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Capecitabine Shows Improved Safety Over 5-fluorouracil-based Adjuvant Treatment for Colon Cancer

For patients with metastatic colorectal cancer, oral capecitabine may be a more attractive first-line therapy over the current choice of 5-fluorouracil-leucovorin (5-FU/LV) based on its improved safety profile, reports a multinational study.

Although adjuvant 5-FU/LV has improved outcomes for patients with Dukes' C colon (stage III) colon cancer and is considered standard treatment, it is often not used in community practice because of associated adverse effects and subsequent poor compliance. Along with a high activity profile, capecitabine has been shown to be well tolerated and convenient or patients with metastatic disease.

To compare the efficacy and safety of capecitabine and 5-FU/LV for patients with Dukes' C colon cancer, W. Scheithauer, MD, Vienna University Medical School, Austria, and colleagues randomised 993 patients to 24 weeks of oral capecitabine (1250 mg/m²), twice daily, days 1-14 every 21 days) and 974 patients to intravenous bolus 5-FU (425 mg/m²) with intravenous leucovorin (20 mg/m²), days 1-5, repeated every 28 days. For patients with moderate renal impairment, the starting dose of capecitabine was eventually reduced by 25%. The purpose of this study was to report the prospective results of a planned safety analysis at 19 months after study enrolment.

Overall, patients receiving capecitabine experienced significantly less adverse events than those receiving 5-FU-LV, with less diarrhoea (46% vs. 64%), nausea/vomiting (36% vs. 51%), alopecia (6% vs. 22%), stomatitis (22% vs. 60%), and neutropenia (2% vs. 8%) (significance of P < .001 for all comparisons). Severe adverse events were also significantly reduced with capecitabine, including less grade 3 or 4 stomatitis (2% vs. 14%), grade 3 or 4 neutropenia (0.6% vs. 5%), and febrile neutropenia/sepsis (0.3% vs. 3%) (significance of P < .001 for all comparisons). Hand-foot syndrome was the only significantly increased adverse event associated with capecitabine (62% vs. 10%; P < .001).

Tolerability of capecitabine was not dependent on age, with comparable early severe toxicities reported in patients 65 years or older or those younger than 65 (4.9% vs. 6.3%, respectively). In contrast, patients over 65 years old who were receiving 5-FU-LV reported higher incidence of early severe toxicities compared to younger patients (20% vs. 15%, respectively).

Although the efficacy results of this trial will not expected until next year, the authors conclude that "from a safety perspective, capecitabine can replace 5-FU-LV as the standard adjuvant treatment for patients with colon cancer."

Annals of Oncology 2003;14:1735-1743. "Oral capecitabine as an alternative to i.v. 5-fluorouracil-based adjuvant therapy for colon cancer: safety results of a randomized, phase III trial"

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