吉西他滨联合奥沙利铂或顺铂治疗老年人晚期非小细胞肺癌的随机对照临床研究

Randomized clinical study comparing gemcitabine and oxaliplatin versus gemcitabine and cisplatin for advanced non-small cell lung cancer in elderly patients

背景与目的化疗可延长患者生存期,改善生活质量,是治疗晚期非小细胞肺癌的主要方法。对于70岁及以上的老年晚期非小细胞肺癌患者,治疗的毒副反应和治疗耐受性尤其重要。本研究的目的是观察比较吉西他滨联合奥沙利铂和吉西他滨联合顺铂治疗70岁及以上老年人晚期非小细胞肺癌的疗效和毒副反应。方法42例患者按随机表法分为GO组20例(吉西他滨1000mg/m2,第1、8天;奥沙利铂65mg/m2,第1、8天)和GP组22例(吉西他滨1000mg/m2,第1、8天;顺铂30mg/m2,第1～3天),28天为一周期,均治疗2周期以上。结果GO组CR1例,PR10例,SD7例,PD2例,有效率为55.0%;中位生存期为11.2月,1年生存率为45%。GP组PR9例,SD10例,PD3例,有效率为40.9%;中位生存期为11.8月,1年生存率为50%。两组有效率、中位生存期和1年生存率比较均无显著性差异(P均>0.05)。毒副反应以白细胞降低和胃肠道反应为主,GP组Ⅲ+Ⅳ度白细胞下降发生率和恶心呕吐发生率均显著高于GO组(17.4%vs4.8%,20.7%vs3.6%,P均<0.05),GP组Ⅰ+Ⅱ度脱发和肾功能异常发生率均显著高于GO组(43.5%vs10.7%,14.1%vs2.4%,P均<0.05)。结论对于70岁及以上老年人晚期非小细胞肺癌,吉西他滨加奥沙利铂方案有较好的近期疗效,毒副反应轻,治疗耐受性好,临床应用更安全。

Background and objective In most instances, advanced non-small cell lung cancer （NSCLC） is treated with primary chemotherapy. Many chemotherapy regimens can palliate cancer-related symptoms. Quality of life and modestly improved survival are very important especially for elderly patients. This clinical trial is to compare the efficacy and toxicity of gemcitabine and oxaliplatin （GO） versus gemcitabine and cisplatin （GP） in treatment of advanced NSCLC in elderly patients. Methods A total of 42 patients with advanced NSCLC diagnosed pathologically were randomly divided into GO group （gerncitabine 1 000 rng/m^2 on days 1, 8; oxaliplatin 65 rng/m^2 on days 1, 8） and GP group （gemcitabine 1 000 mg/m^2 on days 1, 8; cisplatin 30 mg/ m^2 on days 1-3）, 28 days as a cycle. All patients received two cycles of chemotherapy at least. Results In GO group, the response rate was 55.0%. Whereas in GP group, the response rate was 40. 9%. The difference in response rate was not statistically significant between the two groups （P〉0.05）. The median survival duration was 11.2 months in GO group and 11.8 months in GP group. The 1-year survival rate was 45% in GO group and 50% in GP group （P〉0.05）. The main toxicities were well tolerated. Leukopenia and nausea/ vomiting at grade Ⅲ＋ Ⅳ, and alopecia and impaired renal function at grade Ⅰ ＋ Ⅱ occurred more frequently in GP group than those in GO group （P〈0.05）. Conclusion Both of the two regimens are feasible, well-tolerated and effective in treatment of advanced NSCLC in elderly patients. GO regimen may be safer than GP regimen.