General Physical Symptoms, Treatment Side Effects, Acute Distress and Impaired Performance index scores. In addition, there were marked detrimental effects of liver metastasis on Treatment Side Effects, and of brain metastasis on Acute Distress.

CONCLUSIONS: Disease progression has a detrimental impact on cancer-related symptoms. Delaying disease progression may have a positive impact on patients’ HRQoL.

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.

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.

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.

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.

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.

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.

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.

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.

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

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180,000 cancer patients. Data were summarized descriptively. Three illustrative case histories are presented.\nPatients 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. \nAdvanced 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.\n”}” data-sheets-userformat=”{“2″:13123,”3”:{“1″:0},”4″:[null,2,14281427],”9″:0,”11″:4,”12″:0,”15″:”Proxima Nova”,”16″:11}”>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.

“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.

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.

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.

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.

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.

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.

Treatment patterns and clinical effectiveness in metastatic castrate resistant prostate cancer after first-line docetaxel.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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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.