Risk of chemotherapy-induced febrile neutropenia in patients with metastatic cancer not receiving granulocyte colony-stimulating factor prophylaxis in US clinical practice

Abstract

Objectives To evaluate the use of granulocyte colony-stimulating factor (G-CSF) prophylaxis in US patients with selected metastatic cancers and chemotherapy-induced febrile neutropenia (FN) incidence and associated outcomes among the subgroup who did not receive prophylaxis. Methods This retrospective cohort study was conducted at four US health systems and included adults with metastatic cancer (breast, colorectal, lung, non-Hodgkin lymphoma [NHL]) who received myelosuppressive chemotherapy (2009–2017). Patients were stratified by FN risk level based on risk factors and chemotherapy (low/unclassified risk, intermediate risk without any risk factors, intermediate risk with ≥ 1 risk factor [IR + 1], high risk [HR]). G-CSF use was evaluated among all patients stratified by FN risk, and FN/FN-related outcomes were evaluated among patients who did not receive first-cycle G-CSF prophylaxis. Results Among 1457 metastatic cancer patients, 20.5% and 28.1% were classified as HR and IR + 1, respectively. First-cycle G-CSF prophylaxis use was 48.5% among HR patients and 13.9% among IR + 1 patients. In the subgroup not receiving first-cycle G-CSF prophylaxis, FN incidence in cycle 1 was 7.8% for HR patients and 4.8% for IR + 1 patients; during the course, corresponding values were 16.9% and 15.9%. Most (> 90%) FN episodes required hospitalization, and mortality risk ranged from 7.1 to 26.9% across subgroups. Conclusion In this retrospective study, the majority of metastatic cancer chemotherapy patients for whom G-CSF prophylaxis is recommended did not receive it; FN incidence in this subgroup was notably high. Patients with elevated FN risk should be carefully identified and managed to ensure appropriate use of supportive care.

The Impact of Baseline Risk Factors on the Incidence of Febrile Neutropenia in Breast Cancer Patients Receiving Chemotherapy with Pegfilgrastim Prophylaxis: A Real-World Data Analysis

“…Importantly, the previously discussed studies and the majority of published literature regarding patient-specific FN risk factors were developed by studying patients who were not receiving primary prophylaxis. [30][31]37 This study is the first, to our knowledge, to demonstrate the substantial impact of patient-specific risk factors on FN incidence in a population of patients all receiving pegfilgrastim primary prophylaxis in the United States. Because of this, it further validates the importance and absolute necessity of using statistical techniques (eg, propensity score matching) to control for these variables in any real-world study that purports to demonstrate a difference in FN incidence between two pegfilgrastim products.…”

“…This is aligned with previously published literature regarding FN incidence in patients receiving myelosuppressive chemotherapy. 12,30,31 Averin et al conducted a retrospective observational study of 4091 patients receiving chemotherapy at four US health systems from 2009 to 2017. 30 The majority of patients had at least one patient-specific FN risk factor (92%) and received high-or intermediate-risk regimens (20.5% and 30.8%, respectively).…”

“…12,30,31 Averin et al conducted a retrospective observational study of 4091 patients receiving chemotherapy at four US health systems from 2009 to 2017. 30 The majority of patients had at least one patient-specific FN risk factor (92%) and received high-or intermediate-risk regimens (20.5% and 30.8%, respectively). Their results showed that the incidence of FN is elevated in patients for whom primary prophylaxis is recommended but not received (16.9% in patients receiving high-risk regimens and 15.9% in patients receiving intermediate-risk regimens with at least one risk factor measured over all chemotherapy courses) and that FN incidence is frequently associated with severe and costly consequences such as hospitalization, which occurred in greater than 90% of cases in their study.…”

Chemotherapy-induced neutropenia and emerging agents for prevention and treatment: A review

“…FN incidence varies across different tumor types [8,20,21]. A retrospective analysis of patients who received a high-risk chemotherapy regimen and did not receive G-CSF prophylaxis revealed a similar incidence of FN in cycle 1 among patients with breast cancer, lung cancer, and NHL (7.5-8.8%), while no cases of FN were found among patients with colorectal cancer (Fig.…”

Conversion from pegfilgrastim with on-body injector to pegfilgrastim-jmdb: cost-efficiency analysis and budget-neutral expanded access to prophylaxis and treatment

“…Chemotherapy-induced neutropenia and febrile neutropenia (CIN/FN) are potentially life-threatening complications of myelosuppressive therapy 1,2 . FN is a major dose-limiting toxicity of chemotherapy and is associated with increased hospitalizations and mortality risk [3][4][5] .…”