The role of ramucirumab plus paclitaxel as second-line therapy after failure of nivolumab plus doublet chemotherapy in patients with advanced gastric cancer.

Background: Adding nivolumab to fluoropyrimidines and platinum agents has been considered a new standard first-line treatment in previously untreated human epidermal growth factor receptor 2 ( Methods: This analysis included AGC patients with ramucirumab plus paclitaxel as second-line therapy after failing to respond to nivolumab plus doublet chemotherapy [capecitabine plus oxaliplatin (XELOX) or 5-fluorouracil plus oxaliplatin (FOLFOX)] at Samsung Medical Center, Korea. Twenty patients who progressed on nivolumab plus chemotherapy as first-line therapy were treated with ramucirumab plus paclitaxel between December 2021 and September 2022. Results: The median age was 56 (range, 24-76) years, and 13 (65.0%) were men. Of the 20 patients, 15 (75.0%) patients received nivolumab plus capecitabine, and oxaliplatin, while 5 (25.0%) patients received nivolumab plus 5-fluorouracil, and oxaliplatin. Two showed a partial response (PR) to ramucirumab plus paclitaxel, a response rate of 10%. Patients with stable disease (SD) accounted for a disease control rate (DCR) of 55.0%. The median progression-free survival (PFS) to ramucirumab plus paclitaxel was 2.7 months [95% confidence interval (CI): 1.7-3.7]. Subgroup analysis showed that responders (n=7) to first-line therapy had a PFS of 6.9 months compared to 2.3 months in non-responders (n=13) to first-line therapy. The median overall survival (OS) was 6.3 months (95% CI: 5.5-8.3), representing 6.9 months (95% CI: not calculated) in responders and 6.3 months (95% CI: 3.7-8.9) in non-responders (P=0.401). Conclusions: This analysis suggested that ramucirumab plus paclitaxel as second-line therapy might be further studied in AGC patients after failure of nivolumab plus chemotherapy. A new second-line therapy is needed in AGC patients after nivolumab plus chemotherapy.