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The DOI matches its Crossref record; 34 of the 34 references it cites were found in a registry or an index.

Adjuvant Pembrolizumab after Nephrectomy in Renal-Cell Carcinoma

Open access
Choueiri, Toni K., Tomczak, Piotr, Park, Se Hoon, Venugopal, Balaji, Ferguson, Thomas, Chang, Yen-Hwa, Hajek, Jaroslav, Symeonides, Stefan N., Lee, Jae Lyun, Sarwar, Naveed, Thiery-Vuillemin, Antoine, Gross-Goupil, Marine, Mahave, Mauricio, Haas, Naomi B., Sawrycki, Piotr, Gurney, Howard, Chevreau, Christine, Melichar, Bohuslav, Kopyltsov, Evgeniy, Alva, Ajjai, Burke, John M., Doshi, Gurjyot, Topart, Delphine, Oudard, Stephane, Hammers, Hans, Kitamura, Hiroshi, Bedke, Jens, Perini, Rodolfo F., Zhang, Pingye, Imai, Kentaro, Willemann-Rogerio, Jaqueline, Quinn, David I., Powles, Thomas·2021·New England Journal of Medicine

Abstract

BACKGROUND: Patients with renal-cell carcinoma who undergo nephrectomy have no options for adjuvant therapy to reduce the risk of recurrence that have high levels of supporting evidence. METHODS: In a double-blind, phase 3 trial, we randomly assigned, in a 1:1 ratio, patients with clear-cell renal-cell carcinoma who were at high risk for recurrence after nephrectomy, with or without metastasectomy, to receive either adjuvant pembrolizumab (at a dose of 200 mg) or placebo intravenously once every 3 weeks for up to 17 cycles (approximately 1 year). The primary end point was disease-free survival according to the investigator's assessment. Overall survival was a key secondary end point. Safety was a secondary end point. RESULTS: A total of 496 patients were randomly assigned to receive pembrolizumab, and 498 to receive placebo. At the prespecified interim analysis, the median time from randomization to the data-cutoff date was 24.1 months. Pembrolizumab therapy was associated with significantly longer disease-free survival than placebo (disease-free survival at 24 months, 77.3% vs. 68.1%; hazard ratio for recurrence or death, 0.68; 95% confidence interval [CI], 0.53 to 0.87; P = 0.002 [two-sided]). The estimated percentage of patients who remained alive at 24 months was 96.6% in the pembrolizumab group and 93.5% in the placebo group (hazard ratio for death, 0.54; 95% CI, 0.30 to 0.96). Grade 3 or higher adverse events of any cause occurred in 32.4% of the patients who received pembrolizumab and in 17.7% of those who received placebo. No deaths related to pembrolizumab therapy occurred. CONCLUSIONS: Pembrolizumab treatment led to a significant improvement in disease-free survival as compared with placebo after surgery among patients with kidney cancer who were at high risk for recurrence. (Funded by Merck Sharp and Dohme, a subsidiary of Merck; KEYNOTE-564 ClinicalTrials.gov number, NCT03142334.).

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Metadata

Authors
Choueiri, T. K., Tomczak, P., Park, S. H., Venugopal, B., Ferguson, T., Chang, Y.-H., Hajek, J., Symeonides, S. N., Lee, J. L., Sarwar, N., Thiery-Vuillemin, A., Gross-Goupil, M., Mahave, M., Haas, N. B., Sawrycki, P., Gurney, H., Chevreau, C., Melichar, B., Kopyltsov, E., Alva, A., Burke, J. M., Doshi, G., Topart, D., Oudard, S., Hammers, H., Kitamura, H., Bedke, J., Perini, R. F., Zhang, P., Imai, K., Willemann-Rogerio, J., Quinn, D. I., & Powles, T.
Venue
New England Journal of Medicine
Published
2021-08-19
Volume
385
Issue
8
Pages
683-694
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W3196207248
Cited by
785
References
34
FWCI
76.74
Type
journal article
Language
en
Open access
bronze

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CoChat. (2026). Citation check: Adjuvant Pembrolizumab after Nephrectomy in Renal-Cell Carcinoma. https://app.cochat.ai/papers/10.1056/nejmoa2106391
The paper
Choueiri, T. K., Tomczak, P., Park, S. H., Venugopal, B., Ferguson, T., Chang, Y.-H., Hajek, J., Symeonides, S. N., Lee, J. L., Sarwar, N., Thiery-Vuillemin, A., Gross-Goupil, M., Mahave, M., Haas, N. B., Sawrycki, P., Gurney, H., Chevreau, C., Melichar, B., Kopyltsov, E., . . . Powles, T. (2021). Adjuvant Pembrolizumab after Nephrectomy in Renal-Cell Carcinoma. New England Journal of Medicine. https://doi.org/10.1056/nejmoa2106391

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.