塞来昔布/希罗达节拍化疗治疗老年晚期胃癌的临床研究

The Clinical Study of Celecoxib Combined with Xeloda Metronomic Chemotherapy in the Treatment of the Elderly with Advanced Gastric Cancer

目的:评价塞来昔布(Celecoxib)联合希罗达(Xeloda)节拍化疗(metronomic chemotherapy)治疗老年晚期胃癌的客观疗效及毒副反应,探讨老年晚期胃癌高缓解率、低毒性的治疗方法。方法:45例患者随机分为两组。治疗组23例,采用塞来昔布与希罗达节拍化疗,Celecoxib 200 mg Bid,Xeloda 500 mg Bid,连续服药,直至病情进展。4周为一周期,至少1周期后评定疗效。对照组22例,采用FOLFOX4方案化疗:L-OHP 85 mg/m2 iv gtt 2 h d1,CF 200mg/m2 iv gtt 2 h d1、d2,5-FU400 mg/m2 iv bolus d1、d2,5-FU600 mg/m2 civ 22 h d1、d2。每2周重复,4周为1周期,至少1周期后评定疗效。结果:45例患者均获得随访。治疗组与对照组总有效率(RR)、疾病控制率(DCR)、生活质量改善率(QOL)分别为47.8%(11/23)、50.0%(11/22);91.3%(21/23)、63.6%(14/22);82.6%(19/23)、54.5%(12/22)。两组患者中位疾病进展时间(mTTP)、中位生存期(MST)分别为9.5个月、5.5个月;13.5个月、9个月。治疗组与对照组1年生存率分别为56.5%(13/23)、27.3%(6/22)。两组总有效率差异无统计学意义(P>0.05),生活质量改善率、疾病控制率、1年生存率差异有统计学意义(P<0.05)。治疗组毒副反应轻微。结论:塞来昔布联合希罗达节拍化疗治疗老年晚期胃癌安全、有效,患者得到生存受益,依从性好,效价比高,值得临床进一步研究。

Objective：To evaluate the efficacy and side-effects of Celecoxib combined with Xeloda metronomic chemotherapy in the treatment of the elderly with advanced gastric cancer.Methods：45 cases of elderly advanced gastric cancer were divided into two groups randomly.The observed group（23 cases）was treated with Celecoxib and Xeloda metronomic chemotherapy（Celecoxib 200 mg P.O B.i.d and Xeloda 500 mg P.O B.i.d,continuously until progression of disease）,and the contrast group（22 cases） with FOLFOX4 regimen（L-OHP 85mg/m2 ivgtt 2 h d1,CF 200 mg/m2 ivgtt 2 h followed by 5-FU 400 mg/m2 iv bolus and 5-FU 600 mg/m2 civ 22 h d1,d2,repeated every 2 weeks）.The efficacy and the side-effects were evaluated.Results：The total effective rates /disease control rates /improvement of QOL of the observed group and contrast group were 47.8%（11/23）and 50.0%（11/22）;91.3%（21/23）and 63.6%（14/22）;82.6%（19/23）and 54.5%（12 /22）,respectively.The mTTP of two groups were 9.5 months and 5.5 months,MST were 13.5 months and 9months,respectively.The survival rates for 1 year of the observed group and contrast group were 56.5%（13/23）、27.3%（6/22）,respectively.There was no significant difference in the total effective rates（P〉0.05）,but differences were statistically significant in QOL,DCR and the survival rates for 1 year（P〈0.05）.The toxicity of the observed group is mild.Conclusion：Celecoxib combined with Xeloda metronomic chemotherapy is effective and safe for the elderly with advanced gastric cancer.The paitents can gain survival benefit from this treatment.Further clinical study shoud be warranted.