演題抄録

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開催概要
開催回
第58回・2020年・京都
 

進行胃癌に対する免疫チェックポイント阻害薬の免疫関連有害事象と治療成績の検討

演題番号 : P-117

[筆頭演者]
元尾 伊織:1 
[共同演者]
安藤 孝将:1、植田 亮:2、小川 浩平:3、梶浦 新也:1、平野 勝久:4、奥村 知之:4、塚田 健一郎:5、原 拓央:6、鈴木 庸弘:7、中田 直克:8、高取 俊介:9、堀川 直樹:10、藤井 努:4、安田 一朗:1

1:富山大学・第三内科、2:富山赤十字病院・腫瘍内科、3:富山県立中央病院・消化器内科、4:富山大学・第二外科、5:高岡病院・消化器内科、6:高岡病院・外科、7:上越総合病院・消化器内科、8:糸魚川総合病院・内科、9:富山病院・消化器内科、10:高岡市民病院・外科

 

Background: Nivolumab was established as one of the standard treatments for previously treated advanced gastric cancer (AGC), and Pembrolizumab was recommended to microsatellite instability-high solid tumor. The aim of this study is to evaluate the frequency of immune-related adverse events (irAEs) with immune checkpoint inhibitors (ICIs) and the correlation between irAEs and efficacy in AGC patients.
Methods: All patients were divided into two groups based on occurrence of irAEs; those with irAEs (irAEs group) or those without (non-irAEs group). The frequency of irAEs and its treatment outcome (response rate, progression-free survival (PFS) and overall survival (OS)) were evaluated. These survivals were evaluated with 6-week landmark analysis considering lead-time bias.
Results: Between October 2017 and October 2019, 108 patients were studied, irAEs were observed in 17 patients (15.7%), including grade 4 pneumonitis, grade 2 or 3 adrenal insufficiency, and grade 1 or 2 hypothyroidism, encephalitis, colitis/diarrhea and immune thrombocytopenia. The median age, gender, PS, histological type, history of gastrectomy, numbers of metastatic sites, treatment line, and preexisting antibody before ICIs did not differ significantly between the two groups. In the irAE group, RR was 28.5% (4/14) in patients with measurable lesions, mPFS was 7.3 months (95%CI, 3.0-17.2), and mOS was 12.2 months (95% CI, 5.2-28.4) in 6-week landmark analysis. In the non-irAE group, the RR was 3.0% (2/65), mPFS was 2.5 months (95%CI, 1.0-5.9), and OS was 3.9 months (95%CI, 1.8-9.8). The clinical outcome was thus different in two groups. In addition, 10-week landmark analyses showed similar tendency. In univariate and multivariate analysis, irAEs was one of the factors associated with better PFS (HR 2.08, 95%CI:1.34-3.21), although early onset was not associated with better survival.
Conclusions: Development of irAEs was associated with better clinical outcome of ICIs in patients with AGC.

キーワード

臓器別:胃・十二指腸

手法別:腫瘍免疫

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