吉西他滨联合顺铂治疗复发或转移性鼻咽癌的临床研究

Clinical Observation of Gemcitabine Combined with Cisplatin for Recurrent or Metastatic Nasopharyngeal Carcinoma Patients

目的观察吉西他滨联合顺铂治疗复发或转移性鼻咽癌的临床疗效和不良反应.方法吉西他滨1000 mg/m2,分别于第1天和第8天静脉点滴;顺铂80 mg/m2,第1天,或顺铂每天20 mg/m2,第1～4天,21天为1个周期,所有病例接受至少2个周期的化疗.结果28例患者入组,完全缓解6例,部分缓解18例,总有效率为85.7%(24忍8).中位随访时间15个月(6～23个月),1年生存率为86%,中位疾病进展时间为8.6个月(2.5～18个月).主要不良反应为骨髓抑制及恶心、呕吐,有4例(14%,4/28)发生了Ⅲ～Ⅳ度骨髓毒性.结论吉西他滨联合顺铂方案治疗复发或转移性鼻咽癌有较好的疗效,患者耐受性好,值得临床进一步研究.

Objective To evaluate the efficacy and toxicity of Gemcitabine combined with Cisplatin in recurrent or metastatic nasopharyngeal earcinoma（NPC）, Methods Gemcitabine 1 000 mg/m^2 infusion on days 1 and 8,and Cisplatin 80 mg/m2 on day 1 or Cisplatin 20 mg/m^2 daily from day 1 to day 4 were administered every three weeks. All patients received at least two cycles of the treatment, Results Twenty-eight patients were enrolled. All patients were included in the efficacy and adverse events analysis. There were six complete responses, eighteen partial responses, giving an overall response rate of 85.7 % （24/28）. After a median follow-up of 15 months （6-23 months） ,The 1-year overall survival rate was 86% ,the media time to progress was 8.6 months （2.5-18 months）. The major toxicity included myelotoxicity, nausea and vomiting, there were 4 （ 14 %, 4/28） patients experiencing grade Ⅲ-Ⅳ incidence of myelosuppression. Conclusion Gemcitabine combined with Cisplatin offers a satisfactory clinical activity and an acceptable safety profile in patients with recurrent or metastatic NPC. Further investigation is warranted.