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Abstract
Chemotherapy is frequently associated with hematologic toxicity. Neutropenia with or without fever is a relevant cause of morbidity, mortality and costs, compromising treatment administration and clinical outcomes. The development of granulocyte colony-stimulating factors has had a positive impact on the clinician’s approach to neutropenia. Such agents, currently used for primary and secondary prophylaxis of chemotherapy-induced neutropenia and febrile neutropenia (FN), are effective in limiting hematologic toxicities and consequently allow the administration of intensive dose-dense regimens. Several biosimilar products of filgrastim have been developed over the years, showing effects similar to the originator drug. Until now, pegfilgrastim has been the only available long-acting factor, requiring just a single administration per chemotherapy cycle. The recent approval of the novel granulocyte colony-stimulating factors, lipegfilgrastim, offers interesting therapeutic alternatives. In fact, similar to pegfilgrastim, it has been demonstrated to reduce the duration of neutropenia and the occurrence of FN during chemotherapy safely.
Financial & competing interests disclosure
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
No writing assistance was utilized in the production of this manuscript.
Cytotoxic chemotherapy often leads to severe hematologic adverse events, with neutropenia and febrile neutropenia as the most serious consequences of myelosuppression. Neutropenic complications require several medical measures, including hospitalization and iv. antibiotics use, which negatively affect patient’s quality of life, compromise treatment administration and, as a consequence, clinical outcome.
The discovery of granulocyte colony-stimulating factors (G-CSFs) as means to increase the production and number of circulating neutrophils represented a revolution for its clinical implication. Since their introduction in medical practice, filgrastim and pegfilgrastim showed a good safety profile and a high effectiveness in preventing and limiting hematologic toxicity.
On the basis of their clinical action, we used G-CSFs for primary and secondary prophylaxis of chemotherapy-induced neutropenia and febrile neutropenia (FN) and they proved to be very helpful in facilitating the delivery of dose-dense and dose-intense regimens, contributing to improve clinical outcomes.
Pegfilgrastim represented for years the only long-acting GCSF; pegylation mechanism, with which it is developed, determines a slower drug clearance, which in turn increase concentration of the molecule during the period of neutropenia and allows the administration of a single dose of pegfilgrastim per chemotherapy-cycle.
Lipegfilgrastim, a new glycoPegylated G-CSF, was approved by EMA in 2013 for chemotherapy-induced neutropenia and FN prophylaxis. The innovative technique of glycopegylation used for its design allowed to obtain a therapeutic product with an extended half-life, providing an alternative long-acting G-CSF option to pegfilgrastim.
Lipegfilgrastim resulted comparable with pegfilgrastim in terms of safety and clinical efficacy in limiting the occurrence and duration of FN. Its introduction has expanded the choices available for clinicians, contributing to achieve a cost-saving for healthcare system and improvement of patient’s quality of life.