PMID- 28413791
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200930
IS  - 2278-330X (Print)
IS  - 2278-4306 (Electronic)
IS  - 2278-330X (Linking)
VI  - 6
IP  - 1
DP  - 2017 Jan-Mar
TI  - 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.
PG  - 20-24
LID - 10.4103/2278-330X.202560 [doi]
AB  - 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.
FAU - Talwar, Vineet
AU  - Talwar V
AD  - Rajiv Gandhi Cancer Institute and Research Centre, New Delhi, India.
FAU - Nirni, Sharanabasappa S
AU  - Nirni SS
AD  - Medical Oncology, Omega Hospitals, Hyderabad, India.
FAU - Mallavarapu, Krishna Mohan
AU  - Mallavarapu KM
AD  - Basavatarakam Indo-American Cancer Hospital and Research Institute, Hyderabad, 
      India.
FAU - Ramkumar, Anupama
AU  - Ramkumar A
AD  - Clinical Development, Biologics, Dr. Reddy's Laboratories Ltd., Hyderabad, India.
FAU - Sinha, Nitu
AU  - Sinha N
AD  - Clinical Development, Biologics, Dr. Reddy's Laboratories Ltd., Hyderabad, India.
LA  - eng
PT  - Journal Article
PL  - India
TA  - South Asian J Cancer
JT  - South Asian journal of cancer
JID - 101618774
PMC - PMC5379888
OTO - NOTNLM
OT  - Chemotherapy-induced neutropenia
OT  - Peg-grafeel
OT  - febrile neutropenia
OT  - granulocyte colony-stimulating factor
OT  - myelosuppressive chemotherapy
OT  - pegfilgrastim
OT  - postmarketing surveillance study
COIS- Ramkumar Anupama received consultancy fees from Dr. Reddy's Laboratories Ltd. 
      Sinha Nitu is an employee of the study sponsor company, Dr. Reddy's Laboratories 
      Ltd. Nirni Sharanabasappa, Talwar Vineet and Mallavarapu Krishna Mohan have no 
      conflicts to declare.
EDAT- 2017/04/18 06:00
MHDA- 2017/04/18 06:01
PMCR- 2017/01/01
CRDT- 2017/04/18 06:00
PHST- 2017/04/18 06:00 [entrez]
PHST- 2017/04/18 06:00 [pubmed]
PHST- 2017/04/18 06:01 [medline]
PHST- 2017/01/01 00:00 [pmc-release]
AID - SAJC-6-20 [pii]
AID - 10.4103/2278-330X.202560 [doi]
PST - ppublish
SO  - South Asian J Cancer. 2017 Jan-Mar;6(1):20-24. doi: 10.4103/2278-330X.202560.