Nivolumab plus Ipilimumab versus Sunitinib in advanced renal-cell carcinoma

New England Journal of Medicine

Volumn 378, Issue 14, 2018, Pages 1277-1290

  Motzer, R J ^a   Tannir, N M ^c   McDermott, D F ^d   Aren Frontera O ^e   Melichar, B ^h   Choueiri, T K ^f   Plimack, E R ⁱ   Barthelemy P ^j   Porta, C ^m   George, S ^a   Powles, T ^o   Donskov, F ^q   Neiman, V ^r,s   Kollmannsberger, C K ^t   Salman, P ^g   Gurney, H ^b   Hawkins, R ^p   Ravaud, A ^b   Grimm, M O ^v   Bracarda, S ⁿ   Barrios, C H ^w   Tomita, Y ^x   Castellano, D ^y   Rini, B I ^z   Chen, A C ^k,aa   Mekan, S ^aa   McHenry, M B ^aa   Wind Rotolo, M ^aa   Doan, J ^aa   Sharma, P ^c   Hammers, H J ^u,ab   Escudier, B ^l   more..

^a MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^b ROSWELL PARK CANCER INSTITUTE   (United States)

^c UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^d DANA FARBER HARVARD CANCER CENTER   (United States)

^e BRIGHAM AND WOMEN S HOSPITAL   (United States)

^f HARVARD MEDICAL SCHOOL   (United States)

^g Instituto Oncológico Fundación Arturo López Pérez   (Chile)

^h PALACKÝ UNIVERSITY   (Czech Republic)

ⁱ FOX CHASE CANCER CENTER   (United States)

^j UNIVERSITY HOSPITAL OF STRASBOURG   (France)

^k HÔPITAL SAINT ANDRÉ   (France)

^l INSTITUT GUSTAVE ROUSSY   (France)

^m FONDAZIONE IRCCS POLICLINICO SAN MATTEO   (Italy)

ⁿ IRCCS POLICLINICO SAN DONATO   (Italy)

^o QUEEN MARY UNIVERSITY OF LONDON   (United Kingdom)

^p IMPERIAL CANCER RESEARCH FUND   (United Kingdom)

^q AARHUS UNIVERSITY HOSPITAL   (Denmark)

^r RABIN MEDICAL CENTER   (Israel)

^s TEL AVIV UNIVERSITY   (Israel)

^t BRITISH COLUMBIA CANCER AGENCY   (Canada)

^u MACQUARIE UNIVERSITY   (Australia)

^v JENA UNIVERSITY HOSPITAL   (Germany)

^w PONTIFICAL CATHOLIC UNIVERSITY OF RIO GRANDE DO SUL   (Brazil)

^x NIIGATA UNIVERSITY   (Japan)

^y HOSPITAL UNIVERSITARIO 12 DE OCTUBRE   (Spain)

^z LERNER RESEARCH INSTITUTE   (United States)

^aa BRISTOL MYERS SQUIBB   (United States)

^ab JOHNS HOPKINS UNIVERSITY   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

AXITINIB; IPILIMUMAB; NIVOLUMAB; PAZOPANIB; SUNITINIB; ANTINEOPLASTIC AGENT; IMMUNOLOGICAL ANTINEOPLASTIC AGENT; INDOLE DERIVATIVE; MONOCLONAL ANTIBODY; PYRROLE DERIVATIVE;

ADULT; ADVANCED CANCER; AGED; ANEMIA; ARTICLE; ASTHENIA; CANCER SURVIVAL; CONTROLLED STUDY; DECREASED APPETITE; DIARRHEA; DISEASE SEVERITY; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DYSGEUSIA; DYSPEPSIA; FATIGUE; FEMALE; FOLLOW UP; HAND FOOT SYNDROME; HUMAN; HYPERTENSION; HYPOTHYROIDISM; INTERMEDIATE RISK PATIENT; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; OPEN STUDY; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PRURITUS; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RASH; RENAL CELL CARCINOMA; STOMATITIS; SURVIVAL RATE; SYSTEMIC THERAPY; THROMBOCYTOPENIA; TREATMENT DURATION; VOMITING; CLINICAL TRIAL; COMPARATIVE STUDY; DISEASE FREE SURVIVAL; KIDNEY TUMOR; MIDDLE AGED; MORTALITY; RISK; SURVIVAL ANALYSIS; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS, IMMUNOLOGICAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, RENAL CELL; DISEASE-FREE SURVIVAL; HUMANS; INDOLES; IPILIMUMAB; KIDNEY NEOPLASMS; MALE; MIDDLE AGED; PYRROLES; QUALITY OF LIFE; RISK; SURVIVAL ANALYSIS; SURVIVAL RATE;

EID: 85045136401     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa1712126     Document Type: Article

References (32)

1. Motzer RJ, Jonasch E, Agarwal N, et al. Kidney cancer, version 2.2017, NCCN clinical practice guidelines in oncology. J Natl Compr Canc Netw 2017; 15: 804-34.
2. Motzer RJ, Hutson TE, Cella D, et al. Pazopanib versus sunitinib in metastatic renal-cell carcinoma. N Engl J Med 2013; 369:722-31.
3. Choueiri TK, Motzer RJ. Systemic therapy for metastatic renal-cell carcinoma. N Engl J Med 2017; 376: 354-66.
4. Heng DY, Xie W, Regan MM, et al. Prognostic factors for overall survival in patients with metastatic renal cell carcinoma treated with vascular endothelial growth factor-targeted agents: results from a large, multicenter study. J Clin Oncol 2009;27:5794-9.
5. Heng DY, Xie W, Regan MM, et al. External validation and comparison with other models of the International Meta-static Renal-Cell Carcinoma Database Consortium prognostic model: a population-based study. Lancet Oncol 2013; 14: 141-8.
6. Topalian SL, Hodi FS, Brahmer JR, et al. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N Engl J Med 2012;366:2443-54.
7. Opdivo (nivolumab) injection for intravenous use (prescribing information). Princeton, NJ: Bristol-Myers Squibb, 2017.
8. Yervoy (ipilimumab) injection for intravenous use (prescribing information). Princeton, NJ: Bristol-Myers Squibb, 2017.
9. Yang JC, Hughes M, Kammula U, et al. Ipilimumab (anti-CTLA4 antibody) causes regression of metastatic renal cell cancer associated with enteritis and hypophysitis. J Immunother 2007; 30: 825-30.
10. Antonia SJ, López-Martin JA, Bendell J, et al. Nivolumab alone and nivolumab plus ipilimumab in recurrent small-cell lung cancer (CheckMate 032): a multicentre, open-label, phase 1/2 trial. Lancet Oncol 2016;17:883-95.
11. Hammers HJ, Plimack ER, Infante JR, et al. Safety and efficacy of nivolumab in combination with ipilimumab in meta-static renal cell carcinoma: the CheckMate 016 study. J Clin Oncol 2017; 35: 3851-8.
12. Hellmann MD, Rizvi NA, Goldman JW, et al. Nivolumab plus ipilimumab as first-line treatment for advanced non-small-cell lung cancer (CheckMate 012): results of an open-label, phase 1, multico-hort study. Lancet Oncol 2017; 18: 31-41.
13. Larkin J, Chiarion-Sileni V, Gonzalez R, et al. Combined nivolumab and ipilim-umab or monotherapy in untreated melanoma. N Engl J Med 2015; 373: 23-34.
14. Wolchok JD, Kluger H, Callahan MK, et al. Nivolumab plus ipilimumab in advanced melanoma. N Engl J Med 2013; 369:122-33.
15. Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 2009; 45: 228-47.
16. Schag CC, Heinrich RL, Ganz PA. Karnofsky performance status revisited: reliability, validity, and guidelines. J Clin Oncol 1984;2:187-93.
17. Rao D, Butt Z, Rosenbloom S, et al. A comparison of the Renal Cell Carcinoma-Symptom Index (RCC-SI) and the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI). J Pain Symptom Manage 2009;38:291-8.
18. Rothrock NE, Jensen SE, Beaumont JL, et al. Development and initial validation of the NCCN/FACT symptom index for advanced kidney cancer. Value Health 2013;16:789-96.
19. National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. June 14, 2010 (http://ctep.cancer.gov/protocolDevelopment/electronic-applications/ctc.htm#ctc-40).
20. Clopper CP. ES. The use of confidence or fiducial limits illustrated in the case of the binomial. Biometrika 1934; 26: 404-14.
21. Escudier B, Szczylik C, Hutson TE, et al. Randomized phase II trial of first-line treatment with sorafenib versus interferon alfa-2a in patients with metastatic renal cell carcinoma. J Clin Oncol 2009; 27: 1280-9.
22. Motzer RJ, Escudier B, McDermott DF, et al. Nivolumab versus everolimus in advanced renal-cell carcinoma. N Engl J Med 2015;373:1803-13.
23. Choueiri TK, Figueroa DJ, Fay A P, et al. Correlation of PD-L1 tumor expression and treatment outcomes in patients with renal cell carcinoma receiving sunitinib or pazopanib: results from COMPARZ, a randomized controlled trial. Clin Cancer Res 2015;21:1071-7.
24. Hodi FS, Chesney J, Pavlick AC, et al. Combined nivolumab and ipilimumab versus ipilimumab alone in patients with advanced melanoma: 2-year overall survival outcomes in a multicentre, randomised, controlled, phase 2 trial. Lancet Oncol 2016;17:1558-68.
25. Robert C, Long GV, Brady B, et al. Nivolumab in previously untreated melanoma without BRAF mutation. N Engl J Med 2015; 372: 320-30.
26. Kalra S, Rini BI, Jonasch E. Alternate sunitinib schedules in patients with metastatic renal cell carcinoma. Ann Oncol 2015;26:1300-4.
27. Motzer RJ, Hutson TE, Tomczak P, et al. Sunitinib versus interferon alfa in meta-static renal-cell carcinoma. N Engl J Med 2007;356:115-24.
28. Escudier B, Pluzanska A, Koralewski P, et al. Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind phase III trial. Lancet 2007; 370: 2103-11.
29. Rini BI, Halabi S, Rosenberg JE, et al. Bevacizumab plus interferon alfa compared with interferon alfa monotherapy in patients with metastatic renal cell carcinoma: CALGB 90206. J Clin Oncol 2008; 26:5422-8.
30. Sternberg CN, Davis ID, Mardiak J, et al. Pazopanib in locally advanced or meta-static renal cell carcinoma: results of a randomized phase III trial. J Clin Oncol 2010;28:1061-8.
31. Hudes G, Carducci M, Tomczak P, et al. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med 2007;356:2271-81.
32. Choueiri TK, Halabi S, Sanford BL, et al. Cabozantinib versus sunitinib as initial targeted therapy for patients with meta-static renal cell carcinoma of poor or intermediate risk: the Alliance A031203 CABOSUN trial. J Clin Oncol 2017; 35: 591-7.