(Gastric Cancer) Nivolumab Plus Chemotherapy: Is It Effective?
Medical Supporter — Мэдээллийн мэдэгдэл
Энэ нийтлэл нь олон улсын эмнэлгийн мэдээллийн эмхэтгэл бөгөөд эмнэлгийн зөвлөгөө биш; таны эмчийн оношлогоо, эмчилгээний төлөвлөгөөг орлохгүй. Энд буй мэдээлэл нь Японы томоохон эмнэлгийн байгууллагуудын нээлттэй эх сурвалжаас эмхэтгэсэн бөгөөд аливаа эмчилгээний тохиромж, үр дүн өвчтөн бүрээр өөр тул мэргэшсэн эмч тус бүрчлэн үнэлэх ёстой.
- 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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Японд эмчлүүлэхээр төлөвлөж байна уу? Мэдээлэл, тусламж хэрэгтэй юу?
Бид Японд эмчлүүлэхэд шаардлагатай мэдээллийг эмхэтгэх, Японы эмнэлгийн байгууллагуудтай холбогдох, хоёр дахь саналын зөвлөгөө зохион байгуулахад тусална.Анхны зөвлөгөө үнэгүй; зөвлөх таны дараагийн алхмыг тодорхой болгоход тусална.
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