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Background As the combination of systemic and targeted chemotherapies is associated with severe adverse side effects and long-term health complications, there is interest in reducing treatment intensity for patients with early-stage breast cancer (EBC). Clinical trials are needed to determine the feasibility of reducing treatment intensity while maintaining 3-year recurrence-free survival of greater than 92%. To recruit participants for these trials, it is important to understand patient perspectives on reducing chemotherapy. Methods We collected qualitative interview data from twenty-four patients with Stage II-III breast cancer and sixteen patient advocates. Interviews explored potential barriers and facilitators to participation in trials testing reduced amounts of chemotherapy. As the COVID-19 pandemic struck during data collection, seventeen participants were asked about the potential impact of COVID-19 on their interest in these trials. Interviews were audio-recorded and transcribed, and researchers used qualitative content analysis to code for dominant themes. Results Seventeen participants (42.5%) expressed interest in participating in a trial of reduced chemotherapy. Barriers to reducing chemotherapy included (1) fear of recurrence and inefficacy, (2) preference for aggressive treatment, (3) disinterest in clinical trials, (4) lack of information about expected outcomes, (5) fear of regret, and (6) having young children. Facilitators included (1) avoiding physical toxicity, (2) understanding the scientific rationale of reducing chemotherapy, (3) confidence in providers, (4) consistent monitoring and the option to increase dosage, (5) fewer financial and logistical challenges, and (6) contributing to scientific knowledge. Of those asked, nearly all participants said they would be more motivated to reduce treatment intensity in the context of COVID-19, primarily to avoid exposure to the virus while receiving treatment. Conclusions Among individuals with EBC, there is significant interest in alleviating treatment-related toxicity by reducing chemotherapeutic intensity. Patients will be more apt to participate in trials testing reduced amounts of chemotherapy if these are framed in terms of customizing treatment to the individual patient and added benefit—reduced toxicities, higher quality of life during treatment and lower risk of long-term complications—rather than in terms of taking treatments away or doing less than the standard of care. Doctor-patient rapport and provider support will be crucial in this process.

There is increasing interest in patient-reported measures of cancer treatment tolerability. A global measure of bother, the FACT GP5 item ("I am bothered by side effects of treatment") is potentially useful for regulatory, research, and clinical use. To understand this item's appropriateness for capturing treatment tolerability, we conducted cognitive interviews on this item with 3 samples of cancer patients.Patients with ovarian cancer (Study 1: N = 21; on treatment), lymphoma (Study 2: N = 14; on treatment), and colorectal or lung cancer (Study 3: N = 16; treatment naïve) were interviewed about GP5's understandability and relevance to their treatment side effects. What patients think about when answering GP5 was also assessed. In all studies, the interview included both structured and open-ended questions. Qualitative data were coded to extract themes and responses to structured questions were tallied.Most patients on treatment (Studies 1 and 2) reported that the GP5 item wording is appropriate (88%) and its meaning is clear (97%). They were very confident or confident in their response (97%) and stated that GP5 was relevant to their cancer experience (97%). When answering GP5, patients considered their treatment and specific side effects. A large proportion (40%) of the treatment-naïve (Study 3) patients reported that GP5 was not relevant to their cancer treatment, and the largest proportion responded to GP5 thinking of negative side effect expectancies.This study provides assurance that GP5 is a useful indicator of treatment tolerability, and is meaningful to people with cancer, especially once they have started treatment.

Background: Being an oncologist means accepting that some patients will have disease recurrence despite the most expert treatments. The universality of that experience, however, does not negate the potential for decisional regret and emotional distress on the part of the physician. The broad scale movement towards treatment optimization in medicine likely complicates this experience, as enrollment in de-escalation clinical trials inevitably means that the patient will receive less than the current standard of care. The objective of this study was to assess physician perceptions of potential emotional distress and decisional regret following patient recurrence through exploring the broad range of factors that either moderate or exacerbate those experiences. Methods: Physicians who treat breast cancer in academic and community settings across the United States participated in a qualitative interview designed to assess physician perspectives regarding patient enrollment in de-escalation clinical trials. Purposive sampling techniques were utilized to construct a balanced sample (sex, time in practice) of 39 participants. A subsection of the interview schedule centered on the experiences of decisional regret and distress surrounding patient recurrence. Interviews were recorded, transcribed, and analyzed in order to identify shared themes. Two independent coders performed a content analysis, identifying and recording factors that impact the level of distress that the physician may feel. Results: Thirty-six physicians provided in depth responses regarding their experience when a patient recurs. A total of 21 factors that affected recurrence stress were identified and spanned broad categories including patient features, disease biology, the design of the clinical trial, and characteristics of the physician. All participants expressed willingness to enroll patients in de-escalation-focused clinical trials. However, approximately half of the sample indicated that the experience would be worse after enrollment in a de-escalation trial than after a traditional intensification trial, and a quarter admitted that patient recurrence after a de-escalation trial would impact their decision making regarding future patient enrollment. Individuals not likely to experience distress emphasized having a strong trial rationale, informed patient consent, and engaging in shared decision-making, while greater distress centered on the fear of “not doing enough” and the patient missing out on necessary treatment. Conclusions: Many factors contribute to the experience of physician decisional regret and emotional distress after patient recurrence. Although most physicians recognize the importance of de-escalation focused clinical trials, a significant proportion indicated a greater potential for distress following patient recurrence in such trials and offered insight into how trial design and the process of patient enrollment can be improved to minimize potential distress. Citation Format: Nicole L. Henderson, Andrews Courtney, Lawhon Valerie, Stacey A. Ingram, Lisa Zubkoff, Nadine Tung, Lynne Wagner, Lauren P. Wallner, Antonio C. Wolff, Gabrielle B. Rocque. "Clinical Trials are Space Travel": Moderators of Recurrence Stress among Breast Cancer Oncologists [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P6-05-54.

Background The Surveillance, Epidemiology, and End Results (SEER) database and National Cancer Database (NCDB) show improved overall survival (OS) in patients with multiple myeloma (MM) over the last 15 years. This analysis evaluated the validity of the largely community‐based Connect MM Registry as a national reference for MM. Methods Baseline disease characteristics and survival in US newly diagnosed MM patients were examined using the Connect MM Registry as well as SEER and NCDB databases. Baseline characteristics predictive of longer survival in Connect MM were also identified. Results As of February 2017, 3011 patients were enrolled in the Connect MM Registry; 2912 were treated. Median age at time of MM diagnosis and age range were numerically similar from 2010 to 2015 across all 3 registries; SEER had a higher representation of nonwhite racial groups than that in the other 2 registries. OS rates suggest proportionate improvement with year of diagnosis among the 3 registries. A Cox proportional hazards model suggests that younger age (, Survival data from the Connect MM Registry, which is representative of the national MM population, reflect national trends of improvement. This establishes the Connect MM Registry as a reference for MM survival in the US.

Introduction: Elevated allostatic load (AL) has been associated with poor tumor prognostic features in Black breast cancer patients and worse disease specific and overall survival among cancer patients. To date, there are no studies evaluating the relationship between genetic ancestry, allostatic load and clinical trial endpoints such as completion of chemotherapy per protocol or overall survival. Prior evaluations of the ECOG-ACRIN adjuvant breast cancer trial E5103 suggests African ancestry is associated with a worse invasive disease-free survival and lower odds of chemotherapy completion. The objective of this study is to evaluate the association of genetic ancestry and AL with trial completion per protocol and with overall survival among patients in E5103. Methods: ECOG-ACRIN E5103 was a clinical trial that compared doxorubicin and cyclophosphamide (AC) for four cycles, followed by 12 weeks of weekly paclitaxel with placebo (Arm A) to the same chemotherapy with either concurrent bevacizumab (Arm B) or with concurrent plus sequential bevacizumab (Arm C) among women with node positive or high-risk node negative HER2 negative disease. Genetic ancestry groups of African ancestry (AA), European ancestry (EA) and other ancestry (OA) were determined using genome-wide single nucleotide polymorphisms. AL, at trial entry, was comprised of the biomarkers body mass index, systolic blood pressure, diastolic blood pressure, creatinine, IL6, IL10, and TNF alpha. To calculate AL, patients were awarded a point if their biomarker value was above the 75 percentile of the study sample. Logistic regression and Cox-Proportional Hazard models (odds ratio(OR) and hazard ratio (HR) estimates with corresponding 95% confidence intervals (CI)) were used to assess association with chemotherapy completion and with overall mortality. Estimates for AL were adjusted for genetic ancestry. Results: There were 348 patients in the study. The majority of the sample was of EA (EA 80%, AA 10%, OA 10%). Median (range) of AL was 2(0-6). Patients of AA (2.1(1.3)) and EA (1.88(1.4)) had a higher mean (SD) AL score compared to OA patients (0.91(1.1). On adjusted analysis, a 1 unit increased in AL was associated with a 15% reduction in the odds of completing chemotherapy per protocol (OR 0.85, 95% CI 0.72-0.99). Additionally, a 1 unit increase in AL was associated with a 14% increase in the hazard of death (HR 1.14, 95%CI 1.02-1.29). There was no association between ancestry and chemotherapy completion (AA OR 0.95, 95%CI 0.47-1.93; OA 1.82, 95%CI 0.78-4.23; ref EA) or survival (AA HR 1.40, 95% CI 0.85-2.31), OA 0.89 (0.46-1.73; ref EA). Moreover, there was no interaction between AL and ancestry. Conclusion: Among patients enrolled in E5103, AL appeared to be a better predictor of chemotherapy completion and overall survival than genetic ancestry. These results suggest life course exposure to chronic stress has implication in clinical outcomes even within the context of equivalent access to and quality of care. Citation Format: Samilia Obeng-Gyasi, Anne ONeill, Kathy D. Miller, Bryan P. Schneider, Ann H. Patridge, Lava R. Timsina, George W. Sledge, Lynne Wagner, Ruth C. Carlos. The implications of genetic ancestry and allostatic load on clinical outcomes in the ECOG-ACRIN adjuvant breast cancer trial E5103 [abstract]. In: Proceedings of the AACR Virtual Conference: 14th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2021 Oct 6-8. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr PO-219.