Ramaswamy Anant, Joshi Amit, Noronha Vanita, Patil Vijay M, Kothari Rushabh, Sahu Arvind, Kannan Ram Abhinav, Sable Nilesh, Popat Palak, Menon Santosh, Prabhash Kumar
Department of Medical Oncology, Tata Memorial Hospital, Mumbai, India.
Department of Radiology, Tata Memorial Hospital, Mumbai, India.
Clin Genitourin Cancer. 2017 Jun;15(3):e345-e355. doi: 10.1016/j.clgc.2016.09.006. Epub 2016 Oct 19.
The current treatment of metastatic renal cell carcinoma (mRCC) revolves around targeted agents, which have resulted in a median overall survival of 22 to 26 months in registration trials. However, the outcomes in a non-trial, real-world Indian population have not yet been evaluated.
The present study was a part of a prospective Clinical Trials Registry-India-registered study, the Kidney Cancer Registry, a prospectively maintained kidney cancer registry. The data of patients with a diagnosis of mRCC from February 2007 to August 2015 who were potential candidates for systemic therapy were extracted from the database and analyzed for treatment patterns and outcomes.
The data from 212 patients were eligible for analysis. Of these 212 patients, 204 (96.2%) received first-line systemic treatment with sunitinib (40.6%), sorafenib (37.7%), pazopanib (2.8%), temsirolimus (2.8%), or everolimus (1.9%). The risk status of 91% of the patients could be stratified using the Heng criteria into favorable (18.9%), intermediate (43.9%), and poor risk (28.3%) categories. The response rate, clinical benefit rate, median progression-free survival, and median overall survival with first-line targeted therapy were 22.5%, 60.7%, 7.09 months, and 12.87 months, respectively. The common adverse events seen included skin rash (31.7%), hypertension (29.4%), grade 3 hand-foot syndrome (27.4%), mucositis (26.4%), dyslipidemia (20%), and hyperglycemia (17.6%). Patients receiving second-line therapy (22.6%) had superior overall survival to patients who had not (16.46 vs. 10.67 months; P = .032).
The present registry-based study is the first, to the best of our knowledge, of its type from India and showed that the overall outcomes in this real-world cohort appear comparable to non-trial data worldwide. An increased incidence of metabolic adverse events that require monitoring during treatment was also found.
转移性肾细胞癌(mRCC)的当前治疗主要围绕靶向药物展开,在注册试验中,这些药物使中位总生存期达到了22至26个月。然而,印度非试验性真实世界人群的治疗结果尚未得到评估。
本研究是前瞻性注册的印度临床试验注册研究——肾癌注册研究的一部分,这是一个前瞻性维护的肾癌注册库。从2007年2月至2015年8月诊断为mRCC且有全身治疗可能的患者数据中提取数据,并分析治疗模式和结果。
212例患者的数据符合分析要求。在这212例患者中,204例(96.2%)接受了一线全身治疗,使用舒尼替尼的患者占40.6%,索拉非尼占37.7%,帕唑帕尼占2.8%,替西罗莫司占2.8%,依维莫司占1.9%。91%的患者风险状态可根据恒氏标准分为低危(18.9%)、中危(43.9%)和高危(28.3%)三类。一线靶向治疗的缓解率、临床获益率、中位无进展生存期和中位总生存期分别为22.5%、60.7%、7.09个月和12.87个月。常见的不良事件包括皮疹(31.7%)、高血压(29.4%)、3级手足综合征(27.4%)、黏膜炎(26.4%)、血脂异常(20%)和高血糖(17.6%)。接受二线治疗的患者(22.6%)总生存期优于未接受二线治疗的患者(16.46个月对10.67个月;P = 0.032)。
据我们所知,本基于注册库的研究是印度同类研究中的首个研究,表明该真实世界队列中的总体结果与全球非试验数据相当。研究还发现治疗期间需要监测的代谢性不良事件发生率有所增加。