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Japanese Journal of Clinical Oncology Advance Access published online on September 20, 2009
Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hyp119
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© The Author (2009). Published by Oxford University Press. All rights reserved

Phase II Trial of Gemcitabine Combined with 5-fluorouracil and Cisplatin (GFP) Chemotherapy in Patients with Advanced Biliary Tree Cancers

Yo-ichi Yamashita1,2, Akinobu Taketomi1, Shinji Itoh1, Norifumi Harimoto1, Eiji Tsujita1,2, Keishi Sugimachi1, Tomonobu Gion1 and Yoshihiko Maehara1

1 Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka
2 Department of Surgery, Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital, Hiroshima, Japan

For reprints and all correspondence: Yo-ichi Yamashita, Department of Surgery, Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital, Senda-machi 1-9-6, Naka-ku, Hiroshima 730-8619, Japan. E-mail: yamashi{at}surg2.med.kyushu-u.ac.jp

Received June 16, 2009; accepted August 12, 2009

Objective: Advanced biliary tree cancers are often diagnosed at an advanced or metastatic stage and have poor prognoses. We reported the promising anti-tumor activity of gemcitabine/5-fluorouracil (5-FU)/cisplatin (CDDP) therapy, called ‘GFP chemotherapy’ in a pilot study.

Methods: Twenty-one patients with advanced or metastatic biliary tree cancers with no prior chemotherapy were enrolled in this Phase II trial. Patients were treated on 4-week cycle GFP chemotherapy consisting of gemcitabine at 1000 mg/m2 on days 1, 8 and 15, and 5-FU at 150 mg/m2 and CDDP at 3 mg/m2 on days 1–5, 8–12 and 15–19. After two cycles, a 4-week outpatient treatment of gemcitabine (1000 mg/m2) on days 1 and 15 combined with 5-FU (500 mg/m2) and CDDP (7 mg/m2) on days 1 and 15 was commenced. Treatment was repeated until tumor progression or remission allowing curative operation, or unacceptable toxicity occurred.

Results: Of these 21 patients, no complete responses were observed, but 7 patients (33.3%) demonstrated partial responses (PRs) with an additional 12 patients (57.2%) having stable diseases, as assessed by RECIST. Three patients with PRs were treated by curative operation after GFP chemotherapy, and all of them survived with no recurrence for over 3 years. The median overall survival time was 18.8 months, and median time to progression was 13.4 months. Grade 3 side effects such as leukopenia, thrombocytopenia and anemia were found in six patients (28.6%), but no patients dropped out because of toxicity.

Conclusions: This GFP chemotherapy has promising anti-tumor activity and is well tolerated in patients with advanced biliary tree cancers.

Key Words: chemo-Phase I–III • GI-hepatobiliary-Med • GI-hepatobiliary


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