Table 1.
Summary of RCT addressing the role of ramucirumab in the treatment of advanced GC/GEJ
| Study | Study type | Assessment tools | Study end points | Number of patients (safety population)
|
Indication | OS (months) | PFS (months) | ORR (%) | Incidence of serious AEs |
|---|---|---|---|---|---|---|---|---|---|
| Treatment regimen | |||||||||
| Fuchs et al24 | Phase III RCT |
RECISTversion 1.1 | Primary: OS Secondary: PFS, 12-week PFS, ORR, duration of response, quality of life, safety, and ramucirumab immunogenicity |
Arm A: ramucirumab 8 mg/kg plus best supportive care (238 pts) Arm B: placebo plus best supportive care (117 pts) |
Advanced gastric or GEJ adenocarcinoma and disease progression after first-line platinum-containing or fluoropyrimidine-containing chemotherapy | 5.2 vs 3.8 (P=0.047) | 2.1 vs 1.3 (P<0.0001) | 3% in either arm (P=0.76) | 109 (46.2%) vs 51 (44.4%) |
| Wilke et al49 | Phase III RCT |
RECISTversion 1.1 | Primary: OS Secondary: PFS, ORR, DCR, patient-reported outcomes, immunogenicity, and safety |
Arm A: ramucirumab 8 mg/kg intravenously on days 1 and 15 plus paclitaxel 80 mg/m2 intravenously on days 1, 8, and 15 of a 28-day cycle (330 pts) Arm B: placebo intravenously on days 1 and 15 plus paclitaxel 80 mg/m2 intravenously on days 1, 8, and 15 of a 28-day cycle (335 pts) |
Advanced gastric or GEJ adenocarcinoma, with progression after first-line chemotherapy (platinum plus fluoropyrimidine with or without an anthracycline) | 9.6 vs 7.4 (P=0.017) | 4.4 vs 2.9 (P<0.0001) | 28% vs 16% (P=0.0001) | 159 (48.6%) vs 144 (43.8%) |
| Yoon et al48 | Phase II RCT |
RECISTversion 1.1 | Primary: PFS Secondary: OS, RR, and DCR |
Arm A: ramucirumab plus mFOLFOX6 (82 pts) Arm B: placebo plus mFOLFOX6 (80 pts) |
Front-line therapy for advanced gastric or esophageal adenocarcinoma | 11.7 vs 11.5 (HR =1.08) | 6.4 vs 6.7 (P=0.89) | 45.2% vs 46.4% | 48 (58.5%) vs 32 (40%) |
Abbreviations: AEs, adverse events; DCR, disease control rate; GC, gastric cancer; GEJ, gastroesophageal junction; HR, hazard ratio; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; pts, patients; RCT, randomized controlled trial; RECIST, Response Evaluation Criteria In Solid Tumors; REGARD, REbif vs Glatiramer Acetate in Relapsing MS Disease; RR, response rate.