Evaluation of effectiveness of chemotherapy in patients with gastric cancer after curative resection

Background. A prospective randomized study involving gastric cancer patients was undertaken to evaluate combined adjuvant chemotherapy and the prognostic value of biologic markers. Methods. One hundred and eighty-five patients under 75 years of age who underwent a curable resection of pathologic stage II or III gastric cancer were randomly assigned to receive adjuvant chemotherapy containing either: mitomycin C (MMC) plus oral 5-fluorouracil (FU) (MF), epirubicin plus oral FU (EF), or oral FU (F). Tumor tissue collected at surgery was immunohistochemically analyzed for p53 and proliferating cell nuclear antigen, and DNA ploidy was determined. Results. All prognostic factors were equally distributed in each arm. There was no significant difference among the groups in the 5-year overall survival. When the relationship between the biologic markers and prognosis was analyzed, the overall survival of all patients and stage III patients was poorer in those with p53 positivity, but the difference did not achieve significance. For patients with positive nodes, irrespective of the treatment regimen, p53-positivity was significantly associated with poorer prognosis (P = 0.05). In stage III patients, the survival of those with p53-positivity and DNA aneuploidy was significantly worse than that for patients with any other combination (P = 0.02). Conclusion. No survival benefit was observed with the combined chemotherapeutic regimens compared with FU alone. p53 positivity was negatively correlated to survival for node-positive and stage III patients. Received: July 3, 2000 / Accepted: September 21, 2000