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Sunitinib Alone or after Nephrectomy in Metastatic Renal-Cell Carcinoma.
- Source :
-
The New England journal of medicine [N Engl J Med] 2018 Aug 02; Vol. 379 (5), pp. 417-427. Date of Electronic Publication: 2018 Jun 03. - Publication Year :
- 2018
-
Abstract
- 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.<br />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.<br />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.<br />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-Hôpitaux de Paris and others; CARMENA ClinicalTrials.gov number, NCT00930033 .).
- Subjects :
- Adult
Aged
Aged, 80 and over
Antineoplastic Agents adverse effects
Carcinoma, Renal Cell mortality
Carcinoma, Renal Cell secondary
Carcinoma, Renal Cell surgery
Combined Modality Therapy
Female
Follow-Up Studies
Humans
Indoles adverse effects
Kidney Neoplasms mortality
Kidney Neoplasms pathology
Kidney Neoplasms surgery
Male
Middle Aged
Neoplasm Staging
Patient Selection
Postoperative Complications
Prognosis
Pyrroles adverse effects
Risk Assessment
Sunitinib
Survival Analysis
Antineoplastic Agents therapeutic use
Carcinoma, Renal Cell drug therapy
Indoles therapeutic use
Kidney Neoplasms drug therapy
Nephrectomy adverse effects
Pyrroles therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1533-4406
- Volume :
- 379
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- The New England journal of medicine
- Publication Type :
- Academic Journal
- Accession number :
- 29860937
- Full Text :
- https://doi.org/10.1056/NEJMoa1803675