2019 ASCO Annual Meeting!
Session: Breast Cancer—Local/Regional/Adjuvant
Type: Oral Abstract Session
Time: Monday June 3, 9:45 AM to 12:45 PM
Location: Hall D2
Patient-reported outcomes (PROs) in NRG oncology/NSABP B-39/RTOG 0413: A randomized phase III study of conventional whole breast irradiation (WBI) versus partial breast irradiation (PBI) in stage 0, I, or II breast cancer.
2019 ASCO Annual Meeting
J Clin Oncol 37, 2019 (suppl; abstr 508)
Author(s): Patricia A. Ganz, Reena S. Cecchini, Julia R. White, Frank Vicini, Thomas B. Julian, Douglas W Arthur, Rachel Rabinovitch, Robert R. Kuske, David S. Parda, Michael Scheier, Kathryn A. Winter, Soonmyung Paik, Henry Mark Kuerer, Laura Vallow, Lori J. Pierce, Eleftherios P. Mamounas, Joseph P. Costantino, Beryl McCormick, Walter John Curran, Jr., Norman Wolmark; NRG Oncology, and The UCLA Jonsson Comprehensive Cancer Center at UCLA, Los Angeles, CA; NRG Oncology and Biostatistical Center, Pittsburgh, PA; NRG Oncology, and The Ohio State University Comprehensive Cancer Center, Columbus, OH; NRG Oncology, and 21st Century Oncology, Pontiac, MI; NRG Oncology, and The Allegheny Health Network Cancer Institute, Pittsburgh, PA; NRG Oncology/Virginia Commonwealth University, Richmond, VA; NRG Oncology/University of Colorado School of Medicine, Aurora, CO; NRG Oncology, and Arizona Breast Cancer Specialists, Scottsdale, AZ; Allegheny Health Network Cancer Institute, Pittsburgh, PA; Carnegie Mellon University, Pittsburgh, PA; NRG Oncology SDMC - American College of Radiology, Philadelphia, PA; NRG Oncology, and Yonsei University College of Medicine, Seoul, South Korea; NRG Oncology/The University of Texas MD Anderson Cancer Center, Houston, TX; NRG Oncology/Mayo Clinic, Jacksonville, FL; NRG Oncology/University of Michigan Health System, Ann Arbor, MI; NRG Oncology, and Orlando Health UF Cancer Center, Orlando, FL; NSABP Foundation and The University of Pittsburgh, Pittsburgh, PA; NRG Oncology, and Memorial Sloan Kettering Cancer Center, New York, NY; NRG Oncology, and the Winship Cancer Institute, Atlanta, GA
Background: PBI is an alternative to WBI, with potentially greater therapy (tx) compliance, and better integration with chemotherapy (CTX). NSABP B-39/RTOG 0413 clinical outcome results from 2018 did not show equivalence of PBI to WBI in local tumor control; PBI was statistically inferior, but with clinically small differences. PBI may be an acceptable alternative to WBI for some women. Understanding cosmesis and quality of life (QOL) treatment outcomes is important. Methods: B-39/0413 included a prospective QOL substudy with PRO evaluation of breast cancer treatment outcomes (cosmesis, function, pain) and fatigue using BCTOS and SF-36 vitality scales. Secondary QOL parameters included treatment related symptoms, perceived convenience of care, and the BPI pain scale. The study sample was stratified by CTX or not, as CTX is given before WBI but after PBI. PRO assessments occurred before randomization, the last day of adjuvant tx [CTX or radiation], 4 wks later, and 6, 12, 24, and 36 mo later. Primary aims included comparisons of change in fatigue from baseline to end of tx and equivalency of change in cosmesis from baseline to 36 mo for PBI v WBI. Separate analyses were done for CTX and non-CTX pts, controlling for axillary dissection. Each comparison used α=0.0125. Planned sample size was 964. Results: From 3-23-05 to 5-27-09, 975 pts were enrolled in the PRO study; 950 had follow-up data. 504 did not receive CTX and 446 received CTX. In non-CTX pts, PBI had less fatigue (p=0.011) and did not meet criteria for cosmesis equivalence (97.5% CI, -0.02 to 0.22; ∆=0.20). In CTX pts, PBI had worse fatigue (p=0.011) and equivalent cosmesis to WBI (97.5% CI, -0.09 to 0.21; ∆=0.24). In both groups, PBI pts reported less pain at end of tx. In non-CTX pts, PBI had more pain at 36 mo but in CTX pts, there was no difference. Convenience of care and treatment related symptom outcomes will be presented. Conclusions: In non-CTX pts, PBI is more convenient with less fatigue and slightly poorer cosmesis at 36 mo. Cosmesis was equivalent at 36 mo in CTX pts. Support: U10CA180868, -180822, UG1CA189867. Clinical trial information: NCT00103181