Two prospective, randomized trials, TARGIT-A and ELIOT, have shown intraoperative radiation therapy to be a safe alternative, with a low-risk of local recurrence, compared with whole breast radiation therapy, following breast-conserving surgery, for selected low-risk patients. We report the first 1000 tumors treated with this modality at our facility.
A total of 1000 distinct breast cancers in 984 patients (16 bilateral) were treated with breast conserving surgery and X-ray IORT from June 2010 to August 2017. Patients were enrolled in an IORT registry trial. Local recurrence was the primary endpoint.
There have been 28 ipsilateral local recurrences, ten DCIS and 18 invasive. Four local recurrences were within the IORT field, 13 outside of the IORT field but within the same quadrant as the index cancer, and 11 were new cancers in different quadrants. There have been four regional nodal recurrences and one distant recurrence. There have been no breast cancer related deaths and 14 non-breast cancer deaths. With a median follow-up of 36 months, Kaplan–Meier analysis projects 3.9% of patients will recur locally at 4 years. This includes all ipsilateral events in all quadrants.
The local, regional, and distant recurrence rates observed in this trial were comparable to those of the prospective randomized TARGIT-A and ELIOT trials. The low complication rates previously reported by our group as well as the low recurrence rates reported in this study support the cautious use and continued study of X-ray IORT in women with low-risk breast cancer.
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Harris EER, Small W Jr. Intraoperative radiotherapy for breast cancer. Front Oncol. 2017;7:317.
Polgar C, Fodor J, Major T, Sulyok Z, Kasler M. Breast-conserving therapy with partial or whole breast irradiation: ten-year results of the Budapest randomized trial. Radiother Oncol. 2013;108(2):197–202.
Vaidya JS, Joseph DJ, Tobias JS, et al. Targeted intraoperative radiotherapy versus whole breast radiotherapy for breast cancer (TARGIT-A trial): an international, prospective, randomised, non-inferiority phase 3 trial. Lancet. 2010;376(9735):91–102.
Corica T, Nowak A, Saunders C, et al. Cosmesis and breast-related quality of life outcomes after intraoperative radiation therapy for early breast cancer: a substudy of the TARGIT-A Trial. Int J Radiat Oncol. 2016;96(1):55–64.
Vaidya J, Wenz F, Bulsara M, et al. Risk-adapted targeted intraoperative radiotherapy versus whole-breast radiotherapy for breast cancer: 5-year results for local control and overall survival from the TARGIT-A randomised trial. Lancet. 2014;383:603–13.
Veronesi U, Orecchia R, Maisonneuve P, et al. Intraoperative radiotherapy versus external radiotherapy for early breast cancer (ELIOT): a randomised controlled equivalence trial. Lancet Oncol. 2013;14(13):1269–77.
Silverstein MJ, Fastner G, Maluta S, et al. Intraoperative radiation therapy: a critical analysis of the ELIOT and TARGIT trials. Part 1–ELIOT. Ann Surg Oncol. 2014;21(12):3787–92.
Silverstein MJ, Fastner G, Maluta S, et al. Intraoperative radiation therapy: a critical analysis of the ELIOT and TARGIT trials. Part 2–TARGIT. Ann Surg Oncol. 2014;21(12):3793–9.
Correa C, Harris EE, Leonardi MC, et al. Accelerated Partial Breast Irradiation: Executive summary for the update of an ASTRO Evidence-Based Consensus Statement. Pract Radiat Oncol. 2017;7(2):73–9.
Epstein M, Silverstein M, Lin K, et al. (2016) Acute and chronic complications in breast cancer patients treated with intraoperative radiation therapy. Ann Surg Oncol; 23:3304–3309.
Vaidya JS, Wenz F, Bulsara M, et al. An international randomised controlled trial to compare TARGeted Intraoperative radioTherapy (TARGIT) with conventional postoperative radiotherapy after breast-conserving surgery for women with early-stage breast cancer (the TARGIT-A trial). Health Technol Assess. 2016;20(73):1–188.
Silverstein MJ, Epstein MS, Lin K, et al. Intraoperative radiation using low-kilovoltage x-rays for early breast cancer: a single site trial. Ann Surg Oncol. 2017;24(10):3082–7.
Giuliano AE, Connolly JL, Edge SB, et al. Breast cancer: major changes in the American Joint Committee on Cancer eighth edition cancer staging manual. CA Cancer J Clin. 2017;67(4):290-303
Hensley FW. Present state and issues in IORT physics. Radiat Oncol. 2017;12(1):37.
Francis A, Fallowfield L, Rea D. The LORIS Trial: addressing overtreatment of ductal carcinoma in situ. Clin Oncol (R Coll Radiol). 2015;27(1):6–8.
Elshof LE, Tryfonidis K, Slaets L, et al. Feasibility of a prospective, randomised, open-label, international multicentre, phase III, non-inferiority trial to assess the safety of active surveillance for low risk ductal carcinoma in situ—the LORD study. Eur J Cancer. 2015;51(12):1497–510.
Youngwirth LM, Boughey JC, Hwang ES. Surgery versus monitoring and endocrine therapy for low-risk DCIS: The COMET Trial. Bull Am Coll Surg. 2017;102(1):62–3.
Fastner G, Sedlmayer F, Merz F, et al. IORT with electrons as boost strategy during breast conserving therapy in limited stage breast cancer: long term results of an ISIORT pooled analysis. Radiother Oncol. 2013;108(2):279–86.
Lemanski C, Azria D, Thezenas S, et al. Intraoperative radiotherapy given as a boost for early breast cancer: long-term clinical and cosmetic results. Int J Radiat Oncol Biol Phys. 2006;64(5):1410–5.
Vaidya JS, Tobias JS. Targeted intraoperative radiotherapy tumour bed boost during breast-conserving surgery after neoadjuvant chemotherapy. Breast Care (Basel). 2017;12(5):314–6.
Veronesi U, Banfi A, Salvadori B, et al. Breast conservation is the treatment of choice in small breast cancer: long-term results of a randomized trial. Eur J Cancer. 1990;26:668–70.
Veronesi U, Saccozzi R, Del Vecchio M, et al. Comparing radical mastectomy with quadrantectomy, axillary dissection and radiotherapy in patients with small cancers of the breast. N Engl J Med. 1981;305:6–10.
Veronesi U, Cascinelli N, Mariani L, et al. Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer. N Engl J Med. 2002;347:1227–32.
Athas WF, Adams-Cameron M, Hunt WC, Amir-Fazli A, Key CR. Travel distance to radiation therapy and receipt of radiotherapy following breast-conserving surgery. J Natl Cancer Inst. 2000;92(3):269–71.
Ballard-Barbash R, Potosky AL, Harlan LC, Nayfield SG, Kessler LG. Factors associated with surgical and radiation therapy for early stage breast cancer in older women. J Natl Cancer Inst. 1996;88(11):716–26.
The authors thank Cristina De Leon, R.N., January Lopez, M.D., and Ralph MacKintosh, Ph.D. for their contribution to this study.
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Silverstein, M.J., Epstein, M., Kim, B. et al. Intraoperative Radiation Therapy (IORT): A Series of 1000 Tumors. Ann Surg Oncol 25, 2987–2993 (2018). https://doi.org/10.1245/s10434-018-6614-3
- Intraoperative Radiation Therapy (IORT)
- Whole Breast Irradiation (WBRT)
- IORT Field
- Ductal Carcinoma In Situ (DCIS)
- Regional Nodal Recurrences