title: Capecitabine in combination with irinotecan (XELIRI), administered as a 2-weekly schedule, as first-line chemotherapy for patients with metastatic colorectal cancer: a phase II study of the Spanish GOTI group.
abstract: BACKGROUND
  Combination chemotherapy is standard treatment for metastatic colorectal cancer (MCRC). The aim of this study was to determine the efficacy and safety of capecitabine+irinotecan (2-weekly schedule), as first-line therapy of MCRC.
  
  
  METHODS
  Patients received irinotecan 175 mg m(-2) on day 1 and oral capecitabine 1000 mg m(-2) twice daily on days 2-8 every 2 weeks. For patients aged > or =65 years, the starting doses of irinotecan and capecitabine were reduced to 140 and 750 mg m(-2), respectively.
  
  
  RESULTS
  A total of 53 patients were enrolled: 29 (55%) were > or =65 years old. In an intention-to-treat analysis, complete response was achieved in three patients for an overall response rate (ORR) of 32%. The disease control rate (ORR + stable disease) was 66% and the median duration of response was 7.3 months. Median time to progression and overall survival were 9.0 and 19.2 months, respectively. Grade 4 neutropenia was reported in one patient: no other grade 4 toxicities were recorded. Grade 3 diarrhoea occurred in 8 (15%) patients and grade 1-2 hand-foot syndrome in 7 (13%) patients.
  
  
  CONCLUSIONS
  Capecitabine and irinotecan, given every 2 weeks, as first-line treatment of MCRC is an active regimen with a manageable toxicity profile, even in older patients.
authors.affiliation: Medical Oncology Service, Hospital General Universitario Gregorio Marañón, Doctor Esquerdo 46, Madrid 28007, Spain. pgarcaalfonso@gmail.com
authors.forename: P
authors.initials: P
authors.lastname: Garcia-Alfonso
authors.forename: A
authors.initials: A
authors.lastname: Muñoz-Martin
authors.forename: M
authors.initials: M
authors.lastname: Mendez-Ureña
authors.forename: R
authors.initials: R
authors.lastname: Quiben-Pereira
authors.forename: E
authors.initials: E
authors.lastname: Gonzalez-Flores
authors.forename: G
authors.initials: G
authors.lastname: Perez-Manga
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000069287:Capecitabine; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis
chemical_list: D003841:Deoxycytidine; D000069287:Capecitabine; D000077146:Irinotecan; D005472:Fluorouracil; D002166:Camptothecin