The NRG Oncology (NRG)/NSABP B-39/RTOG 0413 clinical trial compared whole-breast irradiation (WBI) to accelerated partial-breast irradiation (APBI) and determined that APBI was not statistically equivalent to WBI in local tumor control. The secondary outcome for the trial was Quality-of-life (QOL).
The study enrolled 4,210 patients with Stage 0, I, or II breast cancer resected by lumpectomy; tumor size ≤ 3.0 cm; and no more than 3 histologically positive nodes with the primary aim to determine whether partial breast irradiation (PBI) limited to the region of the tumor bed following lumpectomy provided equivalent local tumor control in the breast compared to conventional whole breast irradiation (WBI) in the local management of early stage breast cancer.
The QOL sub-study provided an in-depth evaluation of fatigue and treatment toxicities using well-established patient-reported-outcomes measures. With a target accrual of 964 patients (482 with clinician intent to prescribe chemotherapy and 482 without), the QOL sub-study used validated self-report questionnaires including the Breast Cancer Treatment Outcome Scale (BCTOS) and the SF-36 vitality scale. Assessments occurred before randomization, at completion of chemotherapy or radiotherapy, 4-weeks later, and at 6-, 12-, 24-, and 36-months. The primary aims for the QOL sub-study were cosmesis change equivalency and fatigue change superiority for APBI vs WBI, according to patient groups treated with or without chemotherapy.
Cosmetic outcomes were similar for APBI and WBI groups, with small statistically significant differences in other outcomes that varied over time. Differences in fatigue and other symptoms appeared to resolve by ≥6 months. APBI may be preferred by some patients, for whom extended treatment is burdensome.
"Partial- and whole-breast radiation have equivalent cosmetic outcomes at 3 years post-lumpectomy in breast cancer patients, but significantly greater end-of-treatment fatigue occurred in patients receiving whole breast irradiation after lumpectomy without chemotherapy," stated Patricia Ganz, MD, of the University of California Los Angeles, and Behavioral and Health Outcomes Officer for the trial.
This project was supported by grants U10CA180868 (NRG Oncology Operations), U10CA180822 (NRG Oncology SDMC), and UG1CA189867 (NCORP) from the National Cancer Institute (NCI), part of the National Institutes of Health.
Citation
Ganz PA, Cecchini RS, White JR, Vicini FA, Arthur DW, Rabinovitch RA, Kuske RR, Julian TB, Parda DS, Scheier MF, Winter KA, Paik S, Kuerer HM, Vallow LA, Pierce LJ, Mamounas EP, McCormick B, Bear HD, Germain I, Gustafson G, Grossheim L, Petersen IA, Hudes RS, Curran WJ Jr., Wolmark N. Quality-of-Life Outcomes from NRG/NSABP B-39/RTOG 0413: Whole-breast Irradiation vs Accelerated Partial-breast Irradiation after Breast Conserving Surgery, JNCI: Journal of the National Cancer Institute, 2024; djae219, https://doi.org/10.1093/jnci/djae219
About NRG Oncology
NRG Oncology conducts practice-changing, multi-institutional clinical and translational research to improve the lives of patients with cancer. Founded in 2012, NRG Oncology is a Pennsylvania-based nonprofit corporation that integrates the research of the legacy National Surgical Adjuvant Breast and Bowel Project (NSABP), Radiation Therapy Oncology Group (RTOG), and Gynecologic Oncology Group (GOG) programs. The research network seeks to carry out clinical trials with emphases on gender-specific malignancies, including gynecologic, breast, and prostate cancers, and on localized or locally advanced cancers of all types. NRG Oncology's extensive research organization comprises multidisciplinary investigators, including medical oncologists, radiation oncologists, surgeons, physicists, pathologists, and statisticians, and encompasses more than 1,300 research sites located world-wide with predominance in the United States and Canada. NRG Oncology is supported primarily through grants from the National Cancer Institute (NCI) and is one of five research groups in the NCI's National Clinical Trials Network.
www.nrgoncology.org
