A post-marketing surveillance for evaluation of PegaGen® safety and effectiveness in prevention of febrile neutropenia in Iranian cancer patients 65 years and older undergoing first-line chemotherapy

Purpose: Pegfilgrastim, a pegylated recombinant granulocyte colony stimulating factor, is indicated to decrease the incidence of infection (as manifested by febrile neutropenia), in patients with non-myeloid malignancies receiving myelosuppressive cancer chemotherapy associated with a clinically significant incidence of febrile neutropenia (FN). Pegfilgrastim is marketed in Iran as PegaGen®. This post marketing surveillance study was conducted to evaluate the safety and effectiveness of PegaGen® in clinical practice in Iranian cancer patients ≥65 years undergoing first-line chemotherapyPatients and methods: Eligibility criteria for this study was patients aged ≥65 years, with diagnosis of cancer, receiving chemotherapy regimens with a risk of FN of over 20%; or the risk of neutropenic fever between 10% and 20% having at least one of the risk factors. PegaGen® was administered as a single subcutaneous 6 mg dose after administration of cytotoxic chemotherapy for a maximum of 8 cycles. Each cycle of chemotherapy with PegaGen® administration was considered as a distinct entry for safety and effectiveness analysis. Adverse events were recorded for safety analysis and for effectiveness analysis, neutropenic fever was reported.Results: A total of 115 patients were eligible for the present safety and effectiveness analyses of PegaGen®. Bone pain, as the most frequently reported adverse event of PegaGen®, was observed in 119 cycles and 45 patients. Among these, one patient had history of trauma and 6 patients had bone metastasis. The most common location of pain was legs, and the most common pain severity was grade 2. For pain management, acetaminophen was administered in 47.24% of patients, following by NSAIDs (20.86%) and acetaminophen/NSAID combination (19.02%). Fever was also reported as other adverse event. 26 patients experienced fever, 25 patient grade 1 (38-39 ̊C) and the other one grade 2 (39-40 ̊C). No body temperature > 40 ̊C was reported. The overall incidence of FN in the total population studied was 1.73% (10 patients). One patient experienced FN twice in cycles 5 and 6, others reported 1 FN during treatment. Intravenous antibiotics were used in 10 (1.1%) patients. Splenic rupture, as the most severe adverse event of Pegfilgrastim, was not observed in any of patients.Conclusion: The results from this post marketing surveillance study support the safety and effectiveness of PegaGen® administered for prevention of FN among Iranian patients 65 years and older undergoing first-line chemotherapy