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首页> 外文期刊>Radiotherapy and oncology: Journal of the European Society for Therapeutic Radiology and Oncology >A randomised trial of accelerated radiotherapy for localised invasive bladder cancer.
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A randomised trial of accelerated radiotherapy for localised invasive bladder cancer.

机译：加速放疗用于局部浸润性膀胱癌的随机试验。

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BACKGROUND AND PURPOSE: To evaluate the efficacy and toxicity of an accelerated fractionation regimen to treat localised muscle invasive bladder cancer. PATIENTS AND METHODS: A prospective randomised trial was undertaken in 229 patients randomised between 1988 and 1998 comparing accelerated fractionation (AF) to a dose of 60.8 Gy in 32 fractions over 26 days with conventional fractionation (CF) treating to 64 Gy in 32 fractions over 45 days. Accelerated fractionation was delivered using two fractions per day with a 6h gap between fractions and with the first daily fraction size being 1.8 Gy and the second daily fraction size being 2.0 Gy. There was a 1 week treatment gap after the first 12 fractions. Conventional fractionation was one fraction per day, 5 days per week. Eligible patients had clinical stage T2 or T3, N0 or N1, M0 transitional cell carcinoma. The primary endpoint of the trial was local control and the trial was powered to detect a 20% difference (alpha 0.05, power 90%). Secondary endpoints were toxicity and survival. RESULTS: In the initial phase of the trial, randomisation was unequal such that in total 129 patients were randomised to accelerated fractionation and 100 to conventional fractionation. Acute toxicity was evaluable in 121 patients treated with AF and 96 patients treated with CF. RTOG grade 2 or 3 bowel toxicity was noted in 44% of AF patients compared to 26% of CF patients (P trend =0.001). Acute grade 2 or 3 bladder toxicity was seen in 35% of AF patients compared to 36% of CF patients (P=0.99). Late radiation toxicity was evaluated in patients surviving free from local recurrence at 2 years post treatment. Late radiation toxicity equivalent to RTOG grade 2 or more had occurred in 44% (95% CI 34-55%) of AF patients and in 38% (95% CI 26-49%) of CF patients (logrank over 5 years follow-up P=0.23). There was no significant difference in analysis of time to loss of local tumour control comparing the two treatment arms; local recurrence was recorded in 29 of the 100 patientstreated with CF and in 41 of 129 patients treated with AF (logrank P=0.86). There was also no significant difference between the treatment arms comparing disease-free survival and overall survival. The overall survival figures at 3 years were for AF 54% (95% CI 45-63%) and for CF 47% (95% CI 36-57%). By 5 years the overall survival was 37% for AF and 40% for CF. There were two treatment related deaths, both on the AF arm of the trial. CONCLUSIONS: This accelerated fractionation schedule did not improve on the efficacy of conventional fractionation for patients with T2 and T3 bladder cancer and accelerated fractionation was associated with increased acute bowel reactions.
机译：背景与目的：评价加速分馏方案治疗局部性肌肉浸润性膀胱癌的疗效和毒性。患者与方法：这项前瞻性随机试验在1988年至1998年之间对229例患者进行了随机比较，比较了加速分馏（AF）与26天之内的32馏分的60.8 Gy剂量与常规分馏（CF）治疗的32馏分中的64 Gy超过26天的情况45天每天使用两个馏分进行加速分馏，各馏分之间的间隔为6h，第一个每日馏分大小为1.8 Gy，第二个每日馏分大小为2.0 Gy。前12个阶段后有1周的治疗间隔。常规分馏是每天一次，每周5天。符合条件的患者患有T2或T3，N0或N1，M0期移行细胞癌。该试验的主要终点是局部对照，该试验能够检测出20％的差异（α0.05，功效90％）。次要终点是毒性和生存率。结果：在试验的初始阶段，随机分配是不平等的，因此总共129例患者被随机分配为加速分级，而100例为常规分级。在121例接受AF治疗的患者和96例CF治疗的患者中，急性毒性可评估。 AF患者中RTOG 2或3级肠毒性的发生率为44％，而CF患者为26％（P趋势= 0.001）。在35％的AF患者中发现了2级或3级急性膀胱毒性，而在CF患者中则为36％（P = 0.99）。在治疗后2年没有局部复发的患者中评估了晚期放射毒性。在AF患者中有44％（95％CI 34-55％）和在CF患者中有38％（95％CI 26-49％）发生了相当于RTOG 2级或更高的晚期放射毒性（随访5年后的logrank-上P = 0.23）。与两个治疗组相比，失去局部肿瘤控制的时间分析没有显着差异。在接受CF治疗的100例患者中有29例记录了局部复发，而接受AF治疗的129例患者中有41例记录了局部复发（logrank P = 0.86）。比较无病生存期和总生存期，治疗组之间也没有显着差异。 3年的总生存率分别为AF 54％（95％CI 45-63％）和CF 47％（95％CI 36-57％）。到5年时，AF的总生存率为37％，CF的总生存率为40％。在试验的AF臂上有2例与治疗相关的死亡。结论：这种加速分级分离的时间表并未改善常规分级分离对T2和T3膀胱癌患者的疗效，并且加速分级分离与急性肠反应增加有关。

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