Medline ® Abstract for Reference 80
of 'Chemotherapy hepatotoxicity and dose modification in patients with liver disease'
Oral capecitabine as an alternative to i.v. 5-fluorouracil-based adjuvant therapy for colon cancer: safety results of a randomized, phase III trial.
Scheithauer W, McKendrick J, Begbie S, Borner M, Burns WI, Burris HA, Cassidy J, Jodrell D, Koralewski P, Levine EL, Marschner N, Maroun J, Garcia-Alfonso P, Tujakowski J, Van Hazel G, Wong A, Zaluski J, Twelves C, X-ACT Study Group
Ann Oncol. 2003;14(12):1735.
BACKGROUND: Oral capecitabine achieves a superior response rate with an improved safety profile compared with bolus 5-fluorouracil-leucovorin (5-FU/LV) as first-line treatment for patients with metastatic colorectal cancer. We report here the results of a large phase III trial investigating adjuvant oral capecitabine compared with 5-FU/LV (Mayo Clinic regimen) in Dukes' C colon cancer.
PATIENTS AND METHODS: Patients aged 18-75 years with resected Dukes' C colon carcinoma were randomized to receive 24 weeks of treatment with either oral capecitabine 1250 mg/m(2) twice daily, days 1-14 every 21 days (n = 993), or i.v. bolus 5-FU 425 mg/m(2) with i.v. leucovorin 20 mg/m(2) on days 1-5, repeated every 28 days (n = 974).
RESULTS: Patients receiving capecitabine experienced significantly (P<0.001) less diarrhea, stomatitis, nausea/vomiting, alopecia and neutropenia, but more hand-foot syndrome than those receiving 5-FU/LV. Fewer patients receiving capecitabine experienced grade 3 or 4 neutropenia, febrile neutropenia/sepsis and stomatitis (P<0.001), although more experienced grade 3 hand-foot syndrome than those treated with 5-FU/LV (P<0.001). Capecitabine demonstrates a similar, favorable safety profile in patients aged<65 years or>or = 65 years old.
CONCLUSIONS: Based on its improved safety profile, capecitabine has the potential to replace 5-FU/LV as standard adjuvant treatment for patients with colon cancer. Efficacy results are expected to be available in Keywords: Adjuvant treatment, capecitabine, chemotherapy, colorectal cancer
Klinik für Innere Medizin I, Vienna University Medical School, Vienna, Austria. Werner.Scheithauer@akh-wien.ac.at