Pembrolizumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma
| العنوان: | Pembrolizumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma |
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| المؤلفون: | Igor Bondarenko, Viktor Stus, Jens Bedke, Ihor Vynnychenko, Mei Chen, Anna Kryzhanivska, Rustem Gafanov, Qiong Shou, Robert E. Hawkins, Maurice Markus, Sergio J Azevedo, Raymond S. McDermott, Rodolfo F. Perini, Brian I. Rini, Denis Soulières, Dmitry Nosov, Yen-Hwa Chang, Sophie Tartas, Satoshi Tamada, Delphine Borchiellini, Bohuslav Melichar, Frédéric Pouliot, Elizabeth R. Plimack, Thomas Powles, Cezary Szczylik, Michael B. Atkins, Boris Alekseev |
| المصدر: | BASE-Bielefeld Academic Search Engine |
| بيانات النشر: | Massachusetts Medical Society, 2019. |
| سنة النشر: | 2019 |
| مصطلحات موضوعية: | education.field_of_study, medicine.medical_specialty, Sunitinib, business.industry, Population, Hazard ratio, Urology, General Medicine, Pembrolizumab, Interim analysis, Axitinib, medicine, Progression-free survival, education, business, Survival rate, medicine.drug |
| الوصف: | Background The combination of pembrolizumab and axitinib showed antitumor activity in a phase 1b trial involving patients with previously untreated advanced renal-cell carcinoma. Whether pembrolizumab plus axitinib would result in better outcomes than sunitinib in such patients was unclear. Methods In an open-label, phase 3 trial, we randomly assigned 861 patients with previously untreated advanced clear-cell renal-cell carcinoma to receive pembrolizumab (200 mg) intravenously once every 3 weeks plus axitinib (5 mg) orally twice daily (432 patients) or sunitinib (50 mg) orally once daily for the first 4 weeks of each 6-week cycle (429 patients). The primary end points were overall survival and progression-free survival in the intention-to-treat population. The key secondary end point was the objective response rate. All reported results are from the protocol-specified first interim analysis. Results After a median follow-up of 12.8 months, the estimated percentage of patients who were alive at 12 months was 89.9% in the pembrolizumab-axitinib group and 78.3% in the sunitinib group (hazard ratio for death, 0.53; 95% confidence interval [CI], 0.38 to 0.74; P Conclusions Among patients with previously untreated advanced renal-cell carcinoma, treatment with pembrolizumab plus axitinib resulted in significantly longer overall survival and progression-free survival, as well as a higher objective response rate, than treatment with sunitinib. (Funded by Merck Sharp & Dohme; KEYNOTE-426 ClinicalTrials.gov number, NCT02853331.). |
| تدمد: | 1533-4406 0028-4793 |
| DOI: | 10.1056/nejmoa1816714 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1efa547a588204fc933047e6bd802346 https://doi.org/10.1056/nejmoa1816714 |
| Rights: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....1efa547a588204fc933047e6bd802346 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15334406 00284793 |
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| DOI: | 10.1056/nejmoa1816714 |