The Pharmaceutical Journal
Vol 279 No 7471 p343
29 September 2007

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Five-year follow-up data confirm efficacy of oral chemotherapy in early bowel cancer

Oral chemotherapy with capecitabine (Xeloda) achieves equivalent survival to 5-fluorouracil/folinic acid (5-FU/FA) administered as an intravenous bolus in early bowel cancer, according to five-year follow-up results from the X-ACT trial, reported this week at the European Cancer Conference in Barcelona. The data suggest a trend to better survival with capecitabine.

The X-ACT (Xeloda in adjuvant colon cancer therapy) trial randomised 1,897 patients who had undergone surgery for stage III colon cancer to 24 weeks’ treatment with oral capecitabine or bolus 5-FU/FA, which was the standard of care when the trial started.

Patients were followed up for a median of seven years and results show five-year overall survival rates of 71.4 per cent in patients treated with capecitabine and 68.4 per cent in the 5-FU/FA group (hazard ratio 0.86; showing a trend to superiority, P=0.06).

Chris Twelves, professor of clinical cancer pharmacology and oncology at the University of Leeds’ medical school oncology unit, and lead author of the study, explained that the X-ACT trial was designed to establish the equivalence of capecitabine to bolus 5-FU/FA.

“The five-year overall survival results add to the growing body of evidence supporting the fact that capecitabine can replace 5-FU in colorectal cancer regimens,” he said, adding that overall survival was better for capecitabine in all subgroups of patients, including all ages, taking part in the trial.

Capecitabine improved relapse-free survival (hazard ratio 0.86; P=0.0407). Its use was also associated with fewer adverse events than 5-FU/FA (P<0.001). Rates of all grades of severity of diarrhoea, nausea, stomatitis, neutropenia and alopecia were lower with the oral agent, with only hand-foot syndrome occurring at a higher rate.

An audit of an outpatient oral chemotherapy service for the delivery of capecitabine to patients with colorectal cancer in north east Scotland reported encouraging results at the conference. Over the first three years (2003-06), 177 patients had used the service, including 100 with metastatic disease and 77 undergoing adjuvant treatment.

Most (95 per cent) received capecitabine at 75 or 100 per cent of the recommended starting dose (1250mg/m² twice daily) and nearly three-quarters (71 per cent) completed their treatment without further dose adjustment.