title: Audit of postoperative chemoradiotherapy as adjuvant therapy for resected gastroesophageal adenocarcinoma: an Australian multicentre experience.
abstract: BACKGROUND
  Improved disease free and overall survivals were seen in curatively resected patients with gastric and gastroesophageal adenocarcinoma treated with the Intergroup 0116 (INT 0116) protocol of postoperative adjuvant chemoradiotherapy compared to surgery alone. This protocol has not been widely adopted in Australian centres because of perceived risks of toxicity.
  
  
  METHODS
  We reviewed the case records from 45 consecutive patients treated between May 1998 and August 2003 with the INT 0116 protocol and variations at five Australian institutions. The median age was 61.5 years (range 38-79). Twenty-nine patients had gastric and 12 had gastroesophageal junction primaries. All patients had attempted curative resection, however, seven had involved microscopic margins (R1 resection). Thirty-five had regional node involvement and none had evidence of distant metastasis.
  
  
  RESULTS
  The overall National Cancer Institute-Common Toxicity Criteria (NCI-CTC) version 2.0 grade 3 and grade 4 toxicity rates for all patients were 37.8% and 4.4%, respectively. There were no treatment related deaths. Gastrointestinal grade 3 toxicity was observed in 20% of patients, while haematologic grade 3 and 4 toxicity was observed in 17.8%. Toxicities experienced led to chemotherapy dose reductions in 22 patients and dose delay in 11 patients. Seven patients had a delay in radiotherapy and two did not proceed with radiotherapy. At a median follow up of 16 months (range 5-35) from surgery, 28 patients have relapsed (six with local recurrence alone) with 22 deaths occurring, all but one caused by cancer.
  
  
  CONCLUSIONS
  The INT 0116 protocol is a safe and feasible schedule in a multicentre setting with an acceptable rate of toxicity and is an appropriate adjuvant treatment option for high-risk resected gastroesophageal adenocarcinoma.
authors.affiliation: Medical Oncology Unit, The Canberra Hospital, Canberra, ACT, Australia.
authors.forename: Brett G M
authors.initials: BG
authors.lastname: Hughes
authors.forename: Desmond
authors.initials: D
authors.lastname: Yip
authors.forename: Michael
authors.initials: M
authors.lastname: Chao
authors.forename: Peter
authors.initials: P
authors.lastname: Gibbs
authors.forename: Susan
authors.initials: S
authors.lastname: Carroll
authors.forename: David
authors.initials: D
authors.lastname: Goldstein
authors.forename: Bryan
authors.initials: B
authors.lastname: Burmeister
authors.forename: Christos
authors.initials: C
authors.lastname: Karapetis
mesh_terms: D000230:Adenocarcinoma / Q000601:surgery* / Q000628:therapy; D001315:Australia; D017024:Chemotherapy, Adjuvant / Q000009:adverse effects; D018572:Disease-Free Survival; D004938:Esophageal Neoplasms / Q000601:surgery* / Q000628:therapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008485:Medical Audit; D008875:Middle Aged; D011182:Postoperative Care; D018714:Radiotherapy, Adjuvant / Q000009:adverse effects; D012189:Retrospective Studies; D013274:Stomach Neoplasms / Q000601:surgery* / Q000628:therapy; D013997:Time Factors