Edward Stepanski

• PHD
• Consultant at Stepanski Research Consulting

PURPOSE Oral adjuvant endocrine therapy (AET) reduces the risk of cancer recurrence and death for women with hormone receptor–positive (HR+) breast cancer. Because of adverse symptoms and socioecologic barriers, AET adherence rates are low. We conducted post hoc analyses of a randomized trial of a remote symptom and adherence monitoring app to eval...

45 Background: Despite the efficacy of oral adjuvant endocrine therapy (AET) for improving survival among women with hormone receptor-positive early-stage breast cancer, adherence rates remain low. Our THRIVE study (NCT03592771) investigated the effectiveness of a mobile health remote monitoring app with and without tailored educational messages on...

Importance Adjuvant endocrine therapy (AET) use among women with early-stage, hormone receptor–positive breast cancer reduces the risk of cancer recurrence, but its adverse symptoms contribute to lower adherence. Objective To test whether remote monitoring of symptoms and treatment adherence with or without tailored text messages improves outcomes...

Background: Adjuvant endocrine therapy (AET) reduces breast cancer recurrence, but racial differences in nonadherence remains a concern. Differential symptom burden may contribute to disparities in AET adherence. Method: We conducted a post hoc analysis by race among women with breast cancer starting AET who were randomized in THRIVE Study (NCT0359...

512 Background: Adjuvant endocrine therapy (AET) use among women with early-stage, hormone receptor-positive breast cancer reduces the risk of cancer recurrence, but adverse symptoms contribute to lower adherence. We evaluated the effectiveness of an app that integrates patient-reported outcomes with electronic health records and tailored messages....

Background: Symptom burden differences may contribute to racial disparities in breast cancer survival. We compared symptom changes from before to during chemotherapy among women with breast cancer. Methods: This observational study followed a cohort of Black and White women diagnosed with Stage I-III, hormone-receptor positive breast cancer from...

Importance: Adjuvant endocrine therapy (AET) reduces breast cancer recurrence, but symptom burden is a key barrier to adherence. Black women have lower AET adherence and worse health outcomes than White women. Objective: To investigate the association between symptom burden and AET adherence differences by race. Design, setting, and participant...

12102 Background: Low rates of adherence to adjuvant endocrine therapy (AET) is a significant clinical problem. Symptom burden is a key barrier to adherence, but less is known about how changes in symptom burden affects adherence. Moreover, whether higher symptom burden in racial minorities explains their lower rates of adherence, has been relative...

Importance Race disparities persist in breast cancer mortality rates. One factor associated with these disparities may be differences in symptom burden, which may reduce chemotherapy tolerance and increase early treatment discontinuation. Objectives To compare symptom burden by race among women with early-stage breast cancer before starting chemot...

6528 Background: Symptom burden may contribute to racial differences in cancer treatment adherence and survival. Evidence on changes in symptom burden during chemotherapy and whether these differ by race is scarce. We used patient reported outcomes data collected before and after breast cancer chemotherapy initiation to compare symptom burden by ra...

Purpose: Cancer prevalence and outcomes data, necessary to understand disparities in transgender populations, are significantly hampered because gender identity data are not routinely collected. A database of clinical data on people with cancer, CancerLinQ, is operated by the ASCO and collected from practices across the United States and multiple...

Purpose: Cancer clinical trials often accrue slowly or miss enrollment targets. Strict eligibility criteria are a major reason. Restrictive criteria also limit opportunities for patient participation while compromising external validity of trial results. We examined the impact of broadening select eligibility criteria on characteristics and number...

132 Background: Performance status is used to characterize patient ability to tolerate chemotherapy and as a selection criterion for clinical research. Poor performance status can exclude patients from clinical trial participation. Further, African American cancer patients are underrepresented in cancer clinical trials. The study purpose was to doc...

e19318 Background: ECOG PS is a prognostic indicator of outcomes, and scores of 0-1 (good ECOG PS) are often required for clinical trial enrollment. Patients treated in non-trial settings often lack ECOG PS scores limiting the ability of Real World Data from these patients to be used in external control arms (ECAs) or to provide optimal specificity...

e19191 Background: ASCO has implemented the Quality Oncology Practice Initiative (QOPI), a certification program established to evaluate oncology practice performance. Also, a growing number of accreditation (JCAHO) and merit-based organizations (MIPS) maintain falls risk assessment standards. Practices often lack the necessary resources to comply...

The aim of this retrospective study was to assess the efficacy of topical hormonal therapy (THT) to relieve vaginal symptoms resulting from antihormonal therapy in women with hormone receptor–positive breast cancer. A total of 74 breast cancer patients who received THT for vaginal complaints were retrospectively identified and statistically matched...

5 Background: The American Society of Clinical Oncology recommends that providers encourage early advance care planning with their patients; yet, many cancer patients do not have advance directives (ADs). A potential reason for low AD rates is inadequate communication between the provider and patient. To address this gap, we developed an outpatient...

171 Background: ASCO has implemented the Quality Oncology Practice Initiative (QOPI), a certification program established to evaluate oncology practice performance. However, practices often lack the necessary resources to meet the required standards and fulfill required metric reporting. The study purpose was to document the effectiveness of using...

LBA108 Background: Restrictive trial eligibility criteria limit data generalizability and patient opportunity to participate. We compared numbers and characteristics of patients (pts) eligible using traditional vs expanded criteria recommended by ASCO and Friends of Cancer Research. Methods: A retrospective, observational analysis used deidentified...

2566 Background: ICI’s have demonstrated significant clinical benefit since the first FDA approval in 2011 of ipilimumab for metastatic melanoma. Five additional ICI therapies have since been approved across several indications. The objectives of this study were to describe the clinical and demographic features of patients receiving ICI treatment a...

110 Background: Anecdotal and early evidence suggest ICIs are being used in patients with advanced malignancies and history of AD, despite such patients being typically excluded from traditional clinical trials. We compared the outcomes of patients with or without AD, all of whom had ICI treatment for aNSCLC. Methods: We conducted a retrospective,...

6583 Background: Although pts with AD are routinely excluded from ICI clinical trials, evidence suggests they may be receiving ICI therapy once approved. We sought to understand the prevalence of AD among all pts receiving ICIs in real world clinical care, as well as in advanced non-small cell lung cancer (aNSCLC) alone, and to describe the charact...

9110 Background: Immune Checkpoint Inhibitors (ICIs) were first approved for the treatment of aNSCLC in 2014, and since this time have seen rapid adoption in the marketplace. We sought to describe the characteristics of patients with aNSCLC receiving ICIs in the real-world, as well as to examine treatment patterns and outcomes in the time since ini...

e23181 Background: The National Comprehensive Cancer Network and the American Society of Clinical Oncology recommend that providers encourage early advance care planning with their patients ¹ ; yet, many cancer patients do not have advance directives (ADs). A potential reason for low AD rates is inadequate communication between the provider and pat...

Purpose: For postmenopausal women with hormone receptor-positive breast cancer, long-term use of aromatase inhibitors (AIs) significantly reduces the risk of cancer recurrence and improves survival. Still, many patients are nonadherent due to adverse side effects. We conducted a pilot randomized controlled trial to test the use of a web-based appli...

Objective: Nearly 1 in 5 patients hospitalized for ovarian cancer surgery are readmitted for complications that may have been prevented with monitoring. We conducted a randomized controlled feasibility trial to evaluate a postoperative web-based app intervention to provide real-time symptom monitoring among patients diagnosed or with suspected gyn...

Background: This phase 2, single-arm, multicenter study was designed to determine the treatment activity and safety of single-agent pazopanib in patients with unresectable or metastatic liposarcoma. Methods: Eligible patients had high-grade or intermediate-grade liposarcoma with measurable tumors that were unresectable or metastatic, documented...

e12044 Background: For postmenopausal women with hormone receptor-positive breast cancer, use of aromatase inhibitors (AI) significantly reduces the risk of cancer recurrence and improves survival, but many patients are nonadherent due to adverse side effects. We conducted a pilot randomized controlled trial of a web-enabled application (app) to pr...

Accompanied by the change in the traditional medical landscape, advances in wireless technology have led to the development of telehealth or mobile health (mHealth), which offers an unparalleled opportunity for health care providers to continually deliver high-quality care. This revolutionary shift makes the patient the consumer of health care and...

89Background: For postmenopausal women with hormone receptor-positive breast cancer, long-term use of aromatase inhibitors (AI) significantly reduces the risk of cancer recurrence and improves disease free and overall survival. Despite the known benefits of AIs, many patients are nonadherent due to adverse side effects. We conducted a pilot randomi...

Accompanied by the change in the traditional medical landscape, advances in wireless technology have led to the development of telehealth or mobile health (mHealth), which offers an unparalleled opportunity for health care providers to continually deliver high-quality care. This revolutionary shift makes the patient the consumer of health care and...

77 Background: THR is sometimes used for treatment of VC in BC patients previously treated with HT. The safety of this practice remains a question but the effectiveness of this strategy has not been reported. Methods: We conducted a retrospective analysis of patient reported symptoms at the West Cancer Center (WCC) between 2002 and 2014. Early stag...

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...

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 were collected on 466 patients who received first-line therapy from 200...

Background: The association of race with clinical outcomes has been increasingly investigated in non-small cell lung cancer (NSCLC). This prospective observational study evaluated the impact of race on disease control rate (DCR) in patients with NSCLC treated with second-line pemetrexed. Our previous report of this study showed the DCR of African-A...

Background: Second-line treatment with pemetrexed (Pem) has demonstrated safety and efficacy in NSCLC patients. A prospective observational study was conducted to evaluate the impact of race on disease control rate (DCR) in NSCLC patients treated with 2nd line Pem. This analysis focuses on the association of race with tolerability of treatment and...

Background The primary systemic treatments for advanced melanoma have been chemotherapy and immunotherapy. New agents are currently in development. Objectives This study aimed to characterize treatment patterns and outcomes across several lines of therapy and to illustrate the treatment landscape prior to the approval of new therapies. The study en...

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 retrosp...

Objective: To examine the effect of cognitive-behavioral therapy for insomnia (CBT-I) on the underreporting of sleep relative to objective measurement, a common occurrence among individuals with insomnia. Method: Pre-treatment and post-treatment self-report measures of sleep were compared with those obtained from home-based polysomnography (PSG)...

In this phase II study, we explored efficacy and toxicity of combined endocrine and low-dose metronomic chemotherapy therapy consisting of fulvestrant and capecitabine in estrogen and/or progesterone receptor-positive, HER2-negative MBC. Patients with ≤ 1 previous hormonal treatment in the metastatic setting received an injection fulvestrant loadin...

Objective: Understanding the value patients place on avoiding various aspects of chemotherapy induced nausea and vomiting (CINV) can help medical professionals assess whether current and emerging treatments are acceptable based on their costs and expected effects. Little is known, however, about the value patients place on avoiding various aspects...

This prospective observational study evaluated the effect of race on disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) in patients with NSCLC treated with second-line pemetrexed. Eligibility criteria included stage IIIB or IV NSCLC patients receiving single-agent pemetrexed for second-line therapy in routine cli...

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

Readaptation to the sleep laboratory was assessed in 10 volunteers complaining of insomnia with polysomnographic evidence of disturbed sleep. After an initial 3-night adaptation to the laboratory, subjects slept in the laboratory on 2 consecutive nights per week for 10 weeks and were administered medication according to the following protocol: plac...

Learn how to manage JMP data and perform the statistical analyses most commonly used in research in the social sciences and other fields with JMP for Basic Univariate and Multivariate Statistics: Methods for Researchers and Social Scientists, Second Edition. Updated for JMP 10 and including new features on the statistical platforms, this book off...

Purpose: We assessed adding the multikinase inhibitor sorafenib to gemcitabine or capecitabine in patients with advanced breast cancer whose disease progressed during/after bevacizumab. Experimental design: This double-blind, randomized, placebo-controlled phase IIb study (ClinicalTrials.gov NCT00493636) enrolled patients with locally advanced o...

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 ac...

Objective: We examined the safety and efficacy of combining bevacizumab with albumin-bound (ab-) paclitaxel to treat patients with recurrent, platinum-resistant primary epithelial ovarian or peritoneal carcinoma. Methods: Patients had measurable disease per RECIST guidelines, progressing within 6 months after a prior course of platinum-based tre...

Background Bevacizumab (B) and cetuximab (C) are both approved for use in the treatment of metastatic colorectal cancer (mCRC) in the second-line. We examined patient 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 (...

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...

e15061 Background: Targeted therapies are now the standard of care for mRCC with use and expected outcomes defined by clinical trials. What are "real world" patterns of use and survival outcomes in mRCC patients (pts) treated in community oncology (COMM) settings? Methods: We reviewed a retrospective registry of adult mRCC pts from 11 COMM oncology...

406 Background: Targeted therapies have expanded treatment options for mRCC. Using a joint community/academic center database, we determined outcomes for “real world” mRCC patients (pts) in order to understand current treatment patterns and their effectiveness. Methods: A retrospective cohort dataset included all identified adult mRCC pts receiving...

In July 2007, the Centers for Medicare and Medicaid Services (CMS) limited coverage of erythropoiesis-stimulating agents (ESAs) in cancer patients with chemotherapy-induced anemia (CIA) through a National Coverage Determination (NCD). The primary objective of this study was to compare transfusion rates in patients with CIA with lung, breast, or col...

The present study tested two methods of self-help cognitive-behavioral therapy for insomnia (CBT-I) for 106 older adults (mean age = 68) with osteoarthritis (n = 33) or coronary artery disease (n = 33) or no significant medical condition (n = 40). The latter was employed as a comparison group to test the differential efficacy between primary and co...

Background: Few prospective studies have evaluated the impact of race and ethnicity on clinical outcomes, during lung cancer treatment. This prospective observational study evaluated the impact of ethnicity on disease control rate (DCR) in patients with NSCLC treated with second-line pemetrexed (P). Methods: Eligibility criteria included stage IIIB...

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). HER-2 negative mBC patients (n = 102) were enrolled from 7 U.S. community oncology practices....

Distinctive diagnostic classification schemes for insomnia diagnoses are available, but the optimal insomnia nosology has yet to be determined. To test the reliability and validity of insomnia diagnoses listed in the American Psychiatric Association's DSM-IV-TR and the International Classification of Sleep Disorders, second edition (ICSD-2). Multit...

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. 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 new...

1009 Background: SOR, a multikinase inhibitor targeting tumor growth and angiogenesis, is indicated for adv renal and hepatocellular cancer. The Trials to Investigate the Efficacy of SOR (TIES) program is four double-blind, randomized, placebo (PL)-controlled, phase IIb screening trials assessing SOR+CRx for HER2-negative locally adv or metastatic...

e11087 Background: The standard approach to HR+ MBC is sequential single endocrine agents, but in the current era of adjuvant AI therapy, alternatives to AIs for first line MBC endocrine treatment are desirable. We designed this trial to assess the feasibility, safety and efficacy of a combined chemoendocrine approach with continuous low dose oral...

e16598 Background: Bevacizumab (B) and cetuximab (C) are both approved for use in treatment of metastatic colorectal cancer (mCRC) in the second line. We examined self-reported symptom burden as collected by the 86-item Patient Care Monitor (PCM) survey during second line treatment of mCRC delivered in the community setting. Methods: This was a ret...

Background: Trastuzumab (T) is indicated for the adjuvant treatment of HER2-overexpressing breast cancer (BC). We report the results of a retrospective study of patient-reported outcomes (PROs) for patients who received T plus chemotherapy followed by T monotherapy or T as a single-agent. Methods: Included in this analysis were 210 patients with ea...

5009 Background: Ovarian cancer (OC) has the highest mortality of all cancers involving the female genital tract. Platinum-based therapy is standard primary treatment. Treatments to extend survival, while preserving quality of life, are needed for platinum-resistant patients where current treatment options yield < 4 months progression free survival...

e18023 Background: A previous phase II study of pemetrexed (PEM) and gemcitabine (GEM) in combination in elderly patients showed significant activity with little toxicity. Adding VGFR inhibitors to active doublets has increased response rates in patients with non-small cell lung cancer (NSCLC) in previous studies. The present study evaluated the do...

Unhelpful beliefs about sleep have been linked to insomnia, and increasing one's cognitive flexibility about sleep has been linked to posttreatment sleep improvement. This study evaluated whether levels of such beliefs differ across insomnia groups and whether there are particular beliefs that differ for specific insomnia subtypes. Participants (N=...

This article reviews the theoretical and empirical foundation for the new understanding of comorbid insomnia (CI) as a functional equivalent to primary insomnia. In both cases cognitive behavioral therapy for insomnia (CBT-I) should be considered as a highly efficacious first line of treatment. This article reviews the growing body of evidence supp...

2498 Poster Board II-475 Background The use of rituximab maintenance after front line chemotherapy has been shown superior to observation in the treatment of follicular lymphoma (FL). However, the impact of rituximab maintenance (R-M) vs. observation (OBS) on symptom burden has not been thoroughly examined. This study examined treatment patterns a...

2491 Poster Board II-468 Introduction In July 2007, the Centers for Medicare & Medicaid Services issued erythropoiesis-stimulating agent (ESA) coverage limitations for cancer patients with CIA through an NCD, which limits ESA utilization in patients with CIA to hemoglobin (Hb) levels of less than 10 g/dL at ESA initiation and after the initial 4 w...

The purpose of this study was to describe treatment use patterns and outcomes with single-agent erlotinib among patients with advanced non-small-cell lung cancer (NSCLC) in the community oncology setting. Retrospective chart review identified patients treated with single-agent erlotinib as either second- or third-line therapy from 4 community oncol...

Osteoarthritis pain affects more than half of all older adults, many of whom experience co-morbid sleep disturbance. Pain initiates and exacerbates sleep disturbance, whereas disturbed sleep maintains and exacerbates pain, which implies that improving the sleep of patients with osteoarthritis may also reduce their pain. We examined this possibility...

6621 Background: Patients with lung cancer may experience adverse physical symptoms due to cancer, cancer treatment, or comorbid medical conditions. These cancer-related symptoms (CRS) may be associated with functional impairment (FI), and may affect psychosocial functioning. Methods: We conducted a retrospective analysis of self reported symptom b...

e20624 Background: African-Americans are more likely to develop and die from lung cancer than persons of any other ethnic group. Historically, African-Americans have been under-represented in oncology clinical research. This prospective, single-arm, observational study evaluates the impact of ethnicity on disease control rate (DCR) (CR + PR + SD))...

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...

Clinical trials have shown that aromatase inhibitors (AIs) are an important advance in the treatment of early stage breast cancer (ESBC), but practice patterns and the impact of treatment side effects of endocrine therapy in the community setting have not been extensively explored. This retrospective chart review describes practice patterns among p...

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. Demographic, clinical, and patient reported outcomes data from 11,445 cancer patients undergoing treatment...

Insomnia has been identified as a risk factor for tension-type headache, although the pathogenesis of sleep disturbance in this population is unclear. The present study examined pain-related self-management strategies in a nonclinical, young-adult sample for preliminary evidence to support a novel hypothesis for the development of insomnia in this...

Oral chemotherapy regimens have emerged as comparably effective to intravenous regimens with the potential for less resource utilization, fewer treatment side effects and a better quality-of-life outcome. The objective of this retrospective chart review was to examine these issues among patients who received single-agent taxane therapy vs. single-a...

Targeted monoclonal antibodies (MoAbs) have become a promising treatment option for patients with cancer. However, there is a risk of developing infusion reactions (IRs) with MoAbs. This study was conducted to evaluate the impact of IRs on staff time and costs among patients receiving an initial infusion of cetuximab (Erbitux) and rituximab (Rituxa...

6621 Background: Clinical outcomes for patients (pts) treated in non-clinical trial settings have not been compared to clinical trial participant outcomes. Moreover, the degree to which reference regimens (Ref Reg) are utilized in actual clinical settings is not known. We created ETPs based on trial reports and guidelines and measured clinician com...