Hetrombopag for the management of chemotherapy-induced thrombocytopenia in patients with advanced solid tumors: a multicenter, randomized, double-blind, placebo-controlled, phase II study
机构：[1]GI Cancer Center, Nanjing Tianyinshan Hospital, China Pharmaceutical, Nanjing, China [2]First Gastroenterology Ward, Shanxi Provincial Cancer Hospital, Taiyuan, China [3]Department of Oncology, The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, China [4]Department of Hematology, Henan Cancer Hospital, Zhengzhou, China 河南省肿瘤医院[5]Department of Oncology, Xiangyang Central Hospital, Xiangyang, China [6]Department of Oncology, Anhui Provincial Hospital, Hefei, China [7]Department of Oncology, The Second Affiliated Hospital of Anhui Medical University, Hefei, China [8]Department of Oncology, Subei People’s Hospital of Jiangsu Province, Yangzhou, China [9]Department of Oncology, Sichuan Cancer Hospital and Institute, Chengdu, China 四川省肿瘤医院[10]Department of Oncology, Heping Hospital Affiliated to Changzhi Medical College, Changzhi, China [11]Department of Oncology, Shaanxi Provincial Cancer Hospital, Xi’an, China [12]Department of Oncology, The First Affiliated Hospital of Nanyang Medical College, Nanyang, China [13]Department of Oncology, Affiliated Hospital of Jiangnan University, Wuxi, China [14]Department of Oncology, Zhujiang Hospital, Southern Medical University, Guangzhou, China 南方医科大学珠江医院[15]Department of Comprehensive Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, China 浙江省肿瘤医院[16]Department of Oncology, Linfen Central Hospital, Linfen, China [17]Department of Oncology, The Affiliated Hospital of Qingdao University, Qingdao, China [18]Clinical Research & Development, Jiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, China [19]Clinical Research & Development, Jiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, China [20]Clinical Research & Development, Jiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, China [21]Department of Blood Specialty, Harbin Institute of Hematology and Oncology, 151 Diduan Street, Daoli District, Harbin, Heilongjiang 150010, China
Background: Chemotherapy-induced thrombocytopenia (CIT) increases the risk of bleeding, necessitates chemotherapy dose reductions and delays, and negatively impacts prognosis. Objectives: This study aimed to evaluate the efficacy and safety of hetrombopag for the management of CIT in patients with advanced solid tumors. Design: A multicenter, randomized, double-blind, placebo-controlled, phase II study. Methods: Patients with advanced solid tumors who experienced a chemotherapy delay of >= 7 days due to thrombocytopenia (platelet count <75 x 10(9)/L) were randomly assigned (1:1) to receive oral hetrombopag at an initial dose of 7.5 mg once daily or a matching placebo. The primary endpoint was the proportion of treatment responders, defined as patients resuming chemotherapy within 14 days (platelet count >= 100 x 10(9)/L) and not requiring a chemotherapy dose reduction of >= 15% or a delay of >= 4 days or rescue therapy for two consecutive cycles. Results: Between 9 October 2021 and 5 May 2022, 60 patients were randomized, with 59 receiving >= 1 dose of assigned treatment (hetrombopag/placebo arm, n = 28/31). The proportion of treatment responders was significantly higher in the hetrombopag arm than in the placebo arm [60.7% (17/28) versus 12.9% (4/31); difference of proportion: 47.6% (95% confidence interval (CI): 26.0-69.3); odds ratio = 10.44 (95% CI: 2.82-38.65); p value (nominal) based on the Cochran-Mantel-Haenszel: <0.001)]. During the double-blind treatment period, grade 3 or higher adverse events (AEs) occurred in 35.7% (10/28) of patients with hetrombopag and 38.7% (12/31) of patients on placebo. The most common grade 3 or higher AEs were decreased neutrophil count [35.7% (10/28) versus 35.5% (11/31)] and decreased white blood cell count [17.9% (5/28) versus 19.4% (6/31)]. Serious AEs were reported in 3.6% (1/28) of patients with hetrombopag and 9.7% (3/31) of patients with placebo. Conclusion: Hetrombopag is an effective and well-tolerated alternative for managing CIT in patients with solid tumors.
第一作者机构：[1]GI Cancer Center, Nanjing Tianyinshan Hospital, China Pharmaceutical, Nanjing, China
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推荐引用方式(GB/T 7714)：
Shukui Qin,Yusheng Wang,Jun Yao,et al.Hetrombopag for the management of chemotherapy-induced thrombocytopenia in patients with advanced solid tumors: a multicenter, randomized, double-blind, placebo-controlled, phase II study[J].THERAPEUTIC ADVANCES IN MEDICAL ONCOLOGY.2024,16:doi:10.1177/17588359241260985.
APA：
Shukui Qin,Yusheng Wang,Jun Yao,Yanyan Liu,Tienan Yi...&Jun Ma.(2024).Hetrombopag for the management of chemotherapy-induced thrombocytopenia in patients with advanced solid tumors: a multicenter, randomized, double-blind, placebo-controlled, phase II study.THERAPEUTIC ADVANCES IN MEDICAL ONCOLOGY,16,
MLA：
Shukui Qin,et al."Hetrombopag for the management of chemotherapy-induced thrombocytopenia in patients with advanced solid tumors: a multicenter, randomized, double-blind, placebo-controlled, phase II study".THERAPEUTIC ADVANCES IN MEDICAL ONCOLOGY 16.(2024)
