title: A phase I/II study of fixed-dose-rate gemcitabine and S-1 with concurrent radiotherapy for locally advanced pancreatic cancer.
abstract: OBJECTIVE
  This study was conducted to identify the maximum-tolerated dose (MTD) of fixed-dose-rate gemcitabine (FDR-gem) administered concurrently with S-1 and radical radiation for locally advanced pancreatic cancer (LAPC) and to provide efficacy and safety data.
  
  
  METHODS
  Patients with unrespectable pancreatic cancer confined to the pancreatic region were treated with FDR-gem (300-400 mg/m(2), 5 mg/m(2)/min) on days 1, 8, 22, and 29 and 60 mg/m(2) of S-1 orally on days 1-14, 22-35. A total radiation dose of 50.4 Gy (1.8 Gy/day, 28 fractions) was delivered concurrently.
  
  
  RESULTS
  Twenty-five patients were enrolled; all were evaluable for toxicity assessment. In phase I, eight patients were treated in sequential cohorts of three to five patients per dose level. The MTD was reached at level 2, and dose-limiting toxicities were neutropenia and thrombocytopenia. The recommended doses were 300 mg/m(2) of gemcitabine and 60 mg/m(2) of S-1 daily. The overall response rate was 25% and disease control rate (partial response plus stable disease) was 92%. The progression-free survival was 11.0 months. The median overall survival and 1-year survival rates were 16.0 months and 73%, respectively.
  
  
  CONCLUSIONS
  The combination of FDR-gem and S-1 with radiation is a feasible regimen that shows favorable antitumor activity with an acceptable safety profile in patients with LAPC.
authors.affiliation: Department of Gastroenterology and Oncology, Institute of Health Biosciences, University of Tokushima Graduate School, 3-18-15, Kuramoto-cho, Tokushima, 770-8503, Japan.
authors.forename: Takahiro
authors.initials: T
authors.lastname: Goji
authors.forename: Tetsuo
authors.initials: T
authors.lastname: Kimura
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Miyamoto
authors.forename: Masanori
authors.initials: M
authors.lastname: Takehara
authors.forename: Kaizo
authors.initials: K
authors.lastname: Kagemoto
authors.forename: Yasuyuki
authors.initials: Y
authors.lastname: Okada
authors.forename: Jun
authors.initials: J
authors.lastname: Okazaki
authors.forename: Yoshifumi
authors.initials: Y
authors.lastname: Takaoka
authors.forename: Yoshihiko
authors.initials: Y
authors.lastname: Miyamoto
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Mitsui
authors.forename: Sayo
authors.initials: S
authors.lastname: Matsumoto
authors.forename: Tatsuhisa
authors.initials: T
authors.lastname: Sueuchi
authors.forename: Kumiko
authors.initials: K
authors.lastname: Tanaka
authors.forename: Yasuteru
authors.initials: Y
authors.lastname: Fujino
authors.forename: Toshi
authors.initials: T
authors.lastname: Takaoka
authors.forename: Shinji
authors.initials: S
authors.lastname: Kitamura
authors.forename: Koichi
authors.initials: K
authors.lastname: Okamoto
authors.forename: Masako
authors.initials: M
authors.lastname: Kimura
authors.forename: Masahiro
authors.initials: M
authors.lastname: Sogabe
authors.forename: Naoki
authors.initials: N
authors.lastname: Muguruma
authors.forename: Toshiya
authors.initials: T
authors.lastname: Okahisa
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Sato
authors.forename: Tamotsu
authors.initials: T
authors.lastname: Sagawa
authors.forename: Koji
authors.initials: K
authors.lastname: Fujikawa
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Sato
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Ikushima
authors.forename: Tetsuji
authors.initials: T
authors.lastname: Takayama
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D059248:Chemoradiotherapy / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010094:Oxonic Acid / Q000008:administration & dosage / Q000009:adverse effects; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects; D000093542:Gemcitabine
chemical_list: D004338:Drug Combinations; D003841:Deoxycytidine; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D000093542:Gemcitabine