奥沙利铂联合氟脲嘧啶用于胃癌辅助化疗的临床观察

观察奥沙利铂联合氟脲嘧啶用于Ⅱ、Ⅲ期胃癌根治术后辅助化疗的临床疗效及不良反应。方法：分析本院2007年11月至2008年11月间279例接受根治术的Ⅱ、Ⅲ期胃癌患者，其中200例患者术后接受奥沙利铂联合氟脲嘧啶化疗，79例患者术后未行任何治疗，分层分析辅助化疗在不同分期、不同年龄患者中对3年生存率的影响，单因素及多因素分析年龄、性别、手术术式、病理类型、浸润深度、淋巴结转移度、辅助化疗、肿瘤部位、肿瘤大小、化疗时间、切检淋巴结数目等因素对患者预后的影响。根据NCI-CTC 3.0毒性标准来评价化疗的毒性。结果：辅助化疗组与单纯手术组3年生存率分别为61%和52%，差异无统计学意义（P=0.094），进一步分析发现，辅助化疗时间为3~8个周期者（134例）的3年生存率优于未化疗者或化疗时间为1～2个周期者，P值分别为0.025和0.013。亚组分析发现，Ⅲ期患者中及年龄<65岁患者中术后接受≥3个周期辅助化疗者的3年生存率（47%，64%）均优于化疗时间为0~2个周期者（38%，49%），P值分别为0.015和0.006；而在Ⅱ期患者中及年龄≥65岁患者中生存差异均未有统计学意义。Cox多因素分析显示，辅助化疗时间（P<0.001）、浸润深度（P=0.005）、淋巴结转移度（P<0.001）及病理类型（P=0.008）是独立的预后因素。不良反应多为Ⅰ～Ⅱ级，耐受性良好。结论：奥沙利铂联合氟脲嘧啶方案用于Ⅱ、Ⅲ期胃癌根治术后辅助化疗可提高生存率，且耐受性良好。

Clinical Study of Postoperative Adjuvant Chemotherapy with Oxaliplatin Plus Fluorouracil forGastric Cancer

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.