Cargando…
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...
Autores principales: | , , , , , , , , , , , , , |
---|---|
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 |
_version_ | 1783748820514897920 |
---|---|
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). |
format | Online Article Text |
id | pubmed-8419768 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
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 |
work_keys_str_mv | AT ferrarottorenata trilaciclibpriortochemotherapyreducestheusageofsupportivecareinterventionsforchemotherapyinducedmyelosuppressioninpatientswithsmallcelllungcancerpooledanalysisofthreerandomizedphase2trials AT andersonian trilaciclibpriortochemotherapyreducestheusageofsupportivecareinterventionsforchemotherapyinducedmyelosuppressioninpatientswithsmallcelllungcancerpooledanalysisofthreerandomizedphase2trials AT medgyasszaybalazs trilaciclibpriortochemotherapyreducestheusageofsupportivecareinterventionsforchemotherapyinducedmyelosuppressioninpatientswithsmallcelllungcancerpooledanalysisofthreerandomizedphase2trials AT garciacampelomariarosario trilaciclibpriortochemotherapyreducestheusageofsupportivecareinterventionsforchemotherapyinducedmyelosuppressioninpatientswithsmallcelllungcancerpooledanalysisofthreerandomizedphase2trials AT edenfieldwilliam trilaciclibpriortochemotherapyreducestheusageofsupportivecareinterventionsforchemotherapyinducedmyelosuppressioninpatientswithsmallcelllungcancerpooledanalysisofthreerandomizedphase2trials AT feinsteintrevorm trilaciclibpriortochemotherapyreducestheusageofsupportivecareinterventionsforchemotherapyinducedmyelosuppressioninpatientswithsmallcelllungcancerpooledanalysisofthreerandomizedphase2trials AT johnsonjenniferm trilaciclibpriortochemotherapyreducestheusageofsupportivecareinterventionsforchemotherapyinducedmyelosuppressioninpatientswithsmallcelllungcancerpooledanalysisofthreerandomizedphase2trials AT kalmadisujith trilaciclibpriortochemotherapyreducestheusageofsupportivecareinterventionsforchemotherapyinducedmyelosuppressioninpatientswithsmallcelllungcancerpooledanalysisofthreerandomizedphase2trials AT lammersphilipe trilaciclibpriortochemotherapyreducestheusageofsupportivecareinterventionsforchemotherapyinducedmyelosuppressioninpatientswithsmallcelllungcancerpooledanalysisofthreerandomizedphase2trials AT sanchezhernandezalfredo trilaciclibpriortochemotherapyreducestheusageofsupportivecareinterventionsforchemotherapyinducedmyelosuppressioninpatientswithsmallcelllungcancerpooledanalysisofthreerandomizedphase2trials AT pritchettyili trilaciclibpriortochemotherapyreducestheusageofsupportivecareinterventionsforchemotherapyinducedmyelosuppressioninpatientswithsmallcelllungcancerpooledanalysisofthreerandomizedphase2trials AT morrisshannonr trilaciclibpriortochemotherapyreducestheusageofsupportivecareinterventionsforchemotherapyinducedmyelosuppressioninpatientswithsmallcelllungcancerpooledanalysisofthreerandomizedphase2trials AT malikrajeshk trilaciclibpriortochemotherapyreducestheusageofsupportivecareinterventionsforchemotherapyinducedmyelosuppressioninpatientswithsmallcelllungcancerpooledanalysisofthreerandomizedphase2trials AT csoszitibor trilaciclibpriortochemotherapyreducestheusageofsupportivecareinterventionsforchemotherapyinducedmyelosuppressioninpatientswithsmallcelllungcancerpooledanalysisofthreerandomizedphase2trials |