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目的:评价重组人血管内皮抑制素(恩度)联合DP方案治疗远处转移鼻咽癌的临床疗效及安全性。方法:收集2009年1月至2010年12月在本科治疗的远处转移鼻咽癌患者62例,均接受恩度联合DP方案行姑息性化疗。恩度剂量为30 mg/d,加入生理盐水500 mL静滴3~4 h,第1天~第14天,休息一周,重复给药;多西紫杉醇70 mg/m~2,每天加生理盐水500 mL静滴,第1天;顺铂80~100 mg/m~2,加生理盐水500 mL静滴,第1天。21 d为1周期。以RECIST标准评价近期疗效,NCI CTC 3.0评价毒性反应,采用SPSS 13.0软件进行统计分析,Kaplan-Meier法计算生存率,用Log-rsnk进行检验。结果:62例患者中,肝转移28例,肺转移17例,骨转移9例,多器官转移8例。所有患者均可评价毒副作用,60例患者可评价疗效,共完成280个周期,中位数为4个周期。完全缓解(CR)18例,部分缓解(PR)31例,稳定(SD)9例,疾病进展(PD)2例。客观缓解率为81.7%(49/60),疾病控制率为96.7%(58/60)。中位随访25个月,1、2年总生存率分别为69.2%、40.8%,中位生存期和中位无进展生存期分别为18.5个月和10.5个月。主要不良反应为脱发、骨髓抑制、胃肠道反应和神经毒性,多为1~2级,且与化疗相关。结论:恩度联合DP方案一线治疗远处转移鼻咽癌的疗效较好,毒性低,安全可靠。
Objective: To evaluate the clinical efficacy and safety of recombinant human endostatin (Endostar) combined with DP regimen in the treatment of distant metastatic nasopharyngeal carcinoma. Methods: Totally 62 patients with nasopharyngeal carcinoma distant metastasis from January 2009 to December 2010 were enrolled in this study. Endostar dose of 30 mg / d, added 500 mL of saline intravenous infusion of 3 ~ 4 h, the first day to 14 days, rest for one week, repeated administration; docetaxel 70 mg / m ~ 2, daily with saline 500 mL intravenous infusion, on the first day; cisplatin 80 ~ 100 mg / m ~ 2, plus saline 500 mL intravenous infusion, the first day. 21 d for 1 cycle. RECIST criteria were used to evaluate the short-term efficacy. NCI CTC 3.0 was used to evaluate the toxicity. SPSS 13.0 software was used for statistical analysis. Kaplan-Meier method was used to calculate the survival rate and Log-rsnk test. Results: Of the 62 patients, 28 were liver metastases, 17 lung metastases, 9 bone metastases and 8 multiple organ metastases. Toxic side effects were evaluated in all patients. Sixty patients were evaluated for efficacy, with a total of 280 cycles completed, with a median of 4 cycles. There were 18 cases of complete remission (CR), 31 cases of partial remission (PR), 9 cases of stable (SD) and 2 cases of disease progression (PD). The objective response rate was 81.7% (49/60) and the disease control rate was 96.7% (58/60). After a median follow-up of 25 months, the overall survival rates at 1 and 2 years were 69.2% and 40.8%, respectively. The median and median progression-free survival were 18.5 and 10.5 months, respectively. The main adverse reactions are alopecia, myelosuppression, gastrointestinal reactions and neurotoxicity, mostly grade 1 to 2, and associated with chemotherapy. Conclusion: The first-line combination of Endo and DP regimen has better curative effect on nasopharyngeal carcinoma with distant metastasis, low toxicity and safety.