(Breast Cancer) Is Niraparib Plus Pembrolizumab Effective for BRCA Mutation?
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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.
TOPACIO/KEYNOTE-162: Niraparib Plus Pembrolizumab in Triple-Negative Breast Cancer
- July 10, 2019
- Reading time: 2 minutes
On June 13, 2019, the medical journal JAMA Oncology published Phase 2 results from the TOPACIO/KEYNOTE-162 Phase 1/2 trial: "Concurrent use of PARP inhibitor niraparib plus anti-PD-1 antibody pembrolizumab in patients with metastatic triple-negative breast cancer."
Trial Design
The TOPACIO/KEYNOTE-162 trial was an open-label, single-arm Phase 1/2 trial administering niraparib 200 mg once daily plus pembrolizumab 200 mg every 3 weeks to patients with metastatic triple-negative breast cancer. Primary endpoint: ORR. Secondary endpoints: duration of response, disease control rate.
Background: The combination of niraparib plus pembrolizumab enhanced antitumor activity in preclinical models, independent of BRCA mutation or PD-L1 expression status, providing the rationale for this trial.
Efficacy Results
Overall evaluable population:
- ORR: 21%
- Disease control rate: 49%
- Median duration of response: Not reached
By BRCA status:
- BRCA-positive: ORR 47%, response rate ≥6 months: 80%, median PFS: 8.3 months
- BRCA-negative: ORR 11%, response rate ≥6 months: 33%, median PFS: 2.1 months
Safety Profile
Most common adverse events: anemia (18%), fatigue (7%), immune-related adverse events (15%). No new adverse events were identified in this trial.
Conclusions
Based on TOPACIO/KEYNOTE-162 results, Shaveta Vinayak concluded that the combination of PARP inhibitor niraparib plus anti-PD-1 antibody pembrolizumab demonstrated promising antitumor activity in metastatic triple-negative breast cancer, particularly showing a higher ORR in BRCA-positive patients.
Source: Open-Label Clinical Trial of Niraparib Combined With Pembrolizumab for Treatment of Advanced or Metastatic Triple-Negative Breast Cancer. JAMA Oncol. 2019 Jun 13.
Tags: #BreastCancer #TripleNegativeBreastCancer
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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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