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XELOX With Bevacizumab Is Highly Active in Metastatic Colorectal Ca, Preliminary Data Show

XELOX With Bevacizumab Is Highly Active in Metastatic Colorectal Ca, Preliminary Data Show

DURHAM, North Carolina- The addition of bevacizumab (Avastin) to XELOX (capecitabine [Xeloda] and oxaliplatin [Eloxatin]) results in a new, highly active regimen for treating metastatic colorectal cancer (XELOXA), according to preliminary evidence from a phase II trial (abstract 3556). "The reported median time to progression is among the highest yet obtained in the first-line treatment of metastatic colorectal cancer," concluded Nishan Fernando, MD, and colleagues at Duke University in Durham, North Carolina. Convenient Alternative XELOXA was investigated as a more convenient alternative to FOLFOX (fluorouracil [5-FU], leucovorin, oxaliplatin). The investigators noted that FOLFOX "is superior to bolus IFL" (irinotecan [Camptosar], 5-FU, leucovorin) but "requires the inconvenience of an ambulatory infusion pump." Patients with untreated metastatic colorectal cancer initially received capecitabine (1,000 mg/m2) twice daily on days 1 to 5 and 8 to 12, in addition to oxaliplatin (85 mg/m2) on day 1 and bevacizumab (10 mg/kg) on day 1. The capecitabine starting dose was reduced to 850 mg/m2 twice daily due to toxicity in the first 27 patients. This reduced dose "appears to be better tolerated," according to the investigators. The median age of the patients treated was 55.5 years (range, 24-76 years). Response and Toxicity Among the first 30 patients receiving therapy, 1 had a complete response and 16 had partial responses (response rate, 57%; 95% confidence interval [CI]: 37%-75%). Eleven patients (37%) had stable disease. The median time to disease progression was 11.9 months. During treatment, 20 of the first 30 patients (66%) receiving therapy required at least one dose reduction of capecitabine, and 12 patients (40%) required two or more dose reductions, typically for diarrhea or hand-foot syndrome. Diarrhea occurred in 22 of 30 patients (73%); 9 patients (30%) experienced grade 3 diarrhea, but there were no cases of grade 4 diarrhea. Of the three patients who started at the reduced dose of capecitabine (850 mg/ m2 twice daily), none experienced > grade 1 diarrhea. Hand-foot syndrome was observed in 63% of patients: 6 patients (20%) with grade 1, 12 (40%) with grade 2, 9 (30%) with grade 3, and 0 with grade 4. Other toxicities included grade 3 peripheral neuropathy (10%), neutropenia (7%), and nausea and vomiting (7%).

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