局部晚期头颈部鳞癌不同治疗方法的Ⅲ期随机对照研究再分析

Effects of different combinations of comprehensive treatment on survival of patients with locally advanced head and neck squamous cell carcinoma:post-hoc analysis of a phaseⅢrandomized controlled clinical trial

目的比较放疗、化疗和手术不同组合方式的综合治疗对局部晚期期头颈部鳞癌生存的影响。方法2002-2012年间222例局部晚期头颈部鳞癌进入术前同步放化疗与术前单纯放疗随机对照的临床研究。同步化疗采用顺铂30 mg/m^2,单周方案,放疗采用常规技术或调强放疗技术。所有患者在放疗至50 Gy时进行疗中疗效评价,根据疗效决定患者后续治疗接受手术或继续原方案治疗。Kaplan-Meier法分析不同治疗方式的生存情况。结果全组随访中位时间59个月(7~139个月)。单纯放疗(R组84例)、同步放化疗(R+C组67例)、术前放疗(R+S组34例)、术前同步放化疗(R+C+S组37例)组5年总生存率分别为32%、44%、51%、52%(R+C+S组:R组P=0.047),5年无进展生存率分别为34%、48%、49%、61%(R+C组:R组P=0.081,R+C+S组:R组P=0.035),5年无远处转移生存率分别为70%、85%、65%、73%(R+C组:R组P=0.064,R+C组:R+S组P=0.016)。结论综合治疗可提高局部晚期头颈部鳞癌的长期生存,联合化疗有提高无远处转移生存趋势。提高局部晚期头颈鳞癌总生存的最佳综合模式仍然需要进一步研究。

Objective To compare the effects of comprehensive treatment with different combinations of radiotherapy,chemotherapy and surgery on the survival of patients with locally advanced head and neck squamous cell carcinoma(LA-HNSCC).Methods From September 2002 to May 2012,222 patients were enrolled in a randomized controlled clinical trial to compare the clinical efficacy between preoperative radiotherapy and preoperative concurrent chemoradiotherapy.The chemotherapy was performed at the beginning of the radiotherapy,with cisplatin 30 mg/m^2 every week.Conventional radiotherapy or intensity-modulated radiotherapy(IMRT)was adopted.Clinical efficacy was evaluated during radiotherapy to 50Gy in all patients.Whether surgery or original treatment regime was given was determined according to the clinical efficacy.The survival of different therapeutic methods was analyzed by Kaplan-Meier method.ResultsThe median follow-up time was 59 months(7-139 months).All patients were divided into four groups:radiotherapy group(R group,n=84),concurrent chemo-radiotherapy group(R+C group,n=67),preoperative radiotherapy group(R+S group,n=34)and preoperative concurrent chemoradiotherapy group(R+C+S group,n=37).The 5-year overall survival rates were 32%,44%,51%,and 52%,respectively(R+C+S group vs.R group,P=0.047).The 5-year progression-free survival rates were 34%,48%,49%,and 61%,respectively(R+C Group vs.R group,P=0.081;R+C+S group vs.R group,P=0.035).The 5-yeal distant metastasis-free survival rates were 70%,85%,65%,and 73%,respectively(R+C group vs.R+S group,P=0.064;R+C group vs.R+S group,P=0.016).Conclusions Compared with radiotherapy alone,comprehensive treatment with different combinations can improve the long-term survival of LA-HNSCC patients.Radiotherapy combined with chemotherapy has a tendency to improve the distant metastasis-free survival rate,The optimal comprehensive treatment modality that improves the overall survival of LA-HNSCC patients remains to be explored.