亲爱的研友该休息了!由于当前在线用户较少,发布求助请尽量完整地填写文献信息,科研通机器人24小时在线,伴您度过漫漫科研夜!身体可是革命的本钱,早点休息,好梦!

Health-related quality of life and pain outcomes with [177Lu]Lu-PSMA-617 plus standard of care versus standard of care in patients with metastatic castration-resistant prostate cancer (VISION): a multicentre, open-label, randomised, phase 3 trial

医学 前列腺癌 谷氨酸羧肽酶Ⅱ 生活质量(医疗保健) 放射性配体 肿瘤科 内科学 癌症 护理部 受体 氧化物 有机化学 化学
作者
Karim Fizazi,Ken Herrmann,Bernd J. Krause,Kambiz Rahbar,Kim N.,Michael J. Morris,Oliver Sartor,Scott T. Tagawa,A. Tuba Kendi,Nicholas J. Vogelzang,Jérémie Calais,James Nagarajah,Xiao X. Wei,Vadim S. Koshkin,Jean‐Mathieu Beauregard,Brian Chang,Ray Ghouse,Michelle DeSilvio,Richard A. Messmann,Johann S. de Bono
出处
期刊:Lancet Oncology [Elsevier BV]
卷期号:24 (6): 597-610 被引量:56
标识
DOI:10.1016/s1470-2045(23)00158-4
摘要

Background In VISION, the prostate-specific membrane antigen (PSMA)-targeted radioligand therapy lutetium-177 [177Lu]Lu-PSMA-617 (vipivotide tetraxetan) improved radiographic progression-free survival and overall survival when added to protocol-permitted standard of care in patients with metastatic castration-resistant prostate cancer. Here, we report additional health-related quality of life (HRQOL), pain, and symptomatic skeletal event results. Methods This multicentre, open-label, randomised, phase 3 trial was conducted at 84 cancer centres in nine countries in North America and Europe. Eligible patients were aged 18 years or older; had progressive PSMA-positive metastatic castration-resistant prostate cancer; an Eastern Cooperative Oncology Group (ECOG) performance status score of 0–2; and had previously received of at least one androgen receptor pathway inhibitor and one or two taxane-containing regimens. Patients were randomly assigned (2:1) to receive either [177Lu]Lu-PSMA-617 plus protocol-permitted standard of care ([177Lu]Lu-PSMA-617 group) or standard of care alone (control group) using permuted blocks. Randomisation was stratified by baseline lactate dehydrogenase concentration, liver metastases, ECOG performance status, and androgen receptor pathway inhibitor inclusion in standard of care. Patients in the [177Lu]Lu-PSMA-617 group received intravenous infusions of 7·4 gigabecquerel (GBq; 200 millicurie [mCi]) [177Lu]Lu-PSMA-617 every 6 weeks for four cycles plus two optional additional cycles. Standard of care included approved hormonal treatments, bisphosphonates, and radiotherapy. The alternate primary endpoints were radiographic progression-free survival and overall survival, which have been reported. Here we report the key secondary endpoint of time to first symptomatic skeletal event, and other secondary endpoints of HRQOL assessed with the Functional Assessment of Cancer Therapy-Prostate (FACT-P) and EQ-5D-5L, and pain assessed with the Brief Pain Inventory-Short Form (BPI-SF). Patient-reported outcomes and symptomatic skeletal events were analysed in all patients who were randomly assigned after implementation of measures designed to reduce the dropout rate in the control group (on or after March 5, 2019), and safety was analysed according to treatment received in all patients who received at least one dose of treatment. This trial is registered with ClinicalTrials.gov, NCT03511664, and is active but not recruiting. Findings Between June 4, 2018, and Oct 23, 2019, 831 patients were enrolled, of whom 581 were randomly assigned to the [177Lu]Lu-PSMA-617 group (n=385) or control group (n=196) on or after March 5, 2019, and were included in analyses of HRQOL, pain, and time to first symptomatic skeletal event. The median age of patients was 71 years (IQR 65–75) in the [177Lu]Lu-PSMA-617 group and 72·0 years (66–76) in the control group. Median time to first symptomatic skeletal event or death was 11·5 months (95% CI 10·3–13·2) in the [177Lu]Lu-PSMA-617 group and 6·8 months (5·2–8·5) in the control group (hazard ratio [HR] 0·50, 95% CI 0·40–0·62). Time to worsening was delayed in the [177Lu]Lu-PSMA-617 group versus the control group for FACT-P score (HR 0·54, 0·45–0·66) and subdomains, BPI-SF pain intensity score (0·52, 0·42–0·63), and EQ-5D-5L utility score (0·65, 0·54–0·78). Grade 3 or 4 haematological adverse events included decreased haemoglobin (80 [15%] of 529 assessable patients who received [177Lu]Lu-PSMA-617 plus standard of care vs 13 [6%] of 205 who received standard of care only), lymphocyte concentrations (269 [51%] vs 39 [19%]), and platelet counts (49 [9%] vs five [2%]). Treatment-related adverse events leading to death occurred in five (1%) patients who received [177Lu]Lu-PSMA-617 plus standard of care (pancytopenia [n=2], bone marrow failure [n=1], subdural haematoma [n=1], and intracranial haemorrhage [n=1]) and no patients who received standard of care only. Interpretation [177Lu]Lu-PSMA-617 plus standard of care delayed time to worsening in HRQOL and time to skeletal events compared with standard of care alone. These findings support the use of [177Lu]Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer who received previous androgen receptor pathway inhibitor and taxane treatment. Funding Advanced Accelerator Applications (Novartis).
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
1秒前
6秒前
宝贝丫头完成签到 ,获得积分10
16秒前
英姑应助背后的鞋垫采纳,获得10
25秒前
桐桐应助Benhnhk21采纳,获得10
26秒前
Dave发布了新的文献求助10
1分钟前
科研通AI2S应助科研通管家采纳,获得10
1分钟前
Aaron完成签到 ,获得积分0
2分钟前
2分钟前
4分钟前
Liufgui应助Dave采纳,获得10
4分钟前
Benhnhk21发布了新的文献求助10
4分钟前
yydragen应助yyds采纳,获得10
4分钟前
Hisam完成签到,获得积分10
4分钟前
lhy完成签到,获得积分10
5分钟前
lhy发布了新的文献求助10
5分钟前
5分钟前
积极的台灯应助Benhnhk21采纳,获得10
5分钟前
Hisam发布了新的文献求助10
5分钟前
yyds完成签到,获得积分0
5分钟前
科研通AI2S应助科研通管家采纳,获得10
5分钟前
木木完成签到 ,获得积分10
6分钟前
6分钟前
董可以发布了新的文献求助10
6分钟前
小马甲应助董可以采纳,获得10
6分钟前
6分钟前
Boren发布了新的文献求助10
6分钟前
梨子完成签到,获得积分10
6分钟前
Boren完成签到,获得积分10
7分钟前
WerWu完成签到,获得积分10
8分钟前
彭于晏应助Dc采纳,获得10
8分钟前
9分钟前
情怀应助科研通管家采纳,获得10
9分钟前
10分钟前
Dc发布了新的文献求助10
10分钟前
Dc完成签到,获得积分10
10分钟前
11分钟前
幽默平安发布了新的文献求助10
11分钟前
科研通AI2S应助科研通管家采纳,获得10
11分钟前
12分钟前
高分求助中
The Mother of All Tableaux: Order, Equivalence, and Geometry in the Large-scale Structure of Optimality Theory 3000
A new approach to the extrapolation of accelerated life test data 1000
ACSM’s Guidelines for Exercise Testing and Prescription, 12th edition 500
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 3990290
求助须知:如何正确求助?哪些是违规求助? 3532146
关于积分的说明 11256472
捐赠科研通 3271042
什么是DOI,文献DOI怎么找? 1805197
邀请新用户注册赠送积分活动 882302
科研通“疑难数据库(出版商)”最低求助积分说明 809234