title: Multicenter Phase II Study of Intravenous and Intraperitoneal Paclitaxel With S-1 for Pancreatic Ductal Adenocarcinoma Patients With Peritoneal Metastasis.
abstract: To evaluate the clinical efficacy and tolerability of intravenous (i.v.) and intraperitoneal (i.p.) paclitaxel combined with S-1, "an oral fluoropyrimidine derivative containing tegafur, gimestat, and otastat potassium" in chemotherapy-naive pancreatic ductal adenocarcinoma (PDAC) patients with peritoneal metastasis.
  
  
  
  PDAC patients with peritoneal metastasis (peritoneal deposits and/or positive peritoneal cytology) have an extremely poor prognosis. An effective treatment strategy remains elusive.
  
  
  
  Paclitaxel was administered i.v. at 50 mg/m and i.p. at 20 mg/m on days 1 and 8. S-1 was administered at 80 mg/m/d for 14 consecutive days, followed by 7 days of rest. The primary endpoint was 1-year overall survival (OS) rate. The secondary endpoints were antitumor effect and safety (UMIN000009446).
  
  
  
  Thirty-three patients who were pathologically diagnosed with the presence of peritoneal dissemination (n = 22) and/or positive peritoneal cytology (n = 11) without other organ metastasis were enrolled. The tumor was located at the pancreatic head in 7 patients and the body/tail in 26 patients. The median survival time was 16.3 (11.47-22.57) months, and the 1-year survival rate was 62%. The response rate and disease control rate in assessable patients were 36% and 82%, respectively. OS in 8 patients who underwent conversion surgery was significantly higher than that of nonsurgical patients (n = 25, P = 0.0062). Grade 3/4 hematologic toxicities occurred in 42% of the patients and nonhematologic adverse events in 18%. One patient died of thrombosis in the superior mesenteric artery.
  
  
  
  This regimen has shown promising clinical efficacy with acceptable tolerability in chemotherapy-naive PDAC patients with peritoneal metastasis.
authors.affiliation: *Department of Surgery, Kansai Medical University †Department of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine ‡Department of Surgery, Tohoku University Graduate School of Medicine §Department of Surgery, University of Tsukuba ¶Department of Gastroenterology, Graduate School of Medicine, the University of Tokyo ||Department of Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital **Department of Chemotherapy, the University of Tokyo.
authors.forename: Sohei
authors.initials: S
authors.lastname: Satoi
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Fujii
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Yanagimoto
authors.forename: Fuyuhiko
authors.initials: F
authors.lastname: Motoi
authors.forename: Masanao
authors.initials: M
authors.lastname: Kurata
authors.forename: Naminatsu
authors.initials: N
authors.lastname: Takahara
authors.forename: Suguru
authors.initials: S
authors.lastname: Yamada
authors.forename: Tomohisa
authors.initials: T
authors.lastname: Yamamoto
authors.forename: Masamichi
authors.initials: M
authors.lastname: Mizuma
authors.forename: Goro
authors.initials: G
authors.lastname: Honda
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Isayama
authors.forename: Michiaki
authors.initials: M
authors.lastname: Unno
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Kodera
authors.forename: Hironori
authors.initials: H
authors.lastname: Ishigami
authors.forename: Masanori
authors.initials: M
authors.lastname: Kon
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000627:therapeutic use; D021441:Carcinoma, Pancreatic Ductal / Q000188:drug therapy / Q000401:mortality / Q000556:secondary*; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D007274:Injections, Intraperitoneal; D008297:Male; D008875:Middle Aged; D010094:Oxonic Acid / Q000008:administration & dosage* / Q000627:therapeutic use; D017239:Paclitaxel / Q000008:administration & dosage* / Q000627:therapeutic use; D010190:Pancreatic Neoplasms / Q000401:mortality / Q000473:pathology*; D010534:Peritoneal Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000556:secondary*; D016019:Survival Analysis; D005641:Tegafur / Q000008:administration & dosage* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D017239:Paclitaxel