Krstevska Valentina, Crvenkova Simonida
Institute of Radiotherapy and Oncology, Clinical Center, Skopje, R. Macedonia.
Croat Med J. 2006 Feb;47(1):42-52.
To compare the efficacy of two altered fractionation radiotherapy treatment protocols (hyperfractionation and accelerated fractionation with concomitant boost) with conventional fractionation in improvement of locoregional disease control and survival of patients with squamous cell carcinoma of the larynx, oropharynx, or hypopharynx.
From March 1999 to December 2000, 51 patients with previously untreated squamous cell carcinoma of the larynx, oropharynx or hypopharynx underwent conventionally fractionated radiotherapy and received 66-70 Gy in 6(1/2)-7 weeks (2 Gy per fraction a day, 5 fractions a week). From January 2001 to June 2004, 101 patients with the same diagnoses underwent either hyperfractionated radiotherapy, with 74.4-79.2 Gy delivered in 6.2-7 weeks (1.2 Gy per fraction twice a day), or accelerated fractionation with concomitant boost, which delivered 68.7-72 Gy in 6 weeks (1.8 Gy per fraction a day and 1.5 Gy per fraction a day to a boost filed as a second daily treatment for the last 11-12 treatment days). Locoregional relapse and overall survival were recorded.
Complete response to treatment was obtained in 31 of 51 patients treated with conventional fractionation, 33 of 50 patients treated with hyperfractionation, and 36 of 51 patients treated with accelerated fractionation. No significant differences were observed among the patients treated with conventional, hyperfractionated, or accelerated radiotherapy modalities either in locoregional control rate (41% vs 35% vs 49%, respectively; P=0.690) or overall survival rate (50% vs 40% vs 51%, respectively; P=0.760). The grade of acute reactions of the larynx significantly differed among the treatment groups (Fisher exact test; P=0.039). The difference in the grade of acute side effects in the skin among the treatment groups was of borderline significance (chi2(2) test; P=0.054). There was also a borderline difference among the groups in the grade of late side effects in the mucous membrane (chi2(2) test; P=0.055).
Altered fractionation regimens were not more efficacious than conventional fractionation in the treatment of previously untreated head and neck carcinoma.
ClinicalTrials.gov Identifier: NCT00291434.
比较两种改变分割放疗方案（超分割放疗和加速分割同步推量放疗）与传统分割放疗在改善喉、口咽或下咽鳞状细胞癌患者局部区域疾病控制和生存率方面的疗效。
1999年3月至2000年12月，51例既往未经治疗的喉、口咽或下咽鳞状细胞癌患者接受传统分割放疗，在6（1/2）-7周内接受66-70 Gy（每天2 Gy，每周5次分割）。2001年1月至2004年6月，101例诊断相同的患者接受了超分割放疗，在6.2-7周内给予74.4-79.2 Gy（每次分割1.2 Gy，每天2次），或加速分割同步推量放疗，在6周内给予68.7-72 Gy（每天1.8 Gy，在最后11-12个治疗日作为第二次每日治疗对推量野给予每天1.5 Gy）。记录局部区域复发和总生存率。
接受传统分割放疗的51例患者中有31例、接受超分割放疗的50例患者中有33例以及接受加速分割放疗的51例患者中有36例获得了完全缓解。在接受传统、超分割或加速放疗方式治疗的患者中，无论是局部区域控制率（分别为41%、35%和49%；P=0.690）还是总生存率（分别为50%、40%和51%；P=0.760）均未观察到显著差异。治疗组之间喉的急性反应分级有显著差异（Fisher确切概率检验；P=0.039）。治疗组之间皮肤急性副作用分级的差异具有临界显著性（χ2(2)检验；P=0.054）。各组之间黏膜晚期副作用分级也存在临界差异（χ2(2)检验；P=0.055）。
在治疗既往未经治疗的头颈癌方面，改变分割方案并不比传统分割方案更有效。
ClinicalTrials.gov标识符：NCT00291434。
