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A randomized phase III study of hepatic arterial infusion chemotherapy with 5-fluorouracil and subsequent systemic chemotherapy versus systemic chemotherapy alone for colorectal cancer patients with curatively resected liver metastases (Japanese Foundation for Multidisciplinary Treatment of Cancer 32)


1 Kushiro Rosai Hospital, Kushiro, Japan
2 Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Kanagawa, Japan
3 Department of Surgery, Keio University School of Medicine, Tokyo, Japan
4 Department of Surgery, Surgical Oncology and Science, Sapporo Medical University School of Medicine, Sapporo, Hokkaido, Japan
5 Hijirigaoka Hospital, Date, Japan
6 Department of Hepato Biliary Pancreatic Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan
7 Hiroshima University, Hiroshima, Japan
8 Department of Biostatistics, School of Public Health, The University of Tokyo, Tokyo, Japan
9 Tokai Central Hospital, Kakamigahara, Japan
10 Translational Research and Clinical Trial Center, Hokkaido University Hospital, Sapporo, Hokkaido, Japan
11 Japanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo, Japan

Correspondence Address:
Toru Aoyama,
Department of Gastrointestinal Surgery, Kanagawa Cancer Center, 1-1-2 Nakao, Asahi Ku, Yokohama 241-0815
Japan
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Source of Support: None, Conflict of Interest: None

Aim: This randomized phase III trial compared hepatic arterial infusion (HAI) chemotherapy with 5-fluorouracil (5-FU) followed by uracil/tegafur (UFT) and leucovorin (LV) versus UFT/LV alone for patients with curatively resected liver metastases from colorectal cancer (CRC). Methods: The study was designed to include 280 patients to be randomized to receive either HAI with 5-FU followed by UFT/LV (Arm A) or UFT/LV alone (Arm B) to assess whether HAI chemotherapy improved disease-free survival (DFS). Results: Forty-four patients were randomized. Three-year DFS was relatively worse in the experimental arm although this difference was not statistically significant (43.5% in Arm A vs. 58% in Arm B; hazard ratio [HR], 1.304; P = 0.534). The experimental arm also tended to have a worse 3-year overall survival rate (80.2% in Arm A vs. 85.2% in Arm B; HR, 2.255; P = 0.192). There was no significant difference in the frequency of Grade 3 or higher toxicities between the two arms. Conclusion: Although this study was limited by a small sample size after early study termination, our analysis found that HAI with 5-FU followed by UFT/LV did not improve the DFS of patients with curatively resected liver metastases from CRC compared with UFT/LV alone. The future studies are necessary to evaluate the survival benefit of HAI in combination with newer systemic chemotherapeutic agents for patients with resectable liver metastases from CRC.


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    -  Kusano M
    -  Aoyama T
    -  Okabayashi K
    -  Hirata K
    -  Tsuji Y
    -  Nakamori S
    -  Asahara T
    -  Ohashi Y
    -  Yoshikawa T
    -  Sakamoto J
    -  Oba K
    -  Saji S
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