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. et al. (2003) Oral capecitabine as an alternative to i.v. 5-fluorouracil-based adjuvant therapy for colon cancer: safety results of a randomized, phase III trial. Annals of Oncology, 14(12), pp. 1735-1743. (doi: 10.1093/annonc/mdg500)

Abstract

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 greater than or equal to65 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 2004.

• Item Type: Articles
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Cassidy, Professor James
• Authors: Scheithauer, W., McKendrick, J., Begbie, S., Borner, M., Burns, W., Burris, H., Cassidy, J., Jodrell, D., Koralewski, P., Levine, E., Marschner, N., Maroun, J., Garcia-Alfonso, P., Tujakowski, J., Van Hazel, G., Wong, A., Zaluski, J., and Twelves, C.
• College/School: College of Medical Veterinary and Life Sciences > School of Cancer Sciences
• Journal Name: Annals of Oncology
• ISSN: 0923-7534