Safety and tolerability of Peg-grafeel™, a pegfilgrastim, for the prophylactic treatment of chemotherapy-induced neutropenia and febrile neutropenia: A prospective, observational, postmarketing surveillance study in India

Abstract

Background:A granulocyte colony-stimulating factor, pegfilgrastim, is efficacious though expensive for prophylactic treatment of chemotherapy-induced neutropenia and febrile neutropenia. Biologics available and accessible today, having acceptable safety-efficacy profiles, require postapproval studies for better understanding of such drugs in clinical settings.Aim:This postmarketing surveillance study evaluated the safety of prophylactic Peg-grafeel™ (pegfilgrastim) in cancer patients with chemotherapy-induced neutropenia.Settings and Design:This prospective, noninterventional, single-arm, open-label study was conducted at 10 study sites in India.Methods:Patients received subcutaneous 6 mg Peg-grafeel™ approximately 24 h following chemotherapy as part of routine patient care.Statistical Analysis:Data were summarized descriptively.Results:The study included 250 patients (male: female = 36.4%:63.6%; median age, 54 [16–80] years). Most patients had Stage III (33.2%) or IV (41.6%) cancers and received cyclophosphamide (37.2%) and doxorubicin (31.6%) as chemotherapy. On an average, 4 Peg-grafeel™ doses were administered per patient. Treatment-emergent adverse events (AEs) were reported in 115 (46%) patients, the most common being vomiting (11.6%), pain (11.2%), nausea (8.4%), and constipation (8.4%). Peg-grafeel™-related AEs included pain (3.2%), asthenia (2.4%), and arthralgia (1.2%). Bone pain (0.4%) and extremity pain (1.2%) were rare. Grade 3/4 neutropenia and febrile neutropenia occurred in 4 (1.6%) and 3 (1.2%) patients, respectively. Serious AEs included vomiting (2.8%) and pyrexia (2%). No new safety concerns were identified. None of the five deaths was considered related to Peg-grafeel™.Conclusion:The overall safety profile of Peg-grafeel™ was consistent with the expected safety profile of pegfilgrastim in patients with advanced malignancies in a clinical setting.

Assessment of Chemotherapy-Induced Febrile Neutropenia in Cancer Patients

“…[18] The higher incidence of CIFN was shown in Stage 3 of cancer (42.10%), similarly Talwar et al, conducted a study, where most of the patients with CIFN presented in stage 3 (33.2%) and in Stage 4 (41.6%) of cancer. [19] To the best of our knowledge, this is the premier study to analyze the CIFN reactions by using causality, severity, preventability, and predictability scales. As per the WHO and Naranjo's scales, most of the CIFN reactions were classified as probably 81.82% and 77.2%, respectively.…”