title: Intraoperative radiation therapy in early breast cancer using a linear accelerator outside of the operative suite: an "image-guided" approach.
abstract: OBJECTIVE
  To present local control, complications, and cosmetic outcomes of intraoperative radiation therapy (IORT) for early breast cancer, as well as technical aspects related to the use of a nondedicated linear accelerator.
  
  
  METHODS
  This prospective trial began in May of 2004. Eligibility criteria were biopsy-proven breast-infiltrating ductal carcinoma, age >40 years, tumor <3 cm, and cN0. Exclusion criteria were in situ or lobular types, multicentricity, skin invasion, any contraindication for surgery and/or radiation therapy, sentinel lymph node involvement, metastasis, or another malignancy. Patients underwent classic quadrantectomy with intraoperative sentinel lymph node and margins evaluation. If both free, the patient was transferred from operative suite to linear accelerator room, and IORT was delivered (21 Gy). Primary endpoint: local recurrence (LR); secondary endpoints: toxicities and aesthetics. Quality assurance involved using a customized shield for chest wall protection, applying procedures to minimize infection caused by patient transportation, and using portal films to check collimator-shield alignment.
  
  
  RESULTS
  A total of 152 patients were included, with at least 1 year follow-up. Median age (range) was 58.3 (40-85.4) years, and median follow-up time was 50.7 (12-110.5) months. The likelihood of 5-year local recurrence was 3.7%. There were 3 deaths, 2 of which were cancer related. The Kaplan-Meier 5-year actuarial estimates of overall, disease-free, and local recurrence-free survivals were 97.8%, 92.5%, and 96.3%, respectively. The overall incidences of acute and late toxicities were 12.5% and 29.6%, respectively. Excellent, good, fair, and bad cosmetic results were observed in 76.9%, 15.8%, 4.3%, and 2.8% of patients, respectively. Most treatments were performed with a 5-cm collimator, and in 39.8% of the patients the electron-beam energy used was ≥12 MeV. All patients underwent portal film evaluation, and the shielding was repositioned in 39.9% of cases. No infection or anesthesia complications were observed.
  
  
  CONCLUSIONS
  Local control with IORT was adequate, with low complication rates and good cosmetic outcomes. More than one-third of patients benefited from the "image-guidance" approach, and almost 40% benefited from the option of higher electron beam energies.
authors.affiliation: Department of Radiation Oncology, Hospital Sirio-Libanes, Sao Paulo, Brazil. Electronic address: samir.hanna@hsl.org.br.
authors.forename: Samir Abdallah
authors.initials: SA
authors.lastname: Hanna
authors.affiliation: Department of Mastology, Hospital Sirio-Libanes, Sao Paulo, Brazil.
authors.forename: Alfredo Carlos Simões Dornellas
authors.initials: ACSD
authors.lastname: de Barros
authors.affiliation: Department of Mastology, Hospital Sirio-Libanes, Sao Paulo, Brazil.
authors.forename: Felipe Eduardo Martins
authors.initials: FEM
authors.lastname: de Andrade
authors.affiliation: Department of Mastology, Hospital Sirio-Libanes, Sao Paulo, Brazil.
authors.forename: Jose Luiz Barbosa
authors.initials: JLB
authors.lastname: Bevilacqua
authors.affiliation: Department of Mastology, Hospital Sirio-Libanes, Sao Paulo, Brazil; Department of Gynecology, Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.
authors.forename: José Roberto Morales
authors.initials: JRM
authors.lastname: Piato
authors.affiliation: Department of Radiation Oncology, Hospital Sirio-Libanes, Sao Paulo, Brazil.
authors.forename: Edilson Lopes
authors.initials: EL
authors.lastname: Pelosi
authors.affiliation: Department of Radiation Oncology, Hospital Perola Byington, Sao Paulo, Brazil.
authors.forename: Eduardo
authors.initials: E
authors.lastname: Martella
authors.affiliation: Department of Radiation Oncology, Hospital Sirio-Libanes, Sao Paulo, Brazil.
authors.forename: João Luis Fernandes
authors.initials: JLF
authors.lastname: da Silva
authors.affiliation: Department of Radiation Oncology, Hospital Sirio-Libanes, Sao Paulo, Brazil; Department of Radiology and Oncology, Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.
authors.forename: Heloisa de Andrade
authors.initials: HA
authors.lastname: Carvalho
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001943:Breast Neoplasms / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D018270:Carcinoma, Ductal, Breast / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007430:Intraoperative Care; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D009873:Operating Rooms; D010315:Particle Accelerators; D011446:Prospective Studies; D011879:Radiotherapy Dosage; D018714:Radiotherapy, Adjuvant / Q000295:instrumentation / Q000379:methods; D061089:Radiotherapy, Image-Guided / Q000295:instrumentation* / Q000379:methods