OSSMAR: An Observational Study to Describe the Use of Sunitinib in Real-Life Practice for the Treatment of Metastatic Renal Cell Carcinoma

Journal of global oncology Pub Date : 2019-10-28 DOI:10.1200/JGO.18.00238

M. Ghosn, R. Eid, E. Hamada, Hamdy Abdel Azim, J. Zekri, M. Al-Mansour, M. Jaloudi, F. Nasr, H. Errihani, A. Bounedjar, A. Mezlini, H. Boussen, J. Kattan, F. el Karak, F. Farhat

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引用次数: 4

Abstract

PURPOSE Sunitinib offers improved efficacy for patients with metastatic renal cell carcinoma (mRCC). To provide better disease management in the Middle East, we studied its use in mRCC in real-life practice in this region. MATERIAL AND METHODS Patients diagnosed with mRCC and started on sunitinib between 2006 and 2016 from 10 centers in Africa and the Middle East region were studied in this regional, multicenter, observational, retrospective trial to obtain routine clinical practice data on the usage patterns and outcomes of sunitinib in mRCC in real-life practice. RESULTS A total of 289 patients were enrolled. Median age at diagnosis was 58.7 years. The patient characteristics were as follows: 73.6% of patients were males; 85.8% had clear-cell renal cell carcinoma (RCC); 97.5% had unilateral RCC; 66.3% had metastatic disease at initial diagnosis; 56.3% received previous treatment for RCC, among which 98.7% had undergone surgery; and 15.2% and 31.4% were classified in the favorable and poor-risk groups (expanded Memorial Sloan Kettering Cancer Center criteria), respectively. On treatment initiation, the mean total sunitinib dose was 48.1 mg, and 87.6% of patients were started on a sunitinib dose of 50 mg. The mean duration of sunitinib treatment was 9.6 months. Overall response rate was 20.8%, with a median duration of 8.2 months. Median time to progression was 5.7 months. Median follow-up time was 7.8 months. By months 12 and 24, 34.3% and 11.4% of patients, respectively, were still alive. Seventy-six patients (60.9%) experienced 314 adverse events. Twenty-three patients (8.0%) experienced 28 serious adverse events. Overall, 83 patients (28.7%) discontinued their sunitinib treatment. CONCLUSION The results are indicative of the general treatment outcomes of patients with mRCC in the Middle East using sunitinib in routine clinical practice. Reported adverse events are similar to those described in the literature but at lower frequencies.

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OSSMAR：描述舒尼替尼在实际生活中治疗转移性肾细胞癌的观察研究

舒尼替尼可改善转移性肾细胞癌（mRCC）患者的疗效。为了在中东提供更好的疾病管理，我们研究了它在该地区现实生活中的应用。材料和方法在这项区域性、多中心、观察性、回顾性试验中，对2006年至2016年间来自非洲和中东地区10个中心的被诊断为mRCC并开始服用舒尼替尼的患者进行了研究，以获得关于舒尼替尼在mRCC中的实际使用模式和结果的常规临床实践数据。结果共有289名患者入选。诊断时的中位年龄为58.7岁。患者特征如下：男性占73.6%；肾透明细胞癌（RCC）占85.8%；97.5%为单侧RCC；66.3%的患者在初次诊断时有转移性疾病；56.3%曾接受过RCC治疗，其中98.7%曾接受过手术治疗；15.2%和31.4%分别被分为有利和低风险组（扩展了纪念斯隆-凯特琳癌症中心的标准）。在治疗开始时，舒尼替尼的平均总剂量为48.1 mg，87.6%的患者开始服用50 mg的舒尼替尼来治疗。舒尼替尼治疗的平均持续时间为9.6个月。总有效率为20.8%，中位持续时间为8.2个月。中位进展时间为5.7个月。中位随访时间为7.8个月。到第12个月和第24个月，分别有34.3%和11.4%的患者仍然活着。76名患者（60.9%）经历了314次不良事件。23名患者（8.0%）经历了28次严重不良事件。总的来说，83名患者（28.7%）停止了舒尼替尼的治疗。结论该结果可作为中东地区mRCC患者在常规临床实践中使用舒尼替尼的一般治疗结果的指标。报告的不良事件与文献中描述的类似，但发生频率较低。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of global oncology ONCOLOGY-

自引率

0.00%

发文量

审稿时长

20 weeks

期刊介绍： The Journal of Global Oncology (JGO) is an online only, open access journal focused on cancer care, research and care delivery issues unique to countries and settings with limited healthcare resources. JGO aims to provide a home for high-quality literature that fulfills a growing need for content describing the array of challenges health care professionals in resource-constrained settings face. Article types include original reports, review articles, commentaries, correspondence/replies, special articles and editorials.