Sunitinib Alone or after Nephrectomy in Metastatic Renal-Cell Carcinoma

被引：677

作者：

Mejean, A. ^{[1
]}

Ravaud, A. ^{[4
]}

Thezenas, S. ^{[8
]}

Colas, S. ^{[3
]}

Beauval, J. -B. ^{[9
]}

Bensalah, K. ^{[11
]}

Geoffrois, L. ^{[13
]}

Thiery-Vuillemin, A. ^{[14
,15
]}

Cormier, L. ^{[16
]}

Lang, H. ^{[17
]}

Guy, L. ^{[18
,19
]}

Gravis, G. ^{[20
,21
]}

Rolland, F. ^{[23
]}

Linassier, C. ^{[24
,25
]}

Lechevallier, E. ^{[22
]}

Beisland, C. ^{[33
,34
]}

Aitchison, M. ^{[35
]}

Oudard, S. ^{[2
]}

Patard, J. -J. ^{[26
]}

Theodore, C. ^{[27
]}

Chevreau, C. ^{[10
]}

Laguerre, B. ^{[12
]}

Hubert, J. ^{[29
]}

Gross-Goupil, M. ^{[5
]}

Bernhard, J. -C. ^{[6
,7
]}

Albiges, L. ^{[30
,31
]}

Timsit, M. -O. ^{[1
]}

Lebret, T. ^{[28
,32
]}

Escudier, B. ^{[30
,31
]}

机构：

[1] Univ Paris 05, Hop Europeen Georges Pompidou, AP HP, Dept Urol, Paris, France

[2] Univ Paris 05, Hop Europeen Georges Pompidou, AP HP, Dept Med Oncol, Paris, France

[3] AP HP, Paris Descartes Necker Cochin Clin Res Unit, Paris, France

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

[5] Ctr Hosp Univ CHU Bordeaux, Hop St Andre, Dept Med Oncol, Bordeaux, France

[6] CHU Bordeaux, Dept Urol, Bordeaux, France

[7] Univ Bordeaux, Bordeaux, France

[8] Univ Montpellier, Canc Inst Montpellier, Biometr Unit, Montpellier, France

[9] CHU Rangueil, Dept Urol, Toulouse, France

[10] Inst Univ Canc Toulouse Oncopole, Dept Med Oncol, Toulouse, France

[11] Univ Rennes, Dept Urol, Rennes, France

[12] Ctr Eugene Marquis, Dept Med Oncol, Rennes, France

[13] Inst Cancerol Lorraine, Dept Med Oncol, Vandoeuvre Les Nancy, France

[14] CHU Besancon, Dept Med Oncol, Oncol, Besancon, France

[15] Univ Franche Comte, INSERM, Struct Federat Rech Ingn & Biol Cellulaire & Tiss, Unite Mixte Rech UMR 1098, Besancon, France

[16] CHU Francois Mitterrand, Dept Urol, Dijon, France

[17] CHU Strasbourg, Translat Med Federat Strasbourg, Dept Urol, Strasbourg, France

[18] Gabriel Montpied Hosp, Dept Urol, Clermont Ferrand, France

[19] Clermont Auvergne Univ, Clermont Ferrand, France

[20] CNRS, Ctr Rech Cancerol Marseille, Dept Med Oncol, INSERM,UMR 1068,UMR 7258, Marseille, France

[21] Inst Paoli Calmettes, Marseille, France

[22] Aix Marseille Univ, Hop Concept, Dept Urol, Marseille, France

[23] Inst Cancerol Ouest, Dept Med Oncol, Nantes, France

[24] CHU Bretonneau, Dept Med Oncol, Tours, France

[25] Univ Tours, Dept Med, Tours, France

[26] Mt de Marsan Gen Hosp, Dept Urol, Mt De Marsan, France

[27] Hop Foch, Dept Med Oncol, Suresnes, France

[28] Hop Foch, Dept Urol, Suresnes, France

[29] CHU Nancy, INSERM, Imagerie Adaptat Diagnost & Intervent, Dept Urol,U1254, Brabois, France

[30] Gustave Roussy Inst, Dept Med Oncol, 114 Rue Edouard Vaillant, F-94800 Villejuif, France

[31] Univ Paris Saclay, Villejuif, France

[32] Univ Versailles, St Quentin En Yvelines, France

[33] Haukeland Hosp, Dept Urol, Bergen, Norway

[34] Univ Bergen, Dept Clin Med, Bergen, Norway

[35] Royal Free Hosp, Dept Urol, London, England

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2018年 / 379卷 / 05期

关键词：

CLINICAL-PRACTICE GUIDELINES; CYTOREDUCTIVE NEPHRECTOMY; TARGETED THERAPY; RADICAL NEPHRECTOMY; CLASSIFICATION; COMPLICATIONS; SURVIVAL; CANCER;

D O I：

10.1056/NEJMoa1803675

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

BACKGROUND Cytoreductive nephrectomy has been the standard of care in metastatic renal-cell carcinoma for 20 years, supported by randomized trials and large, retrospective studies. However, the efficacy of targeted therapies has challenged this standard. We assessed the role of nephrectomy in patients with metastatic renal-cell carcinoma who were receiving targeted therapies. METHODS In this phase 3 trial, we randomly assigned, in a 1: 1 ratio, patients with confirmed metastatic clear-cell renal-cell carcinoma at presentation who were suitable candidates for nephrectomy to undergo nephrectomy and then receive sunitinib (standard therapy) or to receive sunitinib alone. Randomization was stratified according to prognostic risk (intermediate or poor) in the Memorial Sloan Kettering Cancer Center prognostic model. Patients received sunitinib at a dose of 50 mg daily in cycles of 28 days on and 14 days off every 6 weeks. The primary end point was overall survival. RESULTS A total of 450 patients were enrolled from September 2009 to September 2017. At this planned interim analysis, the median follow-up was 50.9 months, with 326 deaths observed. The results in the sunitinib-alone group were noninferior to those in the nephrectomy-sunitinib group with regard to overall survival (stratified hazard ratio for death, 0.89; 95% confidence interval, 0.71 to 1.10; upper boundary of the 95% confidence interval for noninferiority, <= 1.20). The median overall survival was 18.4 months in the sunitinib-alone group and 13.9 months in the nephrectomy-sunitinib group. No significant differences in response rate or progression-free survival were observed. Adverse events were as anticipated in each group. CONCLUSIONS Sunitinib alone was not inferior to nephrectomy followed by sunitinib in patients with metastatic renal-cell carcinoma who were classified as having intermediate-risk or poor-risk disease. (Funded by Assistance Publique-Hopitaux de Paris and others; CARMENA ClinicalTrials.gov number, NCT00930033.)

引用

页码：417 / 427

页数：11

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