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瑞典对头颈部鳞状细胞癌常规放疗与加速放疗的研究——ARTSCAN 研究的两年结果。

Two-year results from a Swedish study on conventional versus accelerated radiotherapy in head and neck squamous cell carcinoma--the ARTSCAN study.

机构信息

Umeå University Hospital, Sweden.

出版信息

Radiother Oncol. 2011 Jul;100(1):41-8. doi: 10.1016/j.radonc.2010.12.010. Epub 2011 Feb 3.

DOI:10.1016/j.radonc.2010.12.010
PMID:21295880
Abstract

BACKGROUND AND PURPOSE

Studies on accelerated fractionation (AF) in head and neck cancer have shown increased local control and survival compared with conventional fractionation (CF), while others have been non-conclusive. In 1998 a national Swedish group decided to perform a randomised controlled clinical study of AF.

MATERIALS AND METHODS

Patients with verified squamous cell carcinoma of the oral cavity, oropharynx, larynx (except glottic T1-T2, N0) and hypopharynx were included. Patients with prior chemotherapy or surgery were excluded. Patients were randomised to either CF (2Gy/day, 5days/week for 7 weeks, total dose 68Gy) or to AF (1.1Gy+2.0Gy/day, 5days/week for 4.5weeks, total dose 68Gy). An extensive quality assurance protocol was followed throughout the study. The primary end point was loco-regional tumour control (LRC) at two years after treatment.

RESULTS

The study was closed in 2006 when 750 patients had been randomised. Eighty-three percent of the patients had stages III-IV disease. Forty eight percent had oropharyngeal, 21% laryngeal, 17% hypopharyngeal and 14% oral cancers. There were no significant differences regarding overall survival (OS) or LRC between the two regimens. The OS at two years was 68% for AF and 67% for CF. The corresponding figures for LRC were 71% and 67%, respectively. There was a trend towards improved LRC for oral cancers treated (p=0.07) and for large tumours (T3-T4) (p=0.07) treated with AF. The AF group had significantly worse acute reactions, while there was no significant increase in late effects.

CONCLUSION

Overall the AF regimen did not prove to be more efficacious than CF. However, the trend towards improved results in AF for oral cancers needs to be further investigated.

摘要

背景与目的

对头颈部癌症进行加速分割(AF)的研究表明,与常规分割(CF)相比,AF 可提高局部控制率和生存率,但其他研究结果并不一致。1998 年,一个瑞典全国性研究小组决定开展一项关于 AF 的随机对照临床试验。

材料与方法

纳入经证实的口腔、口咽、喉(除声门型 T1-T2、N0)和下咽的鳞状细胞癌患者。排除既往接受过化疗或手术的患者。患者被随机分为 CF 组(2Gy/天,每周 5 天,共 7 周,总剂量 68Gy)或 AF 组(1.1Gy+2.0Gy/天,每周 5 天,共 4.5 周,总剂量 68Gy)。整个研究过程中遵循了广泛的质量保证协议。主要终点是治疗后两年的局部区域肿瘤控制(LRC)。

结果

该研究于 2006 年结束,当时已随机分配了 750 例患者。83%的患者患有 III-IV 期疾病。48%的患者患有口咽癌,21%的患者患有喉癌,17%的患者患有下咽癌,14%的患者患有口腔癌。两种方案在总生存率(OS)或 LRC 方面无显著差异。AF 组的 2 年 OS 为 68%,CF 组为 67%。相应的 LRC 数据分别为 71%和 67%。AF 治疗的口腔癌(p=0.07)和大肿瘤(T3-T4)(p=0.07)的 LRC 有改善趋势。AF 组的急性反应明显更差,而晚期不良反应没有明显增加。

结论

总体而言,AF 方案并未证明比 CF 更有效。然而,AF 治疗口腔癌的结果改善趋势需要进一步研究。

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