(Lung Cancer) Is Ramucirumab (Cyramza) Plus Erlotinib Effective? RELAY Phase 3 Trial Results
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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.
- December 16, 2019
- 2 min read
Updated: January 27, 2020
On October 4, 2019, Kazuhiko Nakagawa published results in The Lancet Oncology from the RELAY Phase 3 clinical trial evaluating the efficacy and safety of ramucirumab (Cyramza, anti-VEGFR antibody) plus erlotinib (EGFR tyrosine kinase inhibitor) in treatment-naive EGFR-positive non-small cell lung cancer (NSCLC) patients.
Trial Design:
The RELAY Phase 3 trial was an international multicenter, double-blind study. Treatment-naive EGFR-positive NSCLC patients (N=449) were randomized to:
- Ramucirumab group (N=224): Ramucirumab 10 mg/kg every 2 weeks + erlotinib 150 mg once daily
- Placebo group (N=225): Placebo every 2 weeks + erlotinib 150 mg once daily
Primary endpoints were PFS and safety; secondary endpoints were OS and ORR.
Background: VEGF and EGFR inhibitors had individually demonstrated efficacy in EGFR-positive NSCLC patients in both preclinical and clinical settings. The RELAY trial was designed to evaluate whether combining a VEGFR antibody with an EGFR TKI would improve outcomes.
Results at median follow-up of 20.7 months:
- Median PFS: Ramucirumab 19.4 months vs. placebo 12.4 months
- 41% reduction in progression risk — statistically significant improvement
Safety:
Grade 3–4 adverse events: Ramucirumab 72% (N=159) vs. placebo 54% (N=121). Most common Grade 3–4 adverse events: Ramucirumab arm — hypertension 24% (N=52), dermatitis 15% (N=30); Placebo arm — dermatitis 9% (N=20), ALT elevation 8% (N=17).
Serious adverse events: Ramucirumab 29% (N=65) vs. placebo 21% (N=47). Most common serious events: Ramucirumab arm — pneumonia 3% (N=7), cellulitis (N=4), pneumothorax (N=4); Placebo arm — fever 1% (N=3), pneumonia 1% (N=3).
Conclusion: Based on the RELAY trial results, Kazuhiko Nakagawa concluded that ramucirumab plus erlotinib significantly improved PFS in treatment-naive EGFR-positive NSCLC patients, with acceptable tolerability.
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Source: Ramucirumab plus erlotinib in patients with untreated, EGFR-mutated, advanced non-small-cell lung cancer (RELAY): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 Oct 4. doi:10.1016/S1470-2045(19)30634-5.
Lung Cancer | Ramucirumab | Cyramza | Erlotinib | RELAY
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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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