Phase II trial of brachytherapy alone after lumpectomy for select @entity0 : XXXX analysis of RTOG 95-17.

@entity1 @entity137 @entity82 @entity0 @entity440 @entity8721 @entity4 @entity281 @entity3 @entity158 @entity925 @entity1168
PURPOSE: Accelerated partial breast irradiation (APBI) can be delivered with brachytherapy within 4-5 days compared with 5-6 weeks for conventional whole breast external beam radiotherapy. Radiation Therapy Oncology Group 95-17 is the first prospective phase I-II cooperative group trial of APBI alone after lumpectomy in select @entity1 with @entity0 . The @entity137 rates are reported for low-dose-rate (LDR) and @entity1168 ( @entity1168 ) APBI on this trial. METHODS AND MATERIALS: The inclusion criteria for this study included @entity3 < or =3 cm after lumpectomy with negative surgical margins and axillary dissection with zero to three positive axillary nodes without extracapsular extension. The @entity1 were treated with either LDR APBI (45 Gy in 3.5-5 days) or @entity1168 APBI (34 Gy in 10 twice-daily fractions within 5 days). Chemotherapy (> or =2 weeks after APBI) and/or @entity440 could be given at the discretion of the treating physicians. RESULTS: Between August 1997 and March 2000, 100 @entity1 were enrolled in this study, and 99 were evaluated. Of the 99 @entity1 , 33 were treated with LDR and 66 with @entity1168 APBI. The median follow-up for all @entity1 was 2.7 years (range, 0.6-4.4 years) and was 2.9 years for LDR and 2.7 years for @entity1168 @entity1 . @entity137 attributed to APBI included erythema, @entity4 , @entity925 , @entity158 , and @entity281 . Of the 66 @entity1 treated with @entity1168 APBI, 2 (3%) had Grade 3 or 4 @entity137 . Of the 33 @entity1 treated with LDR, 3 (9%) had Grade 3 or 4 @entity137 during brachytherapy. Late @entity137 included skin thickening, @entity82 , breast @entity925 , and @entity8721 . No @entity1 experienced late Grade 4 @entity137 ; the rate of Grade 3 @entity137 was 18% for the LDR and 4% for the @entity1168 groups. CONCLUSION: Acute and late @entity137 for this invasive breast radiation technique was modest and acceptable. @entity1 receiving chemotherapy, a nonprotocol therapy, had a greater rate of Grade 3 @entity137 . The study design did not allow for this to be tested statistically.
