(Rectal Cancer) Nivolumab (Opdivo) After Chemoradiotherapy: VOLTAGE Trial Results
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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.
- August 19, 2019
- 2 min read
At the ESMO World Congress on Gastrointestinal Cancer (WCGC 2019), held in Barcelona, Spain from July 3–6, 2019, Takayuki Yoshino presented results from the VOLTAGE trial: "Efficacy and safety of nivolumab (anti-PD-1 antibody) monotherapy following preoperative chemoradiotherapy in microsatellite-stable (MSS) resectable locally advanced rectal cancer patients."
Trial Design:
VOLTAGE was a physician-led, open-label, single-arm trial enrolling patients with microsatellite-stable (MSS; Cohort A1, N=39) and high microsatellite instability (MSI-H; Cohort A2, N=2) resectable locally advanced rectal cancer. Following chemoradiotherapy (capecitabine + 50 Gy), patients received nivolumab 240 mg monotherapy every 2 weeks for 5 cycles within 14 days. The primary endpoint was pathological complete response rate (pCR) by independent central review (expected pCR: 30%); secondary endpoints included per-institution pCR and R0 resection rate.
Results (Cohort A1, N=37 evaluable):
- Primary endpoint pCR (independent central review): 30% (11/37 patients)
pCR by PD-L1 expression (MSS group):
- PD-L1 ≥1%: 60%
- PD-L1 <1%: 19%
CD8/eTreg ratio from pre-chemoradiotherapy biopsy correlated with pCR:
- CD8/eTreg ratio ≥2: pCR 62%
- CD8/eTreg ratio <2: pCR 10%
Safety:
Overall adverse event rate: 51.3%. Grade 3–4 adverse events: 7.7%.
Conclusion: Based on the VOLTAGE trial results, Takayuki Yoshino concluded that nivolumab monotherapy following preoperative chemoradiotherapy achieved the primary endpoint of 30% pCR in microsatellite-stable resectable locally advanced rectal cancer patients.
Source: ESMO WCGC 2019
Rectal Cancer | Immunotherapy | Nivolumab | VOLTAGE Trial
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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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