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Abstract：
UNASSIGNED: Although pretreatment autoantibodies have been associated with immune-related adverse events (irAEs) and immune checkpoint inhibitor treatment efficacy in some types of cancer, their importance has not been evaluated in patients with SCLC.
UNASSIGNED: A multicenter prospective observational study was conducted on a total of 52 patients with extensive-disease SCLC who received immune checkpoint inhibitors in combination with chemotherapy as the first-line treatment at either of the six participating centers in Japan. Pretreatment serum samples were collected and analyzed for autoantibodies (rheumatoid factor, antinuclear antibodies, and antithyroid). Moreover, 12 antineuronal antibodies (AMPH, CV2, PNMA2, Ri, Yo, Hu, Recoverin, SOX1, Titin, Zic4, GAD65, and Tr) were analyzed using immunoblot assays. The primary end point was the incidence of irAEs with or without autoantibodies. The secondary end points were progression-free survival (PFS) and overall survival (OS) on the basis of the presence or absence of autoantibodies.
UNASSIGNED: PFS and OS were 4.4 and 25.3 months, respectively. Autoantibodies (rheumatoid factor, antinuclear antibodies, and antithyroid antibodies) were detected in 29 patients (56%). In total, irAEs were observed in 18 patients (35%); irAE incidence was 48% in the autoantibody-positive group and 17% in the autoantibody-negative group (p = 0.039). There was no difference in PFS or OS between patients with and without autoantibodies (4.4 mo versus 4.6 mo, p = 0.36; 15.3 mo versus 18.2 mo, p = 0.36). Antineuronal antibodies were detected in 16 patients (31%). However, the development of neurologic irAEs was not observed in both groups.
UNASSIGNED: Vigilance is required against the development of irAEs in pretreatment antibody-positive patients.
UNASSIGNED: A multicenter prospective observational study was conducted on a total of 52 patients with extensive-disease SCLC who received immune checkpoint inhibitors in combination with chemotherapy as the first-line treatment at either of the six participating centers in Japan. Pretreatment serum samples were collected and analyzed for autoantibodies (rheumatoid factor, antinuclear antibodies, and antithyroid). Moreover, 12 antineuronal antibodies (AMPH, CV2, PNMA2, Ri, Yo, Hu, Recoverin, SOX1, Titin, Zic4, GAD65, and Tr) were analyzed using immunoblot assays. The primary end point was the incidence of irAEs with or without autoantibodies. The secondary end points were progression-free survival (PFS) and overall survival (OS) on the basis of the presence or absence of autoantibodies.
UNASSIGNED: PFS and OS were 4.4 and 25.3 months, respectively. Autoantibodies (rheumatoid factor, antinuclear antibodies, and antithyroid antibodies) were detected in 29 patients (56%). In total, irAEs were observed in 18 patients (35%); irAE incidence was 48% in the autoantibody-positive group and 17% in the autoantibody-negative group (p = 0.039). There was no difference in PFS or OS between patients with and without autoantibodies (4.4 mo versus 4.6 mo, p = 0.36; 15.3 mo versus 18.2 mo, p = 0.36). Antineuronal antibodies were detected in 16 patients (31%). However, the development of neurologic irAEs was not observed in both groups.
UNASSIGNED: Vigilance is required against the development of irAEs in pretreatment antibody-positive patients.
摘要：
■尽管在某些类型的癌症中，治疗前自身抗体与免疫相关不良事件（irAEs）和免疫检查点抑制剂治疗功效有关，其重要性尚未在SCLC患者中进行评估.
■一项多中心前瞻性观察性研究是对52例广泛性疾病SCLC患者进行的，这些患者在日本六个参与中心中的任何一个接受免疫检查点抑制剂联合化疗作为一线治疗。收集预处理血清样品并分析自身抗体（类风湿因子，抗核抗体,和抗甲状腺）。此外，12抗神经元抗体（AMPH，CV2,PNMA2,Ri,哟,胡,Recoverin,SOX1,Titin,Zic4，GAD65和Tr）使用免疫印迹测定法进行分析。主要终点是有或没有自身抗体的irAE的发生率。次要终点是基于自身抗体存在或不存在的无进展生存期(PFS)和总生存期(OS)。
■PFS和OS分别为4.4和25.3个月，分别。自身抗体（类风湿因子，抗核抗体,和抗甲状腺抗体）在29例患者（56％）中检测到。总的来说,在18例患者中观察到irAE（35％）；自身抗体阳性组的irAE发生率为48％，自身抗体阴性组的irAE发生率为17％（p=0.039）。有和没有自身抗体的患者之间的PFS或OS没有差异（4.4个月对4.6个月，p=0.36；15.3个月对18.2个月，p=0.36）。16例患者（31％）检测到了神经元抗体。然而,两组均未观察到神经系统irAE的发展。
■需要警惕治疗前抗体阳性患者中irAE的发展。
■一项多中心前瞻性观察性研究是对52例广泛性疾病SCLC患者进行的，这些患者在日本六个参与中心中的任何一个接受免疫检查点抑制剂联合化疗作为一线治疗。收集预处理血清样品并分析自身抗体（类风湿因子，抗核抗体,和抗甲状腺）。此外，12抗神经元抗体（AMPH，CV2,PNMA2,Ri,哟,胡,Recoverin,SOX1,Titin,Zic4，GAD65和Tr）使用免疫印迹测定法进行分析。主要终点是有或没有自身抗体的irAE的发生率。次要终点是基于自身抗体存在或不存在的无进展生存期(PFS)和总生存期(OS)。
■PFS和OS分别为4.4和25.3个月，分别。自身抗体（类风湿因子，抗核抗体,和抗甲状腺抗体）在29例患者（56％）中检测到。总的来说,在18例患者中观察到irAE（35％）；自身抗体阳性组的irAE发生率为48％，自身抗体阴性组的irAE发生率为17％（p=0.039）。有和没有自身抗体的患者之间的PFS或OS没有差异（4.4个月对4.6个月，p=0.36；15.3个月对18.2个月，p=0.36）。16例患者（31％）检测到了神经元抗体。然而,两组均未观察到神经系统irAE的发展。
■需要警惕治疗前抗体阳性患者中irAE的发展。
