奥沙利铂联合替吉奥治疗晚期胰腺癌疗效观察

Clinical trial of oxaliplatin and tegafur gimeraci combination therapy on advanced pancreatic cancer

目的评价奥沙利铂联合替吉奥治疗晚期胰腺癌的临床疗效。方法选取50例晚期胰腺癌患者随机分为奥沙利铂联合替吉奥组(观察组)和吉西他滨单药组(对照组),每组25例。观察组患者化学治疗方案为奥沙利铂130 mg·m-2,静脉滴注,第1天,替吉奥40 mg·m-2,口服,每日2次,第1天至第14天,21 d为1个周期;对照组患者化学治疗方案为吉西他滨1 000 mg·m-2,静脉滴注,第1天,第8天,21 d为1个周期。观察2组患者的无进展生存期、客观缓解率、总生存期及药物安全性。结果观察组患者中位无进展生存期明显长于对照组(6.2个月vs 3.6个月,RR=0.64,P=0.036);观察组患者的客观缓解率为28.0%,高于对照组的8.0%(P=0.035);观察组患者的中位总生存期长于对照组(13.0个月vs 8.5个月,RR=0.72,P=0.104),但差异无统计学意义(P>0.05)。2组患者3/4级不良反应相似。结论奥沙利铂联合替吉奥治疗晚期胰腺癌与吉西他滨单药相比,疗效更优,且不良反应相似,联合用药未增加药物毒性,值得进一步开展大规模的Ⅲ期临床研究。

Objective To explore the clinical efficacy of oxaliplatin and tegafur gimeraci （ S-1 ） combination therapy on advanced pancreatic cancer. Methods Fifty cases with advanced pancreatic cancer were randomly divided into observation group and control group ,25 cases in each group. The cases in observation group were given oxaliplatin 130 mg·m-2 by intra- venous drip on the first day, and combining with 40 mg ·m-2 orally twice a day on days 1 - 14. Twenty-one days as a treatment cycle. The cases in control group were treated with gemcitabine alone（ 1 000 mg·m-2 gemcitabine by intravenous drip on the first day and the eighth day）, and twenty-one days as a treatment cycle. Progression-free survival（PFS） , objective response rate （ORR）, overall survival（OS） and safety of the two groups were observed. Results The PFS of observation group was longer than that in control group （6.2 vs 3.6 months, RR = 0.64, P = 0.036 ）. The ORR of observation group was 28.0% , it was higher than that in control group（8.0% ） （ P = 0.035 ）. The OS of observation group was longer than that in control group（ 13.0 vs 8.5 months, RR = 0.72, P = 0. 104 ）, but there was no significant difference between the two groups （ P 〉 0. 05 ）. Overall grade 3 or 4 adverse reactions in observation group were similar with control group. Conclusion Comparing with the gemcitabinem, the combination therapy of oxaliplatin and S-1 has better curative effect, and with the similar adverse reaction. It hasn＇t increased the drug toxicity, and it is worthy to make the m phase clinical