编者按
2019ASCO-GU期间,各国学者讨论了泌尿生殖系肿瘤领域的最新研究进展,本期台州医院柯莽教授与大家分享前列腺诊疗的新进展,并对2019EAU前列腺癌指南更新情况进行对比分析。
-目 录-
➤阿比特龙+泼尼松联合ADT治疗新诊断高危转移性激素敏感前列腺癌(mHSPC):LATITUDE III期临床研究的最终分析
Final analysis of phase 3 LATITUDE study in patients (pts) with newly diagnosed high-risk metastatic castration naïve prostate cancer (NDx-HR mCNPC) treated with abiraterone acetate + prednisone (AA+P) added to androgen deprivation therapy (ADT)
Karim Fizazi, Namphuong Tran, Luis Enrique Fein, Nobuaki Matsubara, Alfredo Rodríguez Antolín, Mustafa Ozguroglu, Dingwei Ye, Susan Feyerabend, Andrew Protheroe, Giri Sulur, Yesenia Luna, Susan Li, Suneel Mundle, Kim N. Chi; Department of Cancer Medicine, Gustave Roussy Cancer Campus, Paris-Sud University, France, Villejuif, France; Janssen Research & Development, Los Angeles, CA; Instituto de Oncología de Rosário, Rosário, Argentina; Division of Breast and Medical Oncology, National Cancer Center Hospital East, Chiba, Japan; Hospital Universitario 12 de Octubre, Madrid, Spain; Cerrahpaşa Medical Faculty, Istanbul University, Istanbul, Turkey; Fudan University Affiliated Cancer Hospital, Shanghai, China; Studienpraxis Urologie, Nurtingen, Germany; Oxford University Hospitals Foundation NHS Trust, Oxford, United Kingdom; Janssen Research & Development, Spring House, PA; Janssen Research & Development, Raritan, NJ; BC Cancer Agency - Vancouver Centre, Vancouver, BC, Canada
LATITUDE 研究设计
*OS:总生存期;rPFS:影像学无进展生存期
*在欧洲、亚太、拉丁美洲和加拿大的34个国家的235个中心进行
*rPFS 数据结果已发表1
LATITUDE 研究的最终分析:OS
AA+P+ADT 治疗高危mHSPC 的中位OS达53.3个月,较安慰剂+ADT治疗显著延长16.8个月。
*OS:总生存期,AA:阿比特龙,P:泼尼松,ADT:雄激素剥夺治疗
LATITUDE 研究的最终分析:次要终点
AAP 持续治疗较安慰剂治疗均显著延长mHSPC患者至疼痛进展时间、至骨相关事件时间、至起始化疗时间、至后续前列腺癌治疗时间和至PFS2时间
LATITUDE 研究的最终分析:特别关注的不良事件
*AA:阿比特龙,P:泼尼松,ADT:雄激素剥夺治疗;ALT:谷丙转氨酶;AST:谷草转氨酶
Phase 3 study of androgen deprivation therapy (ADT) with enzalutamide (ENZA) or placebo (PBO) in metastatic hormone-sensitive prostate cancer (mHSPC): The ARCHES trial
Andrew J. Armstrong, Russell Zelig Szmulewitz, Daniel Peter Petrylak, Arnauld Villers, Arun Azad, Antonio Alcaraz, Boris Y. Alekseev, Taro Iguchi, Neal D. Shore, Brad Rosbrook, Jennifer Sugg, Benoit Baron, Lucy F. Chen, Arnulf Stenzl; Duke Cancer Institute and the Duke Prostate and Urologic Cancer Center, Durham, NC; The University of Chicago, Chicago, IL; Yale Cancer Center, New Haven, CT; Department of Urology, University Hospital Centre, Lille University, Lille, France; Peter MacCallum Cancer Centre, Melbourne, Australia; Urology Department, Hospital Clínic, Barcelona, Spain; P. A. Herzen Moscow Oncology Research Institute, Ministry of Health of the Russian Federation, Moscow, Russian Federation; Osaka City University Graduate School of Medicine, Osaka, Japan; Carolina Urologic Research Center, Myrtle Beach, SC; Pfizer Inc., La Jolla, CA; Astellas Pharma, Inc., Northbrook, IL; B-value, Leiden, Netherlands; Astellas Pharma Inc., Northbrook, IL; Department of Urology, Eberhard-Karls University, Tuebingen, Germany
ARCHES 研究设计:恩杂鲁胺+ADT vs 安慰剂+ADT治疗mHSPC
ARCHES 研究:恩杂鲁胺+ADT可显著改善mHSPC患者rPFS
恩杂鲁胺+ADT较安慰剂+ADT显著改善mHSPC患者rPFS
(61%影像学进展或死亡风险降低;HR=0.39,95%CI 0.30-0.50,p<0.0001)
12个月的无事件率:84.5% vs 63.7%
*中位随访14.4个月,恩杂鲁胺组的中位治疗持续时间12.8个月,安慰剂组为11.6个月
*ENZA:恩杂鲁胺,ADT:雄激素剥夺治疗,PBO:安慰剂,rPFS:影像学无进展生存,NR:未达到
ARCHES 研究:次要终点
*ENZA:恩杂鲁胺,ADT:雄激素剥夺治疗,PBO:安慰剂,NR:未达到
Updated Analysis of Progression-Free Survival With First Subsequent Therapy and Safety in the SPARTAN Study of Apalutamide in Patients With High-Risk Nonmetastatic Castration-Resistant Prostate Cancer
Eric Jay Small, Fred Saad, Simon Chowdhury, Stephane Oudard, Boris A. Hadaschik, Julie Nicole Graff, David Olmos, Paul N. Mainwaring, Ji Youl Lee, Hiroji Uemura, Angela Lopez-Gitlitz, Byron M. Espina, Youyi Shu, Wayne R. Rackoff, Oliver Brendan Rooney, Anil Londhe, Shinta Cheng, Matthew Raymond Smith; Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, CA; Centre Hospitalier de l’Université de Montréal, Université de Montréal, Montréal, QC, Canada; Guy's, King's and St. Thomas' Hospitals, London, United Kingdom; Georges Pompidou Hopital, Paris, France; University of Duisburg-Essen, Essen, Germany; VA Portland Health Care System, Portland and Knight Cancer Institute, Oregon Health & Science University, Portland, OR; Spanish National Cancer Research Centre (CNIO), Madrid and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Madrid, Spain; Centre for Personalized Nanomedicine, University of Queensland, Brisbane, Australia; St. Mary's Hospital of Catholic University, Seoul, Korea, Republic of (South); Yokohama City University Medical Center, Yokohama, Japan; Janssen Research & Development, Los Angeles, CA; Janssen Research & Development, Spring House, PA; Janssen Research & Development, High Wycombe, United Kingdom; Janssen Research & Development, Yardley, PA; Janssen Research & Development, Raritan, NJ; Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston, MA
SPARTAN 研究设计:阿帕鲁胺+ADT vs 安慰剂+ADT治疗nmCRPC
SPARTAN研究:阿帕鲁胺可显著改善nmCRPC患者 PFS2
CRPC转移进展之前接受APA治疗,可显著改善PFS2,且降低二次进展或死亡风险50%,表明早期治疗较等待直至转移进展可能有较好的获益。
KEYNOTE-199:
KEYNOTE-365 “伞式”研究设计
LATITUDE 研究最终分析结果显示,AAP+ADT 可显著延长mHSPC患者OS至53.3个月, AAP+ADT组的PFS2 为53.3个月;
ARCHES 研究显示:恩杂鲁胺治疗mHSPC改善患者rPFS,延迟PSA进展
SPARTAN 研究显示,阿帕鲁胺可显著延长nmCRPC患者PFS2;
KEYNOTE-365 “伞式”研究结果显示,帕博利珠单抗联合其他疗法(奥拉帕尼、多西他赛/泼尼松、恩杂鲁胺)治疗mCRPC 有临床获益,安全性良好。
➤第5.2.4节
多参数磁共振成像(mpMRI)在临床诊断中的作用已经完全修订,纳入了近期一项 Cochrane 评价的数据。因此,指南提供了新的影像学建议。
5.2.4.4 诊断性影像学的证据概述和指南
5.3.5 前列腺分期指南
➤第5.4节
关于健康状况和预期寿命的评估的文献已经全部更新,增添了部分建议。
5.4.5 健康状况和预期寿命评估指南
➤与影像学有关的所有部分均进行了全面修订,因此许多章节中影像学方面的建议也有所更改或增加。
6.2.1.1.3.3 主动监测的影像学指南
6.2.1.4 低危疾病的治疗指南
6.2.2.5 中危疾病的治疗指南
➤第6.2.6节(新增章节)
根治性前列腺切除术后 PSA 持续存在。
6.2.6.6 针对根治性前列腺切除术后 PSA 持续存在的治疗建议
➤第6.3.4节
更新了生化复发患者的影像学指南。
6.3.4.4 生化复发患者的影像学指南
➤第6.3节
治愈性治疗后仅 PSA 复发的管理指南已经完全修订,根据一项系统性评价(SR)的结果,对患者进行生化复发的风险分层:EAU 低风险复发和高风险复发,并给出了新的建议。
6.3.9 治愈性治疗后的二线治疗指南
➤第6.4节
在转移性前列腺癌全部更新的基础上,形成了新的建议。
6.4.9 转移性前列腺癌的一线治疗指南
➤第6.5节(新增章节)
非转移性去势抵抗性前列腺癌的治疗指南。
6.5.14 非转移性去势抵抗性前列腺癌的治疗指南
➤第8.3.2节
更新了接受系统性治疗的患者的生活质量指南。
8.3.2.1 接受系统性治疗患者的生活质量指南
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