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Effect of different PD-1 inhibitor combination therapies for unresectable intrahepatic cholangiocarcinoma

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机构: [1]Hepato-Pancreato-Biliary Center, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China. [2]Department of Surgical Oncology, Qin Huai Medical District of Jinling Hospital, Nanjing University, Nanjing, China. [3]Department of Hepatobiliary and Pancreatic Surgery, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Basic Medicine and Cancer, Chinese Academy of Sciences, Hangzhou, China. [4]Department of Hepatic Surgery II, The Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, China. [5]Department of Hepatobiliary Surgery, General Hospital of Northern Theater Command, Shenyang, China. [6]Department of Medical Oncology, the First Hospital of China Medical University, Shenyang, China. [7]Interventional Radiology Department, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China. [8]Department of General Surgery, Huashan Hospital & Cancer Metastasis Institute, Fudan University, Shanghai, China. [9]Department of Medical Oncology of PLA Cancer Center, Jinling Hospital, Nanjing, China. [10]Department of General Surgery, The First Affiliated Hospital of Soochow University, Suzhou, China. [11]Department of Hepatobiliary Surgery, The Affiliated Drum Tower Hospital, Medical School of Nanjing University, Nanjing, China. [12]Key Laboratory of Tumor Immunopathology, Ministry of Education of China, Institute of Pathology and Southwest Hospital, Third Military Medical University (Army Medical University), Chongqing, China. [13]Department of General Surgery, Zibo Central Hospital, Zibo, China. [14]Department of Hepatobiliary Pancreatic Surgery, Fujian Provincial Hospital, Fuzhou, China. [15]Department of Hepatobiliary Surgery, Hunan Provincial People's Hospital, The First Affiliated Hospital of Hunan Normal University, Changsha, China. [16]Department of Hepatobiliary, The Second Affiliated Hospital of Army Medical University, Chongqing, China. [17]Department of General Surgery, Jiangxi Provincial Clinical Research Center for General Surgery Disease, The Second Affiliated Hospital of Nanchang University, Nanchang, China. [18]Department of Hepatobiliary Surgery, Affiliated Hospital of North Sichuan Medical College, Nanchong, China. [19]Department of Hepatobiliary Surgery, Mengchao Hepatobiliary Hospital, Fujian Medical University, Fuzhou, China. [20]Department of Interventional Radiology, Maanshan People's Hospital, Maanshan, China. [21]Department of Oncology, Seventh People's Hospital of Shanghai University of Traditional Chinese Medicine, Shanghai, China. [22]Hepatobiliary Center, Key Laboratory of Liver Transplantation, Chinese Academy of Medical Sciences, NHC Key Laboratory of Liver Transplantation, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China. [23]Department of Hepatic Surgery VI, The Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, China. [24]Center of Interventional Radiology & Vascular Surgery, Department of Radiology, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China. [25]Zhongda Hospital, School of Life Sciences and Technology, Advanced Institute for Life and Health, Southeast University, Nanjing, China. [26]Department of Surgery, TUM School of Medicine, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany. [27]Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, Special Administrative Region, China. [28]Liver Cancer Center, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin's Clinical Research Center for Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China. [29]Department of Hepatic Surgery IV, The Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, China.
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Immune checkpoint inhibitor (ICI) combination therapy offers a new option for treatment of unresectable intrahepatic cholangiocarcinoma (uICC).To compare the effect of different anti-PD-1 combination therapies as the first-line treatments for uICC.This study included 318 patients who received chemotherapy alone (Chemo), anti-PD-1 plus chemotherapy (ICI-chemo), anti-PD-1 plus targeted therapy (ICI-target) or anti-PD-1 plus targeted therapy and chemotherapy (ICI-target-chemo) as first line for uICC from 22 centres in China. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), objective response rate (ORR) and safety.Patients with ICI-chemo (median PFS [mPFS], 6.3 months; HR: 0.61, 95% CI: 0.42-0.88; p = 0.008; median OS [mOS], 10.7 months; HR: 0.61, 95% CI: 0.39-0.94; p = 0.026), ICI-target (7.2 months; HR: 0.54, 95% CI: 0.36-0.80; p = 0.002; 15.8 months; HR: 0.54, 95% CI: 0.35-0.84; p = 0.006) or ICI-target-chemo (6.9 months; HR: 0.65, 95% CI: 0.47-0.90; p = 0.009; 14.4 months; HR: 0.47, 95% CI: 0.31-0.70; p < 0.001) achieved better clinical outcomes than those with Chemo (3.8 months; 9.3 months). ICI-target was not inferior to ICI-chemo in survival outcomes (HR for PFS: 0.88, 95% CI: 0.55-1.42; p = 0.614; HR for OS: 0.89, 95% CI: 0.51-1.55; p = 0.680). ICI-target-chemo yielded similar prognoses as ICI-chemo (HR for PFS: 1.07, 95% CI: 0.70-1.62; p = 0.764; HR for OS: 0.77, 95% CI: 0.45-1.31; p = 0.328) and ICI-target (HR for PFS: 1.20, 95% CI: 0.77-1.88; p = 0.413; HR for OS: 0.86, 95% CI: 0.51-1.47; p = 0.583) but resulted in more adverse events (p < 0.001; p = 0.010). Multivariable and propensity score analyses supported these findings.Among patients with uICC, ICI-chemo or ICI-target provided more survival benefits than Chemo while achieving comparable prognoses and fewer adverse events than ICI-target-chemo.© 2023 John Wiley & Sons Ltd.

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大类 | 1 区 医学
小类 | 1 区 药学 2 区 胃肠肝病学
最新[2023]版:
大类 | 1 区 医学
小类 | 1 区 药学 2 区 胃肠肝病学
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出版当年[2023]版:
Q1 GASTROENTEROLOGY & HEPATOLOGY Q1 PHARMACOLOGY & PHARMACY
最新[2023]版:
Q1 GASTROENTEROLOGY & HEPATOLOGY Q1 PHARMACOLOGY & PHARMACY

影响因子: 最新[2023版] 最新五年平均 出版当年[2023版] 出版当年五年平均 出版前一年[2022版]

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第一作者机构: [1]Hepato-Pancreato-Biliary Center, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China.
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通讯机构: [1]Hepato-Pancreato-Biliary Center, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China. [23]Department of Hepatic Surgery VI, The Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, China. [28]Liver Cancer Center, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin's Clinical Research Center for Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China. [29]Department of Hepatic Surgery IV, The Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, China. [*1]Hepato-PancreatoBiliary Center, Zhongda Hospital, School of Medicine, Southeast University, Nanjing 210009, China [*2]Department of Hepatic Surgery IV, The Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai 200438, China [*3]Department of Hepatic Surgery VI, The Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, China. [*4]Liver Cancer Center, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin's Clinical Research Center for Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin 300060, China.
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