1. A phase I/II trial of intraoperative breast radiotherapy in an Asian population: 10-year results with critical evaluation.
- Author
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Kawamura M, Itoh Y, Kamomae T, Sawaki M, Kikumori T, Tsunoda N, Ito J, Shimoyama Y, Satake H, and Naganawa S
- Subjects
- Aged, Asian People, Combined Modality Therapy, Contrast Media, Female, Follow-Up Studies, Humans, Intraoperative Care methods, Intraoperative Period, Magnetic Resonance Imaging, Mammography, Mastectomy, Segmental adverse effects, Mastectomy, Segmental methods, Middle Aged, Neoplasm Recurrence, Local, Prospective Studies, Radiotherapy Dosage, Ultrasonography, Mammary, Breast Neoplasms radiotherapy, Radiotherapy methods
- Abstract
Although phase III trials have been published comparing whole breast irradiation (WBI) with accelerated partial breast irradiation (APBI) using intraoperative radiotherapy (IORT), long-term follow-up results are lacking. We report the 10-year follow-up results of a prospective phase I/II clinical trial of IORT. The inclusion criteria were as follows: (i) tumor size <2.5 cm, (ii) desire for breast-conserving surgery, (iii) age >50 years, (iv) negative margins after resection and (v) sentinel lymph node-negative disease. A single dose of IORT (19-21 Gy) was delivered to the tumor bed in the operation room just after wide local excision of the primary breast cancer using a 6-12 MeV electron beam. Local recurrence was defined as recurrence or new disease within the treated breast and was evaluated annually using mammography and ultrasonography. A total of 32 patients were eligible for evaluation. The median patient age was 65 years and the median follow-up time was 10 years. Two patients experienced local recurrence just under the nipple, out of the irradiated field, after 8 years of follow-up. Three patients had contralateral breast cancer and one patient experienced bone metastasis after 10 years of follow-up. No patient experienced in-field recurrence nor breast cancer death. Eight patients had hypertrophic scarring at the last follow-up. There were no lung or heart adverse effects. This is the first report of 10-year follow-up results of IORT as APBI. The findings suggest that breast cancer with extended intraductal components should be treated with great caution., (© The Author(s) 2020. Published by Oxford University Press on behalf of The Japanese Radiation Research Society and Japanese Society for Radiation Oncology.)
- Published
- 2020
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