title: Adjuvant chemoradiation using 5-fluorouracil/folinic acid/cisplatin with or without paclitaxel and radiation in patients with completely resected high-risk gastric cancer: two cooperative phase II studies of the AIO/ARO/ACO.
abstract: BACKGROUND
  The current two studies evaluate the feasibility, toxicity and efficacy of an adjuvant combined modality treatment strategy containing a three to four-drug chemotherapy regimen plus 5-fluorouracil (FU)-based radiochemotherapy.
  
  
  METHODS
  Between December 2000 and October 2003, a total of 86 patients were included in both studies. Patients with completely resected gastric adenocarcinoma including a D1 or D2 lymph node dissection (LND) were eligible. Treatment consisted of two cycles of folinic acid 500 mg/m2, 5-FU 2000 mg/m2 continuous infusion over 24 h once weekly for 6 consecutive weeks, paclitaxel 175 mg/m2 in weeks 1 and 4 and cisplatin 50 mg/m2 in weeks 2 and 5 (FLPP; n=41) or two cycles of the same 5-FU/folinic acid schedule but with cisplatin 50 mg/m2 only in weeks 1, 3 and 5 (FLP; n=45). Radiation with 45 Gy plus concomitantly applied 5-FU 225 mg/m2/24 h was scheduled in between the two cycles.
  
  
  RESULTS
  Patients characteristics were: D1/D2 LND FLP group 53%/42%; FLPP group 27%/68%; stage distribution: UICC stages III/IV(M0) FLP group 63% and FLPP group 66%. Median follow-up was 10 months (3-25) for FLP and 18 months (2-51) for FLPP patients. CTC grade 3/4 toxicities during the first cycle/chemoradiation/second cycle of FLP: granulocytopenia 3%/0/27%, anorexia 6%/10%/8%; diarrhea 8%/0/4%, nausea 3%/0/4%; FLPP: granulocytopenia 0/0/37%, anorexia 5%/11%/6%; diarrhea 5%/0/3, nausea 3%/8%/0%; early death in one patient due to Pneumocystis carinii pneumonia. Projected 2-year progression-free survival was 64% (95% CI 56% to 68%) for the FLP and 61% (95% CI 42% to 78%) for the FLPP group.
  
  
  CONCLUSIONS
  Both chemoradiation regimens appear feasible with an acceptable toxicity profile indicating that cisplatin can be added to 5-FU/FA and that even a four-drug regimen can be investigated further in prospective clinical trials in completely resected gastric cancer patients. Treatment should be given in experienced centres in order to avoid unnecessary toxicity.
authors.affiliation: Department of Hematology/Oncology, Department of Radiation Oncology, University of Tuebingen, Tuebingen.
authors.forename: C
authors.initials: C
authors.lastname: Kollmannsberger
authors.forename: W
authors.initials: W
authors.lastname: Budach
authors.forename: M
authors.initials: M
authors.lastname: Stahl
authors.forename: N
authors.initials: N
authors.lastname: Schleucher
authors.forename: T
authors.initials: T
authors.lastname: Hehr
authors.forename: H
authors.initials: H
authors.lastname: Wilke
authors.forename: J
authors.initials: J
authors.lastname: Schleicher
authors.forename: U
authors.initials: U
authors.lastname: Vanhoefer
authors.forename: E C
authors.initials: EC
authors.lastname: Jehle
authors.forename: K
authors.initials: K
authors.lastname: Oechsle
authors.forename: T
authors.initials: T
authors.lastname: Trarbach
authors.forename: I
authors.initials: I
authors.lastname: Boehlke
authors.forename: L
authors.initials: L
authors.lastname: Kanz
authors.forename: J T
authors.initials: JT
authors.lastname: Hartmann
authors.forename: C
authors.initials: C
authors.lastname: Bokemeyer
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000532:radiotherapy* / Q000556:secondary; D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D005240:Feasibility Studies; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008197:Lymph Node Excision; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage; D018714:Radiotherapy, Adjuvant; D012307:Risk Factors; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D015996:Survival Rate
chemical_list: D017239:Paclitaxel; D002945:Cisplatin; D002955:Leucovorin; D005472:Fluorouracil