尼妥珠单抗联合多西他赛和顺铂一线治疗复发或转移性头颈部鳞癌疗效观察

Clinical Observation of Nimotuzumab Combined with Docetaxel and Cisplatin in FirstlineTreatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

目的观察尼妥珠单抗联合多西他赛和顺铂一线治疗复发或转移性头颈部鳞癌的疗效及安全性。方法回顾性分析28例尼妥珠单抗联合多西他赛+顺铂(观察组)及30例多西他赛+顺铂(对照组)一线治疗复发或转移性头颈部鳞癌患者的临床资料,比较两种方案的客观缓解率(ORR)、疾病控制率(DCR)、无进展生存时间(PFS)及总生存时间(OS),评估安全性。结果观察组和对照组ORR分别为42.9%和16.7%,DCR分别为78.6%和53.3%,中位PFS分别为6.2月和4.3月,差异均有统计学意义(P<0.05);中位OS分别为12.2月和8.5月,差异无统计学意义(P>0.05);两组患者不良反应差异无统计学意义(P>0.05)。结论尼妥珠单抗联合化疗较单纯化疗一线治疗复发或转移性头颈部鳞癌可提高患者近期临床疗效,延长患者无进展生存时间,且不增加不良反应的发生。

Objective To observe the efficacy and safety of nimotuzumab combined with docetaxel and cisplatin in the first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma patients.Methods We retrospectively analyzed the clinical data of recurrent or metastatic head and neck squamous cell carcinoma patients treated with nimotuzumab combined with docetaxel+cisplatin(observation group,n=28)and docetaxel+cisplatin(control group,n=30).We compared the ORR,DCR,PFS and OS between two regimens,and evaluated the safety.Results The ORR of observation and control groups were 42.9%and 16.7%,the DCR were 78.6%and 53.3%,and the median PFS were 6.2 and 4.3 months,respectively(all P<0.05),and the median OS were 12.2 and 8.5 months(P>0.05).There was no significant difference in adverse reactions between two groups(P>0.05).Conclusion Compared with simple chemotherapy,nimotuzumab combined with docetaxel and cisplatin in the first-line treatment could improve the short-term clinical efficacy and prolong the progression-free survival of the patients with recurrent or metastatic head and neck squamous cell carcinoma,and caused no additional adverse reactions.