Multicenter Phase II study of intravenous and intraperitoneal paclitaxel with s-1 for pancreatic ductal adenocarcinoma patients with peritoneal metastasis

Sohei Satoi, Tsutomu Fujii, Hiroaki Yanagimoto, Fuyuhiko Motoi, Masanao Kurata, Naminatsu Takahara, Suguru Yamada, Tomohisa Yamamoto, Masamichi Mizuma, Goro Honda, Hiroyuki Isayama, Michiaki Unno, Yasuhiro Kodera, Hironori Ishigami, Masanori Kon

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77 Citations (Scopus)


Objective: 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. Background: PDAC patients with peritoneal metastasis (peritoneal deposits and/or positive peritoneal cytology) have an extremely poor prognosis. An effective treatment strategy remains elusive. Methods: Paclitaxel was administered i.v. at 50mg/m2 and i.p. at 20mg/m2 on days 1 and 8. S-1 was administered at 80mg/m2/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). Results: 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. Conclusions: This regimen has shown promising clinical efficacy with acceptable tolerability in chemotherapy-naive PDAC patients with peritoneal metastasis.

Original languageEnglish
Pages (from-to)397-401
Number of pages5
JournalAnnals of Surgery
Issue number2
Publication statusPublished - 2017


  • Intraperitoneal chemotherapy
  • Paclitaxel
  • Pancreatic ductal adenocarcinoma
  • Peritoneal metastasis
  • S-1


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