Koerber Stefan Alexander, Winter Erik, Katayama Sonja, Slynko Alla, Haefner Matthias Felix, Uhl Matthias, Sterzing Florian, Habl Gregor, Schubert Kai, Debus Juergen, Herfarth Klaus
Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.
Heidelberg Institute of Radiation Oncology (HIRO), Heidelberg, Germany.
Front Oncol. 2019 Aug 13;9:751. doi: 10.3389/fonc.2019.00751. eCollection 2019.
This prospective, non-randomized phase II trial aimed to investigate the role of additional irradiation of the pelvic nodes for patients with prostate cancer and a high risk for nodal metastases using helical intensity-modulated radiotherapy with daily image guidance (IMRT/IGRT). Between 2009 and 2012, 40 men with treatment-naïve prostate cancer and a risk of lymph node involvement of more than 20% were enrolled in the PLATIN-1 trial. All patients received definitive, helical IMRT of the pelvic nodes (total dose of 51.0 Gy) with a simultaneous integrated boost (SIB) to the prostate (total dose of 76.5 Gy) in 34 fractions. Antihormonal therapy (AHT) was administered for a minimum of 2 months before radiotherapy continuing for at least 24 months. After a median follow-up of 71 months (range: 5-95 months), pelvic irradiation was associated with a 5-year overall survival (OS) and biochemical progression-free survival (bPFS) of 94.3% and 83.6%, respectively. For our cohort, no grade 4 gastrointestinal (GI) and genitourinary (GU) toxicity was observed. Quality of life (QoL) assessed by EORTC QLQ-C30 questionnaire was comparable to EORTC reference values without significant changes. The current trial demonstrates that elective IMRT/IGRT of the pelvic nodes with SIB to the prostate for patients with a high-risk of lymphatic spread is safe and shows an excellent clinical outcome without compromising the quality of life. The PLATIN-1 trial delivers eminent baseline data for future studies using modern irradiation techniques.
这项前瞻性、非随机的II期试验旨在研究,对于前列腺癌且有高淋巴结转移风险的患者,采用每日图像引导的螺旋调强放疗(IMRT/IGRT)对盆腔淋巴结进行额外照射的作用。在2009年至2012年期间,40例未经治疗的前列腺癌且淋巴结受累风险超过20%的男性患者入组PLATIN-1试验。所有患者均接受盆腔淋巴结的根治性螺旋IMRT(总剂量51.0 Gy),同时对前列腺进行同步整合加量(SIB,总剂量76.5 Gy),分34次照射。在放疗前至少给予2个月的抗激素治疗(AHT),并持续至少24个月。中位随访71个月(范围:5 - 95个月)后,盆腔照射的5年总生存率(OS)和生化无进展生存率(bPFS)分别为94.3%和83.6%。对于我们的队列,未观察到4级胃肠道(GI)和泌尿生殖系统(GU)毒性。通过欧洲癌症研究与治疗组织(EORTC)QLQ - C30问卷评估的生活质量(QoL)与EORTC参考值相当,且无显著变化。当前试验表明,对于有高淋巴转移风险的患者,对盆腔淋巴结进行选择性IMRT/IGRT并对前列腺进行SIB是安全的,且显示出优异的临床结果,同时不影响生活质量。PLATIN-1试验为未来使用现代放疗技术的研究提供了重要的基线数据。