Background: Granulocyte-colony stimulating factor (G-CSF) is used in cancer patients to treat chemotherapy-induced neutropenia (CIN). However, G-CSF poses few risks. Despite the regular use of G-CSF in CIN management, there is a paucity of published data on its safety profile in the management of CIN in India. Hence, the present study was designed to demonstrate the safety profile of G-CSF in patients with CIN.
Methods: A prospective observational study was conducted over a period of 5 months enrolling 100 cancer patients aged from 18 years to 70 years. Patients with a diagnosis of CIN who received G-CSF were included. Patients were followed up for 15 days. Adverse events (AEs) were graded according to US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The system organ class and preferred term of Medical Dictionary for Regulatory Activities (MedDRA) were used for reporting the AEs. Causality assessment was done by using the WHO-Uppsala Monitoring Centre scale.
Results: The most frequently reported AEs were musculoskeletal and connective tissue disorders which included bone pain, myalgia, arthralgia, and pain in the extremity. Other AEs reported were general disorders and administration site conditions, and gastrointestinal disorders. The highest grade of toxicity reported was of grade 3 among all AEs. The majority of AEs had a "probable" type of causality relationship with G-CSF.
Conclusion: G-CSF has a safety profile consistent with previous G-CSF studies. Criteria for Adverse Events, filgrastim, granulocyte-colony stimulating factor, Medical Dictionary for Regulatory Activities.
Keywords: Criteria for Adverse Events; Medical Dictionary for Regulatory Activities; filgrastim; granulocyte-colony stimulating factor.