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Title: Multinational Trial Demonstrates Efficacy of Capecitabine (Xeloda) Compared With 5-Fluorouracil and Leucovorin: Presented at ASCO

"Multinational Trial Demonstrates Efficacy of Capecitabine (Xeloda) Compared With 5-Fluorouracil and Leucovorin: Presented at ASCO"

By Cameron E. Johnston ORLANDO, FL -- May 23, 2005 -- An international, multicenter, phase 3 trial evaluating capecitabine (Xeloda) compared with a bolus of 5-fluorouracil and leucovorin (5-FU/LV) demonstrated a "strong trend" toward superiority in favor of capecitabine in patients with Duke's C colon cancer treated for 3 years. Principal investigator Christopher Twelves, MD, senior oncologist, Leeds University and Bradford NHS Trust Hospital, Bradford, United Kingdom, presented the findings of the X-Act trial here on May 17[^th at the American Society of Clinical Oncology Annual Meeting (ASCO).

The trial recruited 1987 patients at 164 centers worldwide between 1998 and 2001. Patients were matched for baseline characteristics: 85% had an ECOG score of 0, three-quarters had stage III disease, and 14% had stage IV. All patients had nodal involvement.

All patients were chemotherapy naïve and underwent surgical resection within the 8 weeks preceding study enrollment.

The study randomized 1004 patients to a regimen of capecitabine 1250 mg BID on days 1 to 14 every 21 days and 983 patients to bolus administration of 5-FU 425 mg/m² per day and leucovorin 20 mg/m² on days 1 to 5 of a 28-day cycle.

There was a strong trend toward improved disease-free survival in the capecitabine group, with a 13% reduction in risk of disease recurrence (P = .0525).

At 3 years of follow-up, there was an absolute difference of 3.6% in disease-free survival between arms, with 64.6% of the capecitabine group and 61.0% of the 5-FU/LV group being disease-free. Overall survival also favored the capecitabine arm. The absolute difference in overall survival was 3.4% (81.7% vs 78.3%).

Multivariate analysis showed a statistically significant benefit in disease-free survival with capecitabine over 5-FU/LV when corrected for variables including age, gender, nodal status and the number of nodes, and baseline cancer embryonic antigen.

Adjuvant capecitabine also showed a superior safety profile compared with 5-FU/LV. The only measure by which 5-FU/LV was better than capecitabine in terms of safety was the incidence of hand-foot syndrome, a finding that was not unexpected, Dr. Twelves said.

Overall, this confirms that capecitabine is consistently superior to 5-FU/LV with at least the equivalent disease-free survival rate and an improved safety profile, Dr Twelves reported.

In addition, the ease and convenience of administration suggest that a greater proportion of patients may benefit from this form of therapy, he added.

[Presentation title: Updated Efficacy Findings From the X-ACT Phase III Trial of Capecitabine (X) Vs. Bolus 5-FU/LV as Adjuvant Therapy for Patients (Pts) With Dukes' C Colon Cancer. Abstract 3521]

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