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Japanese Journal of Clinical Oncology Advance Access originally published online on March 28, 2008
Japanese Journal of Clinical Oncology 2008 38(4):268-274; doi:10.1093/jjco/hyn015
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© The Author (2008). Published by Oxford University Press. All rights reserved

A Phase I Trial of Arterial Infusion Chemotherapy with Gemcitabine and 5-Fluorouracil for Unresectable Advanced Pancreatic Cancer after Vascular Supply Distribution via Superselective Embolization

Koji Miyanishi1, Hirotoshi Ishiwatari1, Tsuyoshi Hayashi1, Minoru Takahashi1, Yutaka Kawano1, Kohichi Takada1, Hideyuki Ihara1, Toshinori Okuda1, Kunihiro Takanashi1, Sho Takahashi1, Yasushi Sato1, Takuya Matsunaga1, Hisato Homma2, Junji Kato1 and Yoshiro Niitsu1

1 Fourth Department of Internal Medicine, Sapporo Medical University School of Medicine, Chuo-ku, Sapporo
2 Department of Gastroenterology, Sapporo Kyoritsu Hospital, Kita-ku, Sapporo, Japan

For reprints and all correspondence: Junji Kato, Fourth Department of Internal Medicine, Sapporo Medical University School of Medicine, South-1, West-16, Chuo-ku, Sapporo, Hokkaido, Japan. E-mail: jkato{at}sapmed.ac.jp

Received December 21, 2007; accepted February 7, 2008

Background: We previously reported that arterial infusion chemotherapy improved the response rate and survival of the patients with pancreatic cancer at advanced stages in an open trial. We conducted a Phase I trial of arterial infusion chemotherapy with gemcitabine and 5-fluorouracil for advanced pancreatic cancer after vascular supply distribution via superselective embolization.

Methods: Patients were treated after arterial embolization for hemodynamic change to restrict the blood flow into the pancreas (mainly to the great pancreatic artery and the caudal pancreatic artery). Arterial infusion chemotherapy consisted of gemcitabine in doses that were increased from 600 to 1000 mg/m2 in subsequent cohorts on Day 1 plus continuous infusion of 5-fluorouracil 300 mg/m2/day on Days 1–5 every 2 weeks.

Result: Twelve patients were enrolled. The maximum tolerated dose of gemcitabine was determined to be Level 3 (1000 mg/m2). Only very mild hematological and non-hematological toxicities were noted. The overall response rate was 33.3%. The median survival time was 22.7 (95% CI; 9.5–24.5) months and the 1- and 2-year overall survival rates were 83.3 and 25.0%, respectively.

Conclusion: Arterial infusion chemotherapy using 1000 mg/m2 gemcitabine on Day 1 and 300 mg/m2/day 5-fluorouracil on Days 1–5 every 2 weeks warrants a Phase II study.

Key Words: chemo-phase I-II-III • GI-pancreas • GI-pancreas-med • GI-pancreas-radoncol • radiology-angio


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