title: Intravenous and intraperitoneal paclitaxel with S-1 for refractory pancreatic cancer with malignant ascites: an interim analysis.
abstract: OBJECTIVE
  Here, we reported an interim analysis of feasibility and safety in the first 10 cases of 30 cases in a phase II trial of intravenous and intraperitoneal paclitaxel combined with S-1 for gemcitabine-refractory pancreatic cancer with malignant ascites.
  
  
  METHODS
  Paclitaxel was administered intravenously at 50 mg/m2 and intraperitoneally at 20 mg/m2 on days 1 and 8 every 3 weeks, and S-1 was administered at 80 mg/m2/day for 14 consecutive days, followed by 7-day rest.
  
  
  RESULTS
  Between April 2011 and February 2012, ten patients were enrolled. A partial response was achieved in two patients (20%) and a disease control rate of 50%. The median time to progression and overall survival were 2.1 and 3.4 months, respectively. Malignant ascites was completely resolved in two patients (20%). Major grade 3/4 adverse events were myelosuppression including neutropenia (50%) and catheter-related infection (10%).
  
  
  CONCLUSIONS
  This novel combination chemotherapy was feasible and showed promising results in pancreatic cancer patients with malignant ascites (clinical trial registration number: UMIN000005306).
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, , Bunkyo-ku, Tokyo, 113-8655, Japan.
authors.forename: Naminatsu
authors.initials: N
authors.lastname: Takahara
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Isayama
authors.forename: Yousuke
authors.initials: Y
authors.lastname: Nakai
authors.forename: Takashi
authors.initials: T
authors.lastname: Sasaki
authors.forename: Hironori
authors.initials: H
authors.lastname: Ishigami
authors.forename: Hiroharu
authors.initials: H
authors.lastname: Yamashita
authors.forename: Hironori
authors.initials: H
authors.lastname: Yamaguchi
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Hamada
authors.forename: Rie
authors.initials: R
authors.lastname: Uchino
authors.forename: Suguru
authors.initials: S
authors.lastname: Mizuno
authors.forename: Koji
authors.initials: K
authors.lastname: Miyabayashi
authors.forename: Dai
authors.initials: D
authors.lastname: Mohri
authors.forename: Kazumichi
authors.initials: K
authors.lastname: Kawakubo
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Kogure
authors.forename: Natsuyo
authors.initials: N
authors.lastname: Yamamoto
authors.forename: Naoki
authors.initials: N
authors.lastname: Sasahira
authors.forename: Kenji
authors.initials: K
authors.lastname: Hirano
authors.forename: Hideaki
authors.initials: H
authors.lastname: Ijichi
authors.forename: Keisuke
authors.initials: K
authors.lastname: Tateishi
authors.forename: Minoru
authors.initials: M
authors.lastname: Tada
authors.forename: Joji
authors.initials: J
authors.lastname: Kitayama
authors.forename: Toshiaki
authors.initials: T
authors.lastname: Watanabe
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Koike
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000556:secondary*; D000368:Aged; D000505:Alopecia / Q000139:chemically induced; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001201:Ascites / Q000188:drug therapy* / Q000209:etiology; D055499:Catheter-Related Infections / Q000453:epidemiology / Q000209:etiology; D003841:Deoxycytidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D004334:Drug Administration Schedule; D004338:Drug Combinations; D019008:Drug Resistance, Neoplasm; D005221:Fatigue / Q000139:chemically induced; D005240:Feasibility Studies; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D007262:Infusions, Intravenous; D007263:Infusions, Parenteral; D008297:Male; D008875:Middle Aged; D010094:Oxonic Acid / Q000008:administration & dosage / Q000009:adverse effects; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D010190:Pancreatic Neoplasms / Q000150:complications / Q000188:drug therapy*; D011446:Prospective Studies; D016879:Salvage Therapy; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D004338:Drug Combinations; D003841:Deoxycytidine; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D017239:Paclitaxel; D000093542:Gemcitabine