دورية أكاديمية
Adjuvant pembrolizumab after nephrectomy in renal-cell carcinoma
| العنوان: | Adjuvant pembrolizumab after nephrectomy in renal-cell carcinoma |
|---|---|
| المؤلفون: | 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. |
| المصدر: | 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 , .... |
| سنة النشر: | 2021 |
| الوصف: | 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. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| DOI: | 10.1056/nejmoa2106391 |
| الإتاحة: | https://doi.org/10.1056/nejmoa2106391Test https://researchers.mq.edu.au/en/publications/239c4bed-f6b8-4786-9cab-d4e55039d85aTest http://www.scopus.com/inward/record.url?scp=85113283089&partnerID=8YFLogxKTest |
| حقوق: | info:eu-repo/semantics/closedAccess |
| رقم الانضمام: | edsbas.E9BF2425 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1056/nejmoa2106391 |
|---|