title: Phase II Study of a Platinum-Based Adapted Chemotherapy Regimen Combined with Radiotherapy in Patients 75 Years and Older with Esophageal Cancer.
abstract: OBJECTIVE
  The management of elderly patients with cancer is a therapeutic challenge and a public health problem. The aim of this phase II single-arm study was to evaluate the acute toxicities and efficacy of chemoradiotherapy (CRT) comprising a single platinum-based agent combined with radiotherapy in elderly patients with esophageal cancer.
  
  
  METHODS
  Between March 2000 and October 2011, patients aged 75 years and older were prospectively treated with external beam radiotherapy combined with cisplatin or oxaliplatin. Other selection criteria included Eastern Cooperative Oncology Group status 0-2, disease stage II-III, squamous cell carcinoma or adenocarcinoma, and an adequate biological profile. The radiotherapy dose was 50 Gy administered over 5 weeks to the primary tumor and involved lymph nodes. Cisplatin was planned at a dose of 75 mg/m(2) on days 1 and 21 and oxaliplatin at 85 mg/m(2) on days 1, 15, and 29. Treatment was delivered an outpatient setting.
  
  
  RESULTS
  Thirty patients with a mean age of 85.2 (range 79.4-92.0) years were included; 28 completed the treatment. Dysphagia was the only grade 4 toxicity to occur during the study; no grade 5 toxicities were observed. Six weeks after the completion of treatment, 16 patients (53.3%) were in complete response. Two patients in complete response died from pneumonitis 5 and 7 months after CRT. With a 36-month median follow-up, 18 patients died from cancer (nine from local failure, nine from metastasis). Seven patients died from other causes and two patients were alive 40.3 and 56 months after the end of their treatment. Three-year overall survival was 22.2%.
  
  
  CONCLUSIONS
  Selected elderly patients with esophageal cancer and adequate functional status should not be excluded from CRT and may be able to tolerate the treatment with acceptable acute toxicities. However, mid-term efficacy is mediocre. Our data also suggest that the therapeutic ratio or locoregional control might be improved by increasing the radiotherapy dose or by testing new radiosensitizer agents since half of the failures were within the treated volume.
  
  
  BACKGROUND
  EudraCT no. 2009-010113-76.
authors.affiliation: Department of Radiation Oncology, Besançon University Hospital, Besançon, France, stephanie.servagi@gmail.com.
authors.forename: Stéphanie
authors.initials: S
authors.lastname: Servagi-Vernat
authors.forename: Gilles
authors.initials: G
authors.lastname: Créhange
authors.forename: Bernard
authors.initials: B
authors.lastname: Roullet
authors.forename: Valentine
authors.initials: V
authors.lastname: Guimas
authors.forename: Philippe
authors.initials: P
authors.lastname: Maingon
authors.forename: Marc
authors.initials: M
authors.lastname: Puyraveau
authors.forename: Jean François
authors.initials: JF
authors.lastname: Bosset
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D059248:Chemoradiotherapy / Q000009:adverse effects / Q000379:methods; D002945:Cisplatin / Q000009:adverse effects / Q000627:therapeutic use*; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D005260:Female; D006801:Humans; D008297:Male; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D000077150:Oxaliplatin; D011446:Prospective Studies; D012074:Remission Induction
chemical_list: D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D002945:Cisplatin