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.
