Incidence of severe and febrile neutropenia in cancer patients treated with myelosuppressive chemotherapy in real clinical oncology practice: Preliminary results from the FLAME study.

Abstract

e18740 Background: Febrile neutropenia (FN) is a life-threatening complication of myelosuppressive chemotherapy (CT). It can lead to infections, subsequent hospitalizations, treatment delays, dose reductions, and additional health care costs. According to guidelines, use of granulocyte colony-stimulating factors (G-CSF) prevents FN. However, in clinical practice, the need for G-CSF use has not been defined due to the lack of national reports on neutropenic complications (NC). Methods: FLAME is the first Russian retrospective non-randomized non-interventional study designed to include 515 patients (pts) with solid tumors receiving myelosuppressive CT with or without targeting and immuno-oncology drugs. The primary objective of this study is to define the actual incidence of NC in clinical practice and to identify patients at high risk of FN. In addition, this study is intended to demonstrate the unmet need for G-CSF prophylaxis of FN. Patients who completed at least the first 2 cycles of treatment in frame of the course between the 1st’Aug 2020 till 30th’October 2021 were eligible to be included in the study. Results: Data were obtained from 492 pts recruited from cancer hospitals throughout Russia. Their characteristics were as follows: median age 56.5; male/female: 36.5%/63.5%. Among 492 pts with various malignancies, 65% had stage III or IV. Breast (68%), colorectal (10%), urogynecological cancer (10%) were the most common. The remaining were gastrointestinal cancer, lung cancer, sarcoma, and CUP. Clinically significant comorbidities were reported in 53.6% of pts. Thirty percent of patients had ≥1 risk factor for FN based on individual and CT analysis. From 29 different CT regimens, 14% had a high risk of FN. Primary prophylaxis was given only to 44.1% pts with a high risk of FN [empegfilgrastim (Extimia®) 19,1%, filgrastim 25%]. The duration of filgrastim administration was 1 to 3 days in 81% of cases. Treatment of NC with corticosteroids and others was prescribed in 12.8% of cases. Three percent (3%) and 3.8% of pts had FN and dose-limiting neutropenia, respectively. Delayed CT at the second cycle was performed in 27%. The dose of CT was reduced by 20-25% in 8.3% of patients. Conclusions: Preliminary results from this study suggest that the risk of FN is higher from the start of CT. Delaying and reducing the dose of CT is still typical for oncologists. This practice is associated with low adherence to guidelines. Further efforts are needed to decrease the risk of NC in clinical practice.

The Role of Granulocyte-Colony Stimulating Factor Biosimilars for Supportive Cancer Care: A Year in Review

“…A retrospective, non-randomised, noninterventional study presented at ASCO 2022 presented data on the use of G-CSFs in clinical practice in Russia. 7 A total of 492 patients with solid tumours receiving myelosuppressive chemotherapy were included in the analysis. The majority of patients presented with breast (68%), colorectal (10%), and urogynaecological cancer (10%).…”

“…[1][2][3][4][5] Development of febrile neutropenia may compromise the treatment response, as it may necessitate dose reduction and treatment delay. 7,8 This imposes a substantial economic burden, 7,8 requiring hospitalisation and treatment with broad-spectrum antibiotics, and is associated with significant morbidity and mortality. 3,6 In patients with early breast cancer, neutropenia is reported to be the most common adverse event experienced, resulting in a reduction in relative dose intensity (RDI) for those receiving chemotherapy, reducing treatment efficiency and overall survival.…”