探索性应用抗PD-1抗体治疗晚期胰腺癌的观察研究
An Observational Study of Exploratory Using Anti-PD-1 Antibody in the Treatment of Advanced Pancreatic Cancer

目的：初步探讨抗PD-1抗体治疗18例晚期胰腺癌的安全性及疗效。方法：本研究收集唐山市工人医院、开滦总医院、唐山市南湖医院2019年1月至2021年9月经一线方案治疗失败的晚期胰腺癌患者18例，以静脉输注抗PD-1抗体作为主要治疗，观察其不良反应(AE)、总生存期(OS)、无进展生存期(PFS)、客观缓解率(ORR)及疾病控制率(DCR)。结果：18例患者的中位无进展生存期(mPFS)为3.6个月(95% CI 3.000~5.050)，ORR为27.8%，DCR为66.7%。单药免疫治疗最常出现的不良反应包括疲乏(16.7%)、发热(11.1%)、贫血(11.1%)；免疫联合化疗最常出现的不良反应包括白细胞减少(44.4%)、粒细胞减少(44.4%)、血小板减少(38.9%)；没有发生与药物有关死亡。疗效相关分析显示，东部肿瘤合作组(ECOG)的表现状态(PS) 0~1 (p = 0.006)是延长OS的因素，但非独立的预后因素。结论：本研究中抗PD-1抗体治疗晚期胰腺癌安全性可期，但由于样本量较小，疗效有待进一步的临床观察。
Objective: To investigate the safety and efficacy of anti-PD-1 antibody in the treatment of 18 patients with advanced pancreatic cancer. Methods: In this study, 18 patients with advanced pancreatic cancer who failed first-line therapy from January 2019 to September 2021 were collected from Tangshan Workers’ Hospital, Kailuan General Hospital and Tangshan Nanhu Hospital. Intravenous infusion of anti-PD-1 antibody was used as the main treatment. Adverse effects (AE), overall survival (OS), progression-free survival (PFS), objective response rate (ORR) and disease control rate (DCR) were observed. Results: The median PFS (mPFS) of 18 patients was 3.6 months (95% CI 3.000~5.050), ORR was 27.8%, and DCR was 66.7%. The most common adverse reactions to monotherapy included fatigue (16.7%), fever (11.1%) and anemia (11.1%). The most common adverse reactions to immunotherapy combined with chemotherapy were leukopenia (44.4%), granulocytopenia (44.4%) and thrombocytopenia (38.9%). No drug-related deaths occurred. Efficacy correlation analysis showed that the Eastern Tumor Cooperative group (ECOG) presentation status (PS) 0~1 (P = 0.006) was a factor of prolonging OS, but not an independent prognostic factor. Conclusions: In this study, anti-PD-1 antibody in the treatment of advanced pancreatic cancer is safe, but due to the small sample size, the efficacy needs further clinical observation.