尼妥珠单抗联合多西他赛-顺铂-氟尿嘧啶治疗晚期头颈鳞状细胞癌

Clinical research of therapeutic efficacy of nimotuzumab plus docetaxel-cisplatin-fluorouracil regimen as induction treatment of advanced head and neck squamous cell carcinoma

目的研究尼妥珠单抗联合多西他赛(TXT)+顺铂(DDP)+5-氟尿嘧啶(5-FU)方案(TPF方案)治疗晚期头颈部鳞状细胞癌(HNSCC)的临床疗效。方法将21例确诊为晚期HNSCC患者随机分成对照组和治疗组。对照组给予TPF化疗方案;治疗组在使用上述TPF化疗方案的同时,给予200 mg尼妥珠单抗静滴。治疗结束后评价疗效;并根据治疗前后患者生存质量评价(KPS)变化,评价患者生存质量;观察治疗过程中出现的副作用。结果在化疗治疗2个周期结束后的第4周进行评价,治疗组完全缓解(CR)3例、部分缓解(PR)7例、疾病稳定(SD)1例;对照组CR 1例、PR 3例、SD 2例,疾病进展(PD)4例。以CR+PR计算两组有效率、CR+PR+SD计算疾病控制率,比较差异均有统计学意义(P<0.05)。两组主要不良反应发生率差异无统计学意义(P>0.05)。KPS评分治疗组高于对照组。结论尼妥珠单抗联合TPF方案能进一步提高晚期HNSCC治疗效果及患者生存质量,且不增加不良反应,值得进一步研究及推广应用。

Objective To evaluate the therapeutic effect of combined nimotuzumab and TPF regimen in the treatment of advanced head and neck squamous cell carcinoma （HNSCC）. Methods Twenty one cases of advanced HNSCC were divided into 2 groups, treatment group and control group. Cases in the control group were treated with docetaxel, cis-platinum and fluorouracil, called TPF regimen. Combination of nimotuzumab and TPF regimen was applied in the treatment group. In order to assess the efficacy of nimotuzumab, after 2 cycles, quality of life was evaluated through comparation of Karnofsky （KPS） score before and after chemotherapy; and toxic and adverse effects were observed. Results At the fourth week after 2 cycles, complete response （CR）, partial response （PR）, stable disease （SD） or progressive disease （PD） were assessed in the two groups. In the treatment group, eases were analysed and the results were CR （3）, PR （7） and SD （1）. In the control group, the results were CR （1）, PR （3）, SD （2） and PD （4）. The response rate （RR, CR＋PR） and the disease control rate （DCR, CR ＋ PR ＋ SD） showed significant difference between the 2 groups （P 〈 0.05）; but the incidence of toxic and adverse effects had no statistic significance （P 〉 0.05）. The KPS score of treatment group was higher than control group. Conclusions For advanced head and neck squamous cell carcinoma, nimotuzumab plus TPF regimen as induction treatment is effective for improving thetherapeutic effect and the quality of life, the toxicities are well tolerable. The regimen is worthy of further research and application.