Overgaard Jens, Hansen Hanne Sand, Specht Lena, Overgaard Marie, Grau Cai, Andersen Elo, Bentzen Jens, Bastholt Lars, Hansen Olfred, Johansen Jørgen, Andersen Lisbeth, Evensen Jan F
Department of Experimental Clinical Oncology, Aarhus University Hospital, Nørrebrogade 44, Building 5, DK-8000 C, Aarhus, Denmark.
Lancet. 2003 Sep 20;362(9388):933-40. doi: 10.1016/s0140-6736(03)14361-9.
Although head and neck cancer can be cured by radiotherapy, the optimum treatment time for locoregional control is unclear. We aimed to find out whether shortening of treatment time by use of six instead of five radiotherapy fractions per week improves the tumour response in squamous-cell carcinoma.
We did a multicentre, controlled, randomised trial. Between January, 1992, and December, 1999, of 1485 patients treated with primary radiotherapy alone, 1476 eligible patients were randomly assigned five (n=726) or six (n=750) fractions per week at the same total dose and fraction number (66-68 Gy in 33-34 fractions to all tumour sites except well-differentiated T1 glottic tumours, which were treated with 62 Gy). All patients, except those with glottic cancers, also received the hypoxic radiosensitiser nimorazole. Analysis was by intention to treat.
More than 97% of the patients received the planned total dose. Median overall treatment times were 39 days (six-fraction group) and 46 days (five-fraction group). Overall 5-year locoregional control rates were 70% and 60% for the six-fraction and five-fraction groups, respectively (p=0.0005). The whole benefit of shortening of treatment time was seen for primary tumour control (76 vs 64% for six and five fractions, p=0.0001), but was non-significant for neck-node control. Six compared with five fractions per week improved preservation of the voice among patients with laryngeal cancer (80 vs 68%, p=0.007). Disease-specific survival improved (73 vs 66% for six and five fractions, p=0.01) but not overall survival. Acute morbidity was significantly more frequent with six than with five fractions, but was transient.
The shortening of overall treatment time by increase of the weekly number of fractions is beneficial in patients with head and neck cancer. The six-fractions-weekly regimen has become the standard treatment in Denmark.
尽管头颈癌可通过放疗治愈，但局部区域控制的最佳治疗时间尚不清楚。我们旨在探讨每周采用6次而非5次放疗分割来缩短治疗时间是否能改善鳞状细胞癌的肿瘤反应。
我们进行了一项多中心、对照、随机试验。在1992年1月至1999年12月期间，在1485例仅接受原发性放疗的患者中，1476例符合条件的患者被随机分配，每周接受5次（n = 726）或6次（n = 750）分割放疗，总剂量和分割次数相同（除高分化T1声门肿瘤接受62 Gy外，所有肿瘤部位均为33 - 34次分割，总剂量66 - 68 Gy）。除声门癌患者外，所有患者还接受了低氧放疗增敏剂尼莫唑。分析采用意向性治疗。
超过97%的患者接受了计划的总剂量。总的中位治疗时间，6次分割组为39天，5次分割组为46天。6次分割组和5次分割组的5年局部区域控制率分别为70%和60%（p = 0.0005）。缩短治疗时间的全部益处体现在原发性肿瘤控制方面（6次和5次分割分别为76%和64%，p = 0.0001），但对颈部淋巴结控制无显著影响。与每周5次分割相比，6次分割可改善喉癌患者的声音保留情况（80%对68%，p = 0.007）。疾病特异性生存率有所提高（6次和5次分割分别为73%和66%，p = 0.01），但总生存率未提高。6次分割组的急性不良反应明显比5次分割组更频繁，但为一过性。
通过增加每周分割次数来缩短总治疗时间对头颈癌患者有益。每周6次分割方案已成为丹麦的标准治疗方案。
