奥沙利铂联合5-氟尿嘧啶治疗中晚期食管癌的临床疗效及安全性评价

Clinical efficacy and safety of oxaliplatin combined with 5-fluorouracil in the treatment of advanced esophageal cancer

目的评价奥沙利铂联合5-氟尿嘧啶治疗中晚期食管癌的临床疗效及安全性。方法将65例局部中晚期不能手术的食管癌患者随机分为对照组32例和试验组33例。2组患者均予以常规分割放疗,每次2.0 Gy,总剂量56~66Gy。化疗在放疗的第1天开始,对照组予以52.5 mg·m^(-2)·d^(-1)顺铂,静脉滴注,第1天+500 mg·m^(-2)·d^(-1)5-氟尿嘧啶,静脉滴注,第1~5天;试验组予以奥沙利铂85~100 mg·m^(-2)·d^(-1),静脉滴注2 h,第1天+500 mg·m^(-2)·d^(-1)5-氟尿嘧啶,静脉滴注,第1~5天。2组患者一个疗程均为4周,共治疗2个疗程。比较2组患者的临床疗效和不良反应发生率。结果治疗后,试验组和对照组的总有效率分别为81.80%和75.00%(P>0.05),疾病控制率分别为96.97%和93.75%(P>0.05),1年的生存率分别为77.30%和68.20%(P>0.05)。试验组的恶心呕吐发生率为36.40%显著低于对照组62.50%(P<0.05);试验组的感觉异常发生率为24.00%显著高于对照组的0(P<0.05)。结论奥沙利铂联合5-氟尿嘧啶同步放化疗治疗中晚期食管癌的近期临床疗效确切,不良反应可控。

Objective To evaluate the clinical efficacy and safety of oxaliplatin combined with 5-fluorouracil（ 5-FU） in the treatment of advanced esophageal cancer. Methods Sixty-five patients with advanced esophageal cancer were randomly divided into control group（ n = 32） and treatment group（ n = 33）. The patients in two groups were treated with conventional fractionated radiotherapy at 2. 0 Gy,with a total dose of 56-66 Gy. Chemotherapy was delivered on the first day of radiotherapy. Control group was received 52. 5 mg · m（-2）·d（-1）cisplatin on day 1 ＋ 500 mg · m（-2）·d（-1）5-Fu on day 1-5 through intravenous drip. Treatment group was received 85-100 mg·m（-2）·d（-1）oxaliplatin through intravenous infusion two hours on day 1 ＋ 500 mg·m（-2）·d（-1）5-FU on day 1-5 through intravenous drip. Every 4 weeks was a cycle,all received two cycles of chemotherapy. The clinical efficacy and incidence of adverse drug reactions between two groups were compared.Results After treatment, total effective rates were 81. 80% and75. 00% in treatment group and control group,disease control rates were96. 97% and 93. 75% in treatment group and control group,one yearsurvival rates were 77. 30% and 68. 20% in treatment group and control group,with no statistical difference between the two groups（ P〈0. 05）. After treatment,the occurrence rate of nausea and vomiting in treatment group was significantly lower than that in control group（ 34. 60% vs 62. 50%,P〈0. 05）. The occurrence rate of sensory neuropathy in treatment group was significantly higher than that in control group（ 24. 00% vs 0,P〈0. 05）. Conclusion Concurrent chemoradiation with oxaliplatin and 5-FU for the treatment of advanced esophageal cancer exhibited a definitive clinical efficacy with clinical manageable adverse drug reactions.