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DAHANCA 6随机试验:声门鳞状细胞癌患者每周放疗6次与5次的疗效比较

The DAHANCA 6 randomized trial: Effect of 6 vs 5 weekly fractions of radiotherapy in patients with glottic squamous cell carcinoma.

作者信息

Lyhne Nina M, Primdahl Hanne, Kristensen Claus A, Andersen Elo, Johansen Jørgen, Andersen Lisbeth J, Evensen Jan, Mortensen Hanna R, Overgaard Jens

机构信息

Department of Experimental Clinical Oncology, Aarhus University Hospital, Denmark.

Department of Oncology, Aarhus University Hospital, Denmark.

出版信息

Radiother Oncol. 2015 Oct;117(1):91-8. doi: 10.1016/j.radonc.2015.07.004. Epub 2015 Aug 6.

Abstract

PURPOSE

The DAHANCA 6 trial evaluated tumor response and morbidity after moderate accelerated radiotherapy compared to conventional fractionated radiotherapy in patients treated for glottic squamous cell carcinoma (SCC). Further, the failure pattern and incidence of new primary tumors were explored.

PATIENTS AND METHODS

Six hundred and ninety-four patients with non-metastatic glottic SCC were randomized between six or five weekly fractions (fx/w) of radiotherapy to the same total dose. The median treatment time was 38 and 46days, respectively. The primary endpoint was loco-regional failure.

RESULTS

Median follow-up time was 14.5years. Of the 177 failures, 167 involved T-site. The cumulative incidence of loco-regional failure (LRF) was 21.6% in the 6fx/w group and 29.3% in the 5fx/w group and the corresponding hazard rate (HR) of LRF was 0.72 (CI: 0.53-0.97, p=0.04). The effect of acceleration on LRF was especially evident in well differentiated tumors (HR=0.42 (CI: 0.23-0.75) and in T1-2 tumors (HR=0.60 (CI: 0.41-0.89)). The HR of laryngectomy was 0.72 (CI: 0.50-1.04) in the 6fx/w group compared to the 5fx/w group. The hazards of disease-specific death, event-free survival, and overall survival were comparable between the two groups. Significantly more patients experienced severe acute mucositis in the 6fx/w group but the incidence of late morbidity was comparable between the groups. New primary tumors occurred in 22.5% of the patients.

CONCLUSION

Moderate accelerated radiotherapy significantly improved loco-regional control in patients with glottic SCC.

摘要

目的

DAHANCA 6试验评估了声门鳞状细胞癌(SCC)患者接受中度加速放疗与传统分割放疗后的肿瘤反应及发病率。此外,还探讨了失败模式和新原发性肿瘤的发生率。

患者与方法

694例非转移性声门SCC患者被随机分为接受相同总剂量的每周6次或5次放疗。中位治疗时间分别为38天和46天。主要终点是局部区域失败。

结果

中位随访时间为14.5年。在177例失败病例中,167例涉及T部位。6次/周组的局部区域失败(LRF)累积发生率为21.6%,5次/周组为29.3%,LRF的相应风险率(HR)为0.72(CI:0.53 - 0.97,p = 0.04)。加速放疗对LRF的影响在高分化肿瘤(HR = 0.42,CI:0.23 - 0.75)和T1 - 2肿瘤(HR = 0.60,CI:0.41 - 0.89)中尤为明显。与5次/周组相比,6次/周组喉切除术的HR为0.72(CI:0.50 - 1.04)。两组之间疾病特异性死亡、无事件生存和总生存的风险相当。6次/周组有更多患者经历严重急性粘膜炎,但两组晚期发病率相当。22.5%的患者发生了新的原发性肿瘤。

结论

中度加速放疗显著改善了声门SCC患者的局部区域控制。

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