TY - JOUR
T1 - RTOG 9804
T2 - A prospective randomized trial for good-risk ductal carcinoma in situ comparing radiotherapy with observation
AU - McCormick, Beryl
AU - Winter, Kathryn
AU - Hudis, Clifford
AU - Kuerer, Henry Mark
AU - Rakovitch, Eileen
AU - Smith, Barbara L.
AU - Sneige, Nour
AU - Moughan, Jennifer
AU - Shah, Amit
AU - Germain, Isabelle
AU - Hartford, Alan C.
AU - Rashtian, Afshin
AU - Walker, Eleanor M.
AU - Yuen, Albert
AU - Strom, Eric A.
AU - Wilcox, Jeannette L.
AU - Vallow, Laura A.
AU - Small, William
AU - Pu, Anthony T.
AU - Kerlin, Kevin
AU - White, Julia
N1 - Publisher Copyright:
© 2015 by American Society of Clinical Oncology.
PY - 2015/3/1
Y1 - 2015/3/1
N2 - 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 lowor 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.
AB - 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 lowor 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.
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U2 - 10.1200/JCO.2014.57.9029
DO - 10.1200/JCO.2014.57.9029
M3 - Article
C2 - 25605856
AN - SCOPUS:84924616285
SN - 0732-183X
VL - 33
SP - 709
EP - 715
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 7
ER -