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阿比特龙用于既往未经激素治疗的前列腺癌
Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy


Nicholas D. James ... 肿瘤 • 2017.07.27
相关阅读
• 奥拉帕尼联合阿比特龙治疗晚期前列腺癌 • 转移性前列腺癌的联合治疗 • ASCO 2017报告——泌尿生殖系统癌症 • 放疗联合或不联合抗雄激素疗法治疗复发性前列腺癌的比较研究

摘要


背景

醋酸阿比特龙与泼尼松龙联用可改善复发性前列腺癌患者的生存期。我们通过多组、多阶段的试验设计,在开始接受长期雄激素剥夺治疗(androgen-deprivation therapy,ADT)的男性中评估了这种联合用药的疗效。

 

方法

我们按照1∶1的比例将患者随机分配接受ADT单独治疗或ADT加醋酸阿比特龙(每日1,000 mg)及泼尼松龙(每日5 mg)治疗(联合治疗)。对于淋巴结阴性、非转移性疾病患者,局部放射治疗是强制性的;对于淋巴结阳性的患者,亦鼓励使用该疗法。对于患非转移性疾病且未计划进行放疗的患者以及转移性疾病患者,治疗持续至出现影像学、临床或前列腺特异抗原(PSA)的疾病进展;否则,治疗持续2年或直至出现任何类型的疾病进展,以先发生的情况为准。主要结局指标为总生存期。中期主要结局为无失败生存期(治疗失败的定义为影像学、临床或PSA的疾病进展或前列腺癌造成的死亡)。

 

结果

从2011年11月至2014年1月共有1,917例患者经随机化。中位年龄为67岁,中位PSA水平为53 ng/mL。共有52%的患者有转移性疾病,20%有淋巴结阳性或淋巴结状态未确定的非转移性疾病,28%有淋巴结阴性非转移性疾病;95%有新诊断出的疾病。中位随访时间为40个月。联合治疗组有184例死亡,与之相比,ADT单独治疗组有262例(风险比,0.63;95%置信区间[CI],0.52~0.76;P<0.001);非转移性疾病患者中的风险比为0.75,而转移性疾病患者中为0.61。联合治疗组有248例次治疗失败事件,与之相比,ADT单独治疗组有535例次(风险比,0.29;95% CI,0.25~0.34;P<0.001);非转移性疾病患者中的风险比为0.21,而转移性疾病患者中的风险比为0.31。3~5级不良事件发生于47%的联合治疗组患者(9例5级事件),以及33%的ADT单独治疗组患者(3例5级事件)。

 

结论

在局部晚期或转移性前列腺癌患者中,ADT加阿比特龙及泼尼松龙治疗与ADT单独治疗相比,与显著更高的总生存率和无失败生存率相关(由英国癌症研究学会[Cancer Research U.K.]和其他机构资助;STAMPEDE在ClinicalTrials.gov注册号为NCT00268476,在Current Controlled Trials注册号为ISRCTN78818544)。





作者信息

Nicholas D. James, Ph.D., Johann S. de Bono, Ph.D., Melissa R. Spears, M.Sc., Noel W. Clarke, Ch.M., Malcolm D. Mason, F.R.C.R., David P. Dearnaley, F.R.C.R., Alastair W.S. Ritchie, M.D., Claire L. Amos, Ph.D., Clare Gilson, M.R.C.P., Rob J. Jones, M.B., Ch.B., David Matheson, Ph.D., Robin Millman, Gerhardt Attard, M.D., Simon Chowdhury, Ph.D., William R. Cross, F.R.C.S., Silke Gillessen, M.D., Christopher C. Parker, M.D., J. Martin Russell, F.R.C.R., Dominik R. Berthold, M.D., Chris Brawley, M.Sc., Fawzi Adab, F.R.C.R., San Aung, M.R.C.P., Alison J. Birtle, F.R.C.R., Jo Bowen, F.R.C.R., Susannah Brock, F.R.C.R., Prabir Chakraborti, F.R.C.R., Catherine Ferguson, F.R.C.R., Joanna Gale, B.M., Emma Gray, F.R.C.R., Mohan Hingorani, Ph.D., Peter J. Hoskin, F.R.C.R., Jason F. Lester, F.R.C.R., Zafar I. Malik, F.R.C.R., Fiona McKinna, F.R.C.R., Neil McPhail, F.R.C.R., Julian Money-Kyrle, F.R.C.R., Joe O’Sullivan, Ph.D., Omi Parikh, F.R.C.R., Andrew Protheroe, F.R.C.P., Angus Robinson, F.R.C.R., Narayanan N. Srihari, F.R.C.R., Carys Thomas, M.R.C.P., John Wagstaff, Ch.B., James Wylie, F.R.C.R., Anjali Zarkar, F.R.C.R., Mahesh K.B. Parmar, D.Phil., and Matthew R. Sydes, M.Sc., for the STAMPEDE Investigators*
From the Institute of Cancer and Genomic Sciences, University of Birmingham (N.D.J.), and University Hospital Birmingham (A.Z.), Birmingham, the Institute of Cancer Research (J.S.B., D.P.D., G.A.), Medical Research Council Clinical Trials Unit at University College London (M.R. Spears, C.L.A., C.G., C.B., M.K.B.P., M.R. Sydes), King’s College London and Guy’s and St. Thomas’ NHS Foundation Trust (S.C.), and Royal Marsden NHS Foundation Trust (C.C.P.), London, Salford Royal NHS Foundation Trust, Salford (N.W.C.), Cardiff University School of Medicine (M.D.M.) and Velindre Cancer Centre (J.F.L.), Cardiff, Gloucestershire Royal Hospital (A.W.S.R.) and Gloucestershire Hospitals NHS Foundation Trust (J.B.), Gloucester, University of Glasgow, Glasgow (R.J.J., J.M.R.), St. James’s University Hospital, Leeds (W.R.C.), University Hospital of North-Midlands, Stoke-on-Trent (F.A.), Royal Devon and Exeter Hospital NHS Foundation Trust, Exeter (S.A.), Rosemere Cancer Centre, Royal Preston Hospital, Preston (A.J.B.), Dorset Cancer Centre, Poole Hospital, Poole (S.B.), Royal Derby Hospital, Derby (P.C.), Weston Park Hospital, Sheffield (C.F.), Portsmouth Oncology Centre, Queen Alexandra Hospital, Portsmouth (J.G.), Musgrove Park Hospital, Taunton (E.G.), Hull and East Yorkshire Hospitals NHS Trust, Hull (M.H.), Mount Vernon Cancer Centre, Northwood (P.J.H.), Clatterbridge Cancer Centre, Wirral (Z.I.M.), Brighton and Sussex University Hospitals NHS Trust (F.M.) and Sussex Cancer Centre, Royal Sussex County Hospital (A.R.), Brighton, NHS Highland, Inverness (N.M.), Royal Surrey County Hospital, Guildford (J.M.-K.), Northern Ireland Cancer and Queens University, Belfast (J.O.), Lancashire Teaching Hospitals NHS Trust, Preston (O.P.), Churchill Hospital, Oxford (A.P.), Shrewsbury and Telford Hospitals NHS Trust, Shrewsbury (N.N.S.), East Kent Hospitals NHS Trust, Canterbury (C.T.), Swansea University College of Medicine, Swansea (J. Wagstaff), and Christie NHS Foundation Trust, Manchester (J. Wylie) — all in the United Kingdom; and the Department of Medical Oncology, Kantonsspital St. Gallen, St. Gallen (S.G.), and University Hospital of Lausanne, Lausanne (D.R.B.) — both in Switzerland. Two of the authors (D.M., R.M.) were unaffiliated lay members of the STAMPEDE investigators.Address reprint requests to Dr. James at the Institute of Cancer and Genomic Sciences, University of Birmingham, Edgbaston, Birmingham B15 2TT, United Kingdom, or atmrcctu.stampede_publications@ucl.ac.uk. * A complete list of the Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy (STAMPEDE) investigators is provided in the Supplementary Appendix, available at NEJM.org.

 

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