title: The pilot trial on intraoperative radiotherapy with electrons (ELIOT): update on the results.
abstract: 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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Division of Breast Surgery, University of Milan, Milan, Italy. alberto.luini@ieo.it
authors.forename: Alberto
authors.initials: A
authors.lastname: Luini
authors.forename: Roberto
authors.initials: R
authors.lastname: Orecchia
authors.forename: Giovanna
authors.initials: G
authors.lastname: Gatti
authors.forename: Mattia
authors.initials: M
authors.lastname: Intra
authors.forename: Mario
authors.initials: M
authors.lastname: Ciocca
authors.forename: Viviana
authors.initials: V
authors.lastname: Galimberti
authors.forename: Paolo
authors.initials: P
authors.lastname: Veronesi
authors.forename: Gabriela Rosali Dos
authors.initials: GR
authors.lastname: Santos
authors.forename: Daniela
authors.initials: D
authors.lastname: Gilardi
authors.forename: Umberto
authors.initials: U
authors.lastname: Veronesi
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001943:Breast Neoplasms / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery*; D005260:Female; D006801:Humans; D007432:Intraoperative Period; D015412:Mastectomy, Segmental / Q000379:methods*; D008875:Middle Aged; D010865:Pilot Projects; D011829:Radiation Dosage; D018714:Radiotherapy, Adjuvant / Q000009:adverse effects / Q000379:methods; D016896:Treatment Outcome