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Phase II Study of Ramucirumab Plus Irinotecan Combination Therapy as Second-Line Treatment in Patients with Advanced Gastric Cancer : HGCSG1603
| Title: | Phase II Study of Ramucirumab Plus Irinotecan Combination Therapy as Second-Line Treatment in Patients with Advanced Gastric Cancer : HGCSG1603 |
| Authors: | Yasuyuki, Kawamoto Browse this author →KAKEN DB | | Satoshi, Yuki Browse this author | | Kentaro, Sawada Browse this author | | Tsuji, Yasushi Browse this author | | Dazai, Masayoshi Browse this author | | Okuda, Hiroyuki Browse this author | | Meguro, Takashi Browse this author | | Harada, Kazuaki Browse this author | | Sekiguchi, Mari Browse this author | | Okada, Kazufumi Browse this author | | Ito, Yoichi M. Browse this author | | Sakata, Yuh Browse this author | | Sakamoto, Naoya Browse this author →KAKEN DB | | Komatsu, Yoshito Browse this author →KAKEN DB |
| Keywords: | gastric cancer | | ramucirumab | | irinotecan | | second-line treatment |
| Issue Date: | Aug-2022 |
| Publisher: | Oxford University Press |
| Journal Title: | The Oncologist |
| Volume: | 27 |
| Issue: | 8 |
| Start Page: | e642 |
| End Page: | e649 |
| Publisher DOI: | 10.1093/oncolo/oyac086 |
| PMID: | 35579511 |
| Abstract: | This article reports the results of a trial that assessed the efficacy and safety of ramucirumab plus irinotecan combination therapy as second-line treatment in patients with previously treated advanced gastric cancer. Background 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. Materials and Methods Patients with advanced gastric cancer refractory or intolerant to primary chemotherapy were included. Ramucirumab 8 mg/kg plus irinotecan 150 mg/m(2) 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. Results 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. Conclusion 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. |
| Type: | article |
| URI: | http://hdl.handle.net/2115/86546 |
| Appears in Collections: | 北海道大学病院 (Hokkaido University Hospital) > 雑誌発表論文等 (Peer-reviewed Journal Articles, etc)
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