Phase II Study of Hepatic Arterial Infusion Chemotherapy with Oxaliplatin and 5-Fluorouracil for Advanced Perihilar Cholangiocarcinoma.
Purpose To evaluate the efficacy and safety of hepatic arterial infusion (HAI) of oxaliplatin and 5-fluorouracil for advanced perihilar cholangiocarcinoma (PCC) in this prospective phase II study. Materials and Methods The protocol was approved by the local ethics committee, and all patients gave informed consent. Patients with nonresectable PCC were included in a prospective, open phase II study investigating HAI through interventionally implanted port catheters. HAI consisted of infusions of oxaliplatin 40 mg/m2for 2 hours, followed by 5-fluorouracil 800 mg/m2for 22 hours on days 1-3 every 3-4 weeks. A maximum of six cycles of HAI were applied for tumor control patients followed by maintenance with oral capecitabine until tumor progression. The primary end points were tumor response and progression-free survival (PFS). The secondary end points were local PFS, overall survival, and adverse events. Kaplan-Meier methodology and Cox regression analysis were used to evaluate the risk factors for survival. Results Between 2012 and 2015, 37 patients were enrolled. The overall response rate was 67.6% (25 of 37), and the disease control rate was 89.2% (33 of 37). Median PFS, local PFS, and overall survival were 12.2, 25.0, and 20.5 months, respectively. All three survival lengths in patients with periductal infiltrating pattern were found to be significantly longer than those in patients with mass-forming pattern (P < .001, hazard ratio < 0.2). Macroscopic growth patterns (P = .018) and number of HAI cycles (P < .001) were independent risk factors of survival. The most frequent adverse events were grades 1 and 2 gastrointestinal side effects and sensory neuropathy in 31 (83.8%) and 28 (75.7%) patients, respectively. Conclusion HAI with oxaliplatin and 5-fluorouracil may be an encouraging treatment choice for advanced PCC due to its high tumor control, survival benefit, and low toxicity, especially in patients with periductal infiltrating pattern.©RSNA, 2016.
From the Department of Interventional Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education) (X.W., J.H., G.C., X.Z., R.Y., H.C., H.X., P.L.), Departments of Radiology (Y.C.), Medical Statistics (X.J.), and GI Oncology (Jian Li, Jie Li, L.S.), and Department of Hepatic, Biliary & Pancreatic Surgery (C.H., B.X.), Peking University Cancer Hospital & Institute, 52 Fucheng Road, Haidian District, Beijing 100142, China; and Department of Mathematics and Statistics, University of Minnesota-Duluth, Duluth, Minn (X.L.).
Xiaodong
X
Wang
From the Department of Interventional Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education) (X.W., J.H., G.C., X.Z., R.Y., H.C., H.X., P.L.), Departments of Radiology (Y.C.), Medical Statistics (X.J.), and GI Oncology (Jian Li, Jie Li, L.S.), and Department of Hepatic, Biliary & Pancreatic Surgery (C.H., B.X.), Peking University Cancer Hospital & Institute, 52 Fucheng Road, Haidian District, Beijing 100142, China; and Department of Mathematics and Statistics, University of Minnesota-Duluth, Duluth, Minn (X.L.).
Jungang
J
Hu
From the Department of Interventional Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education) (X.W., J.H., G.C., X.Z., R.Y., H.C., H.X., P.L.), Departments of Radiology (Y.C.), Medical Statistics (X.J.), and GI Oncology (Jian Li, Jie Li, L.S.), and Department of Hepatic, Biliary & Pancreatic Surgery (C.H., B.X.), Peking University Cancer Hospital & Institute, 52 Fucheng Road, Haidian District, Beijing 100142, China; and Department of Mathematics and Statistics, University of Minnesota-Duluth, Duluth, Minn (X.L.).
Guang
G
Cao
From the Department of Interventional Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education) (X.W., J.H., G.C., X.Z., R.Y., H.C., H.X., P.L.), Departments of Radiology (Y.C.), Medical Statistics (X.J.), and GI Oncology (Jian Li, Jie Li, L.S.), and Department of Hepatic, Biliary & Pancreatic Surgery (C.H., B.X.), Peking University Cancer Hospital & Institute, 52 Fucheng Road, Haidian District, Beijing 100142, China; and Department of Mathematics and Statistics, University of Minnesota-Duluth, Duluth, Minn (X.L.).
Xu
X
Zhu
From the Department of Interventional Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education) (X.W., J.H., G.C., X.Z., R.Y., H.C., H.X., P.L.), Departments of Radiology (Y.C.), Medical Statistics (X.J.), and GI Oncology (Jian Li, Jie Li, L.S.), and Department of Hepatic, Biliary & Pancreatic Surgery (C.H., B.X.), Peking University Cancer Hospital & Institute, 52 Fucheng Road, Haidian District, Beijing 100142, China; and Department of Mathematics and Statistics, University of Minnesota-Duluth, Duluth, Minn (X.L.).
Yong
Y
Cui
From the Department of Interventional Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education) (X.W., J.H., G.C., X.Z., R.Y., H.C., H.X., P.L.), Departments of Radiology (Y.C.), Medical Statistics (X.J.), and GI Oncology (Jian Li, Jie Li, L.S.), and Department of Hepatic, Biliary & Pancreatic Surgery (C.H., B.X.), Peking University Cancer Hospital & Institute, 52 Fucheng Road, Haidian District, Beijing 100142, China; and Department of Mathematics and Statistics, University of Minnesota-Duluth, Duluth, Minn (X.L.).
Xinqiang
X
Ji
From the Department of Interventional Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education) (X.W., J.H., G.C., X.Z., R.Y., H.C., H.X., P.L.), Departments of Radiology (Y.C.), Medical Statistics (X.J.), and GI Oncology (Jian Li, Jie Li, L.S.), and Department of Hepatic, Biliary & Pancreatic Surgery (C.H., B.X.), Peking University Cancer Hospital & Institute, 52 Fucheng Road, Haidian District, Beijing 100142, China; and Department of Mathematics and Statistics, University of Minnesota-Duluth, Duluth, Minn (X.L.).
Xuan
X
Li
From the Department of Interventional Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education) (X.W., J.H., G.C., X.Z., R.Y., H.C., H.X., P.L.), Departments of Radiology (Y.C.), Medical Statistics (X.J.), and GI Oncology (Jian Li, Jie Li, L.S.), and Department of Hepatic, Biliary & Pancreatic Surgery (C.H., B.X.), Peking University Cancer Hospital & Institute, 52 Fucheng Road, Haidian District, Beijing 100142, China; and Department of Mathematics and Statistics, University of Minnesota-Duluth, Duluth, Minn (X.L.).
Renjie
R
Yang
From the Department of Interventional Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education) (X.W., J.H., G.C., X.Z., R.Y., H.C., H.X., P.L.), Departments of Radiology (Y.C.), Medical Statistics (X.J.), and GI Oncology (Jian Li, Jie Li, L.S.), and Department of Hepatic, Biliary & Pancreatic Surgery (C.H., B.X.), Peking University Cancer Hospital & Institute, 52 Fucheng Road, Haidian District, Beijing 100142, China; and Department of Mathematics and Statistics, University of Minnesota-Duluth, Duluth, Minn (X.L.).
Hui
H
Chen
From the Department of Interventional Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education) (X.W., J.H., G.C., X.Z., R.Y., H.C., H.X., P.L.), Departments of Radiology (Y.C.), Medical Statistics (X.J.), and GI Oncology (Jian Li, Jie Li, L.S.), and Department of Hepatic, Biliary & Pancreatic Surgery (C.H., B.X.), Peking University Cancer Hospital & Institute, 52 Fucheng Road, Haidian District, Beijing 100142, China; and Department of Mathematics and Statistics, University of Minnesota-Duluth, Duluth, Minn (X.L.).
Haifeng
H
Xu
From the Department of Interventional Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education) (X.W., J.H., G.C., X.Z., R.Y., H.C., H.X., P.L.), Departments of Radiology (Y.C.), Medical Statistics (X.J.), and GI Oncology (Jian Li, Jie Li, L.S.), and Department of Hepatic, Biliary & Pancreatic Surgery (C.H., B.X.), Peking University Cancer Hospital & Institute, 52 Fucheng Road, Haidian District, Beijing 100142, China; and Department of Mathematics and Statistics, University of Minnesota-Duluth, Duluth, Minn (X.L.).
Peng
P
Liu
From the Department of Interventional Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education) (X.W., J.H., G.C., X.Z., R.Y., H.C., H.X., P.L.), Departments of Radiology (Y.C.), Medical Statistics (X.J.), and GI Oncology (Jian Li, Jie Li, L.S.), and Department of Hepatic, Biliary & Pancreatic Surgery (C.H., B.X.), Peking University Cancer Hospital & Institute, 52 Fucheng Road, Haidian District, Beijing 100142, China; and Department of Mathematics and Statistics, University of Minnesota-Duluth, Duluth, Minn (X.L.).
Jian
J
Li
From the Department of Interventional Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education) (X.W., J.H., G.C., X.Z., R.Y., H.C., H.X., P.L.), Departments of Radiology (Y.C.), Medical Statistics (X.J.), and GI Oncology (Jian Li, Jie Li, L.S.), and Department of Hepatic, Biliary & Pancreatic Surgery (C.H., B.X.), Peking University Cancer Hospital & Institute, 52 Fucheng Road, Haidian District, Beijing 100142, China; and Department of Mathematics and Statistics, University of Minnesota-Duluth, Duluth, Minn (X.L.).
Jie
J
Li
From the Department of Interventional Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education) (X.W., J.H., G.C., X.Z., R.Y., H.C., H.X., P.L.), Departments of Radiology (Y.C.), Medical Statistics (X.J.), and GI Oncology (Jian Li, Jie Li, L.S.), and Department of Hepatic, Biliary & Pancreatic Surgery (C.H., B.X.), Peking University Cancer Hospital & Institute, 52 Fucheng Road, Haidian District, Beijing 100142, China; and Department of Mathematics and Statistics, University of Minnesota-Duluth, Duluth, Minn (X.L.).
Chunyi
C
Hao
From the Department of Interventional Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education) (X.W., J.H., G.C., X.Z., R.Y., H.C., H.X., P.L.), Departments of Radiology (Y.C.), Medical Statistics (X.J.), and GI Oncology (Jian Li, Jie Li, L.S.), and Department of Hepatic, Biliary & Pancreatic Surgery (C.H., B.X.), Peking University Cancer Hospital & Institute, 52 Fucheng Road, Haidian District, Beijing 100142, China; and Department of Mathematics and Statistics, University of Minnesota-Duluth, Duluth, Minn (X.L.).
Baocai
B
Xing
From the Department of Interventional Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education) (X.W., J.H., G.C., X.Z., R.Y., H.C., H.X., P.L.), Departments of Radiology (Y.C.), Medical Statistics (X.J.), and GI Oncology (Jian Li, Jie Li, L.S.), and Department of Hepatic, Biliary & Pancreatic Surgery (C.H., B.X.), Peking University Cancer Hospital & Institute, 52 Fucheng Road, Haidian District, Beijing 100142, China; and Department of Mathematics and Statistics, University of Minnesota-Duluth, Duluth, Minn (X.L.).
Lin
L
Shen
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D001650:Bile Duct Neoplasms / Q000175:diagnosis* / Q000188:drug therapy*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006499:Hepatic Artery; D006801:Humans; D007261:Infusions, Intra-Arterial; D018285:Klatskin Tumor / Q000175:diagnosis* / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D015996:Survival Rate; D016896:Treatment Outcome
D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D005472:Fluorouracil