吉西他滨/多西他赛联合铂类一线治疗转移性鼻咽癌的临床对照研究

Clinical control study of gemcitabine or docetaxel combined with platinum as first-line therapy for metastatic nasopharyngeal carcinoma

目的:观察吉西他滨联合铂类与多西他赛联合铂类方案在转移性鼻咽癌一线治疗中的疗效及耐受性。方法:2011年1月至2015年12月广西医科大学第四附属医院诊疗的转移性鼻咽癌120例。随机分两组接受一线化疗:吉西他滨联合铂类组60例,多西他赛联合铂类组60例。观察疾病缓解率(RR)、疾病控制率(DCR)及不良反应;采用Kaplan-Meier法、Log-rank检验分析中位无进展生存(mPFS)、中位总生存(mOS)。结果:113例可评价病例,吉西他滨联合组56例,多西他赛联合组57例。吉西他滨联合组RR显著高于多西他赛联合组,差异有统计学意义(71. 4%vs 52. 6%,P=0. 04)。中位随访15. 8个月,与多西他赛联合组比较,吉西他滨联合组mPFS、mOS显著延长,差异有统计学意义(mPFS:9. 7个月vs 7. 8个月,P=0. 014;mOS:20. 6个月vs 16. 8个月,P=0. 005)。两组主要不良反应为均为骨髓抑制、胃肠道反应,但差异无统计学意义(P> 0. 05)。多西他赛联合组1级末梢神经损害发生率显著高于吉西他滨联合组,差异有统计学意义(12. 3%vs 1. 8%,P=0. 030),但两组均无2～4级末梢神经损害发生。结论:与多西他赛联合铂类方案比较,吉西他滨联合铂类一线治疗转移性鼻咽癌患者有更高的RR,可显著延长患者的PFS及OS时间,耐受性良好,末梢神经毒性更轻,可作为转移性鼻咽癌一线治疗的良好选择。

Objective： To compare the efficacy and tolerability of gemcitabine combined with platinum and docetaxel combined with platinum in the first-line treatment in metastatic nasopharyngeal carcinoma. Methods： From January 2011 to December 2015,120 cases of first progress metastatic nasopharyngeal carcinoma patients in the Fourth Affiliated Hospital of Guangxi Medical University,were randomly divided into two groups. Gemcitabine combined treatment group（ 60 cases,gemcitabine plus platinum） and docetaxel combined treatment group（ 60 cases,docetaxel plus platinum）. The disease response rates（ RR）,disease control rates（ DCR） and adverse events were observed. Kaplan-Meier method,Log-rank test and Cox risk analysis were adopted to analysis median progression free survival（ m PFS） and median overall survival（ m OS） in patients with metastatic nasopharyngeal carcinoma. Results：The 113 patients can be included in the analysis and evaluation of efficacy and adverse reactions,gemcitabine combined treatment group had 56 cases,docetaxel combined treatment group had 57 cases. There was statistically significant in the RR of gemcitabine combined treatment group and docetaxel combined treatment group（ 71. 4% vs 52. 6%,P = 0. 04）. The median follow-up time was 15. 8 months. There were statistically significant in the m PFS and the m OS of gemcitabine combined treatment group and docetaxel combined treatment group（ m PFS： 9. 7 months vs 7. 8 months,P = 0. 014,m OS： 20. 6 months vs 16. 8 months,P = 0. 005）. The main adverse reaction of all patients were bone marrow suppression,gastrointestinal reactions,there was not statistically significant in the adverse reactions of gemcitabine combined treatment group and docetaxel combined treatment group（ P〉0. 05）. There was statistically significant in the 1 grade of sensory neuritis in the docetaxel combined treatment group and the gemcitabine group（ 12. 3% vs 1. 8%,P = 0. 030）. There was no 2 ～ 4 grade sensory neuritis in the two groups. Conclusion： Compared with docetaxel combination with platinum,gemcitabine combination with platinum as first-line therapy for metastatic nasopharyngeal carcinoma patients had a higher response rate in patients,it can significantly prolong disease-free and overall survival time,well tolerated,it has less sensory neuritis,it can be used as a good choice for first-line treatment of metastatic nasopharyngeal carcinoma.