Phase I/II study evaluating early tolerance in breast cancer patients undergoing accelerated partial breast irradiation treated with the mammosite balloon breast brachytherapy catheter using a 2-day dose schedule.
OBJECTIVE
Initial Phase I/II results using balloon brachytherapy to deliver accelerated partial breast irradiation (APBI) in 2 days in patients with early-stage breast cancer are presented.


METHODS
Between March 2004 and August 2007, 45 patients received adjuvant radiation therapy after lumpectomy with balloon brachytherapy in a Phase I/II trial delivering 2800 cGy in four fractions of 700 cGy. Toxicities were evaluated using the National Cancer Institute Common Toxicity 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 patients (47%) followed >or=1 year, 11 (24%) >or=2 years, and 7 (16%) >or=3 years. At <6 months (n = 45), Grade II toxicity rates were 9% radiation dermatitis, 13% breast pain, 2% edema, and 2% hyperpigmentation. Grade III breast pain was reported in 13% (n = 6). At >or=6 months (n = 43), Grade II toxicity rates were: 2% radiation dermatitis, 2% induration, and 2% hypopigmentation. Grade III breast pain was reported in 2%. Infection was 13% (n = 6) at <6 months and 5% (n = 2) at >or=6 months. Persistent seroma >or=6 months was 30% (n = 13). Fat necrosis developed in 4 cases (2 symptomatic). Rib fractures 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 toxicity rates and similar cosmetic results observed with a standard 5-day accelerated partial breast irradiation schedule.
Wallace
Michelle
M
Department of Radiation Oncology, William Beaumont Hospital, Royal Oak, MI 48073, USA.
Martinez
Alvaro
A
Mitchell
Christina
C
Chen
Peter Y
PY
Ghilezan
Mihai
M
Benitez
Pamela
P
Brown
Eric
E
Vicini
Frank
F
D000368:Aged; D000369:Aged, 80 and over; D001918:Brachytherapy / Q000009:adverse effects* / Q000295:instrumentation / Q000379:methods; D001940:Breast / Q000528:radiation effects; D001941:Breast Diseases / Q000209:etiology; D001943:Breast Neoplasms / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D002408:Catheters, Indwelling; D004487:Edema / Q000209:etiology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015412:Mastectomy, Segmental; D008875:Middle Aged; D010146:Pain / Q000209:etiology; D010859:Pigmentation Disorders / Q000209:etiology; D011446:Prospective Studies; D011855:Radiodermatitis / Q000473:pathology; D011879:Radiotherapy Dosage; D047368:Tumor Burden