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| |  Maintenance Bevacizumab Monotherapy Noninferior to Combination Therapy for Metastatic Colorectal Cancer: Presented at ESMO-GI By Chris Berrie BARCELONA, Spain -- July 5, 2010 -- Maintenance therapy with bevacizumab may be an appropriate treatment option following induction with capecitabine and oxaliplatin plus bevacizumab in patients with metastatic colorectal cancer (mCRC), according to a study presented here at the European Society for Medical Oncology's 12th World Congress on Gastrointestinal Cancer (ESMO-GI). Enrique Aranda, MD, PhD, Hospital Reina Sofia, Cordoba, Spain, presented results of the MACRO study, on behalf of the Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD), here on July 3. The aim of the study was to evaluate the efficacy and tolerability of 6 cycles of oxaliplatin/bevacizumab followed by maintenance therapy with oxaliplatin/bevacizumab or bevacizumab alone. "This was designed as a noninferiority study, assuming 10 months as median progression-free survival for the control arm, and a noninferiority limit of 7.6 months for the experimental arm," Dr. Aranda explained. Patients aged 18 years and older with confirmed mCRC received first-line treatment with capecitabine 1,000 mg/m2 (BID for days 1-14), oxaliplatin 130 mg/m2 (day 1), plus bevacizumab 7.5 mg/kg (day 1) every 3 weeks for 6 cycles. Patients were then randomised to continue with this treatment (n = 239) or to receive maintenance therapy with bevacizumab alone (n = 241). The primary endpoint of progression-free survival (PFS) was not significantly for patients who continued on the combination maintenance therapy versus patients who received bevacizumab monotherapy (10.4 vs 9.7 months). The same was seen for the secondary endpoints of overall survival (23.4 vs 21.7 months) and objective response rate (46% vs 49%). Treatment-related adverse events were observed in more patients in the combination group versus patients in the monotherapy maintenance group: sensory neuropathy (24.8% vs 7.6%), hand-foot skin reaction (12.2% vs 6.7%), and fatigue (10.5% vs. 4.2%), diarrhoea (10.9% vs 13.9%), and hypertension (3.8% vs 7.1%). Funding for this study was provided by Roche and Sanofi-Aventis. [Presentation title: Phase III Study of First-Line XELOX Plus Bevacizumab (BEV) for 6 Cycles Followed by XELOX Plus BEV or Single Agent (s/a) BEV as Maintenance Therapy in Patients (pts) With Metastatic Colorectal Cancer (mCRC): The MACRO Trial. Abstract O-0021]
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