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Addition of Aflibercept to Gemcitabine Does Not Prolong Survival in Patients With Metastatic Pancreatic Cancer: Presented at ESMO-GI By Chris Berrie BARCELONA, Spain -- July 2, 2010 -- Addition of aflibercept to gemcitabine shows no unexpected safety events compared with placebo plus gemcitabine in patients with metastatic pancreatic cancer, but it does not provide significant improvements in overall survival, researchers said here at the European Society for Medical Oncology's 12th World Congress on Gastrointestinal Cancer (ESMO-GI). In a study, patients aged 18 years and older with histologically metastatic pancreatic cancer were randomised to either placebo or intravenous aflibercept 4 mg/kg every 2 weeks, both in combination with weekly intravenous gemcitabine 1,000 mg/m2 (7 weeks on, 1 week off; then days 1, 8, and 15 every 4 weeks). "It was decided to stop the trial for futility and to stop the accrual," said Philippe Rougier, MD, Hôpital Européen Georges-Pompidou, Paris, France, on June 30. This provided an enrolment of 546 patients of which 275 received placebo plus gemcitabine and 271 received aflibercept plus gemcitabine. As indicated by the early closure, the addition of aflibercept to gemcitabine did not result in increased overall survival, compared with patients receiving gemcitabine alone (7.75 vs 6.54 months). For the secondary endpoint of progression-free survival, there was again no patient benefit over placebo for the aflibercept combination (3.71 months for both). Patients in the aflibercept group experienced more grade 3/4 asthenia/fatigue (14.8% vs 10.3%) and hypertension (14.1% vs 3.0%) than patients in the monotherapy groups. Similar numbers of deaths during the study were seen (16.7% vs 14.4%). "Addition of aflibercept to gemcitabine did not lead to a statistically significant improvement in overall survival in patients with metastatic pancreatic cancer," Dr. Rougier concluded. Funding for this study was provided by sanofi-aventis. [Presentation title: Double-Blind, Placebo-Controlled, Randomized Phase III Trial of Aflibercept+Gemcitabine Versus Placebo+Gemcitabine in Patients With Metastatic Pancreatic Cancer. Abstract O-0006] E-mail this page to a friend or colleague! To print, use this version