title: Safety of intraperitoneal administration of paclitaxel after gastrectomy with en-bloc D2 lymph node dissection.
abstract: BACKGROUND
  The aim of this study was to examine the safety, pharmacokinetics, and cytological efficacy against free intraperitoneal cancer cells of intraperitoneal chemotherapy (IPC) with paclitaxel after gastrectomy with en-bloc D2 lymph node dissection (GD2) in cases of gastric cancer with peritoneal carcinomatosis (PC) and/or positive cytological findings in peritoneal washings (CFPW).
  
  
  METHODS
  Twenty-one patients with gastric cancer with PC and/or positive CFPW who underwent GD2 were treated with early, post-operative, intraperitoneal paclitaxel. Intra-chemotherapeutic toxicity and operative complication were measured using the common toxicity criteria of the National Cancer Institute, version 3.0. Intraperitoneal and plasma paclitaxel concentrations were measured using a high-performance liquid chromatography assay.
  
  
  RESULTS
  Grade 3 anemia occurred in two patients (9.5%) and neutropenia was observed in three patients (14.3%). No grade 4 toxicity was observed. A grade 2 operative complication was a superficial surgical site infection (4.8%) that was treated with antibiotics. Cytologically, no viable cancer cells were observed in the intra-abdominal fluid 24 hr after intraperitoneal administration of paclitaxel. The intraperitoneal/plasma area under the drug concentration-time curve (AUC) ratio was 596.9:1.
  
  
  CONCLUSIONS
  IPC with paclitaxel after GD2 is a safe and cytologically effective treatment modality for free intraperitoneal cancer cells. However, additional data are required to determine the effect on survival.
authors.affiliation: Department of Surgery, Kinki University Faculty of Medicine, Osaka-Sayama, Osaka, Japan. imano@med.kindai.ac.jp
authors.forename: Motohiro
authors.initials: M
authors.lastname: Imano
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Imamoto
authors.forename: Tatsuki
authors.initials: T
authors.lastname: Itoh
authors.forename: Takao
authors.initials: T
authors.lastname: Satou
authors.forename: Ying-Feng
authors.initials: YF
authors.lastname: Peng
authors.forename: Atsushi
authors.initials: A
authors.lastname: Yasuda
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Kato
authors.forename: Osamu
authors.initials: O
authors.lastname: Shiraishi
authors.forename: Masayuki
authors.initials: M
authors.lastname: Shinkai
authors.forename: Takushi
authors.initials: T
authors.lastname: Yasuda
authors.forename: Yoshifumi
authors.initials: Y
authors.lastname: Takeyama
authors.forename: Kiyokata
authors.initials: K
authors.lastname: Okuno
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Shiozaki
mesh_terms: D000230:Adenocarcinoma / Q000401:mortality / Q000556:secondary / Q000628:therapy*; D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000627:therapeutic use; D003131:Combined Modality Therapy; D005260:Female; D005500:Follow-Up Studies; D005743:Gastrectomy; D006801:Humans; D007274:Injections, Intraperitoneal; D008197:Lymph Node Excision; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000627:therapeutic use*; D010534:Peritoneal Neoplasms / Q000401:mortality / Q000556:secondary / Q000628:therapy*; D011183:Postoperative Complications; D011446:Prospective Studies; D012449:Safety; D013274:Stomach Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel