Effects of Trilaciclib on Chemotherapy-Induced Myelosuppression and Patient-Reported Outcomes in Patients with Extensive-Stage Small Cell Lung Cancer: Pooled Results from Three Phase II Randomized, Double-Blind, Placebo-Controlled Studies.

Autor: Weiss J; Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC. Electronic address: jared_weiss@med.unc.edu., Goldschmidt J; Blue Ridge Cancer Care, US Oncology Research, Blacksburg, VA., Andric Z; University Hospital Medical Center Bezanijska Kosa, Bezanijska Kosa, Belgrade, Serbia., Dragnev KH; Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center, Lebanon, NH., Gwaltney C; Gwaltney Consulting, Westerly, RI., Skaltsa K; IQVIA Consulting Services, Barcelona, Spain., Pritchett Y; G1 Therapeutics, Inc., Research Triangle Park, NC., Antal JM; G1 Therapeutics, Inc., Research Triangle Park, NC., Morris SR; G1 Therapeutics, Inc., Research Triangle Park, NC., Daniel D; Sarah Cannon Research Institute, Nashville, TN; Chattanooga Oncology Hematology Associates, Chattanooga, TN.
Jazyk: angličtina
Zdroj: Clinical lung cancer [Clin Lung Cancer] 2021 Sep; Vol. 22 (5), pp. 449-460. Date of Electronic Publication: 2021 Mar 26.
DOI: 10.1016/j.cllc.2021.03.010
Abstrakt: Background: Chemotherapy-induced myelosuppression (CIM) and its sequalae cause significant side effects and harm to quality of life. Trilaciclib is an intravenous CDK4/6 inhibitor that is administered prior to chemotherapy to protect hematopoietic stem and progenitor cells from chemotherapy-induced damage (myeloprotection).
Patients and Methods: Data from three randomized, double-blind, placebo-controlled studies (NCT02499770, NCT03041311, and NCT02514447) were pooled to evaluate the effects of trilaciclib administered prior to standard-of-care chemotherapy (first-line etoposide plus carboplatin [E/P], first-line E/P plus atezolizumab, and second-/third-line topotecan) in patients with extensive-stage small cell lung cancer (ES-SCLC). The primary endpoints were duration of severe neutropenia (absolute neutrophil count < 0.5 × 10 9 cells/L) in cycle 1 and occurrence of severe neutropenia. Additional prespecified endpoints further assessed the effect of trilaciclib on myeloprotection, health-related quality of life (HRQoL), antitumor efficacy, and safety.
Results: Of 242 randomized patients, 123 received trilaciclib and 119 received placebo. Compared with placebo, administration of trilaciclib prior to chemotherapy resulted in significant decreases in most measures of multilineage CIM. The reduction in hematologic toxicity translated into the reduced need for supportive care interventions and hospitalizations due to CIM or sepsis and improvements in HRQoL domains related to the protected cell lineages, including fatigue, physical wellbeing, and functional wellbeing. Antitumor efficacy was similar for patients receiving trilaciclib or placebo.
Conclusion: Administering trilaciclib prior to chemotherapy resulted in clinically meaningful reductions in CIM and its consequences and improved patient HRQoL, with no impact on the antitumor efficacy of three individual chemotherapy regimens used in the first- or second-/third-line treatment of ES-SCLC.
(Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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