术前同期放化与单纯放疗局部晚期头颈部鳞癌的Ⅲ期临床研究

Phase HI study of preoperative concurrent chemoradiotherapy compared with preoperative radiotherapy alone in the treatment of locally advanced head and neck squamous call carcinoma

目的比较在局部晚期头颈部鳞癌治疗中术前同期放化疗是否优于术前单纯放疗。方法2002--2008年间157例局部晚期头颈部鳞癌患者通过随机数字表法分入术前同期放化组（81例）和术前单放组（76例），化疗方案为顺铂30mg／m^2（1次／周），放疗Dr50Gy时原发灶疗效达到或者接近完全缓解以及未达完全缓解但患者拒绝手术者继续放疗至根治量70Gy，原发灶疗效未达到或接近完全缓解者休息1个月后行手术治疗。放疗D，50Gy时淋巴结未能达完全缓解和N，期患者行颈淋巴结清扫术。结果随访率为98．1％，随访满5年者91例，同期放化组46例、单放组45例。头颈部鳞癌患者术前同期放化组和术前单放组的5年局部控制率、总生存率、无瘤生存率、无远处转移生存率分别为63％和50％（X^2=0．40，P=0．528）、46％和38％（X^2=0．48，P=0．490）、41％和35％（X^2=0．29，P=0．593）、76％和65％（X^2=3．38，P=0．066）。下咽癌和喉癌患者术前同期放化组、术前单放组2年无远处转移生存率分别为88％、60％（X^2=5．99，P：0．014）。结论在此化疗条件下，头颈部鳞癌术前同期放化疗与术前单纯放疗比较未能提高总生存率；下咽癌和喉癌中术前同期放化疗提高了无远处转移生存率。

Objective To investigate the role of chemoradiotherapy in the preoperative radiotherapy for locally advanced head and neck squamous cell carcinoma. Methods From Sep. 2002 to Dec. 2008, totally 157 locally advanced head and neck squamous cell carcinoma （HNSCC） patients was assigned to preoperative concurrent chemoradiotherapy group （ n = 81 ） or preoperative radiotherapy alone group （ n = 76） randomly. The chemotherapy regimen was consisted of cisplatin 30 mg/m2, weekly. The radiotherapy in both groups was identical. The primary lesion will continue concurrent chemoradiotherapy or radiotherapy for those the tumor response was or nearly complete remission （CR） and those who refused surgery when evaluated at DT50 Gy, the others will receive surgery 1 month later if the tumor response was less than CR. For N3 patients, the planed neck dissection will be done. Results The follow up rate was 98.1%, 91 patients followed up more than 5 years, there were 46 in concurrent chemoradiotherapy group and 45 in radiotherapy alone group. The rate of 5-year local control, overall survival, disease free survival and distant metastasis-free survival for preoperative concurrent chemoradiotherapy group and preoperative radiotherapy alone group were 63 % and 50% （~2 = 0. 40, P = 0. 528 ）, 46 % and 38 % （~2 = 0. 48, P = 0. 490） ,41% and 35 （ X2 = 0. 29, P = 0. 593 ） ,76% and 65 % （ ~2 = 3.38, P = 0. 066 ） respectively. Subgroup analysis showed that the 2-years distant metastasis-free survival of preoperative concurrent chemoradiotherapy group and preoperative radiotherapy alone group were 88% and 60% （~2 = 5.99 ,P = 0. 014）. Conclusions Preoper -ative concurrent chemoraidotherapy with the regimen of cisplatin 30 mg/m2 weekly did not improve the overall survival for locally advanced HNSCC when compared with preoperative radiotherapy alone. Preoperative concurrent chemoradiotherapy improved the distant metastasis-free survival of locally advanced hypopharyngeal and laryngeal carcinoma.