Real-World Outcomes of Trilaciclib Among Patients with Extensive-Stage Small Cell Lung Cancer Receiving Chemotherapy

Abstract

Introduction: Trilaciclib was recently approved in the USA for reducing chemotherapy-induced myelosuppression (CIM) among adults with extensive-stage small cell lung cancer (ES-SCLC) when administered prior to chemotherapy. There is limited understanding of real-world outcomes of trilaciclib.

Methods: A comprehensive literature review was conducted using a keyword search in the MEDLINE, Embase, and conference abstracts. Additional studies were identified through communications with the authors of relevant studies. Published and unpublished real-world studies of trilaciclib- and comparable non-trilaciclib-treated patients with ES-SCLC were included. Evidence on myelosuppressive hematologic adverse events (HAEs), cytopenia-related healthcare utilization, and other reported outcomes (e.g., hospitalizations, dose reduction, and treatment delay) were synthesized. If feasible, outcomes were compared qualitatively between the trilaciclib and historical reference groups, and between first-line trilaciclib initiators and the overall trilaciclib population. Weighted averages were estimated for selected outcomes using sample size as the weight.

Results: The literature search identified five unique studies based on eight records-two included trilaciclib only, two non-trilaciclib only, and one both. In trilaciclib cohorts, the weighted average prevalence of grade ≥ 3 myelosuppressive HAEs in ≥ 1 lineage, ≥ 2 lineages, and all three lineages was 40.5%, 14.5%, and 7.5%, respectively. All rates were numerically lower compared to the historical non-trilaciclib cohorts (58.8%, 28.0%, 13.0% respectively). Cytopenia-related healthcare utilization was also lower in the trilaciclib cohorts. In general, first-line trilaciclib initiators had numerically lower myelosuppressive HAEs and cytopenia-related healthcare utilization than the overall trilaciclib patients.

Conclusions: The existing evidence suggests that trilaciclib may reduce single and multilineage grade ≥ 3 myelosuppressive HAEs and cytopenia-related healthcare utilization among patients with ES-SCLC in the real world. It is a promising new treatment for CIM prevention in ES-SCLC and may bring greater benefits to first-line trilaciclib initiators. Future studies are recommended to further evaluate the real-world effectiveness of trilaciclib.

Keywords: Chemotherapy-induced myelosuppression; Cytopenia; Extensive-stage small cell lung cancer; Real world; Supportive care; Trilaciclib.

Fig. 1

PRISMA diagram based on the literature search. PRISMA Preferred Reporting Items for Systematic Literature Review and Meta-analysis, RWE real-world evidence, SCLC small cell lung cancer. The literature search was conducted in MEDLINE, Embase, and Northern Light Life Sciences Conference Abstract databases on November 28, 2022. The literature search was supplemented by the unpublished studies identified through author communications

Fig. 2

Real-world prevalence of grade ≥ 3 myelosuppressive HAEs by lineage. ANC absolute neutrophil count, iKM iKnowMed, HAE hematologic adverse event, FCS Florida Cancer Specialists and Research Institute, LOT line of therapy. ^aWeighted average prevalence was calculated using sample size as weight. The denominator for each outcome was the number of patients with the relevant lab values. The all trilaciclib group had 131 patients, the LOT1 trilaciclib initiators group had 69 patients, and the non-trilaciclib group had 6547 patients with relevant lab values. For single lineage outcomes, the denominators were the number of patients with non-missing ANC for the prevalence of neutropenia, the number of patients with non-missing hemoglobin value for the prevalence of anemia, the number of patients with non-missing platelet value for the prevalence of thrombocytopenia. For multilineage outcomes, the denominators were the number of patients with non-missing values for ANC, hemoglobin and platelet counts for the prevalence of grade ≥ 3 myelosuppressive HAEs in ≥ 3 and ≥ 2 lineages. ^bThe analysis among LOT1 trilaciclib initiators was conducted on the basis of the iKM network and non-network study populations as well as the FCS study. The two iKM-based studies defined LOT1 trilaciclib initiators as those using trilaciclib before the first cycle in the first-line treatment, while the FCS study defined it as initiation of trilaciclib anytime during the first-line treatment

Fig. 3

Real-world outcomes associated with trilaciclib and non-trilaciclib studies. ESAs erythropoiesis-stimulating agents, G-CSF granulocyte colony-stimulating factors, iKM iKnowMed, LOT line of therapy, RBC red blood cell, FCS Florida Cancer Specialists and Research Institute. ^aWeighted average prevalence was calculated using sample size as weight. The denominator for grade 3 or higher cytopenia outcome was the number of patients with the relevant lab values. The all trilaciclib group had 131 patients, the LOT1 trilaciclib initiators group had 69 patients, and the non-trilaciclib group had 6547 patients with relevant lab values. The denominator for G-CSF administration, ESA and transfusion was the number of patients in the corresponding cohort ^bThe analysis among LOT1 trilaciclib initiators was conducted on the basis of the iKM network and non-network study populations as well as the FCS study. The two iKM-based studies defined LOT1 trilaciclib initiators as those using trilaciclib before the first cycle in the first-line treatment, while the FCS study defined it as initiation of trilaciclib anytime during  the first-line treatment. ^cFor RBC and platelet transfusions, the iKM-based and FCS studies estimated the percentages using the number of patients eligible for transfusion based on their lab values, whereas the Integra Connect study used the number of patients receiving transfusions