Effect of trilaciclib administered before chemotherapy in patients with extensive-stage small-cell lung cancer: A pooled analysis of four randomized studies

Background: Trilaciclib is a transient cyclin-dependent kinase 4/6 (CDK4/6) inhibitor that reduces the incidence of chemotherapy-induced myelosuppression (CIM). In this pooled analysis, we evaluated the multilineage myeloprotection, antitumor efficacy, and safety of trilaciclib treatment in patients...

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Main Authors: Ying Liu, Lin Wu, Dingzhi Huang, Qiming Wang, Chen Yang, Li Zhou, Shuguang Sun, Xiaomei Jiang, Ying Cheng
Format: Article
Language:English
Published: Elsevier 2024-01-01
Series:Cancer Treatment and Research Communications
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Online Access:http://www.sciencedirect.com/science/article/pii/S2468294225000073
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author Ying Liu
Lin Wu
Dingzhi Huang
Qiming Wang
Chen Yang
Li Zhou
Shuguang Sun
Xiaomei Jiang
Ying Cheng
author_facet Ying Liu
Lin Wu
Dingzhi Huang
Qiming Wang
Chen Yang
Li Zhou
Shuguang Sun
Xiaomei Jiang
Ying Cheng
author_sort Ying Liu
collection DOAJ
description Background: Trilaciclib is a transient cyclin-dependent kinase 4/6 (CDK4/6) inhibitor that reduces the incidence of chemotherapy-induced myelosuppression (CIM). In this pooled analysis, we evaluated the multilineage myeloprotection, antitumor efficacy, and safety of trilaciclib treatment in patients with extensive-stage small-cell lung cancer (ES-SCLC). Moreover, myeloprotection effect in 1 L, 2 L/3 L population and effect by risk category were explored. Materials and Methods: Patients with ES-SCLC who received trilaciclib were included. Trilaciclib was administered before chemotherapy in four randomized, double-blind, placebo-controlled studies (NCT02499770, NCT03041311, NCT02514447, and NCT04902885), and data were subsequently extracted. The primary endpoints were the duration of severe neutropenia (DSN) in cycle 1 and/or the incidence of severe neutropenia (SN). Results: The data from 325 patients receiving trilaciclib (n = 164) or placebo (n = 161) were pooled. Trilaciclib demonstrated a clinically and statistically significant reduction in DSN in cycle 1 and in the incidence of SN and febrile neutropenia (FN) in the overall, 1 L, 2 L/3 L populations. The myeloprotection effect was greater in patients with a higher number of FN risk categories. Overall, the median progression-free survival was 5.3 months in the trilaciclib and 4.9 months in the placebo group. The median overall survival was 10.9 months in the trilaciclib and 10.1 months in the placebo group. Trilaciclib showed better capability of reducing CIMs incidence compared with prophylactic G-CSF in the overall and 1 L population. Conclusions: Trilaciclib prior to chemotherapy in patients with ES-SCLC reduced incidence of CIM and need for supportive care in CIM across all treatment settings. Micro Abstract: Area and reason for the study: Extensive-stage small-cell lung cancer (ES-SCLC). To analyze the effect of trilaciclib on Chinese and Caucasian patients. Approach taken, including aspects such as the sample size: This pooled analysis included one study in China and three studies in western countries, and the overall sample size was 325. Overall result: Trilaciclib provides protection from CIM. General significance of the findings: The consistent efficacy of trilaciclib can be observed from pooled data across different treatment lines. All information should be accessible to a nonexpert audience.
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spelling doaj-art-a49e3e98044940fcb468b745d5877e672025-02-09T05:00:48ZengElsevierCancer Treatment and Research Communications2468-29422024-01-0142100869Effect of trilaciclib administered before chemotherapy in patients with extensive-stage small-cell lung cancer: A pooled analysis of four randomized studiesYing Liu0Lin Wu1Dingzhi Huang2Qiming Wang3Chen Yang4Li Zhou5Shuguang Sun6Xiaomei Jiang7Ying Cheng8JILIN Cancer Hospital, Changchun, PR ChinaHunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan, PR ChinaTianjin Medical University Cancer Institute and Hospital, Tianjin, PR ChinaThe Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, PR ChinaState Key Laboratory of Neurology and Oncology Drug Development, Nanjing, PR China; Simcere Zaiming Medical Technology Co., Ltd, Beijing, PR ChinaState Key Laboratory of Neurology and Oncology Drug Development, Nanjing, PR China; Simcere Zaiming Medical Technology Co., Ltd, Beijing, PR ChinaState Key Laboratory of Neurology and Oncology Drug Development, Nanjing, PR China; Simcere Zaiming Medical Technology Co., Ltd, Beijing, PR ChinaState Key Laboratory of Neurology and Oncology Drug Development, Nanjing, PR China; Simcere Zaiming Medical Technology Co., Ltd, Beijing, PR ChinaJILIN Cancer Hospital, Changchun, PR China; Corresponding author at: Department JILIN Cancer Hospital, No. 1066 Jinhu Road, Changchun, PR China.Background: Trilaciclib is a transient cyclin-dependent kinase 4/6 (CDK4/6) inhibitor that reduces the incidence of chemotherapy-induced myelosuppression (CIM). In this pooled analysis, we evaluated the multilineage myeloprotection, antitumor efficacy, and safety of trilaciclib treatment in patients with extensive-stage small-cell lung cancer (ES-SCLC). Moreover, myeloprotection effect in 1 L, 2 L/3 L population and effect by risk category were explored. Materials and Methods: Patients with ES-SCLC who received trilaciclib were included. Trilaciclib was administered before chemotherapy in four randomized, double-blind, placebo-controlled studies (NCT02499770, NCT03041311, NCT02514447, and NCT04902885), and data were subsequently extracted. The primary endpoints were the duration of severe neutropenia (DSN) in cycle 1 and/or the incidence of severe neutropenia (SN). Results: The data from 325 patients receiving trilaciclib (n = 164) or placebo (n = 161) were pooled. Trilaciclib demonstrated a clinically and statistically significant reduction in DSN in cycle 1 and in the incidence of SN and febrile neutropenia (FN) in the overall, 1 L, 2 L/3 L populations. The myeloprotection effect was greater in patients with a higher number of FN risk categories. Overall, the median progression-free survival was 5.3 months in the trilaciclib and 4.9 months in the placebo group. The median overall survival was 10.9 months in the trilaciclib and 10.1 months in the placebo group. Trilaciclib showed better capability of reducing CIMs incidence compared with prophylactic G-CSF in the overall and 1 L population. Conclusions: Trilaciclib prior to chemotherapy in patients with ES-SCLC reduced incidence of CIM and need for supportive care in CIM across all treatment settings. Micro Abstract: Area and reason for the study: Extensive-stage small-cell lung cancer (ES-SCLC). To analyze the effect of trilaciclib on Chinese and Caucasian patients. Approach taken, including aspects such as the sample size: This pooled analysis included one study in China and three studies in western countries, and the overall sample size was 325. Overall result: Trilaciclib provides protection from CIM. General significance of the findings: The consistent efficacy of trilaciclib can be observed from pooled data across different treatment lines. All information should be accessible to a nonexpert audience.http://www.sciencedirect.com/science/article/pii/S2468294225000073TrilaciclibChemotherapy-induced myelosuppressionExtensive-stage small-cell lung cancerSevere neutropeniaHematological toxicity
spellingShingle Ying Liu
Lin Wu
Dingzhi Huang
Qiming Wang
Chen Yang
Li Zhou
Shuguang Sun
Xiaomei Jiang
Ying Cheng
Effect of trilaciclib administered before chemotherapy in patients with extensive-stage small-cell lung cancer: A pooled analysis of four randomized studies
Cancer Treatment and Research Communications
Trilaciclib
Chemotherapy-induced myelosuppression
Extensive-stage small-cell lung cancer
Severe neutropenia
Hematological toxicity
title Effect of trilaciclib administered before chemotherapy in patients with extensive-stage small-cell lung cancer: A pooled analysis of four randomized studies
title_full Effect of trilaciclib administered before chemotherapy in patients with extensive-stage small-cell lung cancer: A pooled analysis of four randomized studies
title_fullStr Effect of trilaciclib administered before chemotherapy in patients with extensive-stage small-cell lung cancer: A pooled analysis of four randomized studies
title_full_unstemmed Effect of trilaciclib administered before chemotherapy in patients with extensive-stage small-cell lung cancer: A pooled analysis of four randomized studies
title_short Effect of trilaciclib administered before chemotherapy in patients with extensive-stage small-cell lung cancer: A pooled analysis of four randomized studies
title_sort effect of trilaciclib administered before chemotherapy in patients with extensive stage small cell lung cancer a pooled analysis of four randomized studies
topic Trilaciclib
Chemotherapy-induced myelosuppression
Extensive-stage small-cell lung cancer
Severe neutropenia
Hematological toxicity
url http://www.sciencedirect.com/science/article/pii/S2468294225000073
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