Pegfilgrastim reduces the incidence of febrile neutropenia in patients with colorectal cancer receiving FOLFOX or FOLFIRI and Bevacizumab


The results from PAVES ( Pegfilgrastim and Anti-VEGF Evaluation Study ), a Phase 3 trial which evaluated Neulasta ( Pegfilgrastim ) in 845 patients receiving FOLFOX or FOLFIRI and Bevacizumab ( Avastin ) for the first-line treatment of locally-advanced or metastatic colorectal cancer were presented.
FOLFOX and FOLFIRI are two of the most commonly used chemotherapy regimens for colorectal cancer.

The study met its primary endpoint, with Neulasta significantly reducing the incidence of febrile neutropenia. Febrile neutropenia is a low white blood cell count accompanied by a fever.1 In the study, the incidence of grade 3 or 4 febrile neutropenia in patients receiving Neulasta 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 ).

PAVES is a Phase 3, randomized, double-blind, placebo-controlled trial evaluating Pegfilgrastim 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 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.

Neulasta was approved by the FDA ( Food and Drug Administration ) in 2002 to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.
Neulasta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Neulasta should not be used in patients with a history of serious allergic reactions to Pegfilgrastim or Filgrastim.
Fatal splenic rupture can occur. Evaluate for splenomegaly or splenic rupture in patients with left upper abdominal or shoulder pain. Acute respiratory distress syndrome ( ARDS ) can occur. It is necessary to evaluate for ARDS in patients who develop fever, lung infiltrates, or respiratory distress. Neulasta should be discontinue in patients with ARDS. Serious allergic reactions, including anaphylaxis, can occur. Permanently discontinue Neulasta in patients with serious allergic reactions. Severe and sometimes fatal sickle cell crises have been reported.

Most common adverse reactions ( greater than or equal to 5% difference in incidence ) in placebo-controlled clinical trials are bone pain and pain in extremity. ( Xagena )

Source: Amgen, 2013

XagenaMedicine_2013



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