A Japanese prospective multi-institutional feasibility study on accelerated partial breast irradiation using interstitial brachytherapy: clinical results with a median follow-up of 26 months
A Japanese prospective multi-institutional feasibility study on accelerated partial breast irradiation using interstitial brachytherapy was performed. The first clinical results were reported with a median follow-up of 26 months.
Patients and methods
Forty-six female breast cancer patients with positive hormone receptors and tumors ≤3 cm, pN0M0, completed the protocol treatment. After breast-conserving surgery and histological confirmation of negative surgical margins and pN0, brachytherapy applicators were implanted either postoperatively (n = 45) or intraoperatively (n = 1). High-dose-rate brachytherapy of 36 Gy/6 fractions was delivered. All clinical data were prospectively collected using case report forms and the Common Terminology Criteria for Adverse Events ver.3.0.
At the median follow-up of 26 months, no breast cancer recurrence of any type was observed. Sequelae ≥G2 were dermatitis (G2, 7 %), fibrosis (G2, 11 %; G3, 4 %), fracture (G2, 2 %), pain (G2, 7 %; G3, 2 %), and soft tissue necrosis (G2, 6 %). Cosmetic outcomes evaluated by excellent/good scores were 100 % at pre-therapy (n = 46), 94 % at 12 months (n = 46), and 81 % at 24 months (n = 36), respectively.
Disease control and sequelae were satisfactory due to the strict eligibility and protocol-defined treatment parameters. The cosmetic outcomes were comparable to those of previous Japanese breast-conserving therapy series.
KeywordsAccelerated partial breast irradiation Breast cancer Radiotherapy Brachytherapy
This study was supported in part by Grants-in-Aid for Cancer Research from the Ministry of Health, Labour and Welfare of the Government of Japan (17-10 and 21-8-2) and also by the Project for Development of Innovative Research on Cancer Therapeutics (P-DIRECT) from the Japan Agency for Medical Research and Development (AMED).
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflict of interest.
- 1.NSABP protocol B-39/RTOG protocol 0413. A randomized phase III study of conventional whole breast irradiation (WBI) versus partial breast irradiation (PBI) for women with stage 0, I, II breast cancer. http://rpc.mdanderson.org/rpc/credentialing/files/B39_Protocol1.pdf. Accessed 10 July 2012.
- 2.European brachytherapy breast cancer GEC-ESTRO working group. Phase III multicenter trial. Interstitial brachytherapy alone versus external beam radiation therapy after breast conserving surgery for low risk invasive carcinoma and low risk duct carcinoma in situ (DCIS) of the female breast. https://www.apbi.uni-erlangen.de/outline/EUROPEAN_BRACHYTHERAPY_PHASE_III_Trial_final_Edition_2004.pdf. Accessed 10 July 2012.
- 4.Ohtake T, Abe R, Kimijima I, Fukushima T, Tsuchiya A, Hoshi K, et al. Intraductal extension of primary invasive breast carcinoma treated by breast-conserving surgery. Computer graphic three-dimensional reconstruction of the mammary duct-lobular systems. Cancer. 1995;76:32–45.CrossRefPubMedGoogle Scholar
- 6.Wazer DE, Kaufman S, Cuttino L, DiPetrillo T, Arthur DW. Accelerated partial breast irradiation: an analysis of variables associated with late toxicity and long-term cosmetic outcome after high-dose-rate interstitial brachytherapy. Int J Radiat Oncol Biol Phys. 2006;64:489–95.CrossRefPubMedGoogle Scholar
- 8.Lovey K, Fodor J, Major T, Szabo E, Orosz Z, Sulyok Z, et al. Fat necrosis after partial-breast irradiation with brachytherapy or electron irradiation versus standard whole-breast radiotherapy-4-year results of a randomized trial. Int J Radiat Oncol Biol Phys. 2007;69:724–31.CrossRefPubMedGoogle Scholar
- 10.Otani Y, Nose T, Dokiya T, Saeki T, Kumazaki Y, Asahi S, et al. A Japanese prospective multi-institutional feasibility study on accelerated partial breast irradiation using interstitial brachytherapy: treatment planning and quality assurance. Radiat Oncol. 2015;10:126–32.CrossRefPubMedPubMedCentralGoogle Scholar
- 12.Ott OJ, Hildebrandt G, Poetter R, Hammer J, Lotter M, Resch A, et al. Accelerated partial breast irradiation with multi-catheter brachytherapy: local control, side effects and cosmetic outcome for 274 patients. Results of the German-Austrian multi-centre trial. Radiother Oncol. 2007;82:281–6.CrossRefPubMedGoogle Scholar
- 17.Polgar C, Sulyok Z, Fodor J, Orosz Z, Major T, Takacsi-Nagy Z, et al. Sole brachytherapy of the tumor bed after conservative surgery for T1 breast cancer: 5-year results of a phase I–II study and initial findings of a randomized phase III trial. J Surg Oncol. 2002;80:121–8.CrossRefPubMedGoogle Scholar
- 19.Nose T, Komoike Y, Yoshida K, Koizumi M, Motomura K, Kasugai T, et al. A pilot study of wider use of accelerated partial breast irradiation: intraoperative margin-directed re-excision combined with sole high-dose-rate interstitial brachytherapy. Breast Cancer. 2006;13:289–99.CrossRefPubMedGoogle Scholar
- 21.Smith GL, Xu Y, Buchholz TA, Giordano SH, Jiang J, Shih YT, et al. Association between treatment with brachytherapy versus whole-breast irradiation and subsequent mastectomy, complications, and survival among older women with invasive breast cancer. JAMA. 2012;307:1827–37.PubMedPubMedCentralGoogle Scholar