Concurrent Versus Sequential Radiation Dose Escalation to the Surgical Cavity for Conservative Treatment of High-Risk Early Breast Cancer: NRG/RTOG 1005 Phase III Trial
Year: 2026
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: PURPOSE For patients with breast cancer undergoing breast conservation, escalating the dose (boost) of radiation to the lumpectomy cavity after whole-breast irradiation (WBI) reduces ipsilateral breast recurrence (IBR) but extends treatment duration. This phase III trial investigated whether boost delivery during WBI versus after WBI provides noninferior IBR and preserves cosmetic appearance. METHODS NRG/RTOG 1005 randomly assigned patients at higher risk for IBR after lumpectomy and axillary surgery to either a sequential boost of 12 Gy in six fractions(F) or 14 Gy in 7F after WBI of 50 Gy in 25F or 42.7 Gy in 16F (sequential arm) or a concurrent boost of 8 Gy in 15F of 0.53 Gy per day with WBI of 40 Gy in 15F (concurrent arm) using 3-dimensional conformal radiation therapy (RT) or intensity-modulated RT. Based on 1.59% 5-year IBR for the sequential arm, defining the noninferiority margin as a hazard ratio upper limit on the 90% CI of 2.12, 2,312 patients provide 80% power for noninferiority of IBR as first recurrence for the concurrent arm. Secondary end points included disease-free survival and overall survival, adverse events (AEs), and cosmetic outcomes. RESULTS Between May 24, 2011, and June 20, 2014, 2,354 patients were randomly assigned, with 2,255 eligible for analysis (sequential arm, n = 1,118; concurrent arm, n = 1,137). With median follow-up of 7.3 years, there were 56 IBR events; 5- and 7-year IBR were 2.1% and 2.2% on the sequential arm and 1.9% and 2.6% on the concurrent arm, respectively. The noninferiority criterion was met: HR (90% CI): 1.31 (0.84 to 2.04), P = .037. No differences were observed in AEs, cosmetic outcomes, or survival between arms. CONCLUSION Concurrent boost during WBI results in noninferior IBR compared with sequential boost without worsening toxicity or cosmetic outcomes and reduces overall treatment time.
Source: Journal of Clinical Oncology
DOI: 10.1200/jco-25-02465
Authors: Frank A. Vicini, Kathryn Winter, Gary M. Freedman, Douglas W. Arthur, Barry S. Rosenstein, Soren M. Bentzen, X. Allen Li, Michele Y. Halyard, Wendy A. Woodward, Richard J. Bleicher, Alphonse Taghian, Janice Lyons, Janice K. Tomberlin, Samantha A. Seaward, Sally B. Cheston, Andrew C. Hoover, Bethany M. Anderson, Francisco E. Perera, Matthew M. Poppe, Ivy A. Petersen, Sachin Jhawar, Tarek Hijal, Jennifer Moughan, Benjamin Movsas, Julia R. White
Institutions: Michigan Healthcare Professionals, NRG Oncology, Abramson Cancer Center, VCU Massey Comprehensive Cancer Center, Mount Sinai Hospital, University of Maryland, Baltimore, University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center, Medical College of Wisconsin, Mayo Clinic Hospital, The University of Texas MD Anderson Cancer Center, Fox Chase Cancer Center, Massachusetts General Hospital, Case Western Reserve University, Texas Oncology, Kaiser Permanente, The University of Kansas Cancer Center, University of Wisconsin–Madison, University of Wisconsin Carbone Cancer Center, Huntsman Cancer Institute, Mayo Clinic, The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, McGill University Health Centre, Henry Ford Hospital
Language: English
Subfield: Cancer Research
Domain: Life Sciences
Open Access status: green
OpenAlex ID: W7160839699