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桓兴医讯 晚期肾细胞癌中纳武单抗+Ipilimumab与舒尼替尼的疗效对
文章来源:北京市朝阳区桓兴肿瘤医院 点击数: 发布时间:2018-03-29 08:47
《新英格兰医学杂志》2018年3月21日在线先发
晚期肾细胞癌中纳武单抗+Ipilimumab与舒尼替尼的疗效对比
背景
在一项初步研究中,纳武单抗+Ipilimumab使晚期肾细胞癌患者产生了客观缓解。这项3期临床试验针对初治的晚期肾透明细胞癌,比较了纳武单抗+Ipilimumab与舒尼替尼的疗效。
方法
我们按1:1比例,将成年患者随机分组,一组接受纳武单抗(3mg/kg体重)+ipilimumab(1mg/kg),1次/3周,静脉注射,共4次剂量,序贯纳武单抗(3mg/kg),1次/2周;另一组口服舒尼替尼50mg,1次/天,用4个星期(6个星期为一疗程)。主要终点为有中高危预后风险的患者的总生存(α水平,0.04)、客观缓解率(α水平,0.001)和无进展生存(α水平,0.009)。
结果
共计对1096名患者分组接受治疗,纳武单抗+ipilimumab组550名,舒尼替尼组546名,分别有425名、422名患者为中高危。中高危患者中位随访25.2个月,纳武单抗+ipilimumab组18个月时总生存率为75%(95%置信区间[CI],70-78),舒尼替尼组60%(95%CI,55-65);纳武单抗+ipilimumab组中位总生存期未到,舒尼替尼组为26.0个月(死亡风险比为0.63,P<0.001);客观缓解率为42%对27%(P<0.001),完全缓解率为9%对比1%;中位无进展生存期分别为11.6个月和8.4个月(疾病进展或死亡的风险比,0.82;P=0.03,按照预先确定的0.009阈值,无显著差异)。纳武单抗+ipilimumab组547名患者中有509名(93%)出现了治疗相关性不良反应,而舒尼替尼组535名患者中有521名(97%);分别有250名(46%)和335名(63%)患者出现了≥3级的不良反应,导致停药的治疗相关不良反应发生率分别为22%和12%。
结论
在初治的中高危晚期肾细胞癌患者中,与舒尼替尼相比,纳武单抗+ipilimumab的总生存率和客观缓解率均明显提高。(百时美施贵宝和小野药业资助,ClinicalTrials.gov网站注册号NCT02231749)。
北京市朝阳区桓兴肿瘤医院 桓兴医讯编译组 白红松
2018年3月29日 星期四
Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma
Background
Nivolumab plus ipilimumab produced objective responses in patients with advanced renal-cell carcinoma in a pilot study. This phase 3 trial compared nivolumab plus ipilimumab with sunitinib for previously untreated clear-cell advanced renal-cell carcinoma.
Methods
We randomly assigned adults in a 1:1 ratio to receive either nivolumab (3 mg per kilogram of body weight) plus ipilimumab (1 mg per kilogram) intravenously every 3 weeks for four doses, followed by nivolumab (3 mg per kilogram) every 2 weeks, or sunitinib (50 mg) orally once daily for 4 weeks (6-week cycle). The coprimary end points were overall survival (alpha level,0.04), objective response rate (alpha level,0.001), and progression-free survival (alpha level,0.009) among patients with intermediate or poor prognostic risk.
Results
A total of 1096 patients were assigned to receive nivolumab plus ipilimumab (550 patients) or sunitinib (546 patients); 425 and 422, respectively, had intermediate or poor risk. At a median follow-up of 25.2 months in intermediate- and poor-risk patients, the 18-month overall survival rate was 75% (95% confidence interval [CI], 70 to 78) with nivolumab plus ipilimumab and 60% (95% CI, 55 to 65) with sunitinib; the median overall survival was not reached with nivolumab plus ipilimumab versus 26.0 months with sunitinib (hazard ratio for death, 0.63; P<0.001). The objective response rate was 42% versus 27% (P<0.001), and the complete response rate was 9% versus 1%. The median progression-free survival was 11.6 months and 8.4 months, respectively (hazard ratio for disease progression or death, 0.82; P=0.03, not significant per the prespecified 0.009 threshold). Treatment-related adverse events occurred in 509 of 547 patients (93%) in the nivolumab-plus-ipilimumab group and 521 of 535 patients (97%) in the sunitinib group; grade 3 or 4 events occurred in 250 patients (46%) and 335 patients (63%), respectively. Treatment-related adverse events leading to discontinuation occurred in 22% and 12% of the patients in the respective groups.
Conclusions
Overall survival and objective response rates were significantly higher with nivolumab plus ipilimumab than with sunitinib among intermediate- and poor-risk patients with previously untreated advanced renal-cell carcinoma. (Funded by Bristol-Myers Squibb and Ono Pharmaceutical; CheckMate 214 ClinicalTrials.gov number, NCT02231749.)

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