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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 Apr 9;
Authors: Ito S, Kodera Y, Mochizuki Y, Kojima T, Nakanishi H, Yamamura Y
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.
PMID: 20379713 [PubMed - as supplied by publisher]