Capecitabine Improved Safety Profile Maintained in Older Pts With Colon Ca

COPENHAGEN-Results of the X-ACT trial of oral capecitabine(Drug information on capecitabine) (Xeloda) vs fluorouracil(Drug information on fluorouracil)/leucovorin (5-FU/LV) as first-line adjuvant therapy for metastatic colon cancer showed that capecitabine had an improved safety profile, compared with 5-FU/ LV, overall and in patients age 65 and older. Christopher Twelves, MD, pro- fessor of clinical cancer pharmacology, University of Leeds and Tom Connors Cancer Research Centre, Bradford, UK, reported the results at ECCO 12, the European Cancer Conference. The data have also been published in Annals of Oncology (14:1735-1743, 2003). The study randomized patients with resected Dukes' C colon cancer to receive 24 weeks of treatment with either capecitabine 1,250 mg/m² twice daily on days 1 to 14 every 21 days (n = 993) or IV bolus 5-FU 425 mg/m² plus IV leucovorin 20 mg/m² on days 1 to 5, repeated every 28 days (n = 974). Efficacy results are expected to be available sometime this year. In a planned safety analysis, patients receiving capecitabine had significantly less grade 3/4 neutropenia, febrile neutropenia/sepsis, and stomatitis (P < .001) but more grade 3 hand-foot syndrome than those treated with 5-FU/LV. Capecitabine had a similar, favorable safety profile in patients less than 65 years of age and in those 65 or older (see Table). In their Annals of Oncology report, the investigators stressed that "good tolerability is a particularly important consideration when chemotherapy is administered in the adjuvant setting," especially considering recent results from trials evaluating 5-FU/LV in combination with irinotecan(Drug information on irinotecan) (Camptosar) or oxaliplatin(Drug information on oxaliplatin) (Eloxatin). For example, in the MOSAIC trial comparing bolus/infusional 5-FU/LV and oxaliplatin (FOLFOX4) vs infusional 5-FU/LV (the de Gramont regimen) as adjuvant therapy for patients with stage II-III colon cancer, FOLFOX4 produced a significant improvement in 3-year disease-free survival but, the investigators said, "at the expense of a higher incidence of grade 3 or 4 neutropenia, and 29% of patients experienced long-term (> 1 year) lowgrade neurotoxicity." The X-ACT researchers concluded that in metastatic colon cancer "capecitabine is an attractive agent to replace 5-FU/LV as the backbone of adjuvant combination treatment for further studies."