title: Multicenter phase II study of fixed sequences of capecitabine combined with oxaliplatin or irinotecan in patients with previously untreated metastatic colorectal cancer.
abstract: OBJECTIVE
  The purpose of this study was to evaluate the antitumor activity and toxicity of fixed sequences of capecitabine/oxaliplatin followed by capecitabine/irinotecan in patients with previously untreated metastatic colorectal cancer.
  
  
  METHODS
  Adult patients with histologically confirmed, previously untreated, nonresectable, locally advanced or metastatic colorectal adenocarcinoma were enrolled in the study. Patients were treated as follows: capecitabine (1000 mg/m2 orally twice daily) on days 1-14 and oxaliplatin (130 mg/m2 2-hour intravenous infusion) on day 1, followed by capecitabine (1000 mg/m2 twice daily) on days 1-14 and irinotecan (240 mg/m2 1.5-hour intravenous infusion) on day 1. Each combination was administered every 21 days during 4 consecutive cycles followed by the alternating sequence to a maximum of 16 cycles.
  
  
  RESULTS
  A total of 35 eligible patients have been included in this ongoing study. Response rate (complete responses plus partial responses) was 37.1%. With a median follow-up of 9.5 months, the median time to disease progression and overall survival were 7.4 months and 16.4 months, respectively. Treatment was well tolerated, with only 6% of the patients developing grade 3/4 neurotoxicity. However, the low number of patients treated beyond 4 cycles limits the interpretation of the data.
  
  
  CONCLUSIONS
  The preliminary results from this ongoing study suggest the feasibility of this strategy, which resulted in promising antitumor activity with less neurotoxicity.
authors.affiliation: Hospital Universitario de Guadalajara, Spain. jacaes@sescam.jccm.es
authors.forename: Javier
authors.initials: J
authors.lastname: Cassinello
authors.forename: Jose Valero
authors.initials: JV
authors.lastname: Alvarez
authors.forename: María José García
authors.initials: MJ
authors.lastname: López
authors.forename: Eduardo
authors.initials: E
authors.lastname: Pujol
authors.forename: Antonio
authors.initials: A
authors.lastname: Colmenarejo
authors.forename: Fernando
authors.initials: F
authors.lastname: Segovia
authors.forename: Fernando
authors.initials: F
authors.lastname: Marcos
authors.forename: Elena
authors.initials: E
authors.lastname: Filipovich
authors.forename: Alberto
authors.initials: A
authors.lastname: Arcediano
authors.forename: Inés García
authors.initials: IG
authors.lastname: Castro
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D000069287:Capecitabine; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D015996:Survival Rate
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000069287:Capecitabine; D000077146:Irinotecan; D005472:Fluorouracil; D002166:Camptothecin