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.
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.
Garcia-Alfonso
P
P
Medical Oncology Service, Hospital General Universitario Gregorio Marañón, Doctor Esquerdo 46, Madrid 28007, Spain. pgarcaalfonso@gmail.com
Muñoz-Martin
A
A
Mendez-Ureña
M
M
Quiben-Pereira
R
R
Gonzalez-Flores
E
E
Perez-Manga
G
G
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
D003841:Deoxycytidine; D000069287:Capecitabine; D000077146:Irinotecan; D005472:Fluorouracil; D002166:Camptothecin