title: Docetaxel, oxaliplatin and capecitabine (TEX regimen) in patients with metastatic gastric or gastro-esophageal cancer: results of a multicenter phase I/II study.
abstract: Three drug taxane-based regimens have shown activity in patients with metastatic or locally advanced gastric or gastro-esophageal cancer (GC/GEC). Limited tolerability of these regimens warrants treatment modification, particularly in regard of the proven equivalence of oxaliplatin and cisplatin as well as capecitabine and 5FU. Thus, a regimen with docetaxel (T), oxaliplatin (E) and capecitabine (X) was established and evaluated.
  
  
  METHODS
  Patients with metastatic or locally advanced GC/GEC, adequate organ function, ECOG PS 0-2 were enrolled. TEX regimen was administered as defined by the phase I trial with T 35 mg/m(2) and E 70 mg/m(2) on days (d) 1, 8 and X 800 mg/m(2) bid on d 1-14 every 22 days. Primary endpoint was progression free survival (PFS) rate after 6 months.
  
  
  RESULTS
  Altogether 70 patients (15 phase I; 55 phase II) were eligible for analysis. Results of the phase II part were as follows: most common grade toxicities diarrhea (30%), nausea/vomiting and infections, PFS rate after 6 months 56.3%, response rate 43%, median PFS 6.9 and overall survival 13 months, respectively.
  
  
  CONCLUSIONS
  The TEX regimen show similar efficacy compared to other infusional 5FU-based taxane and platinum containing triplets, but the reduced tolerability, in particular grade 3 diarrhea, limits the feasibility.
authors.affiliation: Hubertus Wald Tumor Center, University Cancer Center Hamburg, Department of Oncology, Hematology, BMT with Section Pneumology, University Medical Center Hamburg-Eppendorf , Hamburg , Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Stein
authors.forename: Dirk
authors.initials: D
authors.lastname: Arnold
authors.forename: Peter C
authors.initials: PC
authors.lastname: Thuss-Patience
authors.forename: Markus
authors.initials: M
authors.lastname: Moehler
authors.forename: Wilfried
authors.initials: W
authors.lastname: Grothe
authors.forename: Thomas
authors.initials: T
authors.lastname: Seufferlein
authors.forename: Anke
authors.initials: A
authors.lastname: Reinacher-Schick
authors.forename: Michael
authors.initials: M
authors.lastname: Geissler
authors.forename: Ralf-Dieter
authors.initials: RD
authors.lastname: Hofheinz
authors.forename: Hans-Joachim
authors.initials: HJ
authors.lastname: Schmoll
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use*; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D000077143:Docetaxel; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000401:mortality; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D009944:Organoplatinum Compounds; D043823:Taxoids; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000077143:Docetaxel; D000069287:Capecitabine; D005472:Fluorouracil