title: A Phase I Study of S-1 and Gemcitabine with Concurrent Radiotherapy in Patients with Non-Metastatic Advanced Pancreatic Cancer.
abstract: OBJECTIVE
  To determine the recommended dose (RD) for full-dose S-1 and low-dose gemcitabine combined with radiotherapy in patients with non-metastatic advanced pancreatic cancer.
  
  
  METHODS
  Adult patients with non-metastatic advanced pancreatic cancer (Union for International Cancer Control T stage 3 or 4) were eligible. The weekly intravenous gemcitabine (level 0-1: 200 mg/ml,level 2: 300 mg/m on Days 1, 8, 15, 22, 29, 36) dose was escalated starting from level 1 in a 3+3 design along with full dose twice-daily oral S-1 (level 0: 60 mg/m2/day, level 1-2: 80 mg/ml/day), and was administered on the same days as radiotherapy (1.8 Gy x 28 days).
  
  
  RESULTS
  Eight patients were included in this study. A dose-limiting toxicity (DLT) (grade 4 neutropenia) was observed in one of the first three patients in level 1, and three additional patients received the level 1 dose without any severe adverse events. DLTs (grade 3/4 neutropenia) were then observed in the first two patients given level 2 dose. Therefore, level 1 was designated as the RD. Common grade 3/4 toxicities included neutropenia (62.5%), anorexia (37.5%), and pneumonitis (12.5%).
  
  
  CONCLUSIONS
  The combination of S-1 and gemcitabine with concurrent radiotherapy is a feasible regimen at the level 1 dose.
authors.forename: Shin
authors.initials: S
authors.lastname: Kobayashi
authors.forename: Goro
authors.initials: G
authors.lastname: Honda
authors.forename: Masanao
authors.initials: M
authors.lastname: Kurata
authors.forename: Yukihiro
authors.initials: Y
authors.lastname: Okuda
authors.forename: Katsunori
authors.initials: K
authors.lastname: Sakamoto
authors.forename: Katsuyuki
authors.initials: K
authors.lastname: Karasawa
authors.forename: Tachen
authors.initials: T
authors.lastname: Chang
authors.forename: Naoto
authors.initials: N
authors.lastname: Egawa
authors.forename: Terumi
authors.initials: T
authors.lastname: Kamisawa
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Omuro
authors.forename: Koji
authors.initials: K
authors.lastname: Tsuruta
mesh_terms: D000368:Aged; D000855:Anorexia / Q000209:etiology; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D021441:Carcinoma, Pancreatic Ductal / Q000473:pathology / Q000628:therapy*; D059248:Chemoradiotherapy / Q000379:methods*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009503:Neutropenia / Q000209:etiology; D010094:Oxonic Acid / Q000008:administration & dosage; D010190:Pancreatic Neoplasms / Q000473:pathology / Q000628:therapy*; D017564:Radiation Pneumonitis / Q000209:etiology; D005641:Tegafur / Q000008:administration & dosage; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D004338:Drug Combinations; D003841:Deoxycytidine; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D000093542:Gemcitabine