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Real-world evidence for COSELA
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Real-world evidence for COSELA
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Real-world evidence for COSELA

Real-world STUDY Of COSELA EVALUATING IMPACT ON WHITE BLOOD CELLS, RED BLOOD CELLS, AND PLATELETS

Trilaciclib use in extensive-stage small cell lung cancer (ES-SCLC): are clinical benefits seen in the real world?1

Study design: A US-based, single-center, retrospective cohort study1

Real-world evidence is observational and may be subject to limitations, including lack of randomization.

Primary endpoints

  • Incidence of severe neutropenia
  • Defined as an absolute neutrophil count of less than 0.5 x 10⁹ cells/L after cycle 1 and throughout treatment duration

Secondary endpoints

  • Incidence of febrile neutropenia
  • Lineage-specific transfusion and/or growth-factor requirements (red blood cells, platelets, ESA, and G-CSF)
  • Total all-cause chemotherapy reductions and treatment delays during each cycle
  • IV antibiotic use
  • Incidence of systemic infections
  • Hospitalizations secondary to either systemic infections or febrile neutropenia

Limitations of the study are the retrospective and single-center nature, lack of quality of life patient-reported outcomes due to variability in electronic health record documentation amongst providers, as well as lack of standardized system-wide uniform collection of patient-reported outcomes.

ES-SCLC=extensive-stage small cell lung cancer; ESA=erythrocyte-stimulating agent; G-CSF=granulocyte colony-stimulating factor.

a
Exclusion criteria: Inconsistent COSELA utilization from cycle 2 and onward (n=11); No COSELA prior to cycle 1 (n=10); Clinical trial participant (n=7).
b
Exclusion criteria: Lost to follow-up (n=7); carboplatin AUC <3.5 w/cycle 1 (n=6); 1° prophylaxis with GCSF during cycle 1 (n=2); no COSELA prior to cycle 1 (n=3); limited-stage SCLC diagnosis (n=2); receipt of cisplatin with cycle 1 (n=1).