晚期口腔颌面-头颈鳞癌EGFR单抗靶向治疗—71例临床分析

Pilot study of target therapy with EGFR antibody (nimotuzumab) in 71 patients with advanced head and neck squamous cell carcinoma

目的：结合国内实际情况，探索靶向综合治疗晚期口腔颌面-头颈鳞癌，旨在明确其疗效，提高患者的近期生存率。方法：2008年4月-2010年4月综合治疗71例晚期口腔颌面-头颈癌患者，其中男54例，女17例，年龄30-83岁．平均60．2岁。经组织学和影像学证实．局部晚期头颈癌患者具备生物化疗的适应证。卡氏评分〉70分，生存预期不少于6个月。人组者血红蛋白≥110g／L，WBC≥4×10^9／L，血小板≥100×10^9／L，肝、肾功能各项指标均在正常值，血糖正常。化疗方案为方案TPF．即d1 TXT75mg／m^2，d1 CDDP75mg／m2,dl_1d55-Fu750mg／mz,dl、d8尼妥珠200mg/（m^2·周）。结果：完成化疗2-4个疗程，平均3个周期。尼妥珠应用2。8次，平均5次。随访12-24个月，中位随访期20个月。71例中，40例获得相对彻底的手术治疗。CR4例，PR39例，7例无法评价，SD18例，PD3例。CR＋PR=43例，近期总有效率为61％。2例出现轻微皮疹．未见严重不良反应。结论：应用TPF方案治疗71例晚期口腔颌面一头颈鳞癌，患者对尼妥珠有良好的耐受性。尼妥珠可增加晚期口腔颌面一头颈鳞癌的化疗敏感性，并可使临床TNM分期降级，使56％的患者重获手术治疗机会。远期疗效有待进一步观察。

PURPOSE： To explore the efficacy of combination of biological target therapy and chemotherapy in 71 patients with advanced head and neck squamous cell carcinoma（SCC）. METHODS： Seventy-one patients（54 men and 17 women, aged from 30 to 83 years, mean 60 years） with locally advanced head and neck SCC （no indication for surgery, radiotherapy ） confirmed by histology and radiology, were enrolled in this study. The chemotherapy regimen was CDDP 75 mg/m2 dl,TAX 75 mg/m2 dl, 5-Fu 750 mg/m2 d1-d5 and nimotuzumab 200 mg/m2 per week. RESULTS： The patients completed 2 to 4 cycles of chemotherapy （mean 3 cycles）. Nimotuzumab were used for 2 to 8 times （mean 5 times）.The prognosis was as follows： CR in 4 cases, PR in 39 cases, SD in 18 cases, PD in 3 cases and 7 cases could not be evaluated. The total effective rate which was calculated by PR plus CR was 61%. Forty cases of them received surgery after bio-chemotherapy. No serious adverse reaction was found during the course of the treatment, only two cases with slight erythra. CONCLUSION： Nimotuzumab was equally effective in the increase of ehemosensitivity and good tolerability profiles. Supported by International Co-operative Program from Science and Technology Commission of Shanghai Municioalitv （10410711200,11495802000）.