Trilaciclib May Reduce Single, High-Grade Myelosuppression in ES-SCLC

“This review provides important evidence of the broad benefit of trilaciclib utilization among patients with ES-SCLC to support treatment decisions,” according to lead study author Jerome Goldschmidt, medical oncologist at the Blue Ridge Cancer Center in Blacksburg, Virginia and the U.S. Oncology Network.

Treatment with trilaciclib (Cosela) may limit single and multilineage grade 3 or higher myelosuppressive hematologic adverse effects (HAEs) and cytopenia related to health care utilization in patients with extensive-stage small cell lung cancer (ES-SCLC), according to real-world findings published in Advances in Therapy.¹

The weighted average rate of grade 3 or higher myelosuppressive HAEs in a real-world cohort of patients treated with trilaciclib with 1 lineage or more was 40.5%. Moreover, the weighted average rate of grade 3 or higher HAEs across 2 lineages or more was 14.5%, and across all 3 lineages, it was 7.5%.

The weighted average rate of grade 3 neutropenia was comparable between historical cohorts of patients who did not receive trilaciclib (28.3%) and those who did (26.1%). In each respective treatment group, the rates of grade 4 neutropenia were 25.1% vs 9.4%, the rates of grade 3 thrombocytopenia were 28.0% vs 16.8%, and the rates of grade 4 cytopenia were 14.5% vs 3.8%.

In a subgroup analysis of patients who began treatment with trilaciclib in the first line, the average rates of grade 3 or higher neutropenia, thrombocytopenia, and anemia were 28.9%, 8.9%, and 10.5%, respectively. Additionally, the weighted average rates of grade 3 or higher myelosuppressive HAEs in this subgroup were 33.5% with at least 1 line of therapy, 6.0% with at least 2 lineages, and 5.5% with all 3 lineages.

“This review provides important evidence of the broad benefit of trilaciclib utilization among patients with ES-SCLC to support treatment decisions,” lead study author Jerome Goldschmidt, medical oncologist at the Blue Ridge Cancer Center in Blacksburg, Virginia and the U.S. Oncology Network, said in a press release on these findings.²

“The effect of trilaciclib on reducing grade 3 and 4 myelosuppressive HAEs as well as dose reduction and treatment delay should translate into improved clinical outcomes and [quality of life] among these patients. Moreover, potential reduction in cytopenia-related healthcare utilization and hospitalizations may alleviate overall burden of ES-SCLC on healthcare systems.”

Investigators of this study analyzed findings from published and unpublished real-world studies of patients who received trilaciclib and comparable cohorts of patients who did not receive trilaciclib for ES-SCLC. Eligible real-world studies that were included as part of the literature review focused on those with ES-SCLC who were treated with trilaciclib, and included key outcomes of interest related to chemotherapy-induced myelosuppression. Included studies also needed to have been published in English.

The primary outcomes of the literature review were myelosuppressive HAEs, which included grade 3 or higher anemia, neutropenia, and thrombocytopenia. Another primary outcome was cytopenia-related healthcare utilization, which included use of granulocyte colony-stimulating factors (G-CSF), erythropoiesis-stimulating agents (ESAs), red blood cell and platelet transfusions, and intravenous hydration. Investigators also assessed hospitalizations, dose reductions, and treatment delays in eligible studies.

Of 5 studies eligible for review, 1 included a trilaciclib cohort and a historical cohort of patients who did not receive trilaciclib, 2 focused on trilaciclib-treated patients only, and the remainder included corresponding non-trilaciclib cohorts for the studies that only focused on trilaciclib. Investigators conducted subgroup analyses among patients who began trilaciclib treatment in the first line in 2 of 3 trilaciclib studies.

Sample sizes in the trilaciclib studies ranged from 21 to 50 patients, and populations ranged from 959 to 3277 in the non-trilaciclib studies. Across the trilaciclib cohorts, median ages ranged from 67.1 to 70.0 years, and 44.0% to 51.6% of patients were male. Investigators noted that age and gender distributions were comparable between the trilaciclib and non-trilaciclib cohorts. There were generally higher rates of baseline neutropenia, anemia, and thrombocytopenia in the trilaciclib cohorts compared with the non-trilaciclib cohorts.

In the trilaciclib cohorts, the weighted average rates of cytopenia-related healthcare treatment were 16.1% for G-CSF use, 19.7% for ESAs, 15.3% for red blood cell transfusion, 0.7% for platelet transfusion, and 30.2% for intravenous hydration.

In the non-trilaciclib cohorts, the weighted average rate of G-CSF use was 80.2% during the defined outcome observation period and 53.2% within 3 days following the index date. The weighted average rates of red blood transfusion, platelet transfusion, and intravenous hydration in these cohorts, respectively, were 18.8%, 2.6%, and 54.3%.

On average, 11.3% of patients in the trilaciclib cohorts experienced dose reductions compared with 42.3% of those in the historical non-trilaciclib cohorts and 5.4% of those who started trilaciclib in the first line. Additionally, 4.8% of patients in the trilaciclib cohorts underwent hospitalization within 21 days following the index date, and 0.0% were hospitalized between 8 and 16 days following the index date. The corresponding hospitalization rates for patients in the non-trilaciclib cohorts were 18.8% and 7.4%, respectively.

References

1. Goldschmidt J, Hart L, Scott J, et al. Real-world outcomes of trilaciclib among patients with extensive-stage small cell lung cancer receiving chemotherapy. Adv Ther. Published online July 25, 2023. doi:10.1007/s12325-023-02601-2
2. New publication highlights real world impact of trilaciclib on myelosuppressive events in patients with extensive stage small cell lung cancer (ES-SCLC). News release. G1 Therapeutics, Inc. July 31, 2023. Accessed August 4, 2023. https://shorturl.at/imLP7