Apalutamide for Metastatic, Castration-Sensitive Prostate Cancer.
Kim N. Chi,Neeraj Agarwal,Anders Bjartell,Byung Ha Chung,Andrea J. Pereira de Santana Gomes,Robert Given,Álvaro Juárez Soto,Axel S. Merseburger,Mustafa Ozguroglu,Hirotsugu Uemura,Dingwei Ye,Kris Deprince,V. Naini,Jinhui Li,Shinta Cheng,Margaret K. Yu,Ke Zhang,Julie S. Larsen,Sharon Anne McCarthy,Simon Chowdhury +19 more
TLDR
Overall survival and radiographic progression-free survival were significantly longer with the addition of apalutamide to ADT than with placebo plus ADT, and the side-effect profile did not differ substantially between the two groups.Abstract:
Background Apalutamide is an inhibitor of the ligand-binding domain of the androgen receptor. Whether the addition of apalutamide to androgen-deprivation therapy (ADT) would prolong radiographic progression-free survival and overall survival as compared with placebo plus ADT among patients with metastatic, castration-sensitive prostate cancer has not been determined. Methods In this double-blind, phase 3 trial, we randomly assigned patients with metastatic, castration-sensitive prostate cancer to receive apalutamide (240 mg per day) or placebo, added to ADT. Previous treatment for localized disease and previous docetaxel therapy were allowed. The primary end points were radiographic progression-free survival and overall survival. Results A total of 525 patients were assigned to receive apalutamide plus ADT and 527 to receive placebo plus ADT. The median age was 68 years. A total of 16.4% of the patients had undergone prostatectomy or received radiotherapy for localized disease, and 10.7% had received previous docetaxel therapy; 62.7% had high-volume disease, and 37.3% had low-volume disease. At the first interim analysis, with a median of 22.7 months of follow-up, the percentage of patients with radiographic progression-free survival at 24 months was 68.2% in the apalutamide group and 47.5% in the placebo group (hazard ratio for radiographic progression or death, 0.48; 95% confidence interval [CI], 0.39 to 0.60; P Conclusions In this trial involving patients with metastatic, castration-sensitive prostate cancer, overall survival and radiographic progression-free survival were significantly longer with the addition of apalutamide to ADT than with placebo plus ADT, and the side-effect profile did not differ substantially between the two groups. (Funded by Janssen Research and Development; TITAN ClinicalTrials.gov number, NCT02489318.).read more
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EAU-EANM-ESTRO-ESUR-SIOG Guidelines on Prostate Cancer. Part II-2020 Update: Treatment of Relapsing and Metastatic Prostate Cancer
Philip Cornford,Roderick C.N. van den Bergh,Erik Briers,Thomas Van den Broeck,Marcus G. Cumberbatch,Maria De Santis,Maria De Santis,Stefano Fanti,Nicola Fossati,Giorgio Gandaglia,Silke Gillessen,Nikolaos Grivas,Jeremy Grummet,Ann Henry,Theodorus H. van der Kwast,Thomas B. Lam,Thomas B. Lam,Michael Lardas,Matthew Liew,Malcolm David Mason,Lisa Moris,Daniela E. Oprea-Lager,Henk G. van der Poel,Olivier Rouvière,Ivo G. Schoots,Ivo G. Schoots,Derya Tilki,Thomas Wiegel,Peter-Paul M. Willemse,Nicolas Mottet +29 more
TL;DR: The 2020 EAU-EANM-ESTRO-ESUR-SIOG guidelines on PCa summarise the most recent findings and advice for use in clinical practice and guide the clinician in the discussion with the patient on the treatment decisions to be taken.
Journal ArticleDOI
Management of Patients with Advanced Prostate Cancer: The Report of the Advanced Prostate Cancer Consensus Conference APCCC 2017
Silke Gillessen,Gerhardt Attard,Tomasz M. Beer,Himisha Beltran,Alberto Bossi,Robert G. Bristow,Brett S. Carver,Daniel Castellano,Byung Ha Chung,Noel W. Clarke,Gedske Daugaard,Ian D. Davis,Johann S. de Bono,Rodolfo Borges dos Reis,Charles G. Drake,Ros Eeles,Eleni Efstathiou,Christopher P. Evans,Stefano Fanti,Felix Y. Feng,Karim Fizazi,Mark Frydenberg,Martin E. Gleave,Susan Halabi,Axel Heidenreich,Celestia S. Higano,Nicolas James,Philip W. Kantoff,Pirkko-Liisa Kellokumpu-Lehtinen,Raja B. Khauli,Gero Kramer,Chris Logothetis,Fernando C. Maluf,Alicia K. Morgans,Michael J. Morris,Nicolas Mottet,Vedang Murthy,William Oh,Piet Ost,Anwar R. Padhani,Chris Parker,Colin C. Pritchard,Mack Roach,Mark A. Rubin,Charles J. Ryan,Fred Saad,Oliver Sartor,Howard I. Scher,Avishay Sella,Neal D. Shore,Matthew R. Smith,Howard R. Soule,Cora N. Sternberg,Hiroyoshi Suzuki,Christopher Sweeney,Matthew R. Sydes,Ian F. Tannock,Bertrand Tombal,Riccardo Valdagni,Thomas Wiegel,Aurelius Omlin +60 more
TL;DR: The presented expert voting results can be used for support in areas of management of men with APC where there is no high-level evidence, but individualised treatment decisions should as always be based on all of the data available.
Journal ArticleDOI
Prostate cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up.: Annals of oncology : official journal of the European Society for Medical Oncology
Chris Parker,Elena Castro,K. Fizazi,Axel Heidenreich,Piet Ost,Giuseppe Procopio,Bertrand Tombal,Silke Gillessen +7 more
Journal ArticleDOI
Management of Patients with Advanced Prostate Cancer: Report of the Advanced Prostate Cancer Consensus Conference 2019[Formula presented]
Silke Gillessen,Gerhardt Attard,Tomasz M. Beer,Himisha Beltran,Anders Bjartell,Alberto Bossi,Alberto Briganti,Robert G. Bristow,Kim N. Chi,Noel W. Clarke,Ian D. Davis,Johann S. de Bono,Charles G. Drake,Ignacio Duran,Ros Eeles,Eleni Efstathiou,Christopher P. Evans,Stefano Fanti,Felix Y. Feng,Karim Fizazi,Mark Frydenberg,Martin E. Gleave,Susan Halabi,Axel Heidenreich,Axel Heidenreich,Daniel Heinrich,Celestia S. Higano,Celestia S. Higano,Michael S Hofman,Michael S Hofman,Maha Hussain,Nicolas James,Ravindran Kanesvaran,Philip W. Kantoff,Philip W. Kantoff,Raja B. Khauli,Raya Leibowitz,Chris Logothetis,Chris Logothetis,Fernando C. Maluf,Robin Millman,Alicia K. Morgans,Michael J. Morris,Nicolas Mottet,Hind Mrabti,Declan G. Murphy,Declan G. Murphy,Vedang Murthy,William Oh,Piet Ost,Joe M. O'Sullivan,Joe M. O'Sullivan,Anwar R. Padhani,Chris Parker,Darren M.C. Poon,Colin C. Pritchard,Robert E. Reiter,Mack Roach,Mark A. Rubin,Charles J. Ryan,Fred Saad,Juan Pablo Sade,Oliver Sartor,Howard I. Scher,Howard I. Scher,Neal D. Shore,Eric J. Small,Matthew R. Smith,Howard R. Soule,Cora N. Sternberg,Thomas Steuber,Hiroyoshi Suzuki,Christopher Sweeney,Matthew R. Sydes,Mary-Ellen Taplin,Bertrand Tombal,Levent Türkeri,Inge M. van Oort,Almudena Zapatero,Aurelius Omlin,Aurelius Omlin +80 more
TL;DR: These voting results from a panel of prostate cancer experts can help clinicians and patients navigate controversial areas of advanced prostate management for which high-level evidence is sparse and provide a practical guide to help clinicians discuss therapeutic options with patients.
Journal ArticleDOI
Prostate cancer, version 1.2021: Featured updates to the nccn guidelines
Edward M. Schaeffer,Sandy Srinivas,Emmanuel S. Antonarakis,Andrew J. Armstrong,Justin E. Bekelman,Heather H. Cheng,Anthony V. D'Amico,Brian J. Davis,Neil Desai,Tanya B. Dorff,James A. Eastham,Thomas A. Farrington,Xin Gao,Eric M. Horwitz,Joseph E. Ippolito,Michael Kuettel,Joshua M. Lang,Rana R. McKay,Jesse K. McKenney,George J. Netto,David F. Penson,Julio M. Pow-Sang,Robert E. Reiter,Sylvia Richey,Mack Roach,Stan Rosenfeld,Ahmad Shabsigh,Daniel E. Spratt,Benjamin A. Teply,Jonathan D. Tward,Dorothy A. Shead,Deborah A. Freedman-Cass +31 more
TL;DR: The NCCN Guidelines for Prostate Cancer address staging and risk assessment after a prostate cancer diagnosis and include management options for localized, regional, and metastatic disease Recommendations for disease monitoring and treatment of recurrent disease are also included as mentioned in this paper.
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Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial
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Journal ArticleDOI
Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy
Nicholas D. James,Johann S. de Bono,Melissa R. Spears,Noel W. Clarke,Malcolm David Mason,David P. Dearnaley,Alastair W. S. Ritchie,Claire Amos,Clare Gilson,Robert Jones,David Matheson,Robin Millman,Gerhardt Attard,Simon Chowdhury,William Cross,Silke Gillessen,Chris Parker,J. Martin Russell,Dominik Berthold,Chris Brawley,Fawzi Adab,San Aung,Alison Birtle,Jo Bowen,Susannah Brock,Prabir Chakraborti,C.L. Ferguson,Joanna Gale,Emma Gray,Mohan Hingorani,Peter Hoskin,Jason F. Lester,Zafar Malik,Fiona McKinna,Neil McPhail,Julian Money-Kyrle,Joe M. O'Sullivan,Omi Parikh,Andrew Protheroe,Angus Robinson,Narayanan Srihari,Carys Thomas,John Wagstaff,James D. Wylie,Anjali Zarkar,Mahesh K.B. Parmar,Matthew R. Sydes +46 more
TL;DR: Among men with locally advanced or metastatic prostate cancer, ADT plus abiraterone and prednisolone was associated with significantly higher rates of overall and failure‐free survival than ADT alone.
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Tomasz M. Beer,Andrew J. Armstrong,Dana E. Rathkopf,Yohann Loriot,Cora N. Sternberg,Celestia S. Higano,Peter Iversen,Suman Bhattacharya,Joan Carles,Simon Chowdhury,Ian D. Davis,Johann S. de Bono,Christopher P. Evans,Karim Fizazi,Anthony M. Joshua,Choung-Soo Kim,Go Kimura,Paul N. Mainwaring,Harry H. Mansbach,Kurt Miller,Sarah B. Noonberg,Frank Perabo,De Phung,Fred Saad,Howard I. Scher,Mary-Ellen Taplin,Peter Venner,Bertrand Tombal +27 more