Phase II Study of Ramucirumab Plus Irinotecan Combination Therapy as Second-Line Treatment in Patients with Advanced Gastric Cancer: HGCSG1603

• Published in: The oncologist (Dayton, Ohio) Ohio), 2022-08, Vol.27 (8), p.e642-e649
• Main Authors: Kawamoto, Yasuyuki, Yuki, Satoshi, Sawada, Kentaro, Nakamura, Michio, Muto, Osamu, Sogabe, Susumu, Shindo, Yoshiaki, Ishiguro, Atsushi, Sato, Atsushi, Tsuji, Yasushi, Dazai, Masayoshi, Okuda, Hiroyuki, Meguro, Takashi, Harada, Kazuaki, Sekiguchi, Mari, Okada, Kazufumi, Ito, Yoichi M, Sakata, Yuh, Sakamoto, Naoya, Komatsu, Yoshito
• Format: Article
• Language: English
• Subjects: Antibodies; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Cancer; Cancer patients; Care and treatment; Chemotherapy; Chemotherapy, Combination; Diagnosis; Dosage and administration; Drug therapy; Gastrointestinal Cancer; Humans; Irinotecan - therapeutic use; Patient outcomes; Pharmaceutical industry; Ramucirumab; Stomach cancer; Stomach Neoplasms - pathology; Testing; Trifluridine; Tumor Microenvironment; Vascular endothelial growth factor; Vascular Endothelial Growth Factor A; Viral antibodies
• ISSN: 1083-7159; 1549-490X
• DOI: 10.1093/oncolo/oyac086

Ramucirumab is a human IgG1 monoclonal vascular endothelial growth factor receptor-2 antibody that inhibits tumor cell growth and affects the tumor cell microenvironment. We assessed the efficacy and safety of ramucirumab plus irinotecan combination therapy as second-line treatment in patients with previously treated advanced gastric cancer. Patients with advanced gastric cancer refractory or intolerant to primary chemotherapy were included. Ramucirumab 8 mg/kg plus irinotecan 150 mg/m2 combination therapy was administered every 2 weeks. The primary endpoint was progression-free survival rate at 6 months and secondary endpoints were overall survival, progression-free survival, response rate, safety, and dose intensity for each drug. Thirty-five patients were enrolled between January 2018 and September 2019. The progression-free survival rate at 6 months was 26.5% [95%CI, 13.2%-41.8%, P = .1353)]. Median progression-free and overall survivals were 4.2 months (95%CI, 2.5-5.4 months) and 9.6 months (95%CI, 6.4-16.6 months), respectively. The overall response rate was 25.9% (95%CI, 11.1-36.3%) and disease control rate was 85.2% (95%CI, 66.3-95.8%). Grade ≥3 adverse events that occurred in >10% of patients included neutropenia, leucopenia, anemia, anorexia, and febrile neutropenia. No death or new safety signals with a causal relation to the study treatment were observed. Although the primary endpoint was not achieved statistically, combination therapy of ramucirumab plus irinotecan showed anticancer activity and a manageable safety profile for second-line treatment of patients with advanced gastric cancer.