Neulasta® (pegfilgrastim) significantly reduced the incidence of grade 3/4 febrile neutropenia among patients with locally advanced or metastatic colorectal cancer who received chemotherapy with FOLFOX or FOLFIRI followed by Avastin® (bevacizumab), according to the results of a study presented at the 2013 Gastrointestinal Cancers Symposium in San Francisco.
Although chemotherapy improves outcomes for many cancer patients, it is associated with unpleasant and sometimes life-threatening side effects, including neutropenia, which occurs when white blood cells (immune cells) are destroyed by chemotherapy, leaving the immune system unable to fight infections. Some research indicates that the addition of biologic drugs (such as Avastin) to chemotherapy may increase the incidence of clinically significant neutropenia.
Chemotherapy-induced neutropenia can become a serious condition for several reasons: many patients who develop neutropenia will require a delay in treatment or a dose reduction, which can prevent them from receiving full benefits of treatment; patients who develop neutropenia may require hospitalization; and even minor infections can become life-threatening.
Neulasta is a blood cell growth factor that can be an important addition to the chemotherapy regimen for many patients. Neulasta is given by injection during chemotherapy cycles and can reduce infections, hospitalizations, medical cost, dose delays, and death associated with infection in neutropenic patients.
The Pegfilgrastim and Anti-VEGF Evaluation (PAVES) Study, is a Phase 3, randomized, double-blind, placebo-controlled trial evaluating Neulasta in 845 patients receiving FOLFOX or FOLFIRI and 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. All patients in the study received either FOLFOX or FOLFIRI followed by Avastin—and were then randomized to receive either placebo or 6 mg of Neulasta at least 24 hours after each cycle of chemotherapy. The study treatment period included four cycles, but patients could continue their assigned regiment until progression.
The primary endpoint of the study was the incidence of grade 3 or 4 febrile neutropenia during the first four cycles. The results showed that 783 patients completed four cycles of treatment—and the incidence of grade 3 or 4 febrile neutropenia in patients receiving Neulasta across the first four cycles of chemotherapy was 2.4 percent compared to 5.7 percent in the placebo group.
The researchers concluded that the study met its primary endpoint and that Neulasta significantly reduced the incidence of febrile neutropenia in patients with colorectal cancer. Follow-up is ongoing.
Pinter T, Abella S, Cesas A, et al. Results of a phase III, randomized, double-blind, placebo-controlled trial of pegfilgrastim (PEG) in patients (pts) receiving first-line FOLFOX or FOLFIRI and bevacizumab (B) for colorectal cancer (CRC). Journal of Clinical Oncology. 2012; 30(suppl 34): Abstract LBA445.