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- Title
Patient-Reported Outcomes of Omission of Breast Surgery Following Neoadjuvant Systemic Therapy: A Nonrandomized Clinical Trial.
- Authors
Johnson, Helen M.; Lin, Heather; Shen, Yu; Diego, Emilia J.; Krishnamurthy, Savitri; Yang, Wei T.; Smith, Benjamin D.; Valero, Vicente; Lucci, Anthony; Sun, Susie X.; Shaitelman, Simona F.; Mitchell, Melissa P.; Boughey, Judy C.; White, Richard L.; Rauch, Gaiane M.; Kuerer, Henry M.
- Abstract
This nonrandomized clinical trial evaluates patient-reported outcomes in a clinical trial evaluating omission of breast surgery for invasive cancers with exceptional response to neoadjuvant systemic therapy. Key Points: Question: How do patients describe their experiences participating in a clinical trial evaluating omission of breast surgery for invasive cancers with exceptional response to neoadjuvant systemic therapy? Findings: In this nonrandomized phase 2 clinical trial of 31 patients, decisional comfort and health-related qualify of life (HRQOL) were high at baseline and increased significantly during postradiotherapy surveillance (median follow-up 32.4 months). Patients reported a slight increase in cosmetic asymmetry after radiotherapy, but no persistent changes in function, pain, or edema. Meaning: This analysis of patient-reported outcomes demonstrates an overall positive experience for trial participants, with longitudinal improvements in decisional comfort and HRQOL and minimal lasting adverse effects of therapy. Importance: Patients should have an active role in decisions about pursuing or forgoing specific therapies in treatment de-escalation trials. Objective: To evaluate longitudinal patient-reported outcomes (PROs) encompassing decisional comfort and health-related quality of life (HRQOL) among patients who elected to enroll in a clinical trial evaluating radiotherapy alone, without breast surgery, for invasive breast cancers with exceptional response to neoadjuvant systemic therapy (NST). Design, Setting, and Participants: Prospective, single-group, phase 2 clinical trial at 7 US medical centers. Women aged 40 years or older with invasive cT1-2 N0-1 M0 triple-negative or human epidermal growth factor receptor 2 (ERBB2)–positive breast cancer with no pathologic evidence of residual disease following standard NST enrolled from March 6, 2017, to November 9, 2021. Validated PRO measures were administered at baseline and 6, 12, and 36 months post-radiotherapy. Data were analyzed from January to February 2023. Interventions: PRO measures included the Decision Regret Scale (DRS), Functional Assessment of Cancer Therapy—Lymphedema (FACT-B+4), and Breast Cancer Treatment Outcomes Scale (BCTOS). Main Outcomes and Measures: Changes in PRO measure scores and subscores over time. Results: Among 31 patients, the median (IQR) age was 61 (56-66) years, 26 (84%) were White, and 26 (84%) were non-Hispanic. A total of 15 (48%) had triple-negative disease and 16 (52%) had ERBB2-positive disease. Decisional comfort was high at baseline (median [IQR] DRS score 10 [0-25] on a 0-100 scale, with higher scores indicating higher decisional regret) and significantly increased over time (median [IQR] DRS score at 36 months, 0 [0-20]; P <.001). HRQOL was relatively high at baseline (median [IQR] FACT-B composite score 121 [111-134] on a 0-148 scale, with higher scores indicating higher HRQOL) and significantly increased over time (median [IQR] FACT-B score at 36 months, 128 [116-137]; P =.04). Perceived differences between the affected breast and contralateral breast were minimal at baseline (median [IQR] BCTOS score 1.05 [1.00-1.23] on a 1-4 scale, with higher scores indicating greater differences) and increased significantly over time (median [IQR] BCTOS score at 36 months, 1.36 [1.18-1.64]; P <.001). At 36 months postradiotherapy, the cosmetic subscore was 0.45 points higher than baseline (95% CI, 0.16-0.74; P =.001), whereas function, pain, and edema subscores were not significantly different than baseline. Conclusions and Relevance: In this nonrandomized phase 2 clinical trial, analysis of PROs demonstrated an overall positive experience for trial participants, with longitudinal improvements in decisional comfort and overall HRQOL over time and minimal lasting adverse effects of therapy. Trial Registration: ClinicalTrials.gov Identifier: NCT02945579
- Subjects
RESEARCH; STATISTICS; CLINICAL trials; CONFIDENCE intervals; PATIENT decision making; MULTIVARIATE analysis; HEALTH outcome assessment; HEALTH status indicators; QUALITY of life; RESEARCH funding; DESCRIPTIVE statistics; CHI-squared test; COMBINED modality therapy; DATA analysis software; ODDS ratio; BREAST tumors; LONGITUDINAL method; EVALUATION
- Publication
JAMA Network Open, 2023, Vol 6, Issue 9, pe2333933
- ISSN
2574-3805
- Publication type
Article
- DOI
10.1001/jamanetworkopen.2023.33933