title: Capecitabine as first-line treatment in colorectal cancer. Pooled data from two large, phase III trials.
abstract: The oral, tumour-selective fluoropyrimidine capecitabine represents a major new strategy for the treatment of colorectal cancer. Pooled results from two large, multicentre, open-label, phase III studies comparing oral capecitabine (1250 mg/m2 twice daily for 14 days every 3 weeks) with the Mayo Clinic regimen (5-fluorouracil [5-FU] 425 mg/m2 plus leucovorin 20 mg/m2 days 1-5, every 4 weeks) provide information on over 1200 patients receiving first-line chemotherapy for metastatic colorectal cancer. Analysis of all randomised patients demonstrated a significantly superior overall response rate as assessed by the investigator for capecitabine compared with 5-FU/leucovorin (25.7% versus 16.7%, P<0.0002), reinforcing the individual trial results. Median time to disease progression, overall survival and duration of response were equivalent in the two treatment groups. Furthermore, capecitabine showed a superior safety profile compared with 5-FU/leucovorin, with a significantly lower incidence (P<0.001) of diarrhoea, stomatitis, nausea and alopecia, together with a reduced treatment-related hospitalisation rate. In addition, the incidence of neutropenic fever/sepsis was significantly lower in patients receiving capecitabine.
authors.affiliation: Alexander Stone Building, CRC Department of Medical Oncology, Switchback Road, Garscube Estate, Bearsden, Glasgow G61 1BD, UK. c.twelves@beatson.gla.ac.uk
authors.forename: C
authors.initials: C
authors.lastname: Twelves
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D000069287:Capecitabine; D017326:Clinical Trials, Phase III as Topic; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D003841:Deoxycytidine / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007262:Infusions, Intravenous; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D016032:Randomized Controlled Trials as Topic
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000069287:Capecitabine; D002955:Leucovorin; D005472:Fluorouracil