title: GERICO-03 phase II trial of accelerated and partial breast irradiation in elderly women: feasibility, reproducibility, and impact on functional status.
abstract: OBJECTIVE
  To analyze the feasibility, reproducibility, and impact on functional status of postoperative accelerated and partial breast irradiation (APBI) using interstitial high-dose rate-brachytherapy in women older than 70 years.
  
  
  METHODS
  From July 2004 to April 2008, 46 patients were screened for enrollment in a nationwide prospective Phase II trial. A total of 40 patients were eligible according to the inclusion criteria (aged >70 years, T1-2 <30mm, and pN0). The total delivered dose was 34Gy of 10 fractions for 5 days. Feasibility and reproducibility were evaluated using a Quality Index (QI) defined as (V100%-clinical target volume)/V100%. Skin toxicity was reported using Common Terminology Criteria for Adverse Events version 3.0. ABPI impact on functional dependence was evaluated using the Activity of Daily Living and Instrumental Activity of Daily Living scales. Reproducibility and feasibility were assessed with the optimal two-stage design of Simon.
  
  
  RESULTS
  Median age was 74 years (70-87 years). All patients were treated according to the protocol. Median Quality Index calculated for the 40 eligible patients was 13.3% (1-70%). It was considered acceptable, partially acceptable, and nonacceptable in 10, 28, and 2 patients, respectively. Within 12 months after APBI, overall rates of toxicity were 59%, 28%, and 2% for Grade 1, 2, and 3 events, respectively. Twelve months after APBI, 35 patients (87%) achieved excellent/good cosmetic result. Compared with baseline values, Activity of Daily Living and Instrumental Activity of Daily Living scores remained unchanged 6 and 12 months after APBI.
  
  
  CONCLUSIONS
  APBI by means of high-dose rate-brachytherapy is a feasible/reproducible technique without significant impact on functional dependence in the treatment of elderly women with early breast cancer.
authors: Department of Radiotherapy, Antoine Lacassagne Center, Nice, France; University of Nice-Sophia, Italy. jean-michel.hannoun-levi@nice.unicancer.fr
authors: Jean-Michel
authors: JM
authors: Hannoun-Levi
authors: Sophie
authors: S
authors: Gourgou-Bourgade
authors: Yazid
authors: Y
authors: Belkacemi
authors: Claire
authors: C
authors: Chara-Bruneau
authors: Christophe
authors: C
authors: Hennequin
authors: Philippe
authors: P
authors: Quetin
authors: Christine
authors: C
authors: Orsini
authors: Etienne
authors: E
authors: Brain
authors: Hugo
authors: H
authors: Marsiglia
mesh_terms: D000203:Activities of Daily Living; D000368:Aged; D000369:Aged, 80 and over; D001918:Brachytherapy / Q000009:adverse effects / Q000379:methods*; D001943:Breast Neoplasms / Q000532:radiotherapy* / Q000628:therapy; D003131:Combined Modality Therapy; D005260:Female; D015577:Geriatric Assessment; D006801:Humans; D015412:Mastectomy, Segmental; D009364:Neoplasm Recurrence, Local; D017060:Patient Satisfaction; D011446:Prospective Studies; D011879:Radiotherapy Dosage; D015203:Reproducibility of Results