Authors: Saad Nasir, Insia Ali, Mohammad Saad Salim Naviwala, Zayan Alidina, Hiba Idrees, Munira Moosajee
Published: 2024-06-13
DOI: 10.1200/jco.2024.42.16_suppl.12115
Source: Full article
12115 Background: While pegfilgrastim forms the cornerstone in chemotherapy-induced neutropenia prophylaxis, its newer biosimilar agents show potential as compelling options. However, despite head-to-head randomized clinical trials (RCTs) demonstrating comparable efficacy between these biosimilar agents of pegfilgrastim and the conventional pegfilgrastim, a lack of evidence exists to suggest definite clinical benefit. This could be attributed to the low statistical power in the clinical trials. Our systemic review and meta-analysis aim to pool the available evidence and provide a comprehensive understanding of the landscape in the prevention of chemotherapy-induced neutropenia. Methods: A literature search was conducted on online databases including, MEDLINE (PubMed), Embase, SCOPUS, and the Cochrane CENTRAL from their inception to October 2023 to identify phase II or III RCTs comparing the efficacy and safety profiles of the conventional pegfilgrastim and its biosimilar agents. Included studies reported at least one key outcome: the duration of severe neutropenia (DSN) in days after the first cycle of chemotherapy (primary outcome), incidence of febrile neutropenia (FN), and bone pain. Pooled risk ratios (RR) and weighted mean difference (WMD) with 95% confidence interval (CI) were calculated using a random-effects model. Heterogeneity was assessed using I2 statistics. Results: We identified 10 RCTs involving 2237 patients. Our analysis showed a statistically significant and favorable outcome for biosimilar agents in reducing DSN (WMD -0.08 days, 95% CI, -0.15, -0.01, P=0.03, I2=0%). No significant differences were observed in the incidence of FN (RR: 0.98, 95% CI, 0.62, 1.53, I2=0%) or bone pain (RR: 0.98, 95% CI, 0.82, 1.17, I2=0%). In the subgroup analysis based on the subtype of biosimilar agents, eflapegrastim had a statistically significant impact in decreasing DSN compared to the conventional pegfilgrastim (WMD -0.13 days, 95% CI -0.24, -0.03, P=0.01, I2=0%). Conclusions: Growing evidence supports cost-effective biosimilars of pegfilgrastim as comparable in efficacy and safety. Eflapegrastim emerges as a promising alternative, demonstrating a clinically meaningful benefit over the conventional pegfilgrastim.