Efficacy and Safety of Pegfilgrastim in Indian Patients.

ABSTRACT

Context Pegfilgrastim, a pegylated recombinant granulocyte colony stimulating factor, promotes the hematopoietic recovery after cytotoxic chemotherapy and is marketed in India as PegstimTM. Aims: This post marketing surveillance study was undertaken to evaluate the efficacy and safety of PegstimTM in clinical practice in Indian patients. Material and Methods: Investigators participating in this post marketing surveillance were asked to capture data of all the patients who were given PegstimTM along with cytotoxic chemotherapy for their underlying malignancy. PegstimTM was given as a single subcutaneous dose approximately 24 hours after administration of cytotoxic chemotherapy and patients were followed up for 14 days with blood counts at baseline and every alternate day. Each cycle of chemotherapy in which PegstimTM was administered was considered as a distinct patient entity for efficacy and safety analysis. Results: PegstimTM injections were used in 213 patients and led to an increase in Absolute Neutrophil Count (ANC) as early as 2 days after administration of the drug with mean percent increase in ANC of 129.8 ± 210.9% at the end of 14 days. The overall incidence of moderate-severe (grade III/IV) febrile neutropenia in the total population studied was 6.1% (13 patients). Intravenous antibiotics were used in 10 (4.7%) patients while 4 (1.9%) patients required hospitalization. A total of 57 adverse events were reported in 32 patients during the entire course of the study, the most common being musculoskeletal pain in 22 (10.3%) patients. Conclusions: The results from this post marketing surveillance study support the efficacy and tolerability of PegstimTM used for preventing neutropenia across various tumor types and regimens in Indian patients.