Febrile neutropenia (FN) is among the most common complications of chemotherapy, and a recent post-marketing, multi-center, real-world, non-interventional, epidemiological study sought to examine the use, safety, and efficacy of biosimilar filgrastim in the primary and secondary prevention of FN.
Febrile neutropenia (FN) is among the most common complications of chemotherapy, and a recent post-marketing, multi-center, real-world, non-interventional, epidemiological study sought to examine the use, safety, and efficacy of biosimilar filgrastim in the primary and secondary prevention of FN.
Secondary prevention of FN is typically offered to a patient who is in a low-risk category for developing FN, but who develops FN during chemotherapy. Primary prevention of FN is offered to high-risk patients with each cycle of chemotherapy. Of the 170 study participants, an overall risk assessment conducted at the first patient visit resulted in the following determinations:
After the risk assessment, 60% of patients received biosimilar filgrastim (Accofil, manufactured by Accord Healthcare, who sponsored the study) as primary prevention of FN, and 40% received biosimilar treatment as secondary prevention. During the second to fifth patient visit (though in 40.6% of patients, 6 cycles of chemotherapy were planned, and in 28.2% of cases, more than 6 cycles were planned), the course of therapy with biosimilar filgrastim was monitored. Data collected, via questionnaire, included the following:
The researchers calculated continuation of therapy with biosimilar filgrastim, average dose of filgrastim, chemotherapy dosage, and FN at each of the 5 visits, and found the following:
An assessment of patient reports found that 70% of patients self-administered the filgrastim injection, and at each visit, over 50% of patients reported “little” soreness caused by the injection. Patient assessments of the convenience of use (on a scale of 1 to 10, where 1 is the least convenient and 10 is the most convenient), showed that approximately 50% of patients rated the convenience of administration as greater than 8.
Assessment of hematological parameters showed that the median neutrophil count identified at visit 1 (2.2×103/µl) did not fall during any of the 5 visits.
The researchers concluded that biosimilar filgrastim was safe, effective, and well tolerated in patients in the primary and secondary prevention of chemotherapy-induced FN, and that administration of the drug was convenient for, and well accepted by, patients.