Cabozantinib versus sunitinib as initial therapy for metastatic renal cell carcinoma of intermediate or poor risk (Alliance A031203 CABOSUN randomised trial): Progression-free survival by independent review and overall survival update.
Cabozantinib versus sunitinib as initial therapy for metastatic renal cell carcinoma of intermediate or poor risk (Alliance A031203 CABOSUN randomised trial): Progression-free survival by independent review and overall survival update.
复制标题
DOI：
10.1016/j.ejca.2018.02.012
复制
发表时间：
2018-05
期刊：
影响因子：
--
通讯作者：
Morris MJ
中科院分区：
文献类型：
--
作者：
Choueiri TK;Hessel C;Halabi S;Sanford B;Michaelson MD;Hahn O;Walsh M;Olencki T;Picus J;Small EJ;Dakhil S;Feldman DR;Mangeshkar M;Scheffold C;George D;Morris MJ
比较卡博替尼与舒尼替尼作为中等或低风险晚期肾细胞癌（RCC）初始治疗的随机化II期CABOSUN试验符合研究者评估的改善无进展生存期（PFS）的主要终点。我们报告了独立放射学审查委员会（IRC）评估的PFS、IRC评估的ORR和更新的总生存期（OS）。根据IMDC标准，先前未经治疗的中度或低风险晚期RCC患者以1：1随机分配至卡博替尼60 mg/天或舒尼替尼50 mg/天（给药4周/停药2周）。根据风险组和骨转移的存在进行分层。共有157名患者以1：1的比例随机分配至卡博替尼（n = 79）或舒尼替尼（n = 78）。IRC评估的中位PFS为8.6个月（95%置信区间[CI] 6.8-14.0）vs 5.3个月卡博替尼与舒尼替尼（95% CI 3.0-8.2）（风险比[HR] 0.48 [95% CI 0.31-0.74];双侧p = 0.0008），IRC评估的ORR分别为20%（95% CI 12.0-30.8）和9%（95% CI 3.7-17.6）。按分层因素和MET肿瘤表达进行的PFS亚组分析与总体人群的结果一致。中位随访时间为34.5个月，卡博替尼的中位OS为26.6个月（95%CI 14.6-不可估计），舒尼替尼为21.2个月（95%CI 16.3-27.4）（HR 0.80 [95%CI 0.53-1.21]）。卡博替尼3级或4级不良事件的发生率为68%，舒尼替尼为65%。在这项2期试验中，与舒尼替尼相比，卡博替尼治疗显著延长了IRC评估的PFS，作为低风险或中等风险晚期RCC的初始全身治疗。
The randomised phase 2 CABOSUN trial comparing cabozantinib with sunitinib as initial therapy for advanced renal cell carcinoma (RCC) of intermediate or poor risk met the primary end-point of improving progression-free survival (PFS) as assessed by investigator. We report PFS by independent radiology review committee (IRC) assessment, ORR per IRC and updated overall survival (OS). Previously untreated patients with advanced RCC of intermediate or poor risk by IMDC criteria were randomised 1:1 to cabozantinib 60 mg daily or sunitinib 50 mg daily (4 weeks on/2 weeks off). Stratification was by risk group and presence of bone metastases. A total of 157 patients were randomised 1:1 to cabozantinib (n = 79) or sunitinib (n = 78). Median PFS per IRC was 8.6 months (95% confidence interval [CI] 6.8—14.0) versus 5.3 months (95% CI 3.0—8.2) for cabozantinib versus sunitinib (hazard ratio [HR] 0.48 [95% CI 0.31—0.74]; two-sided p = 0.0008), and ORR per IRC was 20% (95% CI 12.0—30.8) versus 9% (95% CI 3.7—17.6), respectively. Subgroup analyses of PFS by stratification factors and MET tumour expression were consistent with results for the overall population. With a median follow-up of 34.5 months, median OS was 26.6 months (95% CI 14.6—not estimable) with cabozantinib and 21.2 months (95% CI 16.3—27.4) with sunitinib (HR 0.80 [95% CI 0.53—1.21]. The incidence of grade 3 or 4 adverse events was 68% for cabozantinib and 65% for sunitinib. In this phase 2 trial, cabozantinib treatment significantly prolonged PFS per IRC compared with sunitinib as initial systemic therapy for advanced RCC of poor or intermediate risk.
登录
查看更多内容
影响因子：
8.4
作者：
Eisenhauer, E. A.;Therasse, P.;Verweij, J.
通讯作者：
Verweij, J.
DOI：
10.1056/nejmoa1510016
发表时间：
2015-11-05
期刊：
The New England journal of medicine
影响因子：
--
作者：
Choueiri TK;Escudier B;Powles T;Mainwaring PN;Rini BI;Donskov F;Hammers H;Hutson TE;Lee JL;Peltola K;Roth BJ;Bjarnason GA;Géczi L;Keam B;Maroto P;Heng DY;Schmidinger M;Kantoff PW;Borgman-Hagey A;Hessel C;Scheffold C;Schwab GM;Tannir NM;Motzer RJ;METEOR Investigators
通讯作者：
METEOR Investigators
影响因子：
168.9
作者：
Escudier, Bernard;Pluzanska, Anna;Moore, Nicola
通讯作者：
Moore, Nicola
影响因子：
6.2
作者：
Motzer, Robert J.;Bukowski, Ronald M.;Kaftan, Michael W.
通讯作者：
Kaftan, Michael W.
影响因子：
158.5
作者：
Motzer, Robert J.;Hutson, Thomas E.;Choueiri, Toni K.
通讯作者：
Choueiri, Toni K.