(Ovarian Cancer) Is Opdivo + Yervoy 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.
On April 10, 2020, Dmitriy Zamarin published in the Journal of Clinical Oncology the "Efficacy and Safety Results of Combined Anti-PD-1 Antibody Opdivo (nivolumab) Plus Anti-CTLA-4 Antibody Yervoy (ipilimumab) in Previously Treated, Recurrent Ovarian Cancer Patients in a Phase II Clinical Trial."
This Phase II clinical trial randomly assigned previously treated, recurrent ovarian cancer patients in a 1:1 ratio to:
- Opdivo monotherapy group (every 2 weeks, N=49)
- Opdivo + Yervoy group (4 cycles every 3 weeks, then Opdivo monotherapy every 2 weeks as maintenance for up to 42 cycles, N=51)
The primary endpoint was the response rate within 6 months, and secondary endpoints were progression-free survival and overall survival.
This trial was initiated because the objective response rate for anti-PD-1 antibody Opdivo in previously treated recurrent ovarian cancer patients was 8-10% with median PFS of approximately 2 months, while combining anti-PD-1 and anti-CTLA-4 antibody drugs was confirmed to increase antitumor efficacy.
Trial results:
- Primary endpoint — response rate within 6 months: Opdivo monotherapy 12.2% vs. Opdivo + Yervoy 31.4%
- Secondary endpoint — median PFS: Opdivo monotherapy 2 months vs. Opdivo + Yervoy 3.9 months, with a 47% reduction in PFS risk in the Opdivo + Yervoy group, showing significant improvement. The 6-month PFS rates were 16.3% vs. 25.5%.
- Median OS: Opdivo monotherapy 21.8 months vs. Opdivo + Yervoy 28.1 months, with a 21% reduction in OS risk in the Opdivo + Yervoy group.
Safety: Grade 3 or higher adverse event rates: Opdivo monotherapy 33% vs. Opdivo + Yervoy 49%. Grade 3 or higher adverse events observed in the Opdivo + Yervoy group included elevated pancreatic enzymes, elevated liver enzymes, anemia, colitis, and diarrhea.
Based on the Phase II trial results, Dmitriy Zamarin concluded: "Combined anti-PD-1 antibody Opdivo plus anti-CTLA-4 antibody Yervoy in previously treated, recurrent ovarian cancer patients showed sustained antitumor effects with significantly improved progression-free survival. The adverse event profile was consistent with those observed in other clinical trials."
Source: Randomized Phase II Trial of Nivolumab Versus Nivolumab and Ipilimumab for Recurrent or Persistent Ovarian Cancer: An NRG Oncology Study (J Clin Oncol. 2020 Apr 10:JCO1902059. doi: 10.1200/JCO.19.02059.)
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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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