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

Publish Year: 1398
نوع سند: مقاله کنفرانسی
زبان: English
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ISMOH18_045

تاریخ نمایه سازی: 8 بهمن 1398

Abstract:

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

Authors

Arash jenabian

Department of Medical Oncology and Hematology, Tehran Medical Sciences Branch, Islamic Azad University, Tehran, Iran

Ali Panahi sharif

Tehran Medical Sciences Branch, Islamic Azad University, Tehran, Iran

Jahangir Raafat

Cancer Research Center, Cancer Institute, Medical Oncology Dept., Tehran, Iran

Seyed Mohammadreza Mortazavizadeh

Department of Internal, Faculty of Medicine, Islamic Azad University, Yazd, Iran

Ali Ehsanpour

Thalassemia and Hemoglobinopathy Research Center, Research Institute of Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran

Adnan Khosravi

Tobacco Prevention and Control Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran