Abstract:
Abstract Objective: To evaluate the clinical efficacy and safety of the regimen with oxaliplatin plus fluorouracil for patients with stage Ⅱ or Ⅲ gastric cancer treated with surgery. Methods: Data from 279 patients with stage II or III gastric cancer who underwent radical surgery for carcinoma of stomach in the Tianjin Medical University Cancer Institute and Hospital between 2007 and November 2008 were retrospectively analyzed. Among these patients, 200 received a regimen of oxaliplatin plus fluorouracil after surgery and 79 were not treated but were observed. The 3 year survival rate of the patients was measured with the life table. Kaplan-Meier method was used for survival analysis. The effects of adjuvant chemotherapy on the three-year survival rate in patients with different stages of gastric cancer and at various ages were analyzed using the analytic hierarchy process ( AHP ) method. The effects of the factors including age, gender, surgical approach, clinical stage, pathologic type, depth of invasion, nodal metastasis, adjuvant chemotherapy, site and size of tumor, number of dissected lymph node, and duration of adjuvant chemotherapy on the prognosis were analyzed by COX regression analysis. NCI-CTC 3.0 criteria was used for evaluating toxicity. Results: The three-year survival rate was 61% and 52% in the group with adjuvant chemotherapy and simple surgery, respectively. No statistical significance between the groups was found ( P = 0.094 ). Further analysis showed that the patients who received 3 cycles to 8 cycles of adjuvant chemotherapy had better survival compared with those who underwent surgery alone or received chemotherapy of less than 3 cycles ( P = 0.025, 0.013, respectively ). Through the AHP method, the patients with stageⅢcancer younger than 65 years old who underwent 3 cycles of chemotherapy or over had better 3-year survival rate ( 47%, 64% ) compared with patients who received chemotherapy of 0 cycles to 2 cycles ( 38%, 49% ) ( P = 0.015, 0.006 ). However, no statistical significance in the survival between patients with stage Ⅲ gastric cancer and those aged 65 years or older was found. Multivariate analysis revealed that the duration of adjuvant chemotherapy ( P = 0.000 ), depth of invasion ( P = 0.005 ), lymph node metastasis ( P = 0.000 ), and pathological type ( P = 0.008 ) are the independent prognostic factors. The adverse events of grades Ⅰ or Ⅱ were relatively common in the adjuvant chemotherapy group, with favorable drug tolerance. Conclusion: The oxaliplatin plus fluorouracil regimen is an effective adjuvant therapy after surgery for patients with stage Ⅱ or Ⅲ gastric cancer.