Phase II clinical trial of postoperative S-1 monotherapy for gastric cancer patients with free intraperitoneal cancer cells detected by real-time RT-PCR

World J Surg. 2010 Sep;34(9):2083-9. doi: 10.1007/s00268-010-0573-6.

Abstract

Background: We have previously reported the molecular detection of peritoneal micrometastases in patients with gastric cancer by quantifying carcinoembryonic antigen (CEA) mRNA in the peritoneal washes. Patients with CEA mRNA exceeding a cutoff value have a significant risk for developing peritoneal carcinomatosis, but optimal treatment for this population remains unknown.

Methods: CEA mRNA (+) patients with gastric cancer were treated postoperatively with S-1 monotherapy. Overall survival, the primary endpoint of this phase II trial, was compared with the historical control, which is comprised of CEA mRNA (+) patients who were not given postoperative chemotherapy.

Results: A total of 32 patients with CEA mRNA (+) gastric cancer were enrolled. Twelve patients (37.5%) relapsed; ten showed peritoneal relapse. Three-year survival was similar between the study population and the historical control (67.3% vs. 67.1%, respectively).

Conclusions: S-1 monotherapy, which significantly reduced risk for recurrence in stage II/III gastric carcinoma in another phase III trial, seems not to be as effective in eradicating free cancer cells in the abdominal cavity.

Publication types

  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adenocarcinoma / drug therapy*
  • Adenocarcinoma / mortality
  • Adenocarcinoma / pathology
  • Adenocarcinoma / surgery
  • Antimetabolites, Antineoplastic / administration & dosage*
  • Carcinoembryonic Antigen / analysis
  • Chemotherapy, Adjuvant
  • Disease-Free Survival
  • Drug Combinations
  • Female
  • Humans
  • Kaplan-Meier Estimate
  • Lymphatic Metastasis
  • Male
  • Middle Aged
  • Neoplasm Staging
  • Oxonic Acid / administration & dosage*
  • Peritoneal Lavage
  • Peritoneal Neoplasms / secondary*
  • Reverse Transcriptase Polymerase Chain Reaction
  • Risk Assessment
  • Stomach Neoplasms / drug therapy*
  • Stomach Neoplasms / mortality*
  • Stomach Neoplasms / pathology
  • Stomach Neoplasms / surgery
  • Tegafur / administration & dosage*

Substances

  • Antimetabolites, Antineoplastic
  • Carcinoembryonic Antigen
  • Drug Combinations
  • S 1 (combination)
  • Tegafur
  • Oxonic Acid