摘要目的 评价以奥沙利铂为基础的化学治疗方案对胃癌术后辅助化学治疗患者及老年患者的有效性和安全性.方法 分析2008年11月至2011年11月间接受以奥沙利铂为基础的术后辅助化学治疗的324例胃癌患者,其中97例为>65岁的老年患者.接受FOLFOX4/6方案(奥沙利铂+5-氟尿嘧啶+亚叶酸钙)者112例,其中老年患者30例;接受EOX方案(奥沙利铂+表柔比星+卡培他滨)者86例,其中老年患者25例;接受XELOX方案(奥沙利铂+卡培他滨)者126例,其中老年患者42例.统计各组的总生存率和无病生存率,分析各化学治疗方案的有效性和安全性.采用卡方检验比较各组患者间的临床资料,采用寿命表法计算累计生存率.结果 324例患者中54例(其中老年患者14例)未完成全程化学治疗.270例完成了全程化学治疗及术后3年随访.中青年组187例患者中,EOX、FOLFOX6、FOLFOX4、XELOX方案的3年无病生存率分别为74.5%、75.5%、73.5%、72.0%,各方案差异无统计学意义(x2=0.016,P=0.899),其3年总生存率分别为77.0%、78.0%、76.0%、76.5%,各方案差异无统计学意义(x2=0.020,P=0.990).老年组83例患者中,EOX、FOLFOX4/6、XELOX方案的3年无病生存率分别为73.0%、75.5%、75.0%,各方案差异无统计学意义(x2=0.017,P=0.894),3年总生存率分别为76.0%、79.0%、78.0%,各方案差异无统计学意义(x2=0.028,P=0.915).其中高分化组患者的3年总生存率为76.0%、无病生存率为73.0%,中分化组3年总生存率为74.0%、无病生存率为72.0%,低分化组3年总生存率为75.0%、无病生存率为73.0%.中青年组生存期达36个月者141例,老年组生存期达36个月者61例,两组生存期差异无统计学意义(U=1.72,P>0.05).主要不良反应包括白细胞和(或)中性粒细胞减少、血小板减少、贫血,恶心、呕吐、腹泻、肝功能异常,周围神经毒性.结论 以奥沙利铂为基础的3种标准方案均能显著延长患者的生存期,不良反应发生率低,安全有效,老年患者耐受性、安全性、依从性亦较好.
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abstractsObjective To evaluate the efficacy and safety of oxaliplatin (OXA)-based chemotherapy as postoperative adjuvant chemotherapy for patients with gastric cancer and the aged patients.Methods From November 2008 to November 2011,324 gastric cancer patients received OXA based postoperative adjuvant chemotherapy were analyzed.Among them,97 patients were over 65 years old.A total of 112 patients accepted FOLFOX4/6 program (OXA + 5-fluorouracil + calicium folinate),among them 30 cases were aged patients.A total of 86 patients accepted EOX program (OXA + epirubicin + capecitabine),and 25 cases of them were aged patients.A total of 126patients accepted XELOX program (OXA + capecitabine),and 42 cases of them were aged patients.The overall survival (OS) and disease-free survival (DFS) of each group were counted.The efficacy and safety of each chemotherapy program were analyzed.Chi square test was performed to compare the clinical data of each group.Life table method was used to calculate the cumulative survival rate.Results Fifty-four cases (14 aged patients included) of 324 patients did not complete the full chemotherapy.A total of 270 cases completed the full chemotherapy and 3-year follow-up.In 187 young and middle-aged cases,the 3-year DFS rate of EOX,FOLFOX6,FOLFOX4 and XELOX programs was 74.5%,75.5%,73.5% and 72.0% respectively,and there was no statistically significant difference between groups (x2=0.016,P=0.899).The 3-year OS rate was 77.0%,78.0%,76.0% and 76.5% respectively,there was no statistically significant difference between groups (x2=0.020,P=0.990).In 83 aged patients,the 3-year DFS rate of EOX,FOLFOX4/6 and XELOX programs was 73.0%,75.5% and 75.0% respectively,there was no statistically significant difference between groups (x2 =0.017,P=0.894),3-year OS rate was 76.0%,79.0% and 78.0% respectively,there was no statistically significant differences between groups (x2=0.028,P=0.915).The 3-year OS and DFS of high differentiation group was 76 % and 73 %,middle differentiation group was 74% and 72%,and low differentiation group was 75% and 73%.There were 141 cases in young and middle-aged group with 36 months survival period,while 61 cases in aged group,and there was no significant difference in survival period between two groups (U=1.72,P>0.05).The main side effects included leukopenia,neutropenia,thrombocytopenia,anemia,nausea,vomiting,peripheral neurotoxicity,diarrhea and abnormal liver function injury.Conclusions All the three OXA-based standard programs could significantly prolong the survival period of patients with low rates of side-effects.They were identified to have good tolerance,high safety and high compliance even in aged patients.
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