Sole brachytherapy of the tumor bed after conservative surgery for T1 breast cancer: Five-year results of a phase I–II study and initial findings of a randomized phase III trial

摘要: Background and Objectives The objectives of this study were to test the feasibility sole interstitial high-dose-rate brachytherapy (HDR-BT) after breast-conserving surgery (BCS) for T1 breast cancer in a phase I–II study, present initial findings III trial comparing efficacy tumor bed radiotherapy (TBRT) alone with conventional whole (WBRT). Methods Forty-five prospectively selected patients undergoing BCS enrolled into TBRT alone, using HDR implants. HDR-BT 7 × 4.33 Gy (n = 8) 7 × 5.2 (n = 37) was delivered bed. Based on results further 126 randomized receive 50 WBRT (n = 63) or (n = 63); latter consisted either (n = 46) 50-Gy wide-field electron irradiation (n = 17). Breast related events side effects assessed. Results In at median follow-up 57 months, 2 (4.4%) local, 3 (6.7%) axillary, distant failures observed. Two died cancer. The 5-year probability cancer-specific, relapse-free local recurrence-free survival 90.0%, 85.9%, 95.6%, respectively. cosmetic judged be excellent 44 45 (97.8%). Severe (higher than grade 2) skin sequelae fibrosis not found. Symptomatic fat necrosis occurred one patient (2.2%). In 30 locoregional control 100% both arms. 3-year cancer-specific 98.1% 98.4% group 94.4% group, respectively (P = NS). There no significant difference between two treatment arms regarding incidence radiation effects. Conclusions Five-year our prove that careful selection adequate quality assurance is feasible alternative WBRT. However, long-term trials are required determine equivalence compared management early J. Surg. Oncol. 2002;80:121–128. © 2002 Wiley-Liss, Inc.