Abida, Wassim, Patnaik, Akash, Campbell, David, Shapiro, Jeremy, Bryce, Alan H. ORCID: 0000-0002-0206-3895, McDermott, Ray, Sautois, Brieuc, Vogelzang, Nicholas J., Bambury, Richard M., Voog, Eric, Zhang, Jingsong, Piulats, Josep M., Ryan, Charles J., Merseburger, Axel S., Daugaard, Gedske, Heidenreich, Axel, Fizazi, Karim, Higano, Celestia S., Krieger, Laurence E., Sternberg, Cora N., Watkins, Simon P., Despain, Darrin, Simmons, Andrew D., Loehr, Andrea, Dowson, Melanie, Golsorkhi, Tony and Chowdhury, Simon (2020). Rucaparib in Men With Metastatic Castration-Resistant Prostate Cancer Harboring a BRCA1 or BRCA2 Gene Alteration. J. Clin. Oncol., 38 (32). S. 3763 - 3775. ALEXANDRIA: AMER SOC CLINICAL ONCOLOGY. ISSN 1527-7755

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Abstract

PURPOSEBRCA1 or BRCA2 (BRCA) alterations are common in men with metastatic castration-resistant prostate cancer (mCRPC) and may confer sensitivity to poly(ADP-ribose) polymerase inhibitors. We present results from patients with mCRPC associated with a BRCA alteration treated with rucaparib 600 mg twice daily in the phase II TRITON2 study.METHODSWe enrolled patients who progressed after one to two lines of next-generation androgen receptor-directed therapy and one taxane-based chemotherapy for mCRPC. Efficacy and safety populations included patients with a deleterious BRCA alteration who received >= 1 dose of rucaparib. Key efficacy end points were objective response rate (ORR; per RECIST/Prostate Cancer Clinical Trials Working Group 3 in patients with measurable disease as assessed by blinded, independent radiology review and by investigators) and locally assessed prostate-specific antigen (PSA) response (>= 50% decrease from baseline) rate.RESULTSEfficacy and safety populations included 115 patients with a BRCA alteration with or without measurable disease. Confirmed ORRs per independent radiology review and investigator assessment were 43.5% (95% CI, 31.0% to 56.7%; 27 of 62 patients) and 50.8% (95% CI, 38.1% to 63.4%; 33 of 65 patients), respectively. The confirmed PSA response rate was 54.8% (95% CI, 45.2% to 64.1%; 63 of 115 patients). ORRs were similar for patients with a germline or somatic BRCA alteration and for patients with a BRCA1 or BRCA2 alteration, while a higher PSA response rate was observed in patients with a BRCA2 alteration. The most frequent grade >= 3 treatment-emergent adverse event was anemia (25.2%; 29 of 115 patients).CONCLUSIONRucaparib has antitumor activity in patients with mCRPC and a deleterious BRCA alteration, but with a manageable safety profile consistent with that reported in other solid tumor types.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Abida, WassimUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Patnaik, AkashUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Campbell, DavidUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Shapiro, JeremyUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bryce, Alan H.UNSPECIFIEDorcid.org/0000-0002-0206-3895UNSPECIFIED
McDermott, RayUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sautois, BrieucUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vogelzang, Nicholas J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bambury, Richard M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Voog, EricUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Zhang, JingsongUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Piulats, Josep M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ryan, Charles J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Merseburger, Axel S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Daugaard, GedskeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Heidenreich, AxelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fizazi, KarimUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Higano, Celestia S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Krieger, Laurence E.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sternberg, Cora N.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Watkins, Simon P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Despain, DarrinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Simmons, Andrew D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Loehr, AndreaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dowson, MelanieUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Golsorkhi, TonyUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Chowdhury, SimonUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-311662
DOI: 10.1200/JCO.20.01035
Journal or Publication Title: J. Clin. Oncol.
Volume: 38
Number: 32
Page Range: S. 3763 - 3775
Date: 2020
Publisher: AMER SOC CLINICAL ONCOLOGY
Place of Publication: ALEXANDRIA
ISSN: 1527-7755
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
DOCETAXEL; CABAZITAXEL; SURVIVAL; OLAPARIB; DEFECTSMultiple languages
OncologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/31166

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