title: Phase III trial in metastatic gastroesophageal adenocarcinoma with fluorouracil, leucovorin plus either oxaliplatin or cisplatin: a study of the Arbeitsgemeinschaft Internistische Onkologie.
abstract: OBJECTIVE
  This study was designed to compare fluorouracil, leucovorin, and oxaliplatin with fluorouracil, leucovorin, and cisplatin in patients with advanced gastric cancer.
  
  
  METHODS
  Patients with previously untreated advanced adenocarcinoma of the stomach or esophagogastric junction were randomly assigned to receive either fluorouracil 2,600 mg/m(2) via 24-hour infusion, leucovorin 200 mg/m(2), and oxaliplatin 85 mg/m(2) (FLO) every 2 weeks or fluorouracil 2,000 mg/m(2) via 24-hour infusion, leucovorin 200 mg/m(2) weekly, and cisplatin 50 mg/m(2) every 2 weeks (FLP). The primary end point was progression-free survival (PFS).
  
  
  RESULTS
  Two hundred twenty patients (median age, 64 years; metastatic, 94%) were randomly assigned. FLO was associated with significantly less (any grade) anemia (54% v 72%), nausea (53% v 70%), vomiting (31% v 52%), alopecia (22% v 39%), fatigue (19% v 34%), renal toxicity (11% v 34%), thromboembolic events (0.9% v 7.8%), and serious adverse events related to the treatment (9% v 19%). FLP was associated with significantly less peripheral neuropathy (22% v 63%). There was a trend toward improved median PFS with FLO versus FLP (5.8 v 3.9 months, respectively; P = .077) and no significant difference in median overall survival (10.7 v 8.8 months, respectively). However, in patients older than 65 years (n = 94), treatment with FLO resulted in significantly superior response rates (41.3% v 16.7%; P = .012), time to treatment failure (5.4 v 2.3 months; P < .001), and PFS (6.0 v 3.1 month; P = .029) and an improved OS (13.9 v 7.2 months) as compared with FLP, respectively.
  
  
  CONCLUSIONS
  FLO reduced toxicity as compared with FLP. In older adult patients, FLO also seemed to be associated with improved efficacy.
authors: Department of Hematology and Oncology, Krankenhaus Nordwest, Frankfurt, Germany. albatran@aol.com
authors: Salah-Eddin
authors: SE
authors: Al-Batran
authors: Joerg Thomas
authors: JT
authors: Hartmann
authors: Stephan
authors: S
authors: Probst
authors: Harald
authors: H
authors: Schmalenberg
authors: Stephan
authors: S
authors: Hollerbach
authors: Ralf
authors: R
authors: Hofheinz
authors: Volker
authors: V
authors: Rethwisch
authors: Gernot
authors: G
authors: Seipelt
authors: Nils
authors: N
authors: Homann
authors: Gerhard
authors: G
authors: Wilhelm
authors: Gunter
authors: G
authors: Schuch
authors: Jan
authors: J
authors: Stoehlmacher
authors: Hans Günter
authors: HG
authors: Derigs
authors: Susanna
authors: S
authors: Hegewisch-Becker
authors: Johannes
authors: J
authors: Grossmann
authors: Claudia
authors: C
authors: Pauligk
authors: Akin
authors: A
authors: Atmaca
authors: Carsten
authors: C
authors: Bokemeyer
authors: Alexander
authors: A
authors: Knuth
authors: Elke
authors: E
authors: Jäger
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D004334:Drug Administration Schedule; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D004943:Esophagogastric Junction / Q000473:pathology; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D005858:Germany; D006801:Humans; D053208:Kaplan-Meier Estimate; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D000077150:Oxaliplatin; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016896:Treatment Outcome
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D002945:Cisplatin; D002955:Leucovorin; D005472:Fluorouracil