(Gastric Cancer) Is Keytruda ± Chemotherapy Effective?
Medical Supporter — إشعار معلوماتي
هذه المقالة ملخص لمعلومات طبية دولية وليست نصيحة طبية، ولا يمكن أن تحل محل تشخيص طبيبك المعالج أو خطة العلاج. المعلومات المعروضة مجمّعة من منشورات عامة وبيانات رسمية لكبرى المؤسسات الطبية اليابانية؛ وتختلف ملاءمة ونتائج أي علاج من مريض لآخر ويجب أن يقيّمها طبيب مؤهل لكل حالة على حدة.
- October 2, 2020
- Reading time: 2 minutes
On September 3, 2020, Kohei Shitara published results in JAMA Oncology from the KEYNOTE-062 Phase 3 clinical trial comparing pembrolizumab (Keytruda) monotherapy and pembrolizumab plus chemotherapy versus placebo plus chemotherapy as first-line treatment in advanced gastric or gastroesophageal junction (G/GEJ) cancer patients.
The KEYNOTE-062 Phase 3 trial randomized advanced G/GEJ cancer patients (N=763) in a 1:1:1 ratio to three first-line treatment arms. Primary endpoints were PFS and OS in PD-L1-positive (CPS ≥1 and CPS ≥10) populations.
- Pembrolizumab monotherapy arm: Keytruda 200 mg every 3 weeks (N=256)
- Pembrolizumab + chemotherapy arm: Keytruda 200 mg every 3 weeks + chemotherapy (N=257)
- Placebo arm: placebo + chemotherapy (N=250)
Results at median follow-up of 29.4 months:
Overall Survival (Primary Endpoint) in PD-L1-positive (CPS ≥1): Median OS was 10.6 months (pembrolizumab monotherapy) / 12.5 months (pembrolizumab + chemotherapy) / 11.1 months (placebo). Although the pembrolizumab monotherapy arm performed better than the placebo arm, superiority was not demonstrated.
Overall Survival in PD-L1-positive (CPS ≥10): Median OS was 17.4 months (pembrolizumab monotherapy) / 12.3 months (pembrolizumab + chemotherapy) / 10.8 months (placebo). Superiority of pembrolizumab was not demonstrated.
Safety: Grade 3–5 adverse events occurred in 17% (pembrolizumab monotherapy) / 73% (pembrolizumab + chemotherapy) / 69% (placebo).
Based on the KEYNOTE-062 trial results, Kohei Shitara concluded that pembrolizumab monotherapy and pembrolizumab plus chemotherapy as first-line treatment for advanced G/GEJ cancer showed better OS than the placebo arm, with a lower incidence of adverse events in the monotherapy arm.
Source: Efficacy and Safety of Pembrolizumab or Pembrolizumab Plus Chemotherapy vs Chemotherapy Alone for Patients With First-line, Advanced Gastric Cancer — The KEYNOTE-062 Phase 3 Randomized Clinical Trial (JAMA Oncol. 2020 Sep 3. doi:10.1001/jamaoncol.2020.3370)
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هل تفكر في تلقّي العلاج في اليابان؟ هل تحتاج إلى معلومات ومساعدة؟
نساعدك في تنظيم المعلومات اللازمة للسفر الطبي إلى اليابان، والتواصل مع المؤسسات الطبية اليابانية، وترتيب استشارة رأي ثانٍ.الاستشارة الأولى مجانية؛ سيساعدك المستشار على توضيح الخطوات التالية.
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