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索拉非尼与舒尼替尼作为中国转移性肾细胞癌患者一线治疗药物的疗效比较:最大规模的多中心生存及预后因素回顾性分析

Sorafenib versus sunitinib as first-line treatment agents in Chinese patients with metastatic renal cell carcinoma: the largest multicenter retrospective analysis of survival and prognostic factors.

作者信息

Zhang Hai-Liang, Sheng Xi-Nan, Li Xue-Song, Wang Hong-Kai, Chi Zhi-Hong, He Zhi-Song, Ye Ding-Wei, Guo Jun

机构信息

Department of Urology, Fudan University Shanghai Cancer Center, Shanghai, 200032, People's Republic of China.

Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 200032, People's Republic of China.

出版信息

BMC Cancer. 2017 Jan 5;17(1):16. doi: 10.1186/s12885-016-3016-4.

Abstract

BACKGROUND

To compare the efficacy of sorafenib and sunitinib with regard to overall survival (OS) and progression free survival (PFS) in Chinese patients with metastatic renal cell carcinoma (mRCC).

METHODS

A multicenter, retrospective study was performed to elucidate the relationship between clinical variables and prognosis comparing sorafenib and sunitinib as first-line treatment agents in Chinese patients with mRCC. Between September 2006 and December 2014, 845 patients received either sorafenib (400 mg bid; n = 483) or sunitinib (50 mg q.d; n = 362). The primary end point was OS and PFS.

RESULTS

The percentage of patients with low and moderate risk according to Memorial Sloan-Kettering Cancer Centre (MSKCC) score was significantly higher in sunitinib group, and that with high risk was significantly higher in sorafenib group (15.1 vs. 5.2%; p < 0.001). Median OS was similar in sorafenib and sunitinib group (24 vs. 24 months; p = 0.298). Sorafenib group exhibited higher mPFS compared to sunitinib group (11.1 vs. 10.0 months; p = 0.028). Treatment (sorafenib vs sunitinib), pathology, Eastern Cooperative Oncology Group (ECOG) performance status, MSKCC scores, Heng's criteria of risk, and number of metastases were identified as significant predictors for OS and along with liver metastasis for PFS. Clinical outcomes in terms of mOS was significantly better with sorafenib in patients ≥65 years of age (p = .041), ECOG 0 (p = 0.0001), and median MSKCC risk score (p = 0.008).

CONCLUSIONS

Sorafenib and sunitinib are both effective in treating mRCC. However, sorafenib might be more effective in elderly patients (≥65 years) and in patients with an ECOG status of 0, classified under MSKCC moderate risk.

摘要

背景

比较索拉非尼和舒尼替尼对中国转移性肾细胞癌(mRCC)患者总生存期(OS)和无进展生存期(PFS)的疗效。

方法

开展一项多中心回顾性研究,以阐明在中国mRCC患者中,将索拉非尼和舒尼替尼作为一线治疗药物时临床变量与预后之间的关系。2006年9月至2014年12月期间,845例患者接受了索拉非尼(400mg,每日两次;n = 483)或舒尼替尼(50mg,每日一次;n = 362)治疗。主要终点为OS和PFS。

结果

根据纪念斯隆凯特琳癌症中心(MSKCC)评分,舒尼替尼组中低风险和中度风险患者的百分比显著更高,而索拉非尼组中高风险患者的百分比显著更高(15.1%对5.2%;p < 0.001)。索拉非尼组和舒尼替尼组的中位OS相似(24个月对24个月;p = 0.298)。与舒尼替尼组相比,索拉非尼组的mPFS更高(11.1个月对10.0个月;p = 0.028)。治疗(索拉非尼对舒尼替尼)、病理、东部肿瘤协作组(ECOG)体能状态、MSKCC评分、Heng氏风险标准和转移灶数量被确定为OS的显著预测因素,而肝转移是PFS的显著预测因素。在≥65岁患者(p = 0.041)、ECOG 0(p = 0.0001)和MSKCC中位风险评分患者(p = 0.008)中,索拉非尼治疗的mOS临床结局显著更好。

结论

索拉非尼和舒尼替尼在治疗mRCC方面均有效。然而,索拉非尼在老年患者(≥65岁)和ECOG体能状态为0且属于MSKCC中度风险的患者中可能更有效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3027/5217658/ebcd39f2f3d0/12885_2016_3016_Fig1_HTML.jpg

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