[Clinical tolerability and pharmacokinetics of troxacitabine]
- PMID: 37355471
- DOI: 10.3760/cma.j.cn112152-20221011-00696
[Clinical tolerability and pharmacokinetics of troxacitabine]
Abstract
Objective: To investigate the safety and efficacy of troxatabine in advanced or relapsed malignant tumors resistant to standard therapy in China. Methods: This is a phase Ⅰ prospective study. During dose escalation, patients in Cancer Hospital, Chinese Academy of Medical Sciences received a single-dose intravenous infusion of troxacitabine. The planned dosing groups were 1.8, 3.6, 4.8, 6.4 and 8.0 mg/m(2) on days 1 and 8 every 3 weeks. The data of all patients were collected for safety analyses. Safety and tolerability were evaluated by monitoring adverse events. Results: Nineteen patients were enrolled from April 2018 to May 2019. The major adverse events were fatigue (89.5%, 17/19), leukopenia (84.2%, 16/19) and neutropenia (78.9%, 15/19). The dose limiting toxicity was neutropenia. The maximum tolerated dose was 6.4 mg/m(2). The best effect was stable disease (43.8%). The half-life of elimination phase from 15.91 hours to 76.63 hours in each dose group. Conclusions: The toxicity of troxacitabine is well tolerant. We recommend that the dose for Phase Ⅱ clinical trial should be 6.4 mg/m(2).
目的： 探讨曲沙他滨在中国晚期或复发、对标准治疗耐药的恶性肿瘤患者中的安全性和疗效。 方法： 研究为Ⅰ期前瞻性研究，选取中国医学科学院肿瘤医院的恶性肿瘤患者，患者接受曲沙他滨剂量递增治疗，共设5个药物剂量组(分别为1.8、3.6、4.8、6.4和8.0 mg/m(2)组)，每周给药1次连用2周，休息1周，每3周为1个治疗周期。收集患者的安全性信息，采用美国国家癌症研究所常见药物毒性反应分级标准4.0版进行评估。 结果： 2018年4月至2019年5月，19例恶性肿瘤患者接受曲沙他滨单药静脉输注，常见的不良反应为乏力(89.5%，17/19)、白细胞减少(84.2%，16/19)和中性粒细胞减少(78.9%，15/19)。剂量限制性不良反应为中性粒细胞减少，最大耐受剂量为6.4 mg/m(2)。全组患者的最佳疗效为疾病稳定(43.8%)。各剂量组的消除相半衰期为15.91~76.63 h。 结论： 曲沙他滨的不良反应可耐受，推荐的Ⅱ期研究剂量为6.4 mg/m(2)。.
Keywords: Malignant tumor; Pharmacokinetics; Phase Ⅰ clinical study; Troxacitabine.
Publication types
MeSH terms
Substances
LinkOut - more resources
Full Text Sources
Miscellaneous
