不同剂量希罗达维持性治疗晚期鼻咽癌的临床研究

Clinical study on different dose of capecitabine in the maintenance treatment for patients with advanced nasopharyngeal carcinoma

目的 探讨应用不同剂量希罗达维持性治疗晚期鼻咽癌的疗效及不良反应。方法 120例确诊晚期鼻咽癌患者随机分为三组,每组40例。对照组患者应用紫杉醇135 mg/m2＋顺铂80 mg/m2,d1,每3周为一个周期,连用4个周期。高剂量维持组患者应用紫杉醇135 mg/m2＋顺铂80 mg/m2,d1,每3周为一个周期,连用4个周期;尔后应用希罗达1 000 mg/m2bid,d1-14,进行维持治疗直至疾病进展。低剂量维持组患者应用紫杉醇135 mg/m2＋顺铂80 mg/m2,d1,每3周为一个周期,连用4个周期;尔后应用希罗达1 000 mg/m2qd,d1-14,进行维持治疗直至疾病进展。结果 120例均可评价疗效。对照组、高剂量维持组和低剂量维持组的有效率分别为45.0%（18/40）、50%（20/40）和47.5%（19/40）;中位进展时间分别为（5.650±0.207）个月、（8.900±0.849）个月和（8.400±1.684）个月;中位生存时间分别为（11.3±0.434）个月、（17.8±1.641）个月和（16.9±3.422）个月;1年生存率分别为27.5%（11/40）、70.0%（28/40）和52.5%（21/40）。三组患者的有效率比较差异无统计学意义（P〉0.05）,但1年生存率、中位进展时间和中位生存时间比较差异均有统计学意义（P〈0.05）。高剂量维持组和低剂量维持组在恶心/呕吐等胃肠道反应方面差异有统计学意义（P〈0.05）,而在血液毒性和手足综合征方面则差异无统计学意义（P〉0.05）。结论 口服希罗达维持治疗晚期鼻咽癌疗效佳,并且在毒副反应上,低剂量明显较高剂量消化道反应轻,应用方便,利于长期使用。

Objective To explore the efficacy and adverse effects of different dose of capecitabine in the maintenance treatment for patients with advanced nasopharyngeal carcinoma. Methods One hundred and twenty pa-tients with advanced nasopharyngeal carcinoma were randomized into three groups evenly. In control group, patients were given Taxol 135 mg/m2 plus Cisplatin 80 mg/m2 d1, which were repeated every three weeks and totally for four cycles. In high dose maintanance group, patients were given Taxol 135 mg/m2 plus Cisplatin 80 mg/m2 d1, which were repeated every three weeks and totally for four cycles, then Capecitabine maintenance treatment was carried out with 1 000 mg/m2 bid for 14 days. In low dose maintance group, patients were given Taxol 135 mg/m2 d1 plus Cisplatin 80 mg/m2 d1, which were repeated every three weeks and totally for four cycles and Capecitabine maintenance treat-ment was then carried out with 1 000 mg/m2 qd for 14 days. Results All 120 patients involved had evaluable lesions. The PR＋CR rates of control group, high dose maintance group and low dose maintance group were 45.0%（18/40）, 50% （20/40） and 47.5%（19/40） respectively. The ratios of TTP of those three groups were （5.650 ± 0.207） months, （8.900 ± 0.849） months and （8.400 ± 1.684） months respectively, and the ratios of MST were （11.3 ± 0.434） months, （17.8 ± 1.641） months, and （16.9 ± 3.422） months respectively. One-year survival rates of the three groups were 27.5%（11/40）, 70.0%（28/40） and 52.5%（21/40） respectively. There were no significant differences among the three groups in PR＋CR rate （P〉0.05）, while there were significant differences among the three groups in one-year survival rate, TTP and MST （P〈0.05）. For the toxicity, there was significant difference between high dose maintanance group and low dose maintanance group in gastrointestinal reaction, while there were no significant differences in hematological toxicity or hand-foot syndrome （P〈0.05）. Conclusion For patients with advanced nasopharyngeal carcinoma, the ef-ficacy of Capecitabine maintenance treatment is good. The gastrointestinal toxicity of low dose group is milder than that of high dose one. Low dose Capecitabine maintenance treatment is convenient for long-term use.