Myelopreservation with Trilaciclib in Patients Receiving Topotecan for Small Cell Lung Cancer: Results from a Randomized
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ORIGINAL RESEARCH
Myelopreservation with Trilaciclib in Patients Receiving Topotecan for Small Cell Lung Cancer: Results from a Randomized, Double-Blind, PlaceboControlled Phase II Study Lowell L. Hart . Renata Ferrarotto . Zoran G. Andric . J. Thaddeus Beck . Janakiraman Subramanian . Davorin Z. Radosavljevic . Bojan Zaric . Wahid T. Hanna . Raid Aljumaily . Taofeek K. Owonikoko . Didier Verhoeven . Jie Xiao . Shannon R. Morris . Joyce M. Antal . Maen A. Hussein Received: September 8, 2020 / Accepted: October 14, 2020 Ó The Author(s) 2020
ABSTRACT Introduction: Multilineage myelosuppression is an acute toxicity of cytotoxic chemotherapy, resulting in serious complications and dose modifications. Current therapies are lineage specific and administered after chemotherapy damage has occurred. Trilaciclib is a cyclin-dependent kinase 4/6 inhibitor that is
Electronic Supplementary Material The online version of this article (https://doi.org/10.1007/s12325020-01538-0) contains supplementary material, which is available to authorized users. L. L. Hart (&) Medical Oncology, Florida Cancer Specialists, Fort Myers, FL, USA e-mail: [email protected] L. L. Hart Department of Medicine, Wake Forest University School of Medicine, Winston-Salem, NC, USA R. Ferrarotto Department of Thoracic and Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA Z. G. Andric Medical Oncology Department, Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia J. T. Beck Department of Medical Oncology and Hematology, Highlands Oncology Group, Rogers, MI, USA
administered prior to chemotherapy to preserve hematopoietic stem and progenitor cells and immune system function during chemotherapy (myelopreservation). Methods: In this randomized, double-blind, placebo-controlled phase II trial, patients with previously treated extensive-stage small cell lung cancer (ES-SCLC) were randomized to receive intravenous trilaciclib 240 mg/m2 or placebo before topotecan 1.5 mg/m2 on days 1–5 of each 21-day cycle. Primary endpoints were duration of severe neutropenia (DSN) in cycle 1 and occurrence of severe neutropenia (SN). Additional endpoints were prespecified to further assess the effect of trilaciclib on J. Subramanian Department of Medicine, Saint Luke’s Hospital, Kansas City, MO, USA D. Z. Radosavljevic Institute for Oncology and Radiology of Serbia, Belgrade, Serbia B. Zaric Faculty of Medicine, Institute for Pulmonary Diseases of Vojvodina, University of Novi Sad, Sremska Kamenica, Serbia W. T. Hanna Hematology/Oncology, University of Tennessee Graduate School of Medicine, Knoxville, TN, USA R. Aljumaily Stephenson Cancer Center, University of Oklahoma, Oklahoma City, OK, USA
Adv Ther
myelopreservation, safety, patient-reported outcomes (PROs), and antitumor efficacy. Results: Thirty-two patients received trilaciclib, and 29 patients received placebo. Compared with placebo, administration of trilaciclib prior to topotecan resulted in statistically significant and clinically meaningful decreases in DSN
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