Background: Intraoperative radiotherapy with electrons (ELIOT) is under evaluation in the conservative treatment of breast carcinoma. At the European Institute of Oncology we started our study on ELIOT in 1999; the first step has been a phase I-II trial to test feasibility and tolerance of ELIOT in patients candidate to breast conserving surgery.
Patients and methods: From July 1999 to September 2000, 101 patients affected by unifocal breast carcinoma up to a diameter of 2.5 cm received wide resection of the breast followed by ELIOT. The trial was based on a dose-escalation starting from 10 Gy: we tested the dose-levels of 10, 15, 17, 19 and 21 Gy. The dose-levels of 10 and 15 Gy were followed by a reduced course of external fractionated radiotherapy. Most patients received 21 Gy intraoperatively. Patients were evaluated 1, 3, 6 and 12 months after surgery, and thereafter every 6 months, to look for early, intermediate, late complications, and other events.
Results: After a mean follow-up of 42 months, 16 patients (16%) developed breast fibrosis, mild in 15, severe in one, which resolved within 24 months. Two patients suffered of postoperative infection, and four developed a lyponecrosis in the treated area.
Conclusion: The first group of patients treated with ELIOT in the phase I-II trial are confirming the good impact of the procedure in terms of tolerance and quality of life.