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  • Trilaciclib prior to chemot...
    Ferrarotto, Renata; Anderson, Ian; Medgyasszay, Balazs; García‐Campelo, Maria Rosario; Edenfield, William; Feinstein, Trevor M.; Johnson, Jennifer M.; Kalmadi, Sujith; Lammers, Philip E.; Sanchez‐Hernandez, Alfredo; Pritchett, Yili; Morris, Shannon R.; Malik, Rajesh K.; Csőszi, Tibor

    Cancer medicine (Malden, MA), September 2021, Letnik: 10, Številka: 17
    Journal Article

    Background Supportive care interventions used to manage chemotherapy‐induced myelosuppression (CIM), including granulocyte colony‐stimulating factors (G‐CSFs), erythropoiesis‐stimulating agents (ESAs), and red blood cell (RBC) transfusions, are burdensome to patients and associated with greater costs to health care systems. We evaluated the utilization of supportive care interventions and their relationship with the myeloprotective agent, trilaciclib. Methods Data were pooled from three independent randomized phase 2 clinical trials of trilaciclib or placebo administered prior to chemotherapy in patients with extensive‐stage small cell lung cancer (ES‐SCLC). The impact of supportive care on the duration of severe neutropenia (DSN), occurrence of severe neutropenia (SN), and occurrence of RBC transfusions on/after week 5 was analyzed across cycles 1–4. Concordance and association between grade 3/4 anemia, RBC transfusions on/after week 5, and ESA administration was also evaluated. Results The use of G‐CSFs, ESAs, or RBC transfusions on/after week 5 was significantly lower among patients receiving trilaciclib versus placebo (28.5% vs. 56.3%, p < 0.0001; 3.3% vs. 11.8%, p = 0.0254; and 14.6% vs. 26.1%, p = 0.0252, respectively). Compared with placebo, trilaciclib significantly reduced DSN and SN, irrespective of G‐CSF administration. RBC transfusions and ESAs were most often administered in patients with grade 3/4 anemia; however, patients typically received RBC transfusions over ESA administration. Conclusions By improving CIM and reducing the need for associated supportive care, trilaciclib has the potential to reduce the burden of myelosuppression on patients receiving myelosuppressive chemotherapy for the treatment of ES‐SCLC. Trial registration ClinicalTrials.gov (NCT02499770; NCT03041311; NCT02514447). Compared with placebo, administering trilaciclib prior to chemotherapy reduces chemotherapy‐induced neutropenia and anemia, with a reduction in the use of hematopoietic growth factors and red blood cell transfusions. By improving key myelosuppressive endpoints and reducing the need for associated supportive care, trilaciclib has the potential to reduce both the societal and economic burden of chemotherapy‐induced myelosuppression on patients with extensive‐stage small cell lung cancer.