Multicenter phase 3 trial of ramucirumab plus paclitaxel as switch maintenance for advanced HER2-negative gastric or gastro-esophageal junction cancer

Paclitaxel plus ramucirumab is recommended as a second-line treatment regimen in patients with advanced HER2-negative gastric or gastro-esophageal junction (G/GEJ) cancer. The multicenter phase 3 ARMANI trial in Italy evaluated this regimen as switch maintenance therapy compared with continuation of FOLFOX or CAPOX as a first-line strategy for these patients. ARMANI included patients with disease control after 3 months of first-line FOLFOX or CAPOX, who were randomized to ramucirumab and paclitaxel (switch maintenance group) or continuation of FOLFOX or CAPOX for another 12 weeks followed by fluoropyrimidine monotherapy maintenance (control group). The primary end point was progression-free survival. Median PFS was 6.6 months in the switch maintenance group versus 3.5 months in the control group (HR 0.61; p=0.0002). No treatment-related deaths occurred. The authors conclude that paclitaxel plus ramucirumab switch maintenance could be a treatment strategy in patients with advanced HER2-negative G/GEJ cancer.