title: Capecitabine plus oxaliplatin (CapOx) versus capecitabine plus gemcitabine (CapGem) versus gemcitabine plus oxaliplatin (mGemOx): final results of a multicenter randomized phase II trial in advanced pancreatic cancer.
abstract: BACKGROUND
  To compare the efficacy and safety of three different chemotherapy doublets in the treatment of advanced pancreatic cancer (PC).
  
  
  METHODS
  At total of 190 patients were randomly assigned to receive capecitabine 1000 mg/m(2) twice daily on days 1-14 plus oxaliplatin 130 mg/m(2) on day 1 (CapOx), capecitabine 825 mg/m(2) twice daily on days 1-14 plus gemcitabine 1000 mg/m(2) on days 1 and 8 (CapGem) or gemcitabine 1000 mg/m(2) on days 1 and 8 plus oxaliplatin 130 mg/m(2) on day 8 (mGemOx). Treatment cycles were repeated every three weeks. The primary end point was progression-free survival (PFS) rate at 3 months; secondary end points included objective response rate, carbohydrate antigen 19-9 response, clinical benefit response, overall survival and toxicity.
  
  
  RESULTS
  The PFS rate after 3 months was 51% in the CapOx arm, 64% in the CapGem arm and 60% in the mGemOx arm. Median PFS was estimated with 4.2 months, 5.7 months and 3.9 months, respectively (P = 0.67). Corresponding median survival times were: 8.1 months (CapOx), 9.0 months (CapGem) and 6.9 months (mGemOx) (P = 0.56). Grade 3/4 hematological toxicities were more frequent in the two Gem-containing arms; grade 3/4 non-hematological toxicity rates did not exceed 15% in any arm.
  
  
  CONCLUSIONS
  CapOx, CapGem and mGemOx have similar clinical efficacy in advanced PC. Each regimen has a distinct but manageable tolerability profile.
authors.affiliation: Medizinische Klinik und Poliklinik III, Klinikum Grosshadern, Ludwig-Maximilians-Universität München, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Boeck
authors.forename: T
authors.initials: T
authors.lastname: Hoehler
authors.forename: G
authors.initials: G
authors.lastname: Seipelt
authors.forename: R
authors.initials: R
authors.lastname: Mahlberg
authors.forename: A
authors.initials: A
authors.lastname: Wein
authors.forename: A
authors.initials: A
authors.lastname: Hochhaus
authors.forename: H-P
authors.initials: HP
authors.lastname: Boeck
authors.forename: B
authors.initials: B
authors.lastname: Schmid
authors.forename: E
authors.initials: E
authors.lastname: Kettner
authors.forename: M
authors.initials: M
authors.lastname: Stauch
authors.forename: F
authors.initials: F
authors.lastname: Lordick
authors.forename: Y
authors.initials: Y
authors.lastname: Ko
authors.forename: M
authors.initials: M
authors.lastname: Geissler
authors.forename: K
authors.initials: K
authors.lastname: Schoppmeyer
authors.forename: G
authors.initials: G
authors.lastname: Kojouharoff
authors.forename: A
authors.initials: A
authors.lastname: Golf
authors.forename: S
authors.initials: S
authors.lastname: Neugebauer
authors.forename: V
authors.initials: V
authors.lastname: Heinemann
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects*; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D005500:Follow-Up Studies; D006801:Humans; D007150:Immunohistochemistry; D007262:Infusions, Intravenous; D053208:Kaplan-Meier Estimate; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D000077150:Oxaliplatin; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology; D011336:Probability; D018570:Risk Assessment; D016037:Single-Blind Method; D016019:Survival Analysis; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil; D000093542:Gemcitabine