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Phase I studies of darinaparsin in patients with relapsed or refractory peripheral T-cell lymphoma: a pooled analysis of two phase I studies conducted in Japan and Korea.

darinaparsin在复发或难治性外周T细胞淋巴瘤患者中的I期研究: 在日本和韩国进行的两项I期研究的汇总分析。

  • 影响因子:2.04
  • DOI:10.1093/jjco/hyaa177
  • 作者列表:"Ogura M","Kim WS","Uchida T","Uike N","Suehiro Y","Ishizawa K","Nagai H","Nagahama F","Sonehara Y","Tobinai K
  • 发表时间:2021-02-08
Abstract

OBJECTIVE:Two phase I studies of darinaparsin including Japanese and Korean patients with relapsed/refractory peripheral T-cell lymphoma were performed to evaluate its safety (primary purpose), efficacy and pharmacokinetic profile (ClinicalTrials.gov: NCT01435863 and NCT01689220). METHODS:Patients received intravenous darinaparsin for 5 consecutive days at 200 mg/m2/day in 4-week cycles, 300 mg/m2/day in 4-week cycles or 300 mg/m2/day in 3-week cycles. RESULTS:Seventeen Japanese and 6 Korean patients were enrolled and treated. Drug-related adverse events developed in 18 patients (78%). Dose-limiting toxicity, grade 3 hepatic dysfunction, was reported on Day 15 of cycle 1 in 1 Japanese patient who received 300 mg/m2/day. The most common drug-related, grade ≥ 3 adverse events were lymphopenia (9%), neutropenia (9%) and thrombocytopenia (9%). No deaths occurred. In 14 evaluable patients, 1 and 3 patients had complete response and partial response, respectively. The plasma concentration-time profiles of arsenic, a surrogate marker for darinaparsin, were similar between Japanese and Korean patients. No significant difference was found in its pharmacokinetic profile. CONCLUSIONS:These data indicate the good tolerability and potential efficacy of darinaparsin in patients with relapsed/refractory peripheral T-cell lymphoma. Darinaparsin 300 mg/m2/day for 5 consecutive days in 3-week cycles is the recommended regimen for phase II study.

摘要

目的: 对包括日本和韩国复发/难治性外周T细胞淋巴瘤患者在内的两项达利那帕辛I期研究进行了评估其安全性 (主要目的) 、疗效和药代动力学特征 (clinicaltrials.Gov: NCT01435863和NCT01689220)。 方法: 患者接受连续5天静脉注射达瑞肝素,4周周期为200 mg/m2/天,4周周期为300 mg/m2/天,3周周期为300 mg/m2/天。 结果: 17名日本和6名韩国患者入组并接受治疗。18例患者 (78%) 发生药物相关不良事件。在1名接受300 mg/m2/天的日本患者中,在周期1的天报告了剂量限制性毒性,3级肝功能障碍。最常见的药物相关、 ≥ 3级不良事件为淋巴细胞减少症 (9%) 、中性粒细胞减少症 (9%) 和血小板减少症 ()。无死亡病例。在14例可评价的患者中,1例和3例患者分别具有完全反应和部分反应。日本和韩国患者的血浆砷浓度-时间曲线相似,砷是达利那帕素的替代标志物。在其药代动力学曲线中没有发现显著差异。 结论: 这些数据表明darinaparsin在复发性/难治性外周T细胞淋巴瘤患者中具有良好的耐受性和潜在疗效。Darinaparsin 300 mg/m2/天,在3周周期中连续5天是II期研究的推荐方案。

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