PURPOSE: Initial Phase I/II results using balloon brachytherapy to deliver accelerated partial breast irradiation (APBI) in 2 days in @entity1 with @entity0 are presented. MATERIALS AND METHODS: Between March 2004 and August 2007, 45 @entity1 received adjuvant radiation therapy after lumpectomy with balloon brachytherapy in a Phase I/II trial delivering 2800 cGy in four fractions of 700 cGy. @entity137 were evaluated using the National @entity5 Institute Common @entity137 Criteria for Adverse Events v3.0 scale and cosmesis was documented at >or=6 months. RESULTS: The median age was 66 years (range, 48-83) and median skin spacing was 12 mm (range, 8-24). The median follow-up was 11.4 months (5.4-48 months) with 21 @entity1 (47%) followed >or=1 year, 11 (24%) >or=2 years, and 7 (16%) >or=3 years. At <6 months (n = 45), Grade II @entity137 rates were 9% radiation @entity1909 , 13% @entity5026 , 2% @entity4 , and 2% @entity2117 . Grade III @entity5026 was reported in 13% (n = 6). At >or=6 months (n = 43), Grade II @entity137 rates were: 2% radiation @entity1909 , 2% induration, and 2% @entity4182 . Grade III @entity5026 was reported in 2%. Infection was 13% (n = 6) at <6 months and 5% (n = 2) at >or=6 months. Persistent @entity2080 >or=6 months was 30% (n = 13). @entity4099 developed in 4 cases (2 symptomatic). Rib @entity174 were seen in 4% (n = 2). Cosmesis was good/excellent in 96% of cases. CONCLUSIONS: Treatment with balloon brachytherapy using a 2-day dose schedule resulted acceptable rates of Grade II/III chronic @entity137 rates and similar cosmetic results observed with a standard 5-day accelerated partial breast irradiation schedule.

Phase I/II study evaluating early tolerance in XXXX @entity1 undergoing accelerated partial breast irradiation treated with the mammosite balloon breast brachytherapy catheter using a 2-day dose schedule.

@entity1 :: ('9606', 'Species') :: ['patients'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity', 'Toxicity', 'Toxicities'] @entity0 :: ('MESH:D001943', 'Disease') :: ['early-stage breast cancer'] @entity4182 :: ('MESH:D017496', 'Disease') :: ['hypopigmentation'] @entity174 :: ('MESH:D050723', 'Disease') :: ['fractures'] @entity5 :: ('MESH:D009369', 'Disease') :: ['Cancer'] @entity4 :: ('MESH:D004487', 'Disease') :: ['edema'] @entity2117 :: ('MESH:D017495', 'Disease') :: ['hyperpigmentation'] @entity5026 :: ('MESH:D059373', 'Disease') :: ['breast pain'] @entity2080 :: ('MESH:D049291', 'Disease') :: ['seroma'] @entity1909 :: ('MESH:D003872', 'Disease') :: ['dermatitis'] @entity4099 :: ('MESH:D005218', 'Disease') :: ['Fat necrosis']
@entity0 :: (MESH:D001943,Disease) :: ['breast cancer']
