title: Assessing clinical benefit response in the treatment of gastric malignant ascites with non-measurable lesions: a multicenter phase II trial of paclitaxel for malignant ascites secondary to advanced/recurrent gastric cancer.
abstract: BACKGROUND
  Paclitaxel has shown promise against advanced gastric cancer and associated malignant ascites with non-measurable lesions. In order to evaluate the therapeutic effect of paclitaxel against malignant gastric ascites, a prospective phase II clinical trial was designed according to our previously proposed criteria represented by the clinical benefit response in gastric cancer (CBR-GC) criteria and the five-point method (5PM).
  
  
  METHODS
  Patients with advanced gastric cancer with malignant ascites were treated with 1-h intravenous (i.v.) infusions of 80 mg/m² of paclitaxel weekly over a 3-week cycle on days 1, 8, and 15, followed by 1 week of rest. Therapeutic responses were measured according to the CBR-GC criteria and the 5PM.
  
  
  RESULTS
  The CBR-GC criteria showed improved ascites volume and functional status in 39.1% of patients. A positive CBR-GC response in abdominal girth was seen in 31.3% of patients, and this was significantly correlated with the 5PM-estimated change in ascites volume (p < 0.001). The median number of treatment cycles was 3 (range 1-12). The most common non-hematological toxicity was anorexia, in 22.2% of patients.
  
  
  CONCLUSIONS
  Weekly i.v. paclitaxel is a safe and effective chemotherapeutic regimen based on validated CBR-CG criteria.
authors.affiliation: Department of Surgery, Kinki University, Osaka, Japan.
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Imamoto
authors.forename: Koji
authors.initials: K
authors.lastname: Oba
authors.forename: Junichi
authors.initials: J
authors.lastname: Sakamoto
authors.forename: Hiroyasu
authors.initials: H
authors.lastname: Iishi
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Narahara
authors.forename: Takeyoshi
authors.initials: T
authors.lastname: Yumiba
authors.forename: Takashi
authors.initials: T
authors.lastname: Morimoto
authors.forename: Masaki
authors.initials: M
authors.lastname: Nakamura
authors.forename: Noboru
authors.initials: N
authors.lastname: Oriuchi
authors.forename: Chieko
authors.initials: C
authors.lastname: Kakutani
authors.forename: Satoshi
authors.initials: S
authors.lastname: Morita
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Shiozaki
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects* / Q000627:therapeutic use*; D001201:Ascites / Q000188:drug therapy* / Q000209:etiology / Q000473:pathology; D001202:Ascitic Fluid / Q000473:pathology; D018450:Disease Progression; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D017239:Paclitaxel / Q000009:adverse effects* / Q000627:therapeutic use*; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D015996:Survival Rate; D017211:Treatment Failure; D016896:Treatment Outcome; D055105:Waist Circumference
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel