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

Vineet Talwar; Sharanabasappa S Nirni; Krishna Mohan Mallavarapu; Anupama Ramkumar; Nitu Sinha

doi:10.4103/2278-330X.202560

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

South Asian J Cancer. 2017 Jan-Mar;6(1):20-24. doi: 10.4103/2278-330X.202560.

Authors

Vineet Talwar¹, Sharanabasappa S Nirni², Krishna Mohan Mallavarapu³, Anupama Ramkumar⁴, Nitu Sinha⁴

Affiliations

¹ Rajiv Gandhi Cancer Institute and Research Centre, New Delhi, India.
² Medical Oncology, Omega Hospitals, Hyderabad, India.
³ Basavatarakam Indo-American Cancer Hospital and Research Institute, Hyderabad, India.
⁴ Clinical Development, Biologics, Dr. Reddy's Laboratories Ltd., Hyderabad, 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.

Keywords: Chemotherapy-induced neutropenia; Peg-grafeel™; febrile neutropenia; granulocyte colony-stimulating factor; myelosuppressive chemotherapy; pegfilgrastim; postmarketing surveillance study.