RTOG 9804: A Prospective Randomized Trial for Good-Risk Ductal Carcinoma In Situ Comparing Radiotherapy With Observation
| Autor: | Kathryn Winter, Amit Shah, Eric A. Strom, Kevin J. Kerlin, Eileen Rakovitch, Alan C. Hartford, Barbara L. Smith, Jennifer Moughan, Eleanor M. Walker, Laura A. Vallow, Clifford A. Hudis, William Small, Albert Yuen, Isabelle Germain, Afshin Rashtian, Beryl McCormick, Anthony T. Pu, Henry Mark Kuerer, Nour Sneige, Jeannette L. Wilcox, Julia White |
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| Rok vydání: | 2015 |
| Předmět: |
Adult
Canada Cancer Research medicine.medical_specialty medicine.medical_treatment Urology Breast Neoplasms Kaplan-Meier Estimate Mastectomy Segmental Risk Assessment Disease-Free Survival Breast cancer Odds Ratio Carcinoma Humans Medicine Cumulative incidence Prospective Studies Watchful Waiting Prospective cohort study Aged business.industry Hazard ratio Disease Management ORIGINAL REPORTS Middle Aged Ductal carcinoma medicine.disease United States Surgery Radiation therapy Carcinoma Intraductal Noninfiltrating Treatment Outcome Oncology Female Radiotherapy Adjuvant Neoplasm Recurrence Local business Mastectomy Mammography |
| Zdroj: | Journal of Clinical Oncology. 33:709-715 |
| ISSN: | 1527-7755 0732-183X |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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