| Abstract: |
Purpose: This prospective study (Radiation Therapy Oncology Group 0319) examines the use of three-dimensional conformal external beam radiotherapy (3D-CRT) to deliver accelerated partial breast irradiation (APBI). Initial data on efficacy and toxicity are presented. Methods and Materials: Patients with Stage I or II breast cancer with lesions ≤3 cm, negative margins and with ≤3 positive nodes were eligible. The 3D-CRT was 38.5 Gy in 3.85 Gy/fraction delivered 2×/day. Ipsilateral breast, ipsilateral nodal, contralateral breast, and distant failure (IBF, INF, CBF, DF) were estimated using the cumulative incidence method. Mastectomy-free, disease-free, and overall survival (MFS, DFS, OS) were recorded. The National Cancer Institute Common Terminology Criteria for Adverse Events, version 3, was used to grade acute and late toxicity. Results: Fifty-eight patients were entered and 52 patients are eligible and evaluable for efficacy. The median age of patients was 61 years with the following characteristics: 46% tumor size <1 cm; 87% invasive ductal histology; 94% American Joint Committee on Cancer Stage I; 65% postmenopausal; 83% no chemotherapy; and 71% with no hormone therapy. Median follow-up is 4.5 years (1.7-4.8). Four-year estimates (95% CI) of efficacy are: IBF 6% (0-12%) [4% within field (0-9%)]; INF 2% (0-6%); CBF 0%; DF 8% (0-15%); MFS 90% (78-96%); DFS 84% (71-92%); and OS 96% (85-99%). Only two (4%) Grade 3 toxicities were observed. Conclusions: Initial efficacy and toxicity using 3D-CRT to deliver APBI appears comparable to other experiences with similar follow-up. However, additional patients, further follow-up, and mature Phase III data are needed to evaluate the extent of application, limitations, and value of this particular form of APBI. © 2010 Elsevier Inc. All rights reserved. |
| Keywords: |
adult; treatment outcome; aged; aged, 80 and over; middle aged; survival analysis; major clinical study; overall survival; clinical trial; three dimensional; radiation dose; chemotherapy; cancer staging; follow up; follow-up studies; cancer incidence; prospective study; prospective studies; reproducibility of results; breast cancer; breast; radiation; mastectomy; tumor volume; radiotherapy; radiation injury; breast neoplasms; cancer invasion; tumor burden; lymph node; breast carcinoma; partial mastectomy; irradiation; disease free interval; telangiectasia; radiotherapy, conformal; external beam radiotherapy; toxicity; radiation safety; computer assisted radiotherapy; postmenopause; hormone therapy; radiation therapy oncology groups; radiation dermatitis; mastectomy, segmental; carcinoma, ductal, breast; tumor size; breast-conserving therapy; accelerated partial breast irradiation; external beam radiation therapy; myositis; adverse events; skin fibrosis; partial breast irradiation; breast carcinomas; common terminology criteria; contralateral breast; cumulative incidence methods; national cancer institute; three-dimensional conformal radiation therapy; breast duct
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