Vargas Carlos Enrique, Hartsell William Fred, Dunn Megan, Keole Sameer Ramchandra, Doh Lucius, Chang John, Larson Gary Lynn
Department of Radiation Oncology, Mayo Clinic Hospital, Phoenix, AZ, USA.
CDH Proton Center, Warrenville, IL, USA.
Rep Pract Oncol Radiother. 2016 May-Jun;21(3):207-12. doi: 10.1016/j.rpor.2016.01.002. Epub 2016 Mar 4.
This interim analysis evaluated changes in quality of life (QOL), American Urological Association Symptom Index (AUA), or adverse events (AEs) among prostate cancer patients treated with hypofractionation.
Results for hypofractionated prostate cancer with photon therapy are encouraging. No prior trial addresses the role of proton therapy in this clinical setting.
Forty-nine patients with low-risk prostate cancer received 38-Gy relative biologic effectiveness in 5 treatments. They received proton therapy at 2 fields a day, magnetic resonance imaging registration, rectal balloon, and fiducial markers for guidance pre-beam. We evaluated AEs, Expanded Prostate Index Composite (EPIC) domains, and AUA at pretreatment and at 3, 6, 12, 18, and 24 months. An AUA change >5 points and QOL change of half a standard deviation (SD) defined clinical significance.
Median follow-up was 18 months; 17 patients reached follow-up of ≥24 months. For urinary function, statistically and clinically significant change was not seen (maximum change, 3). EPIC urinary QOL scores did not show statistically and clinically significant change at any end point (maximum, 0.45 SD). EPIC bowel QOL scores showed small but statistically and clinically significant change at 6, 12, 18, and 24 months (SD range, 0.52-0.62). EPIC sexual scores showed small but statistically and clinically significant change at 24 months (SD, 0.52). No AE grade ≥3 was seen.
Patients treated with hypofractionated proton therapy tolerated treatment well, with excellent QOL scores, persistently low AUA, and no AE grade ≥3.
本中期分析评估了接受大分割放疗的前列腺癌患者的生活质量（QOL）、美国泌尿外科学会症状指数（AUA）或不良事件（AE）的变化。
光子治疗大分割前列腺癌的结果令人鼓舞。此前尚无试验探讨质子治疗在这种临床情况下的作用。
49例低危前列腺癌患者接受5次治疗，总剂量为38 Gy的相对生物效应。他们每天在两个射野接受质子治疗，治疗前进行磁共振成像定位、直肠气囊和基准标记物引导。我们在治疗前以及治疗后3、6、12、18和24个月评估不良事件、扩展前列腺指数综合评分（EPIC）各领域以及AUA。AUA变化>5分和QOL变化半个标准差（SD）定义为具有临床意义。
中位随访时间为18个月；17例患者随访时间≥24个月。对于泌尿功能，未观察到具有统计学意义和临床意义的变化（最大变化为3）。EPIC泌尿QOL评分在任何终点均未显示出具有统计学意义和临床意义的变化（最大变化为0.45 SD）。EPIC肠道QOL评分在6、12、18和24个月时显示出微小但具有统计学意义和临床意义的变化（SD范围为0.52 - 0.62）。EPIC性功能评分在24个月时显示出微小但具有统计学意义和临床意义的变化（SD为0.52）。未观察到≥3级不良事件。
接受大分割质子治疗的患者对治疗耐受性良好，生活质量评分优异，AUA持续较低，且未出现≥3级不良事件。
