title: A phase II trial of perioperative chemotherapy involving a single intraperitoneal administration of paclitaxel followed by sequential S-1 plus intravenous paclitaxel for serosa-positive gastric cancer.
abstract: OBJECTIVE
  We carried out a phase II trial to evaluate the feasibility, efficacy, and tolerability of perioperative chemotherapy including single intraperitoneal(IP) administration of paclitaxel(PTX) followed by intravenous(IV) administrations of PTX with S-1 in a neoadjuvant setting for serosa-positive gastric cancer.
  
  
  METHODS
  Patients with cT4a gastric cancer were enrolled. A laparoscopic survey was performed before study inclusion for the confirmation of serosal invasion, negative lavage cytology, and negative peritoneal metastasis. IP PTX (80 mg/m(2)) was administered, followed by systemic chemotherapy. Surgery was performed after the completion of chemotherapy. The primary endpoint was the treatment completion rate.
  
  
  RESULTS
  37 patients were recruited. The treatment completion rate was 67.6% (25/37; 90% CI, 52.8-80.1%), which was significantly higher than 50%; we set this as a threshold value (P = 2.4% [one-sided]). 14 patients had target lesions; of these, 10 showed a partial response (71.4%), three had stable disease (21.4%), and one had progressive disease(7.2%). The response rate was 71.4% (10/14). All patients underwent gastrectomy with D2 lymph node dissection. The 3- and 5-year OS rates were 78.0 and 74.9%, respectively.
  
  
  CONCLUSIONS
  Perioperative chemotherapy including neoadjuvant IP PTX followed by sequential IV PTX with S-1 for serosa-positive gastric cancer is feasible, safe, and efficient.
authors.affiliation: Department of Surgery, Kinki University, Faculty of Medicine, Osaka-sayama, Osaka, Japan.
authors.forename: Ying-Feng
authors.initials: YF
authors.lastname: Peng
authors.affiliation: Department of Surgery, Kinki University, Faculty of Medicine, Osaka-sayama, Osaka, Japan.
authors.forename: Motohiro
authors.initials: M
authors.lastname: Imano
authors.affiliation: Department of Pathology, Kinki University, Faculty of Medicine, Osaka-sayama, Osaka, Japan.
authors.forename: Tatsuki
authors.initials: T
authors.lastname: Itoh
authors.affiliation: Department of Pathology, Kinki University, Faculty of Medicine, Osaka-sayama, Osaka, Japan.
authors.forename: Takao
authors.initials: T
authors.lastname: Satoh
authors.affiliation: Clinical Research Center, Kinki University Hospital, Osaka-sayama, Osaka, Japan.
authors.forename: Yasutaka
authors.initials: Y
authors.lastname: Chiba
authors.affiliation: Department of Surgery, Kinki University, Faculty of Medicine, Osaka-sayama, Osaka, Japan.
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Imamoto
authors.affiliation: Division of Pharmacotherapy, Kinki University, Faculty of Pharmacy, Higashi-osaka, Osaka, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Tsubaki
authors.affiliation: Division of Pharmacotherapy, Kinki University, Faculty of Pharmacy, Higashi-osaka, Osaka, Japan.
authors.forename: Shozo
authors.initials: S
authors.lastname: Nishida
authors.affiliation: Department of Surgery, Kinki University, Faculty of Medicine, Osaka-sayama, Osaka, Japan.
authors.forename: Takushi
authors.initials: T
authors.lastname: Yasuda
authors.affiliation: Department of Surgery, Kinki University, Faculty of Medicine, Osaka-sayama, Osaka, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Furukawa
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D004338:Drug Combinations; D005240:Feasibility Studies; D005260:Female; D005743:Gastrectomy; D006801:Humans; D057967:Infusions, Intraventricular; D007263:Infusions, Parenteral; D007274:Injections, Intraperitoneal; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D010094:Oxonic Acid / Q000008:administration & dosage*; D017239:Paclitaxel / Q000008:administration & dosage*; D012704:Serous Membrane / Q000473:pathology; D013274:Stomach Neoplasms / Q000188:drug therapy*; D005641:Tegafur / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D017239:Paclitaxel
keywords: intraperitoneal administration; perioperative chemotherapy; serosa-positive gastric cancer