title: Biweekly fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) for patients with metastatic adenocarcinoma of the stomach or esophagogastric junction: a phase II trial of the Arbeitsgemeinschaft Internistische Onkologie.
abstract: BACKGROUND
  The combination of docetaxel (Taxotere), cisplatin, and fluorouracil improved efficacy in gastric cancer, but was associated with substantial toxicity. This study was designed to incorporate docetaxel into a tolerable biweekly (once every 2 weeks) oxaliplatin-based chemotherapy regimen.
  
  
  METHODS
  Patients with measurable, metastatic adenocarcinoma of the stomach or esophagogastric junction and no prior chemotherapy received oxaliplatin 85 mg/m(2), leucovorin 200 mg/m(2), and fluorouracil 2600 mg/m(2) as a 24-h infusion in combination with docetaxel 50 mg/m(2) (FLOT) on day 1 every 2 weeks. Prophylactic growth factors were not administered.
  
  
  RESULTS
  Fifty-nine patients were enrolled; 54 received treatment. Patients had a median age of 60 years (range 29-76) and most (93%) of them had metastatic disease. Objective responses were observed in 57.7% of patients with a median time to treatment response of 1.54 months. Median progression-free survival (PFS) and overall survival were 5.2 and 11.1 months, respectively. Twenty-five percent of patients experienced prolonged (>12 months) PFS. Frequent (>10%) grade 3 or 4 toxic effects included neutropenia in 26 (48.1%), leukopenia in 15 (27.8%), diarrhea in 8 (14.8%), and fatigue in 6 (11.1%) patients. Complicated neutropenia was observed in two (3.8%) patients, only.
  
  
  CONCLUSIONS
  Biweekly FLOT is active and has a favorable safety profile.
authors.affiliation: Klinik für Onkologie und Hämatologie, Krankenhaus Nordwest, Frankfurt, Germany. albatran@aol.com
authors.forename: S-E
authors.initials: SE
authors.lastname: Al-Batran
authors.forename: J T
authors.initials: JT
authors.lastname: Hartmann
authors.forename: R
authors.initials: R
authors.lastname: Hofheinz
authors.forename: N
authors.initials: N
authors.lastname: Homann
authors.forename: V
authors.initials: V
authors.lastname: Rethwisch
authors.forename: S
authors.initials: S
authors.lastname: Probst
authors.forename: J
authors.initials: J
authors.lastname: Stoehlmacher
authors.forename: M R
authors.initials: MR
authors.lastname: Clemens
authors.forename: R
authors.initials: R
authors.lastname: Mahlberg
authors.forename: M
authors.initials: M
authors.lastname: Fritz
authors.forename: G
authors.initials: G
authors.lastname: Seipelt
authors.forename: M
authors.initials: M
authors.lastname: Sievert
authors.forename: C
authors.initials: C
authors.lastname: Pauligk
authors.forename: A
authors.initials: A
authors.lastname: Atmaca
authors.forename: E
authors.initials: E
authors.lastname: Jäger
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D018572:Disease-Free Survival; D000077143:Docetaxel; D004334:Drug Administration Schedule; D004938:Esophageal Neoplasms / Q000188:drug therapy*; D004943:Esophagogastric Junction / Q000473:pathology*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D000077150:Oxaliplatin; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D009944:Organoplatinum Compounds; D043823:Taxoids; D000077150:Oxaliplatin; D000077143:Docetaxel; D002955:Leucovorin; D005472:Fluorouracil