Germ cell tumors are common malignancies, and chemotherapy with a regimen of bleomycin, etoposide, and cisplatin (BEP) has improved the prognosis for patients with these tumors. However, BEP involves significant myelosuppression, and the safety of pegfilgrastim for the prevention of febrile neutropenia related to myelosuppression has not been well investigated in patients with this tumor type.
Germ cell tumors (GCTs) are common malignancies, and chemotherapy with a regimen of bleomycin, etoposide, and cisplatin (BEP) has improved the prognosis for patients with these tumors. However, BEP involves significant myelosuppression, and the safety of pegfilgrastim for the prevention of febrile neutropenia (FN) related to myelosuppression has not been well investigated in patients with this tumor type.
Researchers from Kanazawa University Hospital in Japan reported in In Vivo on their findings from the treatment of 10 patients with GCTs treated with BEP from 2014 to 2016. All of the patients received BEP every 3 weeks for 2 to 4 cycles. Pegfilgrastim was administered to 5 patients subcutaneously on day 7. Five patients received filgrastim.
The nadir absolute neutrophil count value was lower in those who used filgrastim than in those who used pegfilgrastim (P = .003). FN occurred in 2 cycles using filgrastim and in no cycles using pegfilgrastim. The duration of grade 2 to grade 4 neutropenia in cycles using filgrastim was longer than in those using pegfilgrastim (P = .01). No serious adverse events were observed.
The median number of days until maximum neutrophil count (MNC) in cycles using pegfilgrastim and filgrastim were 8 and 6, respectively. Interestingly, the MNC was recorded most frequently after pegfilgrastim injection in 85% of cycles that used pegfilgrastim. However, the MNC was recorded before filgrastim administration in 50% of cycles. “These results indicate that filgrastim injection may not be efficacious for increasing the neutrophil count in patients under BEP treatment,” wrote the authors.
The study was limited by its small size and by the fact that the median number of filgrastim administrations was 5 (while administration of pegfilgrastim is equivalent to an 11-day course of filgrastim). Larger prospective studies with longer follow-up periods will be needed to confirm the findings in this study, but the authors concluded that using pegfilgrastim with BEP for patients with GCTs may be an effective treatment for neutropenia that also has minimal toxicity.
Reference
Iwamoto H, Izumi K, Natsagdorj A, et al. Effectivness and safety of pegfilgrastim in BEP treatment for patients with germ cell tumor. In Vivo. 2018;32(4):899-903. doi: 10.21873/invivo.112326.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
CHMP Pushes 3 Biosimilars Forward, Spelling Hope for Ophthalmology, Supportive Care Markets
February 6th 2025The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 3 biosimilars and new indications for reference biologics, moving them closer to final European approval and expanding patient access.
The Biosimilar Void: 90% of Biologics Coming Off Patent Will Lack Biosimilars
February 5th 2025Of the 118 biologics losing exclusivity over the next decade, only 10% have biosimilars in development, meaning a vast majority of biologics have no pipeline, which limits savings potential for the health care system.