Feasibility of intraoperative radiation therapy for early breast cancer in Japan: a single-center pilot study and literature review
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Intraoperative radiation therapy (IORT) is under evaluation in breast-conserving surgery because the feasibility of the IORT procedure including transportation of the patient under general anesthesia is not well established. Thus, this prospective single-center study aimed to test the feasibility of IORT at a single dose of 21 Gy in Japanese breast cancer patients.
The primary endpoint was early toxicity; the secondary endpoint was late toxicity. Patients with histologically or cytologically proven primary early breast cancer were eligible. Inclusion criteria were as follows: (1) T < 2.5 cm; (2) desire for breast-conserving surgery; (3) age >50 years; (4) surgical margin >1 cm; (5) intraoperative pathologically free margins; and (6) sentinel node negative. Exclusion criteria were (1) contraindications to radiation therapy; (2) past radiation therapy for the same breast or chest; (3) extensive intraductal component; and (4) a tumor located in the axillary tail of the breast. All patients gave written informed consent. Partial resection was performed with at least a margin of 1 cm around the tumor. The patient was transported from the surgical suite to the radiation room. Radiation (Clinac® 21EX, Varian Medical Systems, Inc.) at 21 Gy was delivered directly to the mammary gland. Toxicity was evaluated with the Common Terminology Criteria for Adverse Events V4.0.
Five patients were enrolled in this pilot study and received 21 Gy. Follow-up ranged from 7.8 to 11.0 months (median 10.2). Intraoperative transportation to the radiation room during the surgical procedure under general anesthesia was performed safely in all patients. Treatment-related toxicities within 3 months were deep connective tissue fibrosis (grade 1, n = 3) and pain (grade 1, n = 3). There was no case of wound infection, wound dehiscence, or soft tissue necrosis. Overall, there was no severe adverse event.
The procedure was tolerated very well in this first group of Japanese female patients treated with IORT, as was the case with European women. A longer follow-up is needed for the evaluation of any potential late side effects or recurrences. A phase II study is now being conducted for the next group of patients (UMIN000003578).
KeywordsBreast cancer Intraoperative radiotherapy Early breast cancer
Axillary lymph node dissection
Accelerated partial breast irradiation
American Society for Therapeutic Radiation Oncology
Ductal carcinoma in situ
External beam radiation
Extensive intraductal component
Electron intraoperative therapy
Lobular carcinoma in situ
Lymph-vascular space invasion
Partial breast irradiation
- SN Bx
Sentinel lymph node biopsy
Targeted intraoperative radiotherapy
Whole breast external irradiation therapy
This research was funded in part by the Japanese Foundation for Multidisciplinary Treatment of Cancer.
Conflict of interest
The authors state that they have no conflict of interest.
- 4.Darby S, McGale P, Correa C, Taylor C, Arriagada R, Clarke M, et al. Effect of radiotherapy after breast-conserving surgery on 10-year recurrence and 15-year breast cancer death: meta-analysis of individual patient data for 10,801 women in 17 randomised trials. Lancet. 2011;378:1707–16.PubMedCrossRefGoogle Scholar
- 5.Njeh CF, Saunders MW, Langton CM. Accelerated partial breast irradiation (APBI): a review of available techniques. Radiat Oncol. 2010;5.Google Scholar
- 13.Sawaki M, Sato S, Noda S, Idota A, Uchida H, Tsunoda N, et al. Phase I/II study of intraoperative radiotherapy for early breast cancer in Japan. Breast Cancer. 2011. doi: 10.1007/s12282-011-0294-1.
- 16.Polgár C, Limbergen EV, Pötter R, Kovács G, Polo A, Lyczek J, et al. Patient selection for accelerated partial-breast irradiation (APBI) after breast-conserving surgery: recommendations of the Groupe Européen de Curiethérapie-European Society for Therapeutic Radiology and Oncology (GEC-ESTRO) breast cancer working group based on clinical evidence (2009). Radiother Oncol. 2010;94:264–73.PubMedCrossRefGoogle Scholar
- 22.Antonucci JV, Wallace M, Goldstein NS, Kestin L, Chen P, Benitez P, et al. Differences in patterns of failure in patients treated with accelerated partial breast irradiation versus whole-breast irradiation: a matched-pair analysis with 10-year follow-up. Int J Radiat Oncol Biol Phys. 2009;74:447–52.PubMedCrossRefGoogle Scholar
- 24.Fisher ER. Lumpectomy margins and much more. Cancer. 1997;79:1453–8 (discussion 9–60).Google Scholar
- 26.Bartelink H, Horiot JC, Poortmans PM, Struikmans H, Van den Bogaert W, Fourquet A, et al. Impact of a higher radiation dose on local control and survival in breast-conserving therapy of early breast cancer: 10-year results of the randomized boost versus no boost EORTC 22881-10882 trial. J Clin Oncol. 2007;25:3259–65.PubMedCrossRefGoogle Scholar
- 28.Chao KK, Vicini FA, Wallace M, Mitchell C, Chen P, Ghilezan M, et al. Analysis of treatment efficacy, cosmesis, and toxicity using the MammoSite breast brachytherapy catheter to deliver accelerated partial-breast irradiation: the William Beaumont Hospital experience. Int J Radiat Oncol Biol Phys. 2007;69:32–40.PubMedCrossRefGoogle Scholar
- 32.Houssami N, Ciatto S, Macaskill P, Lord SJ, Warren RM, Dixon JM, et al. Accuracy and surgical impact of magnetic resonance imaging in breast cancer staging: systematic review and meta-analysis in detection of multifocal and multicentric cancer. J Clin Oncol. 2008;26:3248–58.PubMedCrossRefGoogle Scholar
- 40.Nguyen PL, Taghian AG, Katz MS, Niemierko A, Abi Raad RF, Boon WL, et al. Breast cancer subtype approximated by estrogen receptor, progesterone receptor, and HER-2 is associated with local and distant recurrence after breast-conserving therapy. J Clin Oncol. 2008;26:2373–8.PubMedCrossRefGoogle Scholar
- 42.Haffty BG, Vicini FA, Beitsch P, Quiet C, Keleher A, Garcia D, et al. Timing of chemotherapy after MammoSite radiation therapy system breast brachytherapy: analysis of the American Society of Breast Surgeons MammoSite breast brachytherapy registry trial. Int J Radiat Oncol Biol Phys. 2008;72:1441–8.PubMedCrossRefGoogle Scholar
- 44.Rampinelli C, Bellomi M, Ivaldi GB, Intra M, Raimondi S, Meroni S, et al. Assessment of pulmonary fibrosis after radiotherapy (RT) in breast conserving surgery: comparison between conventional external beam RT (EBRT) and intraoperative RT with electrons (ELIOT). Technol Cancer Res Treat. 2011;10:323–9.PubMedGoogle Scholar