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| |  Adding Bevacizumab to Capecitabine Improves Progression-Free Survival in Metastatic Colorectal Cancer: Presented at ECCO-ESMO By Chris Berrie BERLIN -- September 22, 2009 -- Adding bevacizumab to capecitabine, without or with mitomycin C, significantly improves progression-free survival (PFS) compared with capecitabine alone in the first-line treatment of previously untreated patients with metastatic colorectal cancer (mCRC). These final results of the multicentre, randomised, double-blind, phase 3 Australian Gastrointestinal Trials Group (AGITG) MAX study were presented here at the joint 15th Congress of the European Cancer Organisation (ECCO) and 34th Congress of the European Society for Medical Oncology (ESMO). “The median survival for patients with metastatic colorectal cancer has increased over the last 20 years,” said lead investigator Niall Tebbutt, PhD, Austin Health, Melbourne, Australia, on September 21. However, prognosis still remains poor, and not all patients are fit for the standard combination chemotherapy. The study included patients with histologically confirmed, unresectable mCRC with no prior chemotherapy other than adjuvant therapy, and no relapses for the prior 6 months. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2, adequate organ function, and at least 12 weeks life expectancy were also required. Randomisation was stratified according to age (>=65 vs <65 years), ECOG PS (0, 1, 2), and capecitabine dose. The treatment arms were as follows: capecitabine 1.25 g/m2 BID for 14 days in a 3-week cycle (group A; n = 156); or capecitabine 1.25 g/m2 BID plus bevacizumab 7.5 mg/kg once daily for 3 weeks (group B; n = 157); or capecitabine 1.25 g/m2 BID plus bevacizumab 7.5 mg/kg plus mitomycin 7 mg/m2 once daily for 6 weeks (group C; n = 158). “However, recognising that some patients might be of risk from potential toxicity at the full dose of capecitabine, we nominated a lower starting dose as capecitabine 1.0 g/m2 twice a day,” Dr. Tebbutt added. Two-thirds of the patients were started with capecitabine 1.0 g/m2 BID. PFS was improved for both group B (median, 8.5 months) and group C (median, 8.4 months) versus the group receiving capecitabine alone (median, 5.7 months; P < .001 for both). The overall response rate was 30% for patients receiving capecitabine alone, 38% for patients receiving capecitabine plus bevacizumab, and 46% for patients receiving triple therapy (P = .006 vs capecitabine alone). All treatments were well tolerated. “There were no significant differences in any of the toxicities observed, except for hand and foot syndrome,” said Dr. Tebbutt. There were also no differences seen for quality-of-life assessments and for median overall survival in group A, group B, and group C (18.9, 18.9, 16.4 months, respectively). “Capecitabine and bevacizumab is an active, low-toxicity regimen that may be considered as a possible option for patients with metastatic colorectal cancer,” concluded Dr. Tebbutt. Funding for this study was provided by Roche Products Pty Ltd. [Presentation title: International Randomised Phase 3 Study of Capecitabine (Cap), Bevacizumab (Bev) and Mitomycin C (MMC) in First Line Treatment of Metastatic Colorectal Cancer (mCRC): Final Results of the AGITG MAX Trial. Abstract 6001]
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