Oral capecitabine as an alternative to i.v. 5-fluorouracil-based adjuvant therapy for colon cancer: safety results of a randomized, phase III trial.
Authors
Scheithauer, WMcKendrik, J
Begbie, S
Borner, M
Burns, W I
Burris, H A
Cassidy, J
Jodrell, D
Koralewski, P
Levine, Edward
Marschner, N
Maroun, J
Garcia-Alfonso, P
Tujakowski, J
Van Hazel, G
Wong, A
Zaluski, J
Twelves, C
Affiliation
Klinik für Innere Medizin I, Vienna University Medical School, Vienna, Austria. Werner.Scheithauer@akh-wien.ac.atIssue Date
2003-12
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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 cancerCitation
Oral capecitabine as an alternative to i.v. 5-fluorouracil-based adjuvant therapy for colon cancer: safety results of a randomized, phase III trial. 2003, 14 (12):1735-43 Ann. Oncol.Journal
Annals of OncologyDOI
10.1093/annoc/mdg500PubMed ID
14630678Type
ArticleLanguage
enISSN
0923-7534ae974a485f413a2113503eed53cd6c53
10.1093/annoc/mdg500
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