NEXT Study: Biosimilar Filgrastim an Effective Alternative for Chemotherapy-Induced Neutropenia

Meg Barbor, MPH

October 2015, Vol 6, No 9 - Emerging Therapies


Copenhagen, Denmark—Biosimilar filgrastim (Nivestim; Hospira), which was approved earlier this year by the European Commission but not yet by the FDA, showed effectiveness for the treatment of neutropenia and febrile neutropenia (FN) in patients undergoing cytotoxic chemotherapy for solid tumors and hematologic malignancies, according to a study presented at the 2015 Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology meeting.

Didier S. Kamioner, MD, Department of Medical Oncology and Hematology, Hôpital Privé de l’Ouest Parisien, Trappes, France discussed the results of the NEXT (Nivestim Safety Profile in Patients Treated with Cytotoxic Chemotherapy in Real-Life Clinical Practice) study.

FN is a common complication of cytotoxic chemotherapy. Biosimilar filgrastim is a granulocyte colony-stimulating factor (G-CSF) approved by the European Commission, but not yet by the FDA for the treatment of neutropenia and FN induced by myelosuppressive chemotherapy.

According to the updated guidelines from the European Organisation for Research and Treatment of Cancer, the prophylactic use of G-CSF is recommended in patients receiving chemotherapy that carries a high risk for FN, and in patients receiving a chemotherapy regimen that is associated with intermediate risk for FN when other patient-related risk factors are present (ie, older age, history of previous FN, female sex, poor performance status, and/or nutrition status).

“To explore the ‘real-life’ use and safety profile of biosimilar filgrastim, the NEXT study gathered long-term data in patients receiving biosimilar filgrastim as prophylaxis or curative treatment while undergoing chemotherapy for hematological malignancies or solid tumors,” said Dr Kamioner.

The primary study end point was the incidence of adverse events. The secondary end points included patient characteristics and methods of treatment with biosimilar filgrastim in real-life practice, efficacy as measured by the occurrence of FN and infection, and the impact of these events on the chemotherapy regimen.

Low Febrile Neutropenia Rate

Of the 2114 patients enrolled in the study, 2102 were analyzed. Overall, 75% of the patients had solid tumors, and 25% had hematologic malignancies.

The majority (98.2%) of patients received prophylactic biosimilar filgrastim. “The median duration of treatment (5 days) was very short,” added Dr Kamioner.

At study initiation, 92.5% of patients had no previous FN, 34.4% had received previous chemotherapy, and 20.2% had previous G-CSF therapy.

FN occurred in only 4.9% of the patients, with a median of 5.5 days in the hospital. In addition, “patients older than 63 were more likely to have febrile neutropenia than younger patients,” Dr Kamioner reported.

Overall, 4.7% of patients had a reduction in chemotherapy dose, and 7.4% of patients experienced a delay in the administration of chemotherapy.

The investigators noted that the rate of FN in the NEXT study was comparable with other studies, confirming that bone pain is the most common and consistent side effect related to the use of G-CSF.

“We identified factors statistically associated with a higher risk of bone pain occurrence,” said Dr Kamioner. In patients with hematologic malignancies, these factors include age ?68 years, no history of chemotherapy, lymphoma, and acute leukemia compared with chronic lymphocytic leukemia.

In patients with solid tumors, bone pain was associated with female sex; a history of chemotherapy; hemoglobin ?12 g/dL at study inclusion; use of a regimen of fluorouracil, epirubicin hydrochloride, and cyclophosphamide; and use of prophylaxis with anti-­infective therapy.

The investigators concluded that biosimilar filgrastim is an alternative therapeutic option for patients with chemotherapy-induced neutropenia.