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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 objective efficacy and side effects of Celecoxib combined with Xeloda metronomic chemotherapy in the treatment of elderly patients with advanced gastric cancer, and to explore the treatment of elderly patients with advanced gastric cancer with high response rate and low toxicity. Methods: 45 patients were randomly divided into two groups. In the treatment group, 23 patients were treated with Celecoxib and Xeloda Beat Chemotherapy, Celecoxib 200 mg Bid, and Xeloda 500 mg Bid respectively until the disease progressed. 4 weeks for a period of at least 1 cycle after the assessment of efficacy. Control group, 22 cases were treated with FOLFOX4 chemotherapy: L-OHP 85 mg / m2 iv gtt 2 h d1, CF 200 mg / m2 iv gtt 2 h d1, d2,5-FU 400 mg / m2 iv bolus d1, d2,5-FU600 mg / m2 civ 22 h d1, d2. Repeat every 2 weeks, 4 weeks for 1 cycle, at least 1 cycle after the assessment of efficacy. Results: All the 45 patients were followed up. The total effective rate (RR), disease control rate (DCR) and quality of life improvement (QOL) of the treatment group and the control group were 47.8% (11/23), 50.0% (11/22), 91.3% (21/23) ), 63.6% (14/22); 82.6% (19/23), 54.5% (12/22). Median disease progression time (mTTP) and median survival (MST) were 9.5 months, 5.5 months, 13.5 months, and 9 months in both groups. The 1-year survival rates of the treatment group and the control group were 56.5% (13/23) and 27.3% (6/22), respectively. The total effective rate was no significant difference between the two groups (P> 0.05), quality of life improvement, disease control rate, 1 year survival rate difference was statistically significant (P <0.05). Toxicity in treatment group was slight. Conclusion: Celecoxib in combination with Xeloda tempo chemotherapy is safe and effective in elderly patients with advanced gastric cancer. The patients have survival benefit, good compliance and high cost-effectiveness, which deserves clinical further study.