title: Phase II study of oral S-1 and concurrent radiotherapy in patients with unresectable locally advanced pancreatic cancer.
abstract: OBJECTIVE
  S-1 is an oral fluoropyrimidine derivative that has demonstrated favorable antitumor activity in patients with metastatic pancreatic cancer. The aim of this study was to evaluate safety and efficacy of S-1 and concurrent radiotherapy in patients with unresectable locally advanced pancreatic cancer.
  
  
  METHODS
  Patients with histopathologically proven, unresectable, locally advanced pancreatic cancer were eligible. Radiotherapy was delivered in 1.8 Gy daily fractions to a total dose of 50.4 Gy over 5.5 weeks. S-1 was administered orally twice a day at a dose of 80 mg/m(2)/day from day 1 to 14 and 22 to 35. Two weeks after the completion of chemoradiotherapy, maintenance chemotherapy with S-1 was administered for 28 days every 6 weeks until progression.
  
  
  RESULTS
  Thirty-four patients were enrolled in this study. The most common Grade 3 toxicities during chemoradiotherapy were anorexia (24%) and nausea (12%). The overall response rate was 41% (95% confidence interval, 25%-58%) and overall disease control rate (partial response plus stable disease) was 97%. More than 50% decrease in serum CA 19-9 was seen in 27 of 29 evaluable patients (93%). The median progression-free survival was 8.7 months. The median overall survival and 1-year survival rate were 16.8 months and 70.6%, respectively.
  
  
  CONCLUSIONS
  Oral S-1 and concurrent radiotherapy exerted a promising antitumor activity with acceptable toxicity in patients with locally advanced pancreatic cancer. This combination therapy seems to be an attractive alternative to conventional chemoradiotherapy using 5-fluorouracil infusion.
authors.affiliation: Department of Gastroenterology, Chiba Cancer Center, Chiba, Japan. kentarosudo9@yahoo.co.jp
authors.forename: Kentaro
authors.initials: K
authors.lastname: Sudo
authors.forename: Taketo
authors.initials: T
authors.lastname: Yamaguchi
authors.forename: Takeshi
authors.initials: T
authors.lastname: Ishihara
authors.forename: Kazuyoshi
authors.initials: K
authors.lastname: Nakamura
authors.forename: Taro
authors.initials: T
authors.lastname: Hara
authors.forename: Tadamichi
authors.initials: T
authors.lastname: Denda
authors.forename: Katsunobu
authors.initials: K
authors.lastname: Tawada
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Imagumbai
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Araki
authors.forename: Mitsuhiro
authors.initials: M
authors.lastname: Sakai
authors.forename: Kazuo
authors.initials: K
authors.lastname: Hatano
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Kawakami
authors.forename: Takashi
authors.initials: T
authors.lastname: Uno
authors.forename: Hisao
authors.initials: H
authors.lastname: Ito
authors.forename: Osamu
authors.initials: O
authors.lastname: Yokosuka
mesh_terms: D000328:Adult; D000368:Aged; D000855:Anorexia / Q000209:etiology; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D018395:CA-19-9 Antigen / Q000097:blood; D003131:Combined Modality Therapy / Q000009:adverse effects / Q000379:methods; D003841:Deoxycytidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D018450:Disease Progression; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000209:etiology; D010094:Oxonic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D011446:Prospective Studies; D011879:Radiotherapy Dosage; D005641:Tegafur / Q000009:adverse effects / Q000627:therapeutic use*; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D018395:CA-19-9 Antigen; D004338:Drug Combinations; D003841:Deoxycytidine; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D000093542:Gemcitabine