Abiraterone and Olaparib for Metastatic Castration-Resistant Prostate Cancer

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00209805%3A_____%2F22%3A00079095" target="_blank" >RIV/00209805:_____/22:00079095 - isvavai.cz</a>

Result on the web

<a href="https://evidence.nejm.org/doi/pdf/10.1056/EVIDoa2200043" target="_blank" >https://evidence.nejm.org/doi/pdf/10.1056/EVIDoa2200043</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1056/EVIDoa2200043" target="_blank" >10.1056/EVIDoa2200043</a>

Result language

angličtina

Original language name

Abiraterone and Olaparib for Metastatic Castration-Resistant Prostate Cancer

Original language description

BACKGROUND Preclinical studies and results of a phase 2 trial of abiraterone and olaparib suggest a combined antitumor effect when the poly(adenosine diphosphate[ADP]-ribose) polymerase inhibitor olaparib is combined with next-generation hormonal agent abiraterone to treat metastatic castration-resistant prostate cancer (mCRPC). METHODS We conducted a double-blind, phase 3 trial of abiraterone and olaparib versus abiraterone and placebo in patients with mCRPC in the first-line setting. Patients were enrolled regardless of homologous recombination repair gene mutation (HRRm) status. HRRm status was determined following enrollment by tumor tissue and circulating tumor DNA tests. Patients were randomly assigned (1:1) to receive abiraterone (1000 mg once daily) plus prednisone or prednisolone with either olaparib (300 mg twice daily) or placebo. The primary end point was imaging-based progression-free survival (ibPFS) by investigator assessment. Overall survival was among the secondary end points. RESULTS At this planned primary analysis at the first data cutoff, median ibPFS was significantly longer in the abiraterone and olaparib arm than in the abiraterone and placebo arm (24.8 vs. 16.6 months; hazard ratio, 0.66; 95% confidence interval [CI], 0.54 to 0.81; P&lt;0.001) and was consistent with blinded independent central review (hazard ratio, 0.61; 95% CI, 0.49 to 0.74). At this data cutoff, overall survival data were immature (28.6% maturity; hazard ratio, 0.86; 95% CI, 0.66 to 1.12; P=0.29). The safety profile of olaparib and abiraterone was consistent with the known safety profiles of the individual drugs. The most common adverse events in the abiraterone and olaparib arm were anemia, fatigue/asthenia, and nausea. CONCLUSIONS At primary analysis at this first data cutoff, abiraterone combined with olaparib significantly prolonged ibPFS compared with abiraterone and placebo as first-line treatment for patients with mCRPC enrolled irrespective of HRRm status. (Funded by AstraZeneca and Merck Sharp &amp; Dohme, LLC, a subsidiary of Merck &amp; Co., Inc., Rahway, NJ, USA; ClinicalTrials.gov number, NCT03732820.)

Czech name

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Czech description

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Type

J_ost - Miscellaneous article in a specialist periodical

CEP classification

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OECD FORD branch

30204 - Oncology

Project

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Continuities

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2022

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

NEJM evidence

ISSN

2766-5526

e-ISSN

2766-5526

Volume of the periodical

1

Issue of the periodical within the volume

9

Country of publishing house

US - UNITED STATES

Number of pages

16

Pages from-to

1-16

UT code for WoS article

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EID of the result in the Scopus database

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