NOTE
🌱 created from: mgc1l
armani
- Design: Phase III, multi-center, randomized, open-label
- Number of patients: 280
- Patients characteristics: Male sex 67/61%, median age 64/66 years, PS 0 74/65%, GEJ 26/26%, prior gastrectomy 28/23%, peritoneal metastases 53/42%
- Agent: Ramucirumab 8 mg/Kg on days 1,15 plus paclitaxel 80 mg/sqm on days 1,8,15 every 28 days vs CAPOX/FOLFOX at the same doses used in the last induction cycle
- Treatment line: Switch maintenance after 3 months of initial oxaliplatin-based chemotherapy
- Trial Acronym: NCT02934464
- Comparison of efficacy: Median PFS was 6.6 vs. 3.5 mos in Arm A vs. B (HR=0.63, 95%CI 0.49-0.81; P<0.001); Median OS was 12.6 vs. 10.4 mos in Arm A vs. B (HR=0.75, 95%CI 0.58-0.97; P=0.030)
- Highlight of toxicity: Grade ≥3 adverse events were 40.4% vs. 20.7% in arms A vs. B, with main toxicities being neutropenia, febrile neutropenia, hypertension, venous thromboembolism, and peripheral neuropathy
- One line summarize: Switch maintenance with paclitaxel plus ramucirumab after oxaliplatin-based doublets showed improved PFS and OS with manageable toxicity in HER2-negative metastatic gastric/GEJ cancer patients.
References
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