Main Session
Sep
28
PQA 04 - Breast Cancer, Patient Reported Outcomes/QoL/Survivorship, Functional Radiation Medicine, Hematologic Malignancies, Palliative Care, and International/Global Oncology
Presenter(s)
Jane Pearce, MD - MD Anderson Cancer Center, Houston, TX
J. Pearce, S. F. Shaitelman, P. J. Schlembach, M. M. Joyner, C. P. Anakwenze, K. E. Hoffman, V. K. Reed, F. Chino, E. Bloom, C. R. Goodman, I. Y. Arzu, M. C. Stauder, M. P. Mitchell, E. Paredes, R. Zacharia, W. A. Woodward, and B. D. Smith; Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX
Purpose/Objective(s):
Regional nodal irradiation (RNI) is a key component of curative-intent treatment for patients with breast cancer patients who are lymph node-positive or high-risk, node-negative. Historically, conventionally fractionated RNI has been the standard of care, demonstrating reductions in breast cancer–specific and all-cause mortality with acceptable toxicity. More recent studies have evaluated modestly hypofractionated RNI and have shown comparable rates of locoregional control relative to conventional fractionation, supporting modestly hypofractionated RNI as a reasonable standard of care [1-3]. The rationale for the current study is to further advance RNI by evaluating shorter dosing regimens that leverage advanced radiation technologies such as volumetric arc therapy, intensity modulated proton therapy, and simultaneous integrated boost (SiB), to deliver precisely targeted, risk-adapted radiation therapy.Materials/Methods:
SAPPHIRe-II is an ongoing, IRB-approved, multi-institution phase II randomized clinical trial (NCT07076485) that activated August 19, 2025. The trial includes women and men with invasive breast cancer treated with curative-intent surgery for whom RNI is recommended by the radiation oncologist. This trial has four distinct randomized cohorts: low-risk lumpectomy, low-risk mastectomy, high-risk lumpectomy, and high-risk mastectomy. Participants in the low-risk cohorts are randomized to one week of ultrahypofractionated RNI (26 Gy in 5 fractions) versus three weeks of modestly fractionated RNI (40 Gy in 15 fractions). Patients in the high-risk cohorts all receive RNI, 40 Gy in 15 fractions, and are randomized to an SiB (45-48 Gy) versus sequential boost (10-16 Gy). The primary outcome is the cumulative burden of grade 2+ NCI CTCAE toxicity from start of RNI through 18 months follow up. Secondary outcomes include treatment toxicity, cancer control outcomes, patient-reported outcomes, photographic breast appearance, and biometric data collected from patients’ Apple Watches. Each treatment cohort will enroll n=192 patients which, after accounting for drop out, will yield 81% power to detect a non-inferiority margin difference of 15% between the two treatment arms, assuming a baseline grade 2+ toxicity rate of 50% in the control arm of each cohort. Of 118 patients referred to the study team for possible enrollment as of January 27, 2026, the majority (n=63, 53.4%) consented to protocol enrollment. Distribution of enrollment by cohort was as follows: 52% high-risk mastectomy cohort, 21% low-risk lumpectomy cohort, 13% low-risk mastectomy cohort, and 14% high-risk lumpectomy cohort. Age distribution of enrolled patients was 11% <40 years, 51% 40-59 years, 22% 60-69 years, and 16% =70 years. Race/ethnicity distribution of enrolled patients was 6% Asian/Pacific Islander, 8% Black, 22% Hispanic, and 64% White, non-Hispanic.Results:
NAConclusion:
NA 1. SAPHIRE 2. RT CHARM 3. PMID 32780661