腎癌靶向北京腫瘤單中心研究數(shù)據(jù)2016321簡版

1、中央市場部北京大學(xué)腫瘤醫(yī)院索拉非尼 vs 舒尼替尼一線治療轉(zhuǎn)移性腎癌回顧性研究Sheng XN, et al. Oncotarget, 2016 Feb. 15組織學(xué)確認診斷為mRCCKPS:70-100至少一個或多個可測量病灶骨髓造血功能良好肝腎功能良好骨髓造血功能差的患者選擇索拉非尼作為一線治療患者入組標準：PFSOS主要研究終點：索拉非尼400 mg BID連續(xù)給藥舒尼替尼50 mg QD4/2方案n=169n=165治療相關(guān)AE有效率次要研究終點：研究設(shè)計治療方案持續(xù)隨訪Sheng XN, et al. Oncotarget, 2016 Feb. 15基線特征基線情況全體患者(N=33

2、5),%索拉非尼(n=169),%舒尼替尼(n=166),%P值平均年齡（歲）5554550.3445性別男性75.22%73.96%76.51%0.5901病理類型透明細胞癌82.69%80.47%84.94%非透明細胞癌17.31%19.53%15.06%MSKCC危險度分組0.0341N（缺失）9%7%2%低危37.73%34.57%40.85%中危55.83%55.55%56.10%高危6.44%9.88%3.05%基線特征基線情況全體患者(N=335),%索拉非尼(n=169),%舒尼替尼(n=166),%P值Heng評分0.0017N（缺失）10%8%2%低危37.85%34.16

3、%41.46%中危52.00%49.69%54.27%高危10.15%16.15%4.27%骨轉(zhuǎn)移0.3650是35.52%37.87%33.13%肺轉(zhuǎn)移0.1943是75.22%72.19%78.31%轉(zhuǎn)移器官數(shù)量0.6428134.33%33.14%35.54%265.57%66.86%64.46%是否使用二線治療0.1096是28.06%31.95%24.10%有效率結(jié)果療效人數(shù) N索拉非尼（%）舒尼替尼（%）CR20.001.20PR6910.6530.72SD22984.0252.42DCR(CR+PR+SD)30094.6784.33PD355.3315.66Sheng XN, e

4、t al. Oncotarget, 2016 Feb. 15PFS與OS結(jié)果生存概率OS（月）索拉非尼舒尼替尼索拉非尼舒尼替尼P值PFS(月)9.011.00.6289OS(月)28.028.00.979生存概率PFS（月）索拉非尼舒尼替尼Sheng XN, et al. Oncotarget, 2016 Feb. 15非透明細胞腎癌患者: 索拉非尼組OS更長生存概率OS（月）索拉非尼舒尼替尼索拉非尼舒尼替尼P值N(患者數(shù))33250.0232OS(月)13.010.0Sheng XN, et al. Oncotarget, 2016 Feb. 15生存概率PFS（月）索拉非尼舒尼替尼KPS9

5、0患者: 索拉非尼組療效更好索拉非尼舒尼替尼P值PFS(月)7.53.00.0265OS(月)187.50.0506Sheng XN, et al. Oncotarget, 2016 Feb. 15OS（月）生存概率索拉非尼舒尼替尼不良反應(yīng)Sheng XN, et al. Oncotarget, 2016 Feb. 15全體患者(N=335),%索拉非尼(n=169),%舒尼替尼(n=166),%P值所有級別3級所有級別3級所有級別3級所有級別3級所有AE98.81%51.94%97.63%39.05%100.00%65.06%0.13590.0001非血液系統(tǒng)97.31%34.03%94.6

6、7%25.44%100.00%42.77%0.00740.0008HFSR61.49%17.61%62.13%14.2%60.84%21.08%0.80880.0982腹瀉54.36%4.48%53.25%3.55%56.02%5.42%0.61070.4076疲勞44.78%6.57%36.69%5.33%53.01%7.83%0.00270.3546高血壓38.21%5.67%34.91%3.55%41.57%7.83%0.21020.0903皮疹34.93%2.99%39.05%1.18%30.72%4.82%0.1098%0.1022粘膜炎33.43%5.37%23.67%5.92%4

7、3.37%4.82%0.00010.6559惡心29.25%1.49%24.26%0.0034.34%3.01%0.04270.0684厭食27.16%0.90%15.98%0.0038.55%1.81%0.00010.2398不良反應(yīng)全體患者(N=335),%索拉非尼(n=169),%舒尼替尼(n=166),%P值所有級別3級所有級別3級所有級別3級所有級別3級甲狀腺功能減退22.39%0.000.000.0045.18%0.000.0001味覺障礙21.79%0.000.000.0043.98%0.000.0001嘔吐18.81%2.09%16.57%0.0021.08%4.22%0.29

8、020.0206水腫15.82%0.60%0.000.0031.93%1.20%0.00010.2407血液系統(tǒng)73.43%31.04%49.11%18.34%98.19%43.98%0.00010.0001血小板減少37.61%10.45%15.98%1.18%59.64%19.88%0.00010.0001中性粒細胞減少35.22%8.36%17.75%4.73%53.01%12.05%0.00010.0156淋巴細胞減少32.24%9.85%23.67%10.06%40.96%9.64%0.00070.8972貧血21.49%6.27%8.28%2.96%34.94%9.64%0.000

9、10.0117Sheng XN, et al. Oncotarget, 2016 Feb. 15討論一本研究結(jié)果顯示，兩個靶向藥物一線治療晚期腎癌的療效相當，這和之前的一項韓國研究以及瑞金醫(yī)院的研究結(jié)果相似ShengXN,etal.Oncotarget,2016Feb.15Parketal.Chemotherapy2012;58:468474.Juping Zhao, et al .Can Urol Assoc J. 2014 Nov;8(11-12):E821-7北京腫瘤醫(yī)院數(shù)據(jù)韓國Asan中心數(shù)據(jù)瑞金醫(yī)院數(shù)據(jù)SoSuPSoSuPSoSuPPFS (月月)9.011.00.62898.69.

10、90.948-OS (月月)28.028.00.97925.722.60.77425.021.60.276本研究是目前樣本量最大的對比索拉非尼和舒尼替尼一線治療晚期腎癌的研究，結(jié)果與其他中心發(fā)表的中國數(shù)據(jù)相似舒尼替尼組客觀緩解率更高（31.92% vs 10.65%），但是索拉非尼組穩(wěn)定的病人比例更高（84.02% vs 52.42%），結(jié)合最終的OS結(jié)果，再一次證明，疾病穩(wěn)定同樣能夠帶來良好的生存獲益，單純用有效率評價靶向藥物的療效是不全面的Sheng XN, et al. Oncotarget, 2016 Feb. 15討論二Sheng XN, et al. Oncotarget, 2016 Feb. 15預(yù)后因素的分層分析顯示，接受索拉非尼治療的非透明細胞癌患者療效更好(OS, 13 vs 10 months; = 0.0232)，同樣，KPS90的患者索拉非尼也展現(xiàn)了令人印象深刻的療效(PFS, 7.5 vs 3.0 months; P = 0.0265; OS, 18 vs 7.5 months; P = 0.0506)索拉非尼組不良反應(yīng)發(fā)生率及嚴重程