Efficacy and Safety of Nivolumab Plus Ipilimumab versus Sunitinib in First-line Treatment of Patients with Advanced Sarcomatoid Renal Cell Carcinoma

被引：155

作者：

Tannir, Nizar M. ^{[1
]}

Signoretti, Sabina ^{[2
,3
]}

Choueiri, Toni K. ^{[4
]}

McDermott, David F. ^{[5
]}

Motzer, Robert J. ^{[6
]}

Flaifel, Abdallah ^{[2
]}

Pignon, Jean-Christophe ^{[2
,24
]}

Ficial, Miriam ^{[2
]}

Frontera, Osvaldo Aren ^{[7
]}

George, Saby ^{[8
]}

Powles, Thomas ^{[9
]}

Donskov, Frede ^{[10
]}

Harrison, Michael R. ^{[11
]}

Barthelemy, Philippe ^{[12
]}

Tykodi, Scott S. ^{[13
,14
]}

Kocsis, Judit ^{[15
,16
]}

Ravaud, Alain ^{[17
]}

Rodriguez-Cid, Jeronimo R. ^{[18
]}

Pal, Sumanta K. ^{[19
]}

Murad, Andre M. ^{[20
]}

Ishii, Yuko ^{[21
,25
]}

Saggi, Shruti Shally ^{[21
]}

McHenry, M. Brent ^{[22
]}

Rini, Brian, I ^{[23
]}

机构：

[1] Univ Texas MD Anderson Canc Ctr, Dept Genitourinary Med Oncol, Houston, TX 77030 USA

[2] Harvard Med Sch, Brigham & Womens Hosp, Dept Pathol, Boston, MA 02115 USA

[3] Dana Farber Canc Inst, Dept Oncol Pathol, Boston, MA 02115 USA

[4] Dana Farber Canc Inst, Dept Med Oncol, Boston, MA 02115 USA

[5] Dana Farber Harvard Canc Ctr, Beth Israel Deaconess Med Ctr, Div Med Oncol, Boston, MA USA

[6] Mem Sloan Kettering Canc Ctr, Dept Med, 1275 York Ave, New York, NY 10021 USA

[7] Ctr Invest Clin Bradford Hill, Recoleta, Chile

[8] Roswell Pk Canc Inst, Dept Med, Buffalo, NY USA

[9] Queen Mary Univ London, Barts Canc Inst, Dept Urol, Royal Free NHS Trust, London, England

[10] Aarhus Univ Hosp, Dept Oncol, Aarhus, Denmark

[11] Duke Canc Inst, Dept Med, Durham, NC USA

[12] Hop Univ Strasbourg, Med Oncol Unit, Strasbourg, France

[13] Univ Washington, Dept Med, Seattle, WA USA

[14] Fred Hutchinson Canc Res Ctr, 1124 Columbia St, Seattle, WA 98104 USA

[15] Debrecen Univ Clin Ctr, Oncol Dept, Debrecen, Hungary

[16] Bacs Kiskun Cty Teaching Hosp BKMK, Dept Oncoradiol, Ctr Oncoradiol, Kecskemet, Hungary

[17] Bordeaux Univ Hosp, Dept Med Oncol, Bordeaux, France

[18] Hosp Med Sur, Ctr Oncol, Mexico City, DF, Mexico

[19] City Hope Natl Med Ctr, Dept Med Oncol & Therapeut Res, Duarte, CA USA

[20] CENANTRON PERSONAL Precis Oncol, Belo Horizonte, MG, Brazil

[21] Bristol Myers Squibb Co, Dept Clin Trials, Princeton, NJ USA

[22] Bristol Myers Squibb Co, Dept Biostat, Princeton, NJ USA

[23] Vanderbilt Ingram Canc Ctr, Div Hematol Oncol, Nashville, TN USA

[24] Bristol Myers Squibb Co, Princeton, NJ USA

[25] Astellas Pharma, Dept Translat Sci, Northbrook, IL USA

来源：

CLINICAL CANCER RESEARCH | 2021年 / 27卷 / 01期

关键词：

SYSTEMIC THERAPY; GEMCITABINE; DOXORUBICIN; SURVIVAL; ANTIBODY; PD-1;

D O I：

10.1158/1078-0432.CCR-20-2063

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Purpose: Patients with advanced renal cell carcinoma with sarcomatoid features (sRCC) have poor prognoses and suboptimal outcomes with targeted therapy. This post hoc analysis of the phase III CheckMate 214 trial analyzed the efficacy of nivolumab plus ipilimumab (NIVO+IPI) versus sunitinib in patients with sRCC. Patients and Methods: Patients with sRCC were identified via independent central pathology review of archival tumor tissue or histologic dassification per local pathology report. Patients were randomized 1:1 to receive nivolumab (3 mg/kg) plus ipilimumab (1 mg/kg) every 3 weeks (four doses) then nivolumab 3 mg/kg every 2 weeks, or sunitinib 50 mg orally every day (4 weeks; 6-week cydes). Outcomes in patients with sRCC were not prespecified. Endpoints in patients with sRCC and International Metastatic Renal Cell Carcinoma Database Consortium intermediate/poorrisk disease included overall survival (OS), progression-free survival (PFS) per independent radiology review, and objective response rate (ORR) per RECIST v1.1. Safety outcomes used descriptive statistics. Results: Of 1,096 randomized patients in CheckMate 214, 139 patients with sRCC and intermediate/poor-risk disease and six with favorable-risk disease were identified. With 42 months' minimum follow-up in patients with sRCC and intermediate/poor-risk disease, median OS [95% confidence interval (CI)] favored NIVO+IPI [not reached (NR) (25.2-not estimable [NE]); n = 74] versus sunitinib [14.2 months (9.3-22.9); n = 65; HR, 0.45 (95% CI, 0.3-0.7; P = 0.0004)]; PFS benefits with NIVO+IPI were similarly observed [median 26.5 vs. 5.1 months; HR, 0.54 (95% CI, 0.33-0.86; P = 0.0093)]. Confirmed ORR was 60.8% with NIVO+IPI versus 23.1% with sunitinib, with complete response rates of 18.9% versus 3.1%, respectively. No new safety signals emerged. Conclusions: NIVO+IPI showed unprecedented long-term survival, response, and complete response benefits versus sunitinib in previously untreated patients with sRCC and intermediate/poor-risk disease, supporting the use of first-line NIVO+IPI for this population.

引用

页码：78 / 86

页数：9

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