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Trilaciclib prior to chemotherapy reduces the usage of supportive care interventions for chemotherapy‐induced myelosuppression in patients with small cell lung cancer: Pooled analysis of three randomized phase 2 trials

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 cos...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8419768/
https://www.ncbi.nlm.nih.gov/pubmed/34405547
http://dx.doi.org/10.1002/cam4.4089
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author 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
author_facet 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
author_sort Ferrarotto, Renata
collection PubMed
description 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).
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spelling pubmed-84197682021-09-08 Trilaciclib prior to chemotherapy reduces the usage of supportive care interventions for chemotherapy‐induced myelosuppression in patients with small cell lung cancer: Pooled analysis of three randomized phase 2 trials 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 Med Clinical Cancer Research 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). John Wiley and Sons Inc. 2021-08-18 /pmc/articles/PMC8419768/ /pubmed/34405547 http://dx.doi.org/10.1002/cam4.4089 Text en © 2021 The Authors. Cancer Medicine published by John Wiley & Sons Ltd. https://creativecommons.org/licenses/by/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle Clinical Cancer Research
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
Trilaciclib prior to chemotherapy reduces the usage of supportive care interventions for chemotherapy‐induced myelosuppression in patients with small cell lung cancer: Pooled analysis of three randomized phase 2 trials
title Trilaciclib prior to chemotherapy reduces the usage of supportive care interventions for chemotherapy‐induced myelosuppression in patients with small cell lung cancer: Pooled analysis of three randomized phase 2 trials
title_full Trilaciclib prior to chemotherapy reduces the usage of supportive care interventions for chemotherapy‐induced myelosuppression in patients with small cell lung cancer: Pooled analysis of three randomized phase 2 trials
title_fullStr Trilaciclib prior to chemotherapy reduces the usage of supportive care interventions for chemotherapy‐induced myelosuppression in patients with small cell lung cancer: Pooled analysis of three randomized phase 2 trials
title_full_unstemmed Trilaciclib prior to chemotherapy reduces the usage of supportive care interventions for chemotherapy‐induced myelosuppression in patients with small cell lung cancer: Pooled analysis of three randomized phase 2 trials
title_short Trilaciclib prior to chemotherapy reduces the usage of supportive care interventions for chemotherapy‐induced myelosuppression in patients with small cell lung cancer: Pooled analysis of three randomized phase 2 trials
title_sort trilaciclib prior to chemotherapy reduces the usage of supportive care interventions for chemotherapy‐induced myelosuppression in patients with small cell lung cancer: pooled analysis of three randomized phase 2 trials
topic Clinical Cancer Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8419768/
https://www.ncbi.nlm.nih.gov/pubmed/34405547
http://dx.doi.org/10.1002/cam4.4089
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