1. Myelopreservation with trilaciclib in patients receiving Topotecan for small cell lung cancer : results from a randomized, double-blind, placebo-controlled phase II study
- Author
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Maen A. Hussein, Raid Aljumaily, Shannon R. Morris, Bojan Zaric, Wahid Hanna, Didier Verhoeven, Z. Andric, Jie Xiao, J. Thaddeus Beck, Janakiraman Subramanian, Renata Ferrarotto, Joyce M Antal, Davorin Radosavljevic, Lowell L. Hart, and Taofeek K. Owonikoko
- Subjects
030213 general clinical medicine ,medicine.medical_specialty ,Lung Neoplasms ,Neutropenia ,Anemia ,Myelosuppression ,medicine.medical_treatment ,Phases of clinical research ,Placebo ,Gastroenterology ,03 medical and health sciences ,0302 clinical medicine ,Double-Blind Method ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,Trilaciclib ,Medicine ,Humans ,Chemotherapy ,Pharmacology (medical) ,Pyrroles ,Progenitor cell ,Adverse effect ,Original Research ,Patient-reported outcomes ,Small cell lung cancer ,business.industry ,Pharmacology. Therapy ,General Medicine ,medicine.disease ,Small Cell Lung Carcinoma ,Pyrimidines ,030220 oncology & carcinogenesis ,Quality of Life ,Myelopreservation ,Topotecan ,Human medicine ,business ,medicine.drug - 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 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 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 in cycle 1 (mean [standard deviation] 2 [3.9] versus 7 [6.2] days; adjusted one-sided P
- Published
- 2021