Adjuvant radiotherapy versus early salvage radiotherapy plus short-term androgen deprivation therapy in men with localised prostate cancer after radical prostatectomy (GETUG-AFU 17): a randomised, phase 3 trial

医学 前列腺切除术 雄激素剥夺疗法 前列腺癌 临床终点 放射治疗 泌尿科 曲普瑞林 人口 内科学 外科 肿瘤科 随机对照试验 癌症 激素 促黄体激素 促性腺激素释放激素 环境卫生
作者
Paul Sargos,Sylvie Chabaud,I. Latorzeff,Nicolas Magné,Ahmed Benyoucef,S. Supiot,Dominique Pasquier,Menouar Samir Abdiche,O. Gilliot,P. Graff-Cailleaud,Marlon Silva,Philippe Bergerot,Pierre Baumann,Yazid Belkacémi,D. Azria,Meryem Brihoum,M. Soulié,Pierre Richaud
出处
期刊:Lancet Oncology [Elsevier BV]
卷期号:21 (10): 1341-1352 被引量:232
标识
DOI:10.1016/s1470-2045(20)30454-x
摘要

Adjuvant radiotherapy reduces the risk of biochemical progression in prostate cancer patients after radical prostatectomy. We aimed to compare adjuvant versus early salvage radiotherapy after radical prostatectomy, combined with short-term hormonal therapy, in terms of oncological outcomes and tolerance.GETUG-AFU 17 was a randomised, open-label, multicentre, phase 3 trial done at 46 French hospitals. Men aged at least 18 years who had an Eastern Cooperative Oncology Group performance status of 1 or less, localised adenocarcinoma of the prostate treated with radical prostatectomy, who had pathologically-staged pT3a, pT3b, or pT4a (with bladder neck invasion), pNx (without pelvic lymph nodes dissection), or pN0 (with negative lymph nodes dissection) disease, and who had positive surgical margins were eligible for inclusion in the study. Eligible patients were randomly assigned (1:1) to either immediate adjuvant radiotherapy or delayed salvage radiotherapy at the time of biochemical relapse. Random assignment, by minimisation, was done using web-based software and stratified by Gleason score, pT stage, and centre. All patients received 6 months of triptorelin (intramuscular injection every 3 months). The primary endpoint was event-free survival. Efficacy and safety analyses were done on the intention-to-treat population. The trial is registered with ClinicalTrials.gov, NCT00667069.Between March 7, 2008, and June 23, 2016, 424 patients were enrolled. We planned to enrol 718 patients, with 359 in each study group. However, on May 20, 2016, the independent data monitoring committee recommended early termination of enrolment because of unexpectedly low event rates. At database lock on Dec 19, 2019, the overall median follow-up time from random assignment was 75 months (IQR 50-100), 74 months (47-100) in the adjuvant radiotherapy group and 78 months (52-101) in the salvage radiotherapy group. In the salvage radiotherapy group, 115 (54%) of 212 patients initiated study treatment after biochemical relapse. 205 (97%) of 212 patients started treatment in the adjuvant group. 5-year event-free survival was 92% (95% CI 86-95) in the adjuvant radiotherapy group and 90% (85-94) in the salvage radiotherapy group (HR 0·81, 95% CI 0·48-1·36; log-rank p=0·42). Acute grade 3 or worse toxic effects occurred in six (3%) of 212 patients in the adjuvant radiotherapy group and in four (2%) of 212 patients in the salvage radiotherapy group. Late grade 2 or worse genitourinary toxicities were reported in 125 (59%) of 212 patients in the adjuvant radiotherapy group and 46 (22%) of 212 patients in the salvage radiotherapy group. Late genitourinary adverse events of grade 2 or worse were reported in 58 (27%) of 212 patients in the adjuvant radiotherapy group versus 14 (7%) of 212 patients in the salvage radiotherapy group (p<0·0001). Late erectile dysfunction was grade 2 or worse in 60 (28%) of 212 in the adjuvant radiotherapy group and 17 (8%) of 212 in the salvage radiotherapy group (p<0·0001).Although our analysis lacked statistical power, we found no benefit for event-free survival in patients assigned to adjuvant radiotherapy compared with patients assigned to salvage radiotherapy. Adjuvant radiotherapy increased the risk of genitourinary toxicity and erectile dysfunction. A policy of early salvage radiotherapy could spare men from overtreatment with radiotherapy and the associated adverse events.French Health Ministry and Ipsen.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
kingwill应助南韵采纳,获得20
1秒前
3秒前
Poik完成签到,获得积分10
3秒前
刘娅铷发布了新的文献求助10
3秒前
5秒前
小小吴完成签到,获得积分10
6秒前
不孤独的发卡完成签到,获得积分20
6秒前
潘善若发布了新的文献求助30
9秒前
zzzjh完成签到,获得积分10
9秒前
香蕉觅云应助超级采纳,获得10
11秒前
11秒前
安然完成签到 ,获得积分10
16秒前
桔子完成签到,获得积分10
16秒前
16秒前
落后的哈密瓜完成签到,获得积分10
17秒前
潘善若发布了新的文献求助10
18秒前
Rainbow完成签到 ,获得积分10
19秒前
21秒前
SciGPT应助momo采纳,获得10
21秒前
21秒前
Lili完成签到,获得积分10
22秒前
22秒前
23秒前
congyjs完成签到,获得积分20
25秒前
超级发布了新的文献求助10
26秒前
26秒前
潘善若发布了新的文献求助10
27秒前
Rondab应助胡图图采纳,获得10
27秒前
27秒前
29秒前
nilu完成签到,获得积分10
29秒前
congyjs发布了新的文献求助10
30秒前
31秒前
CodeCraft应助落后的哈密瓜采纳,获得10
31秒前
31秒前
王汉韬发布了新的文献求助10
32秒前
Nature_Science完成签到,获得积分10
32秒前
33秒前
lihan完成签到,获得积分10
34秒前
34秒前
高分求助中
A new approach to the extrapolation of accelerated life test data 1000
ACSM’s Guidelines for Exercise Testing and Prescription, 12th edition 500
‘Unruly’ Children: Historical Fieldnotes and Learning Morality in a Taiwan Village (New Departures in Anthropology) 400
Indomethacinのヒトにおける経皮吸収 400
Phylogenetic study of the order Polydesmida (Myriapoda: Diplopoda) 370
基于可调谐半导体激光吸收光谱技术泄漏气体检测系统的研究 350
Robot-supported joining of reinforcement textiles with one-sided sewing heads 320
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 3989297
求助须知:如何正确求助?哪些是违规求助? 3531418
关于积分的说明 11253893
捐赠科研通 3270097
什么是DOI,文献DOI怎么找? 1804884
邀请新用户注册赠送积分活动 882087
科研通“疑难数据库(出版商)”最低求助积分说明 809158