Efficacy And Safety Of Nivolumab Monotherapy As The Late Line For Patients With Advanced Gastric Cancer In The Real-World.

e14074 Background: The ATTRACTION-2 study found that nivolumab showed a significant survival benefit for the patients with unresectable metastatic or locally advanced gastric cancer (AGC) following more than 2 regimens. Based on this trial, nivolumab was currently proved to be one of the most effective regimens for the patients with AGC as the 3rd-line treatment in Japan. We herein examined the clinical significance and validation of nivolumab as late line chemotherapy in patients with AGC. Methods: In October 2017 to December 2018, 26 patients received nivolumab monotherapy in our institute. We conducted a retrospective review of the data of 23 patients with AGC who received more than 2 cycles of nivolumab following the standard chemotherapy regimens including fluoropyrimidines, platinum derivatives and taxanes. Adverse events, tumor responses, and survival data were analyzed. Results: Only 2 patients enrolled here showed ECOG performance status (PS) 2 in the study. The time to treatment failure of them were shorter than those of the other patients with PS 0/1. Four patients quitted the continuation of nivolumab except for the progressive disease, due to non-hematological toxicities higher than grade 3 including myositis, hypothyroidism, dermatitis and liver dysfunction. The rate of hematological toxicities, which showed severe anemia of higher than grade 3 was 21.7%. The ORR and the DCR were 4.3% and 52.3% for the patients in this study. The survival data showed that the median PFS and the OS after nivolumab administration were 75 days and 274 days, respectively. Conclusions: Nivolumab monotherapy might be one of the best regimens for Japanese patients with AGC as the late line treatment following the standard chemotherapy.