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Postmarketing observational study of pazopanib in patients with metastatic soft tissue sarcoma in Japan.

帕唑帕尼在日本转移性软组织肉瘤患者中的上市后观察研究。

  • 影响因子:2.04
  • DOI:10.1093/jjco/hyaa208
  • 作者列表:"Teshima Y","Nomura S","Fukasawa N
  • 发表时间:2021-04-01
Abstract

BACKGROUND:This study evaluated the safety and efficacy of pazopanib in patients with metastatic soft tissue sarcoma in routine clinical use in Japan. METHODS:It was a multicentre, centrally registered and uncontrolled observational study in patients who received pazopanib for metastatic soft tissue sarcoma, with an observation period of 1 year after the start of drug administration. The study was conducted at 378 investigational sites in Japan from September 2012 to September 2019. Progression-free survival (PFS) and overall survival (OS) were the efficacy endpoints of the study. RESULTS:A total of 1970 patients were enrolled. Of these, 680 with finalized study forms were included in the analysis. Overall, 649 patients were included in the safety analysis set, and 569 were included in the efficacy analysis set. Most of the patients (81.97%) experienced at least one adverse drug reaction (ADR); 22.34% of patients reported serious ADRs and 34.98% of patients experienced grade ≥ 3 ADRs in the safety set. Hypertension (40.37%) and hepatic dysfunction (26.50%) were the two most common ADRs. A total of 262 deaths were reported, of which 12 were due to ADRs. The median PFS was 3.09 months, whereas the median OS was not reached at the end of the 1-year observation period. CONCLUSIONS:The safety and efficacy profiles in this postmarketing observational study were consistent with prior data and registration clinical trials. No new safety signals were observed while treating patients with metastatic soft tissue sarcoma with pazopanib.

摘要

背景: 本研究评估了帕唑帕尼在日本常规临床应用的转移性软组织肉瘤患者中的安全性和有效性。 方法: 这是一项多中心、集中注册和不受控制的观察性研究,在接受帕唑帕尼治疗转移性软组织肉瘤的患者中进行,观察期为开始给药后1年。本研究于2012年9月至2019年9月在日本的378个研究中心进行。无进展生存期 (PFS) 和总生存期 (OS) 是本研究的疗效终点。 结果: 共纳入1970例患者。其中,680份研究表格已完成,纳入分析。总体而言,649例患者纳入安全性分析集,569例患者纳入疗效分析集。大多数患者 (81.97%) 经历了至少一种药物不良反应 (ADR); 22.34% 的患者报告了严重的ADR,34.98% 的患者在安全性集中经历了 ≥ 3级ADR。高血压 (40.37%) 和肝功能损害 (26.50%) 是最常见的两种不良反应。共报告262例死亡,其中12例是由于不良反应。中位PFS为3.09个月,而中位OS在1年观察期结束时未达到。 结论: 这项上市后观察性研究的安全性和有效性特征与先前的数据和注册临床试验一致。在用帕唑帕尼治疗转移性软组织肉瘤患者时,没有观察到新的安全性信号。

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