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Biosimilar Proves Safe, Effective in Patients With DLBCL

February 16, 2018

A recent study found that a biosimilar provides improved outcomes without increased risk of toxicity for patients with diffuse large B-cell lymphoma (DLBCL) and treatment-induced neutropenia.

Currently, the standard of care for treating patients with DLBCL is chemotherapy with cyclophosphamide, doxorubicin, vincristine, and prednisone plus immunotherapy with rituximab. However, this regimen is associated with a significant risk of chemotherapy-induced neutropenia and febrile neutropenia. Prophylaxis of neutropenia is needed for patients with DLBCL receiving this treatment.

A study published in the European Journal of Hematology (December 2017; doi:10.1111/ejh.13002) led by Pere Gascón, department of Hematology-Oncology, University of Barcelona (Spain), reported DLBCL-specific findings from a pan-European, multicenter, prospective, observational study (MONITOR-GCSF) that described the treatment patterns and clinical outcomes of patients who received the biosimilar filgrastim-sndz in the prophylaxis of chemotherapy-induced neutropenia and febrile neutropenia. A total of 245 patients with DLBCL were included in the study, of which 239 had available data on filgrastim-sndz outcomes, including 123 patients aged 65 years or older.

Researchers found that 87 patients experienced at least one episode of chemotherapy-induced neutropenia and 24 experienced febrile neutropenia during the study. Episodes of neutropenia led to frequent changes to chemotherapy, including receiving fewer than six cycles of chemotherapy, dose reduction, dose delay, or cycle cancellation.

Commonly-reported reasons for discontinuation were unavailability of the biosimilar in the hospital, stopping chemotherapy, change of granulocyte-colony-stimulating factor agent, and cancellation of the chemotherapy protocol.


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Frequently-reported adverse events included bone pain, arthralgia, and back pain.

Authors of the study concluded that the MONITOR-GCSF study supports the safety and efficacy of filgrastim-sndz in patients with DLBCL in a real-world setting. The large proportion of patients who were aged 65 years or older contributes to the body of evidence of optimal treatment strategy for those who receive myelosuppressive chemotherapy for DLBCL, they wrote.—Zachary Bessette

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