1. RTOG 9804: a prospective randomized trial for good-risk ductal carcinoma in situ comparing radiotherapy with observation.
- Author
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McCormick B, Winter K, Hudis C, Kuerer HM, Rakovitch E, Smith BL, Sneige N, Moughan J, Shah A, Germain I, Hartford AC, Rashtian A, Walker EM, Yuen A, Strom EA, Wilcox JL, Vallow LA, Small W Jr, Pu AT, Kerlin K, and White J
- Subjects
- Adult, Aged, Breast Neoplasms diagnostic imaging, Breast Neoplasms pathology, Breast Neoplasms prevention & control, Breast Neoplasms surgery, Canada, Carcinoma, Intraductal, Noninfiltrating diagnostic imaging, Carcinoma, Intraductal, Noninfiltrating surgery, Disease Management, Disease-Free Survival, Female, Humans, Kaplan-Meier Estimate, Mammography, Middle Aged, Odds Ratio, Prospective Studies, Radiotherapy, Adjuvant, Risk Assessment, Treatment Outcome, United States, Breast Neoplasms radiotherapy, Carcinoma, Intraductal, Noninfiltrating radiotherapy, Mastectomy, Segmental, Neoplasm Recurrence, Local prevention & control, Watchful Waiting
- Abstract
Purpose: The Radiation Therapy Oncology Group 9804 study identified good-risk patients with ductal carcinoma in situ (DCIS), a breast cancer diagnosis found frequently in mammographically detected cancers, to test the benefit of radiotherapy (RT) after breast-conserving surgery compared with observation., Patients and Methods: This prospective randomized trial (1998 to 2006) in women with mammographically detected low- or intermediate-grade DCIS, measuring less than 2.5 cm with margins ≥ 3 mm, compared RT with observation after surgery. The study was designed for 1,790 patients but was closed early because of lower than projected accrual. Six hundred thirty-six patients from the United States and Canada were entered; tamoxifen use (62%) was optional. Ipsilateral local failure (LF) was the primary end point; LF and contralateral failure were estimated using cumulative incidence, and overall and disease-free survival were estimated using the Kaplan-Meier method., Results: Median follow-up time was 7.17 years (range, 0.01 to 11.33 years). Two LFs occurred in the RT arm, and 19 occurred in the observation arm. At 7 years, the LF rate was 0.9% (95% CI, 0.0% to 2.2%) in the RT arm versus 6.7% (95% CI, 3.2% to 9.6%) in the observation arm (hazard ratio, 0.11; 95% CI, 0.03 to 0.47; P < .001). Grade 1 to 2 acute toxicities occurred in 30% and 76% of patients in the observation and RT arms, respectively; grade 3 or 4 toxicities occurred in 4.0% and 4.2% of patients, respectively. Late RT toxicity was grade 1 in 30%, grade 2 in 4.6%, and grade 3 in 0.7% of patients., Conclusion: In this good-risk subset of patients with DCIS, with a median follow-up of 7 years, the LF rate was low with observation but was decreased significantly with the addition of RT. Longer follow-up is planned because the timeline for LF in this setting seems protracted., (© 2015 by American Society of Clinical Oncology.)
- Published
- 2015
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