LBA86 Androgen receptor pathway inhibitors or taxanes for patients with metastatic castration-resistant prostate cancer: A direct comparison in ProBio, a randomized, outcome-adaptive, biomarker-driven platform trial

医学 恩扎鲁胺 前列腺癌 卡巴齐塔塞尔 生物标志物 肿瘤科 多西紫杉醇 危险系数 内科学 雄激素受体 临床终点 随机对照试验 紫杉烷 癌症 雄激素剥夺疗法 置信区间 乳腺癌 化学 生物化学
作者
Henrik Grönberg,Johan Lindberg,Bram De Laere,Alessio Crippa,Andrea Discacciati,Camilla Thellenberg Karlsson,Anders Ullén,Elin Jänes,Ashkan Mortezavi,Piet Ost,Gunilla Enblad,Jan Oldenburg,J. Sandzén,Linn Pettersson,M.N. Vigmostad,Marie Hjälm-Eriksson,Mats J. Olsson,Peter Schatteman,Christophe Ghysel,Martin Eklund
出处
期刊:Annals of Oncology [Elsevier BV]
卷期号:34: S1327-S1327
标识
DOI:10.1016/j.annonc.2023.10.088
摘要

The Prostate Biomarker (ProBio) trial is an international biomarker-driven, randomized, outcome-adaptive platform trial in men with metastatic castrate resistant prostate cancer (mCRPC) evaluating multiple agents. We used outcome-adaptive randomization to compare biomarker-driven treatment selection (experimental arms) against physician’s choice standard-of-care (SOC; control arm), and to compare agents against each other within the experimental treatment arms. Men with mCRPC were randomized based on genomic alterations in circulating tumor DNA in five biomarker signatures: (1) AR wt and TP53 wt; (2) TP53 mut; (3) DRD; (4) TMPRSS2:ERG fusion; (5) all biomarkers signatures combined. Androgen receptor pathway inhibitors (ARPi; abiraterone and enzalutamide) and taxanes (docetaxel and cabazitaxel) were evaluated, using progression-free survival, by no longer clinically benefiting per PCWG3 criteria (PFS), as primary endpoint. Enrollment in the experimental group was stopped when the Bayesian probability of superiority reached prespecified thresholds (“graduation”). In total, 219 men were randomized: 92 to SOC, vs. 76 and 51 to taxanes and ARPi, respectively, in the biomarker-driven arms. ARPi graduated in the “signature all”, i.e. a signature encompassing all biomarkers. The median estimated PFS was 11.3 months (90% Bayesian credible interval [CI], 9.8 to 13.1) for ARPi compared with 7.2 months (90% CI, 6.5 to 8.1) in the SOC arm, for a hazard ratio (HR) of 0.52 (90% CI 0.37 to 0.72). ARPi demonstrated superiority to taxanes within the experimental arms (HR 0.54; 90% CI 0.38 to 0.76). We observed suggestive differential treatment effects for patients with TP53 mut and TMPRSS2:ERG fusion disease. The median estimated overall survival (OS) was 37.3 months (CI, 27.7 to NA) for ARPi compared with 20.2 months (90% CI, 18.4 to 23.0) taxanes within the experimental arms. ARPi increases PFS and OS both compared to SOC and taxanes in patients with mCRPC. These are directly randomized data for ARPi and taxanes, showing the first evidence of a difference in PFS and OS for these agents in the mCRPC setting.

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
舟遥遥完成签到,获得积分10
刚刚
华仔应助大橙子采纳,获得10
2秒前
桐桐应助Bismarck采纳,获得10
6秒前
CLY完成签到,获得积分10
7秒前
8秒前
rita_sun1969完成签到,获得积分10
9秒前
研友_8K2QJZ完成签到,获得积分10
9秒前
蝴蝶完成签到 ,获得积分10
10秒前
ARIA完成签到 ,获得积分10
10秒前
大橙子发布了新的文献求助10
13秒前
Bismarck完成签到,获得积分20
14秒前
14秒前
爱笑子默完成签到,获得积分10
15秒前
15秒前
一点完成签到,获得积分10
17秒前
研友_VZG7GZ应助大葱鸭采纳,获得10
17秒前
DezhaoWang完成签到,获得积分10
18秒前
知犯何逆发布了新的文献求助10
19秒前
原本完成签到,获得积分10
19秒前
Bismarck发布了新的文献求助10
20秒前
苗条丹南完成签到 ,获得积分10
22秒前
yu完成签到 ,获得积分10
25秒前
skyleon完成签到,获得积分10
25秒前
无心的天真完成签到 ,获得积分10
26秒前
Engen完成签到,获得积分20
26秒前
27秒前
学术小垃圾完成签到,获得积分10
27秒前
dreamwalk完成签到 ,获得积分10
27秒前
黄淮科研小白龙完成签到 ,获得积分10
28秒前
齐嫒琳完成签到,获得积分10
30秒前
研友_Lav0Qn完成签到,获得积分10
30秒前
大橙子发布了新的文献求助10
31秒前
GreenT完成签到,获得积分10
31秒前
鳄鱼队长完成签到,获得积分10
32秒前
Zengyuan完成签到,获得积分10
32秒前
研友_Lav0Qn发布了新的文献求助10
33秒前
perry4rosa完成签到,获得积分0
33秒前
量子星尘发布了新的文献求助10
34秒前
LIFE2020完成签到 ,获得积分10
34秒前
科研人完成签到,获得积分10
35秒前
高分求助中
【提示信息,请勿应助】关于scihub 10000
Les Mantodea de Guyane: Insecta, Polyneoptera [The Mantids of French Guiana] 3000
徐淮辽南地区新元古代叠层石及生物地层 3000
The Mother of All Tableaux: Order, Equivalence, and Geometry in the Large-scale Structure of Optimality Theory 3000
Handbook of Industrial Diamonds.Vol2 1100
Global Eyelash Assessment scale (GEA) 1000
Picture Books with Same-sex Parented Families: Unintentional Censorship 550
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 4038157
求助须知:如何正确求助?哪些是违规求助? 3575869
关于积分的说明 11373842
捐赠科研通 3305650
什么是DOI,文献DOI怎么找? 1819255
邀请新用户注册赠送积分活动 892655
科研通“疑难数据库(出版商)”最低求助积分说明 815022