Abstract CT216: Anti-EGFR in combination with paclitaxel as second-line therapy for gastric cancer with EGFR overexpression

Abstract

Abstract Background: We and other investigators reported that EGFR gene is amplified in 2-4% of gastric cancer with protein overexpression (Gastroenterology 2017 Aug;153(2):536-549; Cancer Cell 2019 Jan 14; 35:1:111:E10), but EGFR-targeted therapy has not entered into clinic. Patients and Methods: As a subprotocol of the investigator-initated of umbrella trial, patients with metastatic gastric cancer received weekly anti-EGFR monoclonal antibody (GC-1118 (GC Biopharma), 2.5mg/kg) in combination with paclitaxel 80mg/m2 (D1, D8, D15) every 4 weeks as a second-line therapy, if the gastric cancer tissue sample revealed EGFR protein overexpression (NCT04077255). Projected accrual was 19 based on minimax two-stage design (P1=45%; P0=15%; alpha and beta errors, 0.05 and 0.1, respectively). Results: Among 19 evaluable patients, 6 patients had objective clinical response (RR, 31.6%). Median progression-free survival was 4.7 months (95% CI, 1.8-5.1). Median overall survival was 7.6 months (95% CI, 4.2-11.1). Predictive biomarkers were explored by post hoc correlative analyses. Conclusion: EGFR inhibition, in combination with paclitaxel, demonstrated modest activity for gastric cancer refractory to first-line 5-FU/platinum-based chemotherapy. (This study was supported by a grant from the National R&D Program for Cancer Control, Ministry of Health & Welfare, Republic of Korea (HA22C0056.)) Citation Format: Dong-Hoe Koo, Jin-Young Kim, Jae-Joon Kim, Sung Y. Oh, Min-Hee Ryu, Dae Y. Zang, Hark K. Kim. Anti-EGFR in combination with paclitaxel as second-line therapy for gastric cancer with EGFR overexpression [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(7_Suppl):Abstract nr CT216.