Risks of haematological malignancies in patients treated for solid tumours associated with the use of pegylated...

The use of pegylated granulocyte colony-stimulating factors (PGCSFs), specifically pegfilgrastim and lipegfilgrastim, has been widely adopted to reduce the incidence of febrile neutropenia in patients undergoing chemotherapy. However, concerns regarding the long-term safety of PGCSFs, particularly the risk of secondary haematological malignancies, remain. The present study aimed to evaluate the incidence of secondary haematological malignancies in patients treated for solid tumours with PGCSFs at a single institution from 2005 to 2019. A retrospective analysis was conducted using an electronically managed database of 1,577 patients who received PGCSFs during chemotherapy for solid tumours. Patients with a history of any granulocyte or granulocyte-macrophage colony-stimulating factor administered prior to PGCSF were excluded. The incidence of secondary malignancies was assessed from the first application of PGCSF until the last patient contact, with a maximum follow-up time until December 2023. Among the evaluated cohort of 1,577 patients with the median follow-up time of 4.75 (0.0-18.1) years, respectively, with 757 (36.4%) patients followed-up for ≥5 years and 203 (18.1%) patients for ≥10 years; 7 (0.44%) patients were diagnosed with secondary haematological malignancies, including myelodysplastic syndrome in 2 patients, multiple myeloma in 3 patients and non-Hodgkin lymphoma in 2 patients. The present study findings demonstrated that the long-term use of PGCSFs in patients treated for solid tumours does not substantially increase the risk of secondary haematological malignancies, which supports their safety profile in clinical practice. However, a longer follow-up is necessary to further evaluate the safety of PGCSFs, particularly for biosimilars.