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首页> 外文期刊>Journal of Clinical Oncology >Pazopanib, a multikinase angiogenesis inhibitor, in patients with relapsed or refractory advanced soft tissue sarcoma: a phase II study from the European organisation for research and treatment of cancer-soft tissue and bone sarcoma group (EORTC study 62043).
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Pazopanib, a multikinase angiogenesis inhibitor, in patients with relapsed or refractory advanced soft tissue sarcoma: a phase II study from the European organisation for research and treatment of cancer-soft tissue and bone sarcoma group (EORTC study 62043).

机译：Pazopanib是一种多激酶血管生成抑制剂，用于患有复发性或难治性晚期软组织肉瘤的患者：来自欧洲组织的研究和治疗癌症软组织和骨肉瘤组的II期研究（EORTC研究62043）。

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PURPOSE Given the importance of angiogenesis in soft tissue sarcoma (STS), pazopanib, an oral angiogenesis inhibitor that targets vascular endothelial growth factor receptor and platelet-derived growth factor receptor, was explored in patients with advanced STS. PATIENTS AND METHODS Patients with intermediate- or high-grade advanced STS who were ineligible for chemotherapy or who had received no more than two prior cytotoxic agents for advanced disease, who had documented progression, who had adequate performance status, and who had good organ function were eligible. Pazopanib 800 mg was given daily. The primary end point was progression-free rate at 12 weeks (PFR(12 weeks)). Secondary end points were response, safety, and overall survival. Four different strata were studied: adipocytic STS, leiomyosarcomas, synovial sarcomas, and other STS types. A Simon two-stage design was applied (P1 = 40%; P0 = 20%; alpha = beta = .1) for each stratum. Results One hundred forty-two patients were enrolled. The adipocytic STS stratum was closed after the first stage, given insufficient activity (PFR(12 weeks), five [26%] of19). PFR(12 weeks) was 18 (44%) of 41 patients in the leiomyosarcoma cohort, 18 (49%) of 37 in the synovial sarcomas, and 16 (39%) of 41 in the other STS types. Compared with historical controls who were treated with second-line chemotherapy, progression-free and overall survivals were prolonged in the three cohorts in which the primary end point was reached. The most frequent drug-related toxicities were hypertension, fatigue, hypopigmentation, and nausea. Other toxicities included liver enzyme elevations, myelosuppression, and proteinuria, all of which were mostly grades 1 to 2. The most frequent grades 3 to 4 toxicities were hyperbilirubinemia (6.3%), hypertension (7.7%), and fatigue (7.7%). CONCLUSION Pazopanib is well tolerated in patients with relapsed, advanced STS and demonstrates interesting activity that warrants additional study in patients with leiomyosarcomas, synovial sarcomas, and other STS types.
机译：目的考虑到血管生成在软组织肉瘤（STS）中的重要性，对患有晚期STS的患者探索了以血管内皮生长因子受体和血小板源性生长因子受体为目标的口服血管生成抑制剂pazopanib。患者和方法中级或高级晚期STS患者不适合化疗，或接受不超过两种先前用于晚期疾病的细胞毒性药物，具有进展的证据，具有良好的表现状态，并且器官功能良好有资格。每天服用Pazopanib 800 mg。主要终点是12周（PFR（12周））的无进展率。次要终点是反应，安全性和总生存期。研究了四种不同的层：脂肪细胞STS，平滑肌肉瘤，滑膜肉瘤和其他STS类型。对每个层应用了西蒙两阶段设计（P1 = 40％; P0 = 20％; alpha = beta = .1）。结果共纳入142例患者。由于活动不足（PFR（12周），占五个[26％] 19），第一阶段后脂肪细胞STS层关闭。在平滑肌肉肉瘤队列中，PFR（12周）为41例患者中的18例（44％），滑膜肉瘤为37例中的18例（49％），其他STS类型为41例中的16例（39％）。与接受二线化疗的历史对照相比，在达到主要终点的三个队列中无进展生存期和总生存期均得到延长。与药物相关的最常见的毒性是高血压，疲劳，色素沉着和恶心。其他毒性包括肝酶升高，骨髓抑制和蛋白尿，所有这些大多为1至2级。最常见的3至4级毒性为高胆红素血症（6.3％），高血压（7.7％）和疲劳（7.7％）。结论帕唑帕尼对复发，晚期STS患者具有良好的耐受性，并显示出有趣的活性，值得对平滑肌肉瘤，滑膜肉瘤和其他STS类型的患者进行进一步研究。

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