Zheng Yu, Wang Fuli, Wu Guojun, Zhang Longlong, Wang Yangmin, Wang Zhiping, Chen Peng, Wang Qing, Lu Jingyi, Wang Yujie, Li Peijun, Wang Jian, Lu Xitao, Yuan Jianlin
From the Department of Urology, Xijing Hospital, Fourth Military Medical University, Xi'an, Shaanxi Province (YZ, FW, GW, LZ, JY); Department of Urology, General Hospital of Lanzhou Military Area Command of Chinese PLA (YW); Department of Urology, The Second Affiliated Hospital of Lanzhou University, Lanzhou, Gansu Province (ZW); Department of Urology, Affiliated Tumor Hospital of Xinjang Medical University (PC); Department of Urology, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi (QW); Department of Urology, Xinjiang karamay Central Hospital, Karamay (JL); Department of Urology, The First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang Uyghur Autonomous Region (YW); Department of Urology, General Hospital of Ningxia Medical University, Yinchuan, Ningxia Hui Autonomous Region (PL); Department of Urology, Qinghai University Affiliated Hospital, Xining, QingHai Province (JW); and Department of Urology, First People's Hospital of Shizuishan, Shizuishan, Ningxia Hui Autonomous Region, China (XL).
Medicine (Baltimore). 2015 Dec;94(49):e2222. doi: 10.1097/MD.0000000000002222.
The aim of the study is to evaluate the relationship between the adverse events and efficacy of sorafenib in patients with metastatic renal cell carcinoma (mRCC), with a purpose to guide the judgment of efficacy in sorafenib treatment.Eighty-three mRCC patients who received sorafenib therapy at northwest China were studied retrospectively. Univariate and multivariate analyses were performed to correlate tumor response, progression-free survival (PFS), and overall survival (OS) with adverse event types and grades.Among 83 patients who underwent sorafenib therapy, 2 cases (2.4%) had completed response (CR), 14 cases (16.9%) had partial response (PR), 57 cases (68.7%) had stable disease (SD), and 10 cases (12.0%) developed progressive disease (PD). The median PFS and OS were 15.0 and 29.0 months, respectively. The most frequent grade 1 or 2 adverse events included hand-foot syndrome (68.7%), diarrhea (54.2%), and alopecia (51.8%). The most common grade 3 or 4 adverse events were hand-foot syndrome (6.0%), hypertension (4.8%), and diarrhea (3.6%). The frequency and severity of adverse events correlated with tumor response rate (both with P < 0.05). Multivariate analysis showed the independent predictors of better PFS included rash (OR 0.307, 95%CI 0.148-0.636, P = 0.001) and diarrhea (OR 0.391, 95%CI 0.169-0.783, P = 0.008). Elevated transaminase was the independent predictor of poor PFS (OR 2.606, 95%CI 1.299-5.532, P = 0.012). For OS, rash (OR 0.473, 95%CI 0.253-0.886, P = 0.019) and diarrhea (OR 0.321, 95%CI 0.171-0.605, P = 0.000) correlated with better OS.Sorafenib-related adverse events are associated with efficacy in patients with mRCC from northwest China. Rash and diarrhea are independent protective factors of both PFS and OS, and elevated transaminase is an independent risk factor of PFS. A large prospective study is warranted.
本研究旨在评估索拉非尼在转移性肾细胞癌（mRCC）患者中的不良事件与疗效之间的关系，以指导索拉非尼治疗疗效的判断。对中国西北地区83例接受索拉非尼治疗的mRCC患者进行回顾性研究。进行单因素和多因素分析，以将肿瘤反应、无进展生存期（PFS）和总生存期（OS）与不良事件类型和分级相关联。在83例接受索拉非尼治疗的患者中，2例（2.4%）达到完全缓解（CR），14例（16.9%）达到部分缓解（PR），57例（68.7%）疾病稳定（SD），10例（12.0%）疾病进展（PD）。中位PFS和OS分别为15.0个月和29.0个月。最常见的1级或2级不良事件包括手足综合征（68.7%）、腹泻（54.2%）和脱发（51.8%）。最常见的3级或4级不良事件是手足综合征（6.0%）、高血压（4.8%）和腹泻（3.6%）。不良事件的频率和严重程度与肿瘤反应率相关（均P<0.05）。多因素分析显示，PFS较好的独立预测因素包括皮疹（OR 0.307，95%CI 0.148 - 0.636，P = 0.001）和腹泻（OR 0.391，95%CI 0.169 - 0.783，P = 0.008）。转氨酶升高是PFS较差的独立预测因素（OR 2.606，95%CI 1.299 - 5.532，P = 0.012）。对于OS，皮疹（OR 0.473，95%CI 0.253 - 0.886，P = 0.019）和腹泻（OR 0.321，95%CI 0.171 - 0.605，P = 0.000）与较好的OS相关。索拉非尼相关不良事件与中国西北地区mRCC患者的疗效相关。皮疹和腹泻是PFS和OS的独立保护因素，转氨酶升高是PFS的独立危险因素。有必要进行一项大型前瞻性研究。
