title: Four consecutive multicenter phase II trials of adjuvant chemoradiation in patients with completely resected high-risk gastric cancer: the experience of the German AIO/ARO/CAO group.
abstract: OBJECTIVE
  Feasibility and efficacy of four different adjuvant radiochemotherapy regimens in patients with completely resected gastric cancer were evaluated in consecutive cooperative phase II trials using different 5-fluorouracil (5-FU)-based combination chemotherapies (CTX) and 5-FU-enhanced radiotherapy.
  
  
  METHODS
  Between 2000 and 2005, 157 patients with completely resected gastric adenocarcinoma were included. The study design was based on two cycles of CTX and irradiation with 45 Gy plus concomitant 5-FU 225 mg/m(2) per 24 h between these two cycles. CTX cycles consisted of 5-FU, folinic acid (FA), cisplatin plus paclitaxel (FLPP); 5-FU, FA and cisplatin (FLP); 5-FU, FA and irinotecan (FLI); or 5-FU, cisplatin plus docetaxel (FPD).
  
  
  RESULTS
  Median follow-up for all four trials was 18 months (range, 1-64) without significant difference between the four regimens: FLPP 30 months (2-46+), FLP 18 months (1-64+), FLI 15 months (1-26), FPD 10 months (5-19+). Treatment associated toxicity was tolerable and did not differ significantly between the four CTX regimens. Across all patients grade (3/4), toxicities during the first cycle/chemoradiation/second cycle consisted of leukocytopenia 4%/2%/30%, anorexia 5%/10%/6%, diarrhea 6%/1%/3%, nausea 2%/7%/2%. Early death occurred in one patient due to Pneumocystis carinii pneumonia. Median progression free survival was 23 months for FLPP, 18 months for FLP, 14 months for FLI, 9 months for FPD (not significant). One-year-overall survival rates were 95% for FLPP, 82% for FLP, 94% for FLI, 86% for FPD.
  
  
  CONCLUSIONS
  Adjuvant radiochemotherapy in patients with gastric cancer can be safely given continuous infusion of 5-FU at 225 mg/m(2) per day. In addition, a variety of 5-FU-based multiagent chemotherapy regimen with defined activity in gastric cancer appears both safe and effective when given prior and after radiochemotherapy in this setting.
authors.affiliation: Department of Oncology/Hematology/Bone marrow transplantation/Pneumology, University Medical Center Eppendorf, Martinistr. 52, 20246, Hamburg, Germany. k.oechsle@uke.uni-hamburg.de
authors.forename: Karin
authors.initials: K
authors.lastname: Oechsle
authors.forename: Carsten
authors.initials: C
authors.lastname: Bokemeyer
authors.forename: Jörg T
authors.initials: JT
authors.lastname: Hartmann
authors.forename: Wilfried
authors.initials: W
authors.lastname: Budach
authors.forename: Tanja
authors.initials: T
authors.lastname: Trarbach
authors.forename: Michael
authors.initials: M
authors.lastname: Stahl
authors.forename: Ina
authors.initials: I
authors.lastname: Boehlke
authors.forename: Christian
authors.initials: C
authors.lastname: Kollmannsberger
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use*; D017322:Clinical Trials, Phase II as Topic; D003131:Combined Modality Therapy; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects* / Q000627:therapeutic use*; D005500:Follow-Up Studies; D005743:Gastrectomy; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009367:Neoplasm Staging; D012008:Recurrence; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy / Q000601:surgery*; D016896:Treatment Outcome
chemical_list: D005472:Fluorouracil