Focalized intraoperative irradiation after conservative surgery for early-stage breast cancer

At the European Institute of Oncology we are evaluating intraoperative elec tron-beam radiation therapy (IOERT) as a sole modality of radiation in sele cted patients with early-stage breast cancer. Three clinical phases have be en developed: a dose-escalation study in order to define the maximum tolera ble dose of IOERT, a phase II study in order to assess toxicity. and a pers pective randomized study which compares standard treatment to IOERT. From J uly 1999 to February 2001 more than 140 patients have been treated. The IOE RT dose of 21 Gy has been reached without severe acute side-effects. Since November 2000. patients with breast cancer up to 2.5 cm diameter. aged more than 48 years. unifocal lesion not close to the skin and not located in th e high axillary tail, are randomized to receive. after quadrantectomy, a do se of 21 Gy to the index quadrant or the standard external radiation regime n. (C) 2001 Harcourt Publishers Ltd.