PAVES ( Pegfilgrastim and Anti-VEGF Evaluation Study ) trial has evaluated Pegfilgrastim ( Neulasta ) in 845 patients receiving FOLFOX or FOLFIRI and Bevacizumab ( Avastin ) for the first-line treatment of locally-advanced or metastatic colorectal cancer.
FOLFOX and FOLFIRI are two of the most commonly used chemotherapy regimens for colorectal cancer.
The study met its primary endpoint, with Pegfilgrastim significantly reducing the incidence of febrile neutropenia. In the study, the incidence of grade 3 or 4 febrile neutropenia in patients receiving Pegfilgrastim across the first four cycles of chemotherapy was 2.4% compared to 5.7% in 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 ).
In PAVES trial, 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 Pegfilgrastim 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.
One of the most common side effects of myelosuppressive chemotherapy is a low white blood cell count. An abnormally low level of neutrophils, an important infection-fighting white blood cell, is called neutropenia. The fewer neutrophils a patient has – and the longer the neutrophil count remains low – the greater the risk of developing a potentially serious infection.
Febrile neutropenia is neutropenia complicated by a fever. Fever is frequently a sign of infection and, in patients receiving myelosuppressive chemotherapy, it can sometimes be the only sign. Febrile neutropenia is a medical emergency and is associated with several potential downstream consequences. ( Xagena )
Source: Gastrointestinal Cancers Symposium, 2013