Two decades of pegfilgrastim: what have we learned? Where do we go from here?

Chemotherapy-induced febrile neutropenia (FN) is a medical emergency that may occur in patients with malignancies receiving myelosuppressive chemotherapy. FN requires early therapeutic intervention since it is associated with increased hospitalizations and high mortality risk of 5%-20%. FN-related hospitalizations are higher in patients with myeloid malignancies than in those with solid tumors due to the myelotoxicity of chemotherapy regimens and the compromised bone marrow function. FN increases the burden of cancer by causing chemotherapy dose reductions and delays. The administration of the first granulocyte colony-stimulating factor (G-CSF) filgrastim reduced the incidence and duration of FN in patients undergoing chemotherapy. Filgrastim later evolved into pegfilgrastim, which has a longer half-life than filgrastim and is associated with a lower rate of severe neutropenia, chemotherapy dose reduction, and treatment delay. Nine million patients have received pegfilgrastim since its approval in early 2002. The pegfilgrastim on-body injector (OBI) is an innovative device facilitating the time-released auto-injection of pegfilgrastim approximately 27 h after chemotherapy, as clinically recommended for the prevention of FN, thus eliminating the need for a next-day hospital visit. Since its introduction in 2015, one million patients with cancer have received pegfilgrastim using the OBI. Subsequently, the device was approved in the United States (US), European Union, Latin America, and Japan, with studies and a postmarketing commitment demonstrating device reliability. A recent prospective observational study conducted in the US demonstrated that the OBI substantially improved the adherence to and compliance with clinically recommended pegfilgrastim therapy; patients receiving pegfilgrastim via the OBI experienced a lower incidence of FN than those receiving alternatives for FN prophylaxis. This review discusses the evolution of G-CSFs leading to the development of the OBI, current recommendations for G-CSF prophylaxis in the clinic, continued evidence supporting next-day pegfilgrastim administration, and improvements in patient care made possible with the OBI. PLAIN LANGUAGE SUMMARY For over 20 years, treatment with pegfilgrastim (a therapy that supports the growth of immune cells) has been used in patients with cancer to prevent febrile neutropenia (FN) - an unwanted effect of cancer treatment or chemotherapy. FN is defined as the loss of healthy immune cells and development of fever possibly due to an infection. Patients with FN may be very ill or may die, depending on the seriousness of the condition. However, treatment with pegfilgrastim reduces the occurrence of FN and improves survival. Treatment guidelines recommend that pegfilgrastim should be given 24 h after chemotherapy, requiring patients to travel to the hospital on the next day of chemotherapy. Some patients may choose the less helpful option of receiving pegfilgrastim on the same day of chemotherapy to avoid travel. This need led to the development of an on-body injector (OBI) device that is applied on the skin on the last day of chemotherapy and administers pegfilgrastim approximately 27 h after chemotherapy. The highly reliable OBI ensures timely delivery of therapy with a success rate of 99.9%, reduces the travel burden, and helps in following the recommended guidelines for pegfilgrastim administration. For two decades, pegfilgrastim has played a significant role in the treatment and prevention of FN, and the new OBI device provides the required treatment support for improving patient care.

Automated summary

Chemotherapy-induced febrile neutropenia (FN) is a medical emergency that requires early therapeutic intervention. The administration of pegfilgrastim via the on-body injector (OBI) has significantly improved the adherence to and compliance with clinically recommended pegfilgrastim therapy, reducing the incidence of FN. Pegfilgrastim has played a crucial role in the treatment of FN, and the introduction of the OBI device has further improved patient care.