Phase III data for pegfilgrastim (Neulasta®) in patients receiving chemotherapy for colorectal cancer

Source: BioSpace Area: News BioSpace has reported data from the double-blind, placebo-controlled PAVES study which is evaluating pegfilgrastim (Neulasta®) in patients receiving FOLFOX or FOLFIRI and bevacizumab for the first-line treatment of locally-advanced or metastatic colorectal cancer (n=845).   In the study, all patients received treatment with FOLFOX or FOLFIRI plus bevacizumab and they were randomised to one of two treatment arms that also received either placebo or 6mg of pegfilgrastim at least 24 hours after each cycle of chemotherapy. The primary endpoint was the incidence of grade 3 or 4 febrile neutropoenia during the first four cycles - this occurred in 2.4% of patients in the pegfilgrastim group and in 5.7% of the placebo group (OR 0.41, p=0.014). A similar incidence of grade 3 or higher adverse events was seen in both arms of the trial (28% placebo; 27% pegfilgrastim).   Full results of the study were due for presentation at the 2013 Gastrointestinal Cancers Symposium. ...
Source: NeLM - News - Category: Drugs & Pharmacology Source Type: news