دورية أكاديمية
Lenvatinib Plus Pembrolizumab Versus Sunitinib in First-Line Treatment of Advanced Renal Cell Carcinoma: Final Prespecified Overall Survival Analysis of CLEAR, a Phase III Study.
| العنوان: | Lenvatinib Plus Pembrolizumab Versus Sunitinib in First-Line Treatment of Advanced Renal Cell Carcinoma: Final Prespecified Overall Survival Analysis of CLEAR, a Phase III Study. |
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| المؤلفون: | Motzer, Robert J, Porta, Camillo, Eto, Masatoshi, Powles, Thomas, Grünwald, Viktor, Hutson, Thomas E, Alekseev, Boris, Rha, Sun Young, Merchan, Jaime, Goh, Jeffrey C, Lalani, Aly-Khan A, De Giorgi, Ugo, Melichar, Bohuslav, Hong, Sung-Hoo, Gurney, Howard, Méndez-Vidal, María José, Kopyltsov, Evgeny, Tjulandin, Sergei, Gordoa, Teresa Alonso, Kozlov, Vadim, Alyasova, Anna, Winquist, Eric, Maroto, Pablo, Kim, Miso, Peer, Avivit, Procopio, Giuseppe, Takagi, Toshio, Wong, Shirley, Bedke, Jens, Schmidinger, Manuela, Rodriguez-Lopez, Karla, Burgents, Joseph, He, Cixin, Okpara, Chinyere E, McKenzie, Jodi, Choueiri, Toni K, CLEAR Trial Investigators |
| المساهمون: | Gennigens, Christine |
| المصدر: | Journal of Clinical Oncology, JCO2301569 (2024-01-16) |
| بيانات النشر: | American Society of Clinical Oncology (ASCO), 2024. |
| سنة النشر: | 2024 |
| مصطلحات موضوعية: | Cancer Research, Oncology, Human health sciences, Sciences de la santé humaine, Oncologie |
| الوصف: | Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical trial updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.We present the final prespecified overall survival (OS) analysis of the open-label, phase III CLEAR study in treatment-naïve patients with advanced renal cell carcinoma (aRCC). With an additional follow-up of 23 months from the primary analysis, we report results from the lenvatinib plus pembrolizumab versus sunitinib comparison of CLEAR. Treatment-naïve patients with aRCC were randomly assigned to receive lenvatinib (20 mg orally once daily in 21-day cycles) plus pembrolizumab (200 mg intravenously once every 3 weeks) or sunitinib (50 mg orally once daily [4 weeks on/2 weeks off]). At this data cutoff date (July 31, 2022), the OS hazard ratio (HR) was 0.79 (95% CI, 0.63 to 0.99). The median OS (95% CI) was 53.7 months (95% CI, 48.7 to not estimable [NE]) with lenvatinib plus pembrolizumab versus 54.3 months (95% CI, 40.9 to NE) with sunitinib; 36-month OS rates (95% CI) were 66.4% (95% CI, 61.1 to 71.2) and 60.2% (95% CI, 54.6 to 65.2), respectively. The median progression-free survival (95% CI) was 23.9 months (95% CI, 20.8 to 27.7) with lenvatinib plus pembrolizumab and 9.2 months (95% CI, 6.0 to 11.0) with sunitinib (HR, 0.47 [95% CI, 0.38 to 0.57]). Objective response rate also favored the combination over sunitinib (71.3% v 36.7%; relative risk 1.94 [95% CI, 1.67 to 2.26]). Treatment-emergent adverse events occurred in >90% of patients who received either treatment. In conclusion, lenvatinib plus pembrolizumab achieved consistent, durable benefit with a manageable safety profile in treatment-naïve patients with aRCC. |
| نوع الوثيقة: | journal article http://purl.org/coar/resource_type/c_6501Test article peer reviewed |
| اللغة: | English |
| العلاقة: | https://ascopubs.org/doi/pdfdirect/10.1200/JCO.23.01569Test; urn:issn:0732-183X; urn:issn:1527-7755 |
| DOI: | 10.1200/JCO.23.01569 |
| الوصول الحر: | https://orbi.uliege.be/handle/2268/315809Test |
| حقوق: | open access http://purl.org/coar/access_right/c_abf2Test info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsorb.315809 |
| قاعدة البيانات: | ORBi |
| DOI: | 10.1200/JCO.23.01569 |
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