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Phase I study of gemcitabine, cisplatin, and S‐1 combination therapy for patients with untreated advanced biliary tract cancer
Author(s) -
Moriwaki Toshikazu,
Ishida Hiroyasu,
Araki Masahiro,
Endo Shinji,
Yoshida Shigemasa,
Kobayashi Mariko,
Hamano Yukako,
Sugaya Akinori,
Shimoyamada Masahiro,
Hasegawa Naoyuki,
Imanishi Mamiko,
Ito Yuka,
Sato Daiki,
Hyodo Ichinosuke
Publication year - 2015
Publication title -
journal of hepato‐biliary‐pancreatic sciences
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.63
H-Index - 60
eISSN - 1868-6982
pISSN - 1868-6974
DOI - 10.1002/jhbp.255
Subject(s) - gemcitabine , medicine , cisplatin , regimen , neutropenia , leukopenia , phases of clinical research , chemotherapy , adverse effect , deoxycytidine , gastroenterology , cancer , oncology
Background To develop a triplet regimen containing gemcitabine, cisplatin, and S‐1 (GPS), we assessed the recommended dose for patients with untreated advanced biliary tract cancer in this phase I study. Methods Dose‐limiting toxicities (DLTs) were evaluated for the following two dose levels: gemcitabine (1000 mg/m 2 for level 1 and 1200 mg/m 2 for level 2 on day 1), cisplatin (30 mg/m 2 fixed dose on day 1), and S‐1 (40–60 mg/day fixed dose twice a day for 7 days), every 2 weeks until progression. DLTs for each level were evaluated in six or more patients during the first two cycles. Results A total of 18 patients were enrolled and 16 patients were evaluated. DLTs at level 1 were observed in two of 10 patients. At level 2, a DLT was observed in one of six patients. The main grade 3 or 4 treatment‐related adverse events were neutropenia and leukopenia, and a few non‐hematological toxicities were observed. Among 14 patients with measurable lesions, the best response rate was 50%. Conclusions GPS with a relative dose intensity corresponding to 90% of the standard gemcitabine plus cisplatin regimen could be administered safely, and showed preliminary antitumor activity. Survival benefits will be studied subsequently.