(Gastric Cancer) Nivolumab Plus Chemotherapy: Is It Effective?
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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.
- January 26, 2022
- Reading time: 2 minutes
On January 11, 2022, Yoon-Koo Kang and colleagues at the University of Ulsan College of Medicine published in the medical journal The Lancet the efficacy and safety results of the ATTRACTION-4 Phase 2/3 trial evaluating first-line treatment with the anti-PD-1 antibody nivolumab plus chemotherapy in patients with HER2-negative unresectable or recurrent gastric cancer and gastroesophageal junction (GEJ) cancer.
ATTRACTION-4 Phase 2/3 Trial Design
ATTRACTION-4 was a multicenter, double-blind trial. Patients with HER2-negative unresectable or recurrent gastric cancer and GEJ cancer (N=724) were randomized 1:1 to:
- Nivolumab group: 360 mg nivolumab + chemotherapy on Day 1 of each 3-week cycle (N=362)
- Placebo group: Placebo + chemotherapy (N=362)
The primary endpoint was progression-free survival (PFS).
Efficacy Results
At a median follow-up of 11.6 months, median PFS was:
- Nivolumab group: 10.45 months / Placebo group: 8.34 months
- The nivolumab group showed a 32% reduction in the risk of disease progression or death
At a median follow-up of 26.6 months, median overall survival (OS) was:
- Nivolumab group: 17.45 months / Placebo group: 17.15 months
- The nivolumab group showed a 10% reduction in the risk of death for OS
Safety Profile
Grade 3–4 adverse events most commonly confirmed in patients were:
- Neutropenia: Nivolumab 20% (N=71/359) / Placebo 16% (N=57/358)
- Thrombocytopenia: Nivolumab 9% (N=34) / Placebo 9% (N=33)
- Serious adverse events: Nivolumab 25% (N=88) / Placebo 14% (N=51)
- Most common: decreased appetite (Nivolumab 5% [N=18] / Placebo 3% [N=10])
Conclusions
Based on the ATTRACTION-4 results, Yoon-Koo Kang and colleagues concluded that first-line nivolumab plus chemotherapy significantly improved PFS in HER2-negative unresectable or recurrent gastric cancer and GEJ cancer patients. Although the improvement in OS was more modest, this combination is expected to become a promising new first-line treatment option.
Source: https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(21)00692-6/fulltext
- Immunotherapy
- Clinical trial drug
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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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