未经评估:报告单份早期前列腺照射(SiFEPI)2期前瞻性试验的结果。
UNASSIGNED:SiFEPI试验(NCT02104362)评估了高剂量率近距离放射治疗(HDB)对低(LR)和有利中度(FIR)风险前列腺癌的单个部分。直肠垫片放置后,将20Gy的单个部分递送至前列腺。肿瘤结果(生化(bRFS)和局部(lRFS)复发,无病(DFS)和总体(OS)生存率和毒性(急性/晚期生殖泌尿(GU),研究了胃肠道(GI)和性(S)毒性。
UNASSIGNED:从2014年3月到2017年10月,注册了35名其中33人可以评估。年龄中位数为66岁[46-79],LR和FIR分别为25例(76%)和8例(24%)。MFU为72.8个月[64-86],6y-bRFS,lRFS和mRFS为62%[45-85],分别为61%[44-85]和93%[85-100],而6y-DFS,CSS和OS为54%[37-77],分别为100%和89%[77-100]。晚GU,在11名患者中观察到GI和S毒性(33%;18G1),分别为4分(12%;4G1)和7分(21%;1G1、5G2、1G3)。在11名患者中观察到生化复发(BR)(33%;7LR,4FIR),HDB和BR之间的中位时间间隔为51个月[24-69]。其中9例(82%)经组织学证实为孤立的局部复发。
UNASSIGNED:SiFEPI试验的长期结果表明,20Gy的单个部分导致LR/FIR前列腺癌的生化控制次优。晚期GU和GI毒性特征令人鼓舞,导致考虑将HDB作为一种安全的辐照技术。
UNASSIGNED: To report the results of the Single Fraction Early Prostate Irradiation (SiFEPI) phase 2 prospective trial.
UNASSIGNED: The SiFEPI trial (NCT02104362) evaluated a single fraction of high-dose rate brachytherapy (HDB) for low- (LR) and favorable-intermediate (FIR) risk prostate cancers. After rectal spacer placement, a single fraction of 20 Gy was delivered to the prostate. Oncological outcome (biochemical (bRFS) and local (lRFS) relapses, disease-free (DFS) and overall (OS) survivals and toxicity (acute/late genito-urinary (GU), gastro-intestinal (GI) and sexual (S) toxicities were investigated.
UNASSIGNED: From 03/2014 to 10/2017, 35 pts were enrolled, of whom 33 were evaluable. With a median age of 66 y [46-79], 25 (76 %) and 8 (24 %) pts were LR and FIR respectively. With a MFU of 72.8 months [64-86], 6y-bRFS, lRFS and mRFS were 62 % [45-85], 61 % [44-85] and 93 % [85-100] respectively while 6y-DFS, CSS and OS were 54 % [37-77], 100 % and 89 % [77-100] respectively. Late GU, GI and S toxicities were observed in 11 pts (33 %;18G1), 4 pts (12 %;4G1) and 7 pts (21 %;1G1,5G2,1G3) respectively. Biochemical relapse (BR) was observed in 11 pts (33 %;7LR,4FIR) with a median time interval between HDB and BR of 51 months [24-69]. Nine of these pts (82 %) presented a histologically proven isolated local recurrence.
UNASSIGNED: Long-term results of the SiFEPI trial show that a single fraction of 20 Gy leads to sub-optimal biochemical control for LR/FIR prostate cancers. The late GU and GI toxicity profile is encouraging, leading to consideration of HDB as a safe irradiation technique.