老年中晚期鼻咽癌患者尼妥珠单抗联合顺铂及5-氟尿嘧啶放化疗的临床研究

Clinical observation and evaluation of the combination of nimotuzumab with radiotherapy and cisplatin +5FU in the treatment of elderly patients with nasopharyngeal carcinoma

目的评价老年中晚期鼻咽癌患者应用尼妥珠单抗联合放疗及诱导化疗治疗的临床疗效和安全性。方法将42例老年中晚期鼻咽癌患者随机分为两组,一组为尼妥珠单抗联合治疗组(试验组),另一组为放化疗治疗对照组(对照组)。试验组给予顺铂联合5-氟尿嘧啶(5-fluorouracil,5-Fu)诱导化疗后行放疗治疗,放疗期间加用尼妥珠单抗;对照组给予顺铂联合5Fu诱导化疗后行放疗治疗,两组进行疗效及不良反应比较。结果治疗结束后3个月,总有效数试验组19例,占95.0%,对照组15例,占68.2%,两组差异有统计学意义。治疗结束2年后,总有效数试验组17例,占85.0%,对照组15例,占68.2%,差异无统计学意义。KPS评分的增加值试验组要高于对照组,差异有统计学意义。3年总生存率及无瘤生存率,试验组较对照组高,差异无统计学意义。两组均出现了一定程度的不良反应,但差异无统计学意义。结论老年中晚期鼻咽癌患者在顺铂联合5Fu的诱导化疗而后放疗的基础上,联合尼妥珠单抗可改善近期疗效,增加生活质量,同时耐受性好,不良反应可控,远期疗效仍需进一步观察。

Objective To evaluate the clinical efficacy and safety of nimotuzumab combined with radiotherapy and chemotherapy for elderly patients with advanced nasopharyngeal carcinoma. Methods 42 cases of elderly patients with ad- vanced nasopharyngeal carcinoma were randomly divided into two groups. One group was treated with nimotuzuma combi- nation therapy group （experimental group） and the other group was treated with radiotherapy and chemotherapy （control group）. The experimental group was treated with cisplatin ＋5Fu induction chemotherapy and then radiotherapy, plus the use of nimotuzumab during radiotherapy. The control group was treated with cisplatin ＋5Fu induction chemotherapy and then radiotherapy, and comparison of efficacy and adverse reactions between the two groups. Results After the end of treat- ment 3 months, the total effective number experimental group 19 cases, accounting for 95 %, the control group of 15 cases, accounting for 68.2%, the difference between the two groups was statistically significant. After 2 years of treatment, the total effective number experimental group of 17 cases, accounting for 85%, the control group of 15 cases, accounting for 68.2%, the difference was not statistically significant. Statistics of the two groups before and after treatment of the KPS score, found that the KPS score of the experimental group was higher than the control group, the difference was statistically significant. The 3 year overall survival rate and disease-free survival rate of the experimental group was higher than the control group, but the difference was not statistically significant. There was a certain degree of adverse reactions in the two groups, but there was no significant difference between the two groups in the treatment of adverse reactions. Candusiau Elderly patients with advanced nasopharyngeal carcinoma （NPC） in cisplatin ＋5Fu induction chemotherapy and then ra- diotherapy, combined with nimotuzumab can improve the short-term efficacy and increase the quality of life, and good tol- erability, adverse reaction controlled, long-term efficacy still need to further observation.