Niraparib and Abiraterone Acetate for Metastatic Castration-Resistant Prostate Cancer.


Journal

Journal of clinical oncology : official journal of the American Society of Clinical Oncology
ISSN: 1527-7755
Titre abrégé: J Clin Oncol
Pays: United States
ID NLM: 8309333

Informations de publication

Date de publication:
20 06 2023
Historique:
medline: 16 6 2023
pubmed: 24 3 2023
entrez: 23 3 2023
Statut: ppublish

Résumé

Metastatic castration-resistant prostate cancer (mCRPC) remains a lethal disease with current standard-of-care therapies. Homologous recombination repair (HRR) gene alterations, including MAGNITUDE (ClinicalTrials.gov identifier: NCT03748641) is a phase III, randomized, double-blinded study that evaluates niraparib and abiraterone acetate plus prednisone (niraparib + AAP) in patients with (HRR+, n = 423) or without (HRR-, n = 247) HRR-associated gene alterations, as prospectively determined by tissue/plasma-based assays. Patients were assigned 1:1 to receive niraparib + AAP or placebo + AAP. The primary end point, radiographic progression-free survival (rPFS) assessed by central review, was evaluated first in the Median rPFS in the Combination treatment with niraparib + AAP significantly lengthened rPFS in patients with HRR+ mCRPC compared with standard-of-care AAP. [Media: see text].

Identifiants

pubmed: 36952634
doi: 10.1200/JCO.22.01649
pmc: PMC10431499
doi:

Substances chimiques

Abiraterone Acetate EM5OCB9YJ6
BRCA1 protein, human 0
niraparib HMC2H89N35
BRCA1 Protein 0
BRCA2 protein, human 0
BRCA2 Protein 0
Prednisone VB0R961HZT

Banques de données

ClinicalTrials.gov
['NCT03748641']

Types de publication

Randomized Controlled Trial Clinical Trial, Phase III Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

3339-3351

Investigateurs

Maria Alvarez (M)
Gabriela Gatica (G)
Martin Greco (M)
Ernesto Korbenfeld (E)
Esteban Metrebian (E)
Jorge Salinas (J)
Alejandro Salvatierra (A)
Marcelo Tatangelo (M)
Tom Ferguson (T)
Howard Gurney (H)
Elizabeth Hovey (E)
Anthony Joshua (A)
Matos Marco (M)
Gavin Marx (G)
Michelle Morris (M)
Siobhan Ng (S)
David Pook (D)
Shahneen Sandhu (S)
Ali Tafreshi (A)
Thean Hsiang Tan (TH)
Tsvetanka Tosheva (T)
Livia Andrade (L)
Felipe Cruz (F)
Luiza Faria (L)
Jose Figueiredo (J)
Fabio Franke (F)
Andrea Juliana Gomes (AJ)
Ariel Kann (A)
Celio Kussumoto (C)
Suelen Martins (S)
Andre Murad (A)
Helio Pinczowski (H)
Giovani Pioner (G)
Luis Pires (L)
Daniel Preto (D)
Gisele Santos (G)
Eduardo Silva (E)
Jamile Silva (J)
Luciano Viana (L)
Karina Vianna (K)
Adriano Paula (A)
Zhiwen Chen (Z)
Kim Chi (K)
Urban Emmenegger (U)
Neil Fleshner (N)
Sunil Parimi (S)
Fred Saad (F)
Francisco Vera-Badillo (F)
Hongqian Guo (H)
Hong Luo (H)
Lulin Ma (L)
Mingxing Qui (M)
Wei Xue (W)
Guo Yonglian (G)
Lei Li (L)
Jinxian Pu (J)
Song Zheng (S)
Qing Zou (Q)
Milos Brodak (M)
Milan Hora (M)
Vladimir Samal (V)
Vladimir Student (V)
Jaroslav Vanasek (J)
Emmanuelle Bompas (E)
Philippe Barthelemy (P)
Delphine Borchiellini (D)
Aude Flechon (A)
Hakim Mahammedi (H)
Guilhem Roubaud (G)
Antoine Thiery-Vuillemin (A)
Diego Tosi (D)
Spaeth Dominique (S)
Carole Helissey (C)
Martin Boegemann (M)
Susan Feyerabend (S)
Eva Hellmis (E)
Martin Schostak (M)
Gerhardt Attard (G)
Anna Lydon (A)
Ian Sayers (I)
Omi Parikh (O)
Duncan Wheatley (D)
Peter Arkosy (P)
Jozsef Erfan (J)
Lajos Geczi (L)
Peter Nyirady (P)
Judit Olah (J)
Istvan Papos (I)
Bela Piko (B)
Raanan Berger (R)
Avivit Peer (A)
Umberto Basso (U)
Sergio Bracarda (S)
Orazio Caffo (O)
Francesco Carrozza (F)
Gianluca Del Conte (G)
Luca Galli (L)
Donatello Gasparro (D)
Sandro Pignata (S)
Riccardo Ricotta (R)
Daniele Santini (D)
Giampaolo Tortora (G)
Seoksoo Byun (S)
SeolHo Choo (S)
ByungHa Chung (B)
Jaeyoung Joung (J)
Wonho Jung (W)
Taek Won Kang (TW)
Cheol Kwak (C)
TaeGyun Kwon (T)
Hyo Jin Lee (HJ)
Ji Youl Lee (JY)
SeongIl Seo (S)
YoungDeuk Choi (Y)
HongKoo Ha (H)
ChoungSoo Kim (C)
Flora Li Tze Chong (FL)
Chun Sen Lim (CS)
Vijayan Manogran (V)
Hwoei Fen Soo Hoo (HF)
Guan Chou Teh (GC)
Marniza Saad (M)
David Calvo Dominguez (DC)
Abraham Cardenas (A)
Julia Saenz (J)
Andre Bergman (A)
Helgi Helgason (H)
C B Hunting (CB)
Rik Somford (R)
Tomasz Byrski (T)
Tomasz Drewa (T)
Dorota Filarska (D)
Jolanta LuniewskaBury (J)
Adam Marcheluk (A)
Konrad Talasiewicz (K)
Krzysztof Tupikowski (K)
Renata Zaucha (R)
Bogdan Zurawski (B)
Pedro Madeira (P)
Andre Mansinho (A)
Nuno Vau (N)
Anna Alyasova (A)
Victoria Chistyakova (V)
Denis Khvorostenko (D)
Dmitry Kirtbaya (D)
Gennady Kolesnikov (G)
Evgeny Kopyltsov (E)
Igor Lifirenko (I)
Alexander Lykov (A)
Konstantin Penkov (K)
Andrey Semenov (A)
Mikhail Shkolnik (M)
Pavel Skopin (P)
Roman Smirnov (R)
Evgeny Usynin (E)
Sergey Varlamov (S)
Vladimir Vladimirov (V)
Teresa Alonso (T)
Sara Breijo (S)
Elena Castro (E)
Enrique Gallardo (E)
Jose Gutierrez Banos (JG)
Alvaro Juarez (A)
Rebeca Lozano (R)
Pablo Maroto (P)
Javier Puente (J)
Alejo Rodriguez-Vida (A)
Regina Girones (R)
Begona Mellado (B)
Enrique Castellanos (E)
Chunde Li (C)
Chao-Hsiang Chang (CH)
Hsiao-Jen Chung (HJ)
Kuan-Hua Huang (KH)
Yen-Chuan Ou (YC)
Yu-Chieh Tsai (YC)
Shian-Shiang Wang (SS)
Wen-Jeng Wu (WJ)
See Tong Pang (ST)
Cagatay Arslan (C)
Devrim Cabuk (D)
Hasan Coskun (H)
Mahmut Gumus (M)
Mustafa Ozguroglu (M)
Berna Oksuzoglu (B)
Berksoy Sahin (B)
Deniz Tural (D)
Bulent Yalcin (B)
Irfan Cicin (I)
Igor Bondarenko (I)
Yaroslav Gotsuliak (Y)
Yevhen Hotko (Y)
Gennadii Khareba (G)
Oleksandr Lychkovskyy (O)
Iryna Lytvyn (I)
Taron Nalbandyan (T)
Viktor Paramonov (V)
Valerii Sakalo (V)
Eduard Stakhovsky (E)
Viktor Stus (V)
Sunil Babu (S)
Alan Bryce (A)
David Cahn (D)
Herta Chao (H)
Franklin Chu (F)
Curtis Dunshee (C)
Oscar Goodman (O)
Michael Grable (M)
Jason Hafron (J)
Joelle Hamilton (J)
Ralph Hauke (R)
Joseph Maly (J)
David Morris (D)
Gregg Newman (G)
Patrick Pilie (P)
Neal Shore (N)
Paul Sieber (P)
Matthew Smith (M)
Andrew Trainer (A)
Ronald Tutrone (R)

Commentaires et corrections

Type : CommentIn
Type : CommentIn

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Auteurs

Kim N Chi (KN)

BC Cancer - Vancouver Center, University of British Columbia, Vancouver, BC, Canada.

Dana Rathkopf (D)

Memorial Sloan Kettering Cancer Center and Weill Cornell Medicine, New York, NY.

Matthew R Smith (MR)

Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston, MA.

Eleni Efstathiou (E)

Houston Methodist Cancer Center, Houston, TX.

Gerhardt Attard (G)

University College London, London, UK.

David Olmos (D)

Department of Medical Oncology, Hospital Universitario 12 de Octubre, Instituto de Investigación Sanitaria Hospital 12 de Octubre (imas12), Madrid, Spain.

Ji Youl Lee (JY)

Department of Urology Cancer Center, Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, South Korea.

Eric J Small (EJ)

Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA.

Andrea J Pereira de Santana Gomes (AJ)

Liga Norte Riograndense Contra o Câncer, Natal, Brazil.

Guilhem Roubaud (G)

Department of Medical Oncology, Institut Bergonié, Bordeaux, France.

Marniza Saad (M)

Department of Clinical Oncology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.

Bogdan Zurawski (B)

Department of Outpatient Chemotherapy, Professor Franciszek Lukaszczyk Oncology Center, Bydgoszcz, Poland.

Valerii Sakalo (V)

Kyiv City Clinical Oncology Center and Academician O.F. Vozianov Institute of Urology of the National Academy of Medical Sciences of Ukraine, Kyiv, Ukraine.

Gary E Mason (GE)

Janssen Research & Development, LLC, Spring House, PA.

Peter Francis (P)

Janssen Research & Development, LLC, Raritan, NJ.

George Wang (G)

Janssen Research & Development, LLC, Spring House, PA.

Daphne Wu (D)

Janssen Research & Development, LLC, Los Angeles, CA.

Brooke Diorio (B)

Janssen Research & Development, LLC, Titusville, NJ.

Angela Lopez-Gitlitz (A)

Janssen Research & Development, LLC, Los Angeles, CA.

Shahneen Sandhu (S)

Peter MacCallum Cancer Centre and the University of Melbourne, Melbourne, Australia.

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