About PAVESPAVES is a Phase 3, randomized, double-blind, placebo-controlled trial evaluating Neulasta in 845 patients receiving FOLFOX or FOLFIRI and bevacizumab for the first-line treatment of locally-advanced or metastatic colorectal cancer. The trial was multicenter and multinational. All patients received treatment with either FOLFOX or FOLFIRI plus bevacizumab and were randomized to one of two treatment arms that also received either placebo or 6 mg of Neulasta at least 24 hours after each cycle of chemotherapy. The primary endpoint was the incidence of grade 3 or 4 febrile neutropenia during the first four cycles. The study was not designed to define the febrile neutropenia rate of FOLFOX or FOLFIRI plus bevacizumab. Other endpoints include overall response rate, progression-free survival, overall survival, time to progression and adverse events.
Amgen Announces Results From Phase 3 PAVES Study Evaluating Neulasta® (pegfilgrastim) In Patients With Colorectal Cancer
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