Abstract：
BACKGROUND: Between 2012 and 2015 we conducted a randomized controlled trial in prostate cancer patients comparing weekly 2-D portal imaging versus daily 3-D verification.
OBJECTIVE: To evaluate the clinical outcomes of image guided radiotherapy by presenting rectal and urinary side effects, health related quality of life and progression free survival after 5-years follow up of a randomized controlled trial.
METHODS: We randomized 260 men with intermediate or high-risk prostate cancer to weekly 2-D portal imaging with 15 mm margin from CTV to PTV (Arm A) or daily 3-D cone-beam computer tomography with 7 mm margins (Arm B). Prescribed doses were 78 Gy/39 fractions. All patients received hormonal therapy. Primary end point was patient reported bowel symptoms and secondary outcomes were patient reported urinary symptoms, health- related quality of life and progression free survival.
RESULTS: Of the 216 patients available for analyses at 5 years more than 90 % completed patient reported outcome measures. There were no significant differences between study arms for any single items nor scales evaluating bowel symptoms. There were also no differences in self-reported urinary symptoms nor in health-related quality of life. Symptom scores were low in both study arms. Progression free survival was similar in Arm B as compared to arm A (Hazard ratio 1.01; 95 % CI 0.57 to 1.97).
CONCLUSIONS: Our results support that both 2-D weekly and 3-D daily image guided radiotherapy are safe and efficient treatments for PC and emphasize the need to evaluate technological progress in clinical trials with long follow-up.
OBJECTIVE: To evaluate the clinical outcomes of image guided radiotherapy by presenting rectal and urinary side effects, health related quality of life and progression free survival after 5-years follow up of a randomized controlled trial.
METHODS: We randomized 260 men with intermediate or high-risk prostate cancer to weekly 2-D portal imaging with 15 mm margin from CTV to PTV (Arm A) or daily 3-D cone-beam computer tomography with 7 mm margins (Arm B). Prescribed doses were 78 Gy/39 fractions. All patients received hormonal therapy. Primary end point was patient reported bowel symptoms and secondary outcomes were patient reported urinary symptoms, health- related quality of life and progression free survival.
RESULTS: Of the 216 patients available for analyses at 5 years more than 90 % completed patient reported outcome measures. There were no significant differences between study arms for any single items nor scales evaluating bowel symptoms. There were also no differences in self-reported urinary symptoms nor in health-related quality of life. Symptom scores were low in both study arms. Progression free survival was similar in Arm B as compared to arm A (Hazard ratio 1.01; 95 % CI 0.57 to 1.97).
CONCLUSIONS: Our results support that both 2-D weekly and 3-D daily image guided radiotherapy are safe and efficient treatments for PC and emphasize the need to evaluate technological progress in clinical trials with long follow-up.
摘要：
背景：在2012年至2015年之间，我们在前列腺癌患者中进行了一项随机对照试验，比较了每周2-D门静脉成像与每日3-D验证。
目的：通过表现直肠和尿路副作用来评估影像引导放疗的临床效果，一项随机对照试验5年随访后，健康相关的生活质量和无进展生存期。
方法：我们将260名中危或高危前列腺癌患者随机分组，每周进行2-D门静脉成像，从CTV到PTV（A组），边缘15mm，或每天进行3-D锥束计算机断层扫描，边缘7mm（B组）。规定剂量为78Gy/39分数。所有患者均接受激素治疗。主要终点为患者报告的肠道症状，次要终点为患者报告的泌尿症状。健康相关的生活质量和无进展生存期。
结果：在5年可用于分析的216例患者中，90%以上完成了患者报告的结果指标。对于任何单个项目或评估肠道症状的量表，研究组之间没有显着差异。自我报告的泌尿症状和与健康相关的生活质量也没有差异。两个研究组的症状评分都很低。与A组相比，B组的无进展生存率相似（危害比1.01；95％CI0.57至1.97）。
结论：我们的结果支持每周2-D和每天3-D图像引导放疗都是安全有效的PC治疗方法，并强调需要在长期随访的临床试验中评估技术进展。
目的：通过表现直肠和尿路副作用来评估影像引导放疗的临床效果，一项随机对照试验5年随访后，健康相关的生活质量和无进展生存期。
方法：我们将260名中危或高危前列腺癌患者随机分组，每周进行2-D门静脉成像，从CTV到PTV（A组），边缘15mm，或每天进行3-D锥束计算机断层扫描，边缘7mm（B组）。规定剂量为78Gy/39分数。所有患者均接受激素治疗。主要终点为患者报告的肠道症状，次要终点为患者报告的泌尿症状。健康相关的生活质量和无进展生存期。
结果：在5年可用于分析的216例患者中，90%以上完成了患者报告的结果指标。对于任何单个项目或评估肠道症状的量表，研究组之间没有显着差异。自我报告的泌尿症状和与健康相关的生活质量也没有差异。两个研究组的症状评分都很低。与A组相比，B组的无进展生存率相似（危害比1.01；95％CI0.57至1.97）。
结论：我们的结果支持每周2-D和每天3-D图像引导放疗都是安全有效的PC治疗方法，并强调需要在长期随访的临床试验中评估技术进展。
