Source: J Clin Otorhinolaryngol  |  Posted 7 years ago

By Charlene Laino

NEW YORK -- November 12, 2004 -- When used as adjuvant treatment in patients with surgically resected Dukes' C colon cancer, oral capecitabine (Xeloda) is associated with a consistent, absolute improvement of nearly 4% in disease-free survival, compared with standard intravenous therapy, a large international phase 3 trial shows.

Chris Twelves, MD, professor of clinical cancer pharmacology and oncology, University of Leeds, and cancer director, Tom Connors Cancer Research Centre, Bradford, United Kingdom, presented the findings here on November 10th at the Chemotherapy FOUNDATIONS Symposium XXII: Innovative Cancer Therapy for Tomorrow.

Previously, studies showed that patients vastly prefer oral chemotherapy, which provided the rationale for the current study, he said.

The study, known as the Xeloda in Adjuvant Colon Cancer Therapy (X-ACT) trial, randomized 1987 patients to receive 24 weeks of treatment with either oral capecitabine or bolus 5-FU/LV. The 1104 patients who received capecitabine and the 983 patients on 5-FU/LV were balanced with respect to age, performance status, sex, nodal status, and tumor differentiation.

At a median follow-up of 3.8 years, 64.2% of patients in the capecitabine arm were alive and disease free, compared with 60.6% of patients in the 5-FU/LV arm, Dr. Twelves said. The 3-year overall survival rates were 81.3% and 77.6%, respectively, in the capecitabine and 5-FU/LV arms.

The primary endpoint of the trial, disease-free survival that was at least equivalent between the 2 arms, was "clearly met," Dr. Twelves said. In the disease-free survival per protocol population, the hazard ratio (HR) was 0.89 (95% CI 0.76-1.04). In an intent-to-treat analysis, the HR for disease-free survival for capecitabine versus 5-FU/LV was 0.87 (95% CI 0.75-1.00).

"At least equivalence was not only met, but there was also a strong trend toward improved disease-free survival versus 5-FU/LV," he said, citing a P value of.0528.

A tumor-selective fluoropyrimidine, capecitabine was consistently effective in all subgroups studied, including patients 70 years of age and older and younger patients, he added.

"The key take-home message: Oral capecitabine is as effective, if not more effective, as intravenous 5-FU/leucovorin as adjuvant therapy in these patients," Dr. Twelves said.

[Presentation title: Oral Capecitabine (Xeloda) as a Replacement for I.V. 5-FU-Based Adjuvant Therapy for Colon Cancer: Results of a Large Phase III Trial (The X-ACT Trial).]