Authors: Hiroo Katsuya, Koichi Suyama, Kazuma Kobayashi, Naoki Izawa, Yoshikazu Uenosono, Qingjiang Hu, Tetsuya Kusumoto, Hajime Otsu, Hiroyuki Orita, Hirofumi Kawanaka, Kazunori Shibao, Satoshi Koga, Mototsugu Shimokawa, Akitaka Makiyama, Hiroshi Saeki, Eiji Oki, Hideo Baba, Masaki Mori
Published: 2021-06-02
DOI: 10.1200/jco.2021.39.15_suppl.4043
Source: Full article
4043 Background: Elderly patients are often intolerable in the combination with cytotoxic agents. Therapy with S-1 alone is a key option for initial chemotherapy for Japanese elderly patients with unresectable gastric cancer in clinical practice. However, there are some cases in which the antitumor effects with S-1 alone are insufficient. We aimed to investigate the efficacy and safety of S-1 plus ramucirumab therapy to elderly patients with advanced/recurrent gastric cancer. Methods: Patients aged 70 years and older with previously untreated unresectable or recurrent gastric cancer patients were included in Japan. They received S-1 therapy (40-60 mg twice daily for 28 days, every 6 weeks) plus ramucirumab therapy (8 mg/kg, every 2 weeks) until disease progression. The primary endpoint was the one-year survival rate and null hypothesis of one-year survival was set as 40%, which is the lower bound of the 95% confidence interval in previously reported studies on S-1 therapy. The secondary endpoints included progression-free survival (PFS), overall survival (OS), response rate (RR), and safety. Results: Between September 2017 and November 2019, 48 patients were enrolled in this study. The characteristics of patients were male/female: 34/14, median age: 77.5 years (range: 71-87), and PS (0/1): 20/28. The one-year survival rate was 65.2% (95% confidence interval 49.8-78.6%), which means this trial met the primary endpoint. The median OS and PFS were 16.4 months (95%CI:12.0–20.7) and 5.8 months (95%CI:4.0–7.2), respectively. The best RR (CR+PR) was 60.9%. The frequent grade 3 or grade 4 adverse events were neutropenia (27.7%), anorexia (23.4%), anemia (19.1%), hypertension (14.9%), leucopenia (12.8%) and hypoalbuminemia (12.8%). Conclusions: Based on the observed efficacy and safety, S-1 plus ramucirumab is an appropriate first-line treatment for elderly patients with advanced/recurrent gastric cancer. Clinical trial information: UMIN000028309.