title: Is concurrent radiation therapy required in patients receiving preoperative chemotherapy for adenocarcinoma of the oesophagus? A randomised phase II trial.
abstract: BACKGROUND
  Preoperative chemotherapy (CT) and preoperative chemoradiation therapy (CRT) for resectable oesophageal cancer have been shown to improve overall survival in meta-analyses. There are limited data comparing these preoperative therapies. We report the outcomes of a randomised phase II trial comparing preoperative CT and CRT for resectable adenocarcinoma of the oesophagus and gastro-oesophageal junction.
  
  
  METHODS
  Patients were randomised to receive preoperative CT with cisplatin (80 mg/m(2)) and infusional 5 fluorouracil (1000 mg/m(2)/d) on days 1 and 21, or preoperative CRT with the same drugs accompanied by concurrent radiation therapy commencing on day 21 of chemotherapy and the 5 fluorouracil reduced to 800 mg/m(2)/d. The radiation dose was 35 Gy in 15 fractions over 3 weeks. The endpoints were toxicity, response rates, resection (R) status, progression-free survival (PFS), overall survival (OS) and quality of life.
  
  
  RESULTS
  Seventy-five patients were enrolled on the study: 36 received preoperative CT and 39 preoperative CRT. Toxicity was similar for CT and CRT. Eight patients (11%) did not proceed to resection. The histopathological response rate (CRT 31% versus CT 8%, p = 0.01) and R1 resection rate (CRT 0% versus CT 11%, p = 0.04) favoured those receiving CRT. The median PFS was 14 and 26 months for CT and CRT respectively (p = 0.37). The median OS was 29 months for CT compared with 32 months for CRT (p = 0.83).
  
  
  CONCLUSIONS
  Despite no difference in survival, the improvement from preoperative CRT with respect to margin involvement makes this treatment a reasonable option for bulky, locally advanced resectable adenocarcinoma of the oesophagus.
authors.affiliation: Division of Cancer Services, University of Queensland, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia. Bryan_Burmeister@health.qld.gov.au
authors.forename: Bryan H
authors.initials: BH
authors.lastname: Burmeister
authors.forename: Janine M
authors.initials: JM
authors.lastname: Thomas
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Burmeister
authors.forename: Euan T
authors.initials: ET
authors.lastname: Walpole
authors.forename: Jennifer A
authors.initials: JA
authors.lastname: Harvey
authors.forename: Damien B
authors.initials: DB
authors.lastname: Thomson
authors.forename: Andrew P
authors.initials: AP
authors.lastname: Barbour
authors.forename: David C
authors.initials: DC
authors.lastname: Gotley
authors.forename: B Mark
authors.initials: BM
authors.lastname: Smithers
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000009:adverse effects / Q000379:methods; D009364:Neoplasm Recurrence, Local / Q000209:etiology; D011183:Postoperative Complications / Q000209:etiology; D011878:Radiotherapy / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D002945:Cisplatin; D005472:Fluorouracil