Phase II trial of gemcitabine combined with 5-fluorouracil and cisplatin (GFP) chemotherapy in patients with advanced biliary tree cancers

Yo ichi Yamashita, Akinobu Taketomi, Shinji Itoh, Norifumi Harimoto, Eiji Tsujita, Keishi Sugimachi, Tomonobu Gion, Yoshihiko Maehara

Research output: Contribution to journalArticlepeer-review

20 Citations (Scopus)


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/m. 2 on days 1, 8 and 15, and 5-FU at 150 mg/m. 2 and CDDP at 3 mg/m. 2 on days 1-5, 8-12 and 15-19. After two cycles, a 4-week outpatient treatment of gemcitabine (1000 mg/m. 2) on days 1 and 15 combined with 5-FU (500 mg/m. 2) and CDDP (7 mg/m. 2) 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.

Original languageEnglish
Article numberhyp119
Pages (from-to)24-28
Number of pages5
JournalJapanese journal of clinical oncology
Issue number1
Publication statusPublished - Sept 20 2009

All Science Journal Classification (ASJC) codes

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research


Dive into the research topics of 'Phase II trial of gemcitabine combined with 5-fluorouracil and cisplatin (GFP) chemotherapy in patients with advanced biliary tree cancers'. Together they form a unique fingerprint.

Cite this