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Clinical Trial
. 2021 Sep;10(17):5748-5756.
doi: 10.1002/cam4.4089. Epub 2021 Aug 18.

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

Renata Ferrarotto  1 , Ian Anderson  2 , Balazs Medgyasszay  3 , Maria Rosario García-Campelo  4 , William Edenfield  5 , Trevor M Feinstein  6 , Jennifer M Johnson  7 , Sujith Kalmadi  8 , Philip E Lammers  9 , Alfredo Sanchez-Hernandez  10 , Yili Pritchett  11 , Shannon R Morris  11 , Rajesh K Malik  11 , Tibor Csőszi  12
Affiliations
Clinical Trial

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

Renata Ferrarotto et al. Cancer Med. 2021 Sep.

Abstract

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).

Keywords: anemia; erythropoiesis-stimulating agent; granulocyte colony-stimulating factor; neutropenia; red blood cell transfusion; trilaciclib.

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Conflict of interest statement

Outside of the submitted work, Renata Ferrarotto has received personal fees from Ayala Pharma, Carevive, Cellestia Biotech, Klus Pharma, Medscape, Prelude, and Regeneron‐Sanofi, and has received grants from AstraZeneca, Genentech, Inc., Merck, Oropharynx Program Stiefel clinical trials, Pfizer, the ASCO Career Development Award, and the MD Anderson Khalifa Award; William Edenfield serves as a consultant for Chimerix Corp, and Jennifer M. Johnson has received research funding from AstraZeneca, Bristol Myers Squibb, and Merck, and has served as a consultant for Rakuten Medical and Foundation Medicine. Yili Pritchett and Rajesh K. Malik are employees and shareowners of G1 Therapeutics, Inc. Shannon R. Morris was an employee of G1 Therapeutics, Inc., at the time of study. Ian Anderson, Balazs Medgyasszay, Maria Rosario García‐Campelo, Trevor M. Feinstein, Sujith Kalmadi, Philip Lammers, A. Sanchez‐Hernandez, and Tibor Csőszi have no conflicts of interest to declare.

The authors declare that they have no competing interests.

Figures

FIGURE 1
FIGURE 1
Occurrence of RBC transfusions in cycles 1 to 4 by treatment group. RBC indicates red blood cell
See this image and copyright information in PMC

References

    1. Horn L, Mansfield AS, Szczęsna A, et al; IMpower133 Study Group . First‐line atezolizumab plus chemotherapy in extensive‐stage small‐cell lung cancer. N Engl J Med. 2018;379:2220‐2229. - PubMed
    1. von Pawel J , Jotte R, Spigel DR, et al. Randomized phase III trial of amrubicin versus topotecan as second‐line treatment for patients with small‐cell lung cancer. J Clin Oncol. 2014;32:4012‐4019. - PubMed
    1. Povsic M, Enstone A, Wyn R, Kornalska K, Penrod JR, Yuan Y. Real‐world effectiveness and tolerability of small‐cell lung cancer (SCLC) treatments: a systematic literature review (SLR). PLoS One. 2019;14:e0219622. - PMC - PubMed
    1. Paz‐Ares L, Dvorkin M, Chen Y, et al.; CASPIAN Investigators . Durvalumab plus platinum‐etoposide versus platinum‐etoposide in first‐line treatment of extensive‐stage small‐cell lung cancer (CASPIAN): a randomised, controlled, open‐label, phase 3 trial. Lancet. 2019;394:1929‐1939. - PubMed
    1. Trigo J, Subbiah V, Besse B, et al. Lurbinectedin as second‐line treatment for patients with small‐cell lung cancer: a single‐arm, open‐label, phase 2 basket trial. Lancet Oncol. 2020;21:645‐654. - PubMed

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