Geriatric-8 (G8) screening tool stratified the efficacy of S-1 plus ramucirumab in elderly patients with advanced/recurrent gastric cancer: A post-hoc analysis of the KSCC1701 trial.

Authors

null

Qingjiang Hu

Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan

Qingjiang Hu , Koichi Suyama , Kazuma Kobayashi , Hiroo Katsuya , Naoki Izawa , Yoshikazu Uenosono , Tetsuya Kusumoto , Hajime Otsu , Hiroyuki Orita , Hirofumi Kawanaka , Kazunori Shibao , Satoshi Koga , Mototsugu Shimokawa , Akitaka Makiyama , Hiroshi Saeki , Eiji Oki , Hideo Baba , Masaki Mori

Organizations

Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan, Department of Medical Clinical Oncology, Toranomon Hospital, Tokyo, Japan, Department of Surgery, Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan, Division of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Saga University Faculty of Medicine, Saga, Japan, Department of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan, Department of Surgery, Imamura General Hospital, Kagoshima, Japan, Department of Gastroenterological Surgery and Clinical Research Institute Cancer Research Division, National Kyushu Medical Center, Beppu, Japan, Department of Surgery, Kyushu University Beppu Hospital, Beppu, Japan, Department of Surgery, Nakatsu Municipal Hospital, Nakatsu, Japan, Clinical Research Institute and Department of Surgery, National Hospital Organization Beppu Medical Center, Beppu, Japan, Department of Surgery 1, Hospital of the University of Occupational and Environmental Health, Kitakyushu, Japan, Department of Surgery, Iizuka Hospital, Iizuka, Japan, Department of Biostatistics, Yamaguchi University Graduate School of Medicine, Ube, Japan, Cancer Center, Gifu University Hospital, Kitakyushu, Japan, Department of General Surgical Science, Graduate School of Medicine, Gunma University, Maebashi, Japan, Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan, Tokai University, Hiratsuka, Japan

Research Funding

Other Foundation

Background: KSCC1701 trial showed the efficacy and safety of S-1 plus ramucirumab as a first-line treatment for elderly patients with advanced/recurrent gastric cancer. However, some frail patients may not benefit from S-1 plus ramucirumab. We aimed to clarify the usefulness of G8 screening tool for stratifying the efficacy and safety of S-1 plus ramucirumab therapy to elderly patients with advanced/recurrent gastric cancer. Methods: Patients aged 70 and older with previously untreated unresectable or recurrent gastric cancer were included from 23 institutes in Japan. They received S-1 (40-60 mg twice daily for 28 days, every 6 weeks) plus ramucirumab (8 mg/kg, every 2 weeks) until disease progression. The primary endpoint was the one-year survival rate. The secondary endpoints included progression-free survival (PFS), overall survival (OS), response rate (RR), and safety. The exploratory endpoint was detection of differences in treatment response by G8 screening tool. Results: Between September 2017 and November 2019, 48 patients were enrolled in this study. The cut-off value of G8 was determined as 11 by time-dependent ROC curve analysis for OS. Patients of G8 high (> = 11) and low (< 11) were 31 and 15, respectively. The characteristics of patients with G8 high/low were male: 21 (65.6%)/13 (81.3%), median age: 77/78 years, and PS (0): 16 (50.0%)/4 (25.0%). The one-year survival rate (total/G8-high/G8-low) was 65.2%/82.6%/26.7%. The median OS and PFS (total/G8-high/G8-low) were 16.4/20.7/6.9 months and 5.8/7.2/3.9 months, respectively. On Cox proportional hazards regression analysis for OS and PFS, the hazard ratio of G8-high was 0.156 [95%CI:0.066-0.367 (p < 0.0001)] and 0.391 [95%CI:0.202-0.755 (p = 0.0038)], respectively. The best RR (total/G8-high/G8-low) was 41.9%/55.6%/23.1%. The frequent grade 3 adverse events (total/G8-high/G8-low) was 78.7%/77.4%/81.3%. The frequent grade 4 adverse events (total/G8-high/G8-low) was 14.9%/16.1%/12.5%. Conclusions: Based on the results, G8 screening tool is useful for selecting elderly patients with advanced/recurrent gastric cancer in whom S-1 plus ramucirumab treatment shows a longer survival and a higher RR. Further examination including adverse events is therefore warranted. Clinical trial information: UMIN000028309.

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Abstract Details

Meeting

2022 ASCO Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session A: Cancers of the Esophagus and Stomach and Other GI Cancers

Track

Esophageal and Gastric Cancer,Other GI Cancer

Sub Track

Patient-Reported Outcomes and Real-World Evidence

Clinical Trial Registration Number

UMIN000028309

DOI

10.1200/JCO.2022.40.4_suppl.256

Abstract #

256

Poster Bd #

Online Only

Abstract Disclosures

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