title: A phase II trial of gefitinib in combination with capecitabine and oxaliplatin as first-line chemotherapy in patients with advanced colorectal cancer.
abstract: OBJECTIVE
  This study was designed as a multicentre phase II trial to assess the efficacy and safety of gefitinib in association with capecitabine and oxaliplatin in patients with untreated metastatic colorectal cancer.
  
  
  METHODS
  Patients with metastatic colorectal cancer that had received no prior chemotherapy for advanced disease were treated with oral gefitinib (250 mg daily) plus oral capecitabine (1000 mg/m2 twice a day on Days 1-14) and intravenous oxaliplatin (120 mg/m2 on Day 1 of each 3-week cycle).
  
  
  RESULTS
  Thirty-five patients were enrolled. In the intention-to-treat analysis, 3 (8.6%) patients experienced a complete response (CR), 14 (40%) a partial response (PR) and 11 (31.4%) had stable disease (SD). The disease control rate (CR + PR + SD) was 80%, the median time to progression was 7.3 months (95%CI: 4.76-9.2) and the estimated median overall survival was 21.9 months (95% CI: 15.1--not reached). The most common grade 3 to 4 toxicities included diarrhoea (31%) and vomiting (5.7%).
  
  
  CONCLUSIONS
  The combination of capecitabine, oxaliplatin and gefitinib appears to have promising activity in chemotherapy-naïve metastatic colorectal cancer. A higher disease control rate and an increase in median overall survival were seen compared with previous reports with capecitabine and oxaliplatin in similar patient populations. The tolerability profile appears to be predictable and similar to capecitabine/oxaliplatin regimens.
authors.affiliation: Department of Medical Oncology, Regina Elena National Cancer Institute, Rome, Italy. agelibter@yahoo.it
authors.forename: Alain J
authors.initials: AJ
authors.lastname: Gelibter
authors.forename: Teresa
authors.initials: T
authors.lastname: Gamucci
authors.forename: Camillo F
authors.initials: CF
authors.lastname: Pollera
authors.forename: Francesco
authors.initials: F
authors.lastname: Di Costanzo
authors.forename: Carmen
authors.initials: C
authors.lastname: Nuzzo
authors.forename: Angela
authors.initials: A
authors.lastname: Gabriele
authors.forename: Carlo
authors.initials: C
authors.lastname: Signorelli
authors.forename: Silvia
authors.initials: S
authors.lastname: Gasperoni
authors.forename: Virginia
authors.initials: V
authors.lastname: Ferraresi
authors.forename: Diana
authors.initials: D
authors.lastname: Giannarelli
authors.forename: Francesco
authors.initials: F
authors.lastname: Cognetti
authors.forename: Massimo
authors.initials: M
authors.lastname: Zeuli
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077156:Gefitinib; D006801:Humans; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D011799:Quinazolines / Q000008:administration & dosage; D015996:Survival Rate
chemical_list: D009944:Organoplatinum Compounds; D011799:Quinazolines; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000069287:Capecitabine; D000077156:Gefitinib; D005472:Fluorouracil