Tumor Genomic Testing for >4,000 Men with Metastatic Castration-resistant Prostate Cancer in the Phase III Trial PROfound (Olaparib)

被引:70
作者
Hussain, Maha [1 ]
Corcoran, Claire [2 ]
Sibilla, Caroline [2 ]
Fizazi, Karim [3 ]
Saad, Fred [4 ]
Shore, Neal [5 ]
Sandhu, Shahneen [6 ,7 ]
Mateo, Joaquin [8 ,9 ]
Olmos, David [10 ,11 ]
Mehra, Niven [12 ]
Kolinsky, Michael P. [13 ,14 ]
Roubaud, Guilhem [15 ]
Ozguroglu, Mustafa [16 ]
Matsubara, Nobuaki [17 ]
Gedye, Craig [18 ]
Choi, Young Deuk [19 ]
Padua, Charles [20 ]
Kohlmann, Alexander [21 ]
Huisden, Robert [2 ]
Elvin, Julia A. [22 ]
Kang, Jinyu [21 ]
Adelman, Carrie A. [2 ]
Allen, Allison [2 ]
Poehlein, Christian [23 ]
de Bono, Johann [24 ,25 ]
机构
[1] Northwestern Univ, Robert H Lurie Comprehens Canc Ctr, Feinberg Sch Med, Chicago, IL 60611 USA
[2] AstraZeneca, Cambridge, England
[3] Univ Paris Sud, Inst Gustave Roussy, Villejuif, France
[4] Ctr Hosp Univ Montreal CRCHUM, Montreal, PQ, Canada
[5] Carolina Urol Res Ctr, Myrtle Beach, SC USA
[6] Peter MacCallum Canc Ctr, Melbourne, Vic, Australia
[7] Univ Melbourne, Melbourne, Vic, Australia
[8] Vall dHebron Inst Oncol, Barcelona, Spain
[9] Vall dHebron Univ Hosp, Barcelona, Spain
[10] Spanish Natl Canc Res Ctr CNIO, Madrid, Spain
[11] Inst Invest Biomed Malaga IBIMA, Malaga, Spain
[12] Radboud Univ Nijmegen, Med Ctr, Nijmegen, Netherlands
[13] Cross Canc Inst, Edmonton, AB, Canada
[14] Univ Alberta, Edmonton, AB, Canada
[15] Inst Bergonie, Bordeaux, France
[16] Istanbul Univ Cerrahpasa, Cerrahpasa Sch Med, Istanbul, Turkey
[17] Natl Canc Ctr Hosp East, Chiba, Japan
[18] Calvary Mater Newcastle, Waratah, Australia
[19] Yonsei Univ, Coll Med, Seoul, South Korea
[20] Cetus Med Oncol, Betim, Brazil
[21] AstraZeneca, Gaithersburg, MD USA
[22] Fdn Med Inc, Cambridge, MA USA
[23] Merck & Co Inc, Kenilworth, NJ USA
[24] Inst Canc Res, London, England
[25] Royal Marsden Hosp, London, England
关键词
DNA;
D O I
10.1158/1078-0432.CCR-21-3940
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose: Successful implementation of genomic testing in clinical practice is critical for identification of men with metastatic castration-resistant prostate cancer (mCRPC) eligible for olaparib and future molecularly targeted therapies. Patients and Methods: An investigational clinical trial assay, based on the FoundationOneCDx tissue test, was used to prospectively identify patients with qualifying homologous recombination repair gene alterations in the phase III PROfound study. Evaluation of next-generation sequencing (NGS) tissue test outcome against preanalytic parameters was performed to identify key factors influResults: A total of 4,858 tissue samples from 4,047 patients were tested and reported centrally. NGS results were obtained in 58% (2,792/4,858) of samples (69% of patients). Of samples submitted, 83% were primary tumor samples (96% were archival and 4% newly
引用
收藏
页码:1518 / 1530
页数:13
相关论文
共 32 条
[1]   Prospective Genomic Profiling of Prostate Cancer Across Disease States Reveals Germline and Somatic Alterations That May Affect Clinical Decision Making [J].
Abida, Wassim ;
Armenia, Joshua ;
Gopalan, Anuradha ;
Brennan, Ryan ;
Walsh, Michael ;
Barron, David ;
Danila, Daniel ;
Rathkopf, Dana ;
Morris, Michael ;
Slovin, Susan ;
McLaughlin, Brigit ;
Curtis, Kristen ;
Hyman, David M. ;
Durack, Jeremy C. ;
Solomon, Stephen B. ;
Arcila, Maria E. ;
Zehir, Ahmet ;
Syed, Aijazuddin ;
Gao, Jianjiong ;
Chakravarty, Debyani ;
Vargas, Hebert Alberto ;
Robson, Mark E. ;
Vijai, Joseph ;
Offit, Kenneth ;
Donoghue, Mark T. A. ;
Abeshouse, Adam A. ;
Kundra, Ritika ;
Heins, Zachary J. ;
Penson, Alexander V. ;
Harris, Christopher ;
Taylor, Barry S. ;
Ladanyi, Marc ;
Mandelker, Diana ;
Zhang, Liying ;
Reuter, Victor E. ;
Kantoff, Philip W. ;
Solit, David B. ;
Berger, Michael F. ;
Sawyers, Charles L. ;
Schultz, Nikolaus ;
Scher, Howard I. .
JCO PRECISION ONCOLOGY, 2017, 1 :1-26
[2]   Identification of major factors associated with failed clinical molecular oncology testing performed by next generation sequencing (NGS) [J].
Al-Kateb, Hussam ;
Nguyen, TuDung T. ;
Steger-May, Karen ;
Pfeifer, John D. .
MOLECULAR ONCOLOGY, 2015, 9 (09) :1737-1743
[3]  
American Cancer Society, 2021, Survival rates for prostate cancer
[4]  
Chi KN, 2021, J Clin Oncol, V39
[5]  
Chowdhury S, 2018, ANN ONCOL, V29, P273
[6]   Prospective Comprehensive Genomic Profiling of Primary and Metastatic Prostate Tumors [J].
Chung, Jon H. ;
Dewal, Ninad ;
Sokol, Ethan ;
Mathew, Paul ;
Whitehead, Robert ;
Millis, Sherri Z. ;
Frampton, Garrett M. ;
Bratslavsky, Gennady ;
Pal, Sumanta K. ;
Lee, Richard J. ;
Necchi, Andrea ;
Gregg, Jeffrey P. ;
Lara, Primo, Jr. ;
Antonarakis, Emmanuel S. ;
Miller, Vincent A. ;
Ross, Jeffrey S. ;
Ali, Siraj M. ;
Agarwal, Neeraj .
JCO PRECISION ONCOLOGY, 2019, 3 :1-23
[7]   Olaparib for Metastatic Castration-Resistant Prostate Cancer [J].
de Bono, J. ;
Mateo, J. ;
Fizazi, K. ;
Saad, F. ;
Shore, N. ;
Sandhu, S. ;
Chi, K. N. ;
Sartor, O. ;
Agarwal, N. ;
Olmos, D. ;
Thiery-Vuillemin, A. ;
Twardowski, P. ;
Mehra, N. ;
Goessl, C. ;
Kang, J. ;
Burgents, J. ;
Wu, W. ;
Kohlmann, A. ;
Adelman, C. A. ;
Hussain, M. .
NEW ENGLAND JOURNAL OF MEDICINE, 2020, 382 (22) :2091-2102
[8]   68Ga-PSMA-Guided Bone Biopsies for Molecular Diagnostics in Patients with Metastatic Prostate Cancer [J].
de Jong, Anouk C. ;
Smits, Minke ;
van Riet, Job ;
Futterer, Jurgen J. ;
Brabander, Tessa ;
Hamberg, Paul ;
van Oort, Inge M. ;
de Wit, Ronald ;
Lolkema, Martijn P. ;
Mehra, Niven ;
Segbers, Marcel ;
van der Veldt, Astrid A. M. .
JOURNAL OF NUCLEAR MEDICINE, 2020, 61 (11) :1607-1614
[9]   Acid-Based Decalcification Methods Compromise Genomic Profiling from DNA and RNA [J].
Duncan, Ian ;
Danziger, Natalie ;
Duncan, Daniel ;
Hemmerich, Amanda ;
Edgerly, Claire ;
Huang, Richard ;
Vergilio, Jo-Anne ;
Elvin, Julia A. ;
He, Jie ;
Britt, Nicholas ;
Reddy, Prasanth ;
Sathyan, Pratheesh ;
Alexander, Brian ;
Ross, Jeffrey S. ;
Brown, Charlotte ;
Ramkissoon, Shakti H. ;
Severson, Eric A. .
BLOOD, 2019, 134
[10]  
EMA, 2020, LYNPARZA (olaparib) summary of product characteristics