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Cancer Chemotherapy and Pharmacology

, Volume 74, Issue 5, pp 1079–1087 | Cite as

Phase I trial of hepatic arterial infusion (HAI) of floxuridine with modified oxaliplatin, 5-fluorouracil and leucovorin (m-FOLFOX6) in Chinese patients with unresectable liver metastases from colorectal cancer

  • Cong Li
  • Yangkui Gu
  • Ming Zhao
  • Yunfei Yuan
  • Fenghua Wang
  • Zhiqiang Wang
  • Wang Li
  • Huiyan Luo
  • Cui Chen
  • Gong Chen
  • Peirong Ding
  • Xiaojun Wu
  • Zhenhai Lu
  • Zhizhong Pan
  • Ruihua Xu
  • Youjian He
  • Desen Wan
  • Yuhong LiEmail author
Clinical Trial Report

Abstract

Purpose

To determine the maximum tolerated dose (MTD) and preliminary efficacy of concurrent hepatic arterial infusion (HAI) of floxuridine (FUDR) and systemic modified oxaliplatin, 5-fluorouracil and leucovorin (m-FOLFOX6) in Chinese patients with unresectable hepatic metastases from colorectal cancer.

Patients and methods

Thirty-five patients with unresectable liver metastases with or without extrahepatic disease were treated with concurrent HAI and systemic m-FOLFOX6. HAI FUDR was delivered in a 14-day infusion with escalating dose levels, and each cycle was repeated every 4 weeks.

Results

The MTD for FUDR was 0.12 mg/kg/day when combined with systemic m-FOLFOX6. The dose-limited toxicities were neutropenia (8.6 %), alanine aminotransferase/aspartate aminotransferase elevation (5.7 %) and diarrhea (11.4 %). The overall response rate was 68.6 % for hepatic metastases and 14.3 % for extrahepatic metastases. The median progression-free survival and overall survival were 8.23 and 25 months, respectively.

Conclusion

The recommended dose of FUDR was 0.12 mg/kg/day when combined with systemic m-FOLFOX6. This combination achieved a high response rate in hepatic disease and a high control rate in extrahepatic disease. Further study is needed to assess the potential additional value of HAI therapy in converting patients with hepatic metastases to candidates for resection.

Keywords

Hepatic arterial infusion Chemotherapy Colorectal cancer Liver metastases 

Notes

Acknowledgments

This clinical trial is funded by single disease fund of Sun Yat-Sen University Cancer Center.

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Copyright information

© Springer-Verlag Berlin Heidelberg 2014

Authors and Affiliations

  • Cong Li
    • 1
  • Yangkui Gu
    • 2
  • Ming Zhao
    • 2
  • Yunfei Yuan
    • 3
  • Fenghua Wang
    • 1
  • Zhiqiang Wang
    • 1
  • Wang Li
    • 2
  • Huiyan Luo
    • 1
  • Cui Chen
    • 4
  • Gong Chen
    • 5
  • Peirong Ding
    • 5
  • Xiaojun Wu
    • 5
  • Zhenhai Lu
    • 5
  • Zhizhong Pan
    • 5
  • Ruihua Xu
    • 1
  • Youjian He
    • 1
  • Desen Wan
    • 5
  • Yuhong Li
    • 1
    Email author
  1. 1.Department of Medical OncologySun Yat-Sen University Cancer CenterGuangzhouChina
  2. 2.Department of Interventional RadiologySun Yat-Sen University Cancer CenterGuangzhouChina
  3. 3.Department of Hepatic SurgerySun Yat-Sen University Cancer CenterGuangzhouChina
  4. 4.Department of Medical OncologyFirst Affiliated Hospital of Sun Yat-Sen UniversityGuangzhouChina
  5. 5.Department of Colorectal SurgerySun Yat-Sen University Cancer CenterGuangzhouChina

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