FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W4324136952> ?p ?o ?g. }

• W4324136952 endingPage "160" @default.
• W4324136952 startingPage "160" @default.
• W4324136952 abstract "160 Background: Darolutamide is androgen-receptor (AR) inhibitor with low blood–brain barrier penetration and limited potential for clinically relevant drug–drug interactions. Darolutamide has been shown to increase overall survival in combination with androgen deprivation therapy (ADT) in patients with newly diagnosed metastatic hormone sensitive prostate cancer (PC) and, in combination with docetaxel, in men with non-metastatic castration resistant PC. This phase 2 study assessed the efficacy and safety of DARO as a monotherapy without ADT in patients with non-castrate testosterone (T) levels (≥230 ng/dL). Methods: This was a 24-wk, open-label, randomized study of patients with hormone-naïve, histologically confirmed prostate cancer (all stages, with a max of 4 metastatic lesions) requiring hormonal treatment, an ECOG PS score of 0, and a life expectancy >1 y. All patients received DARO 600 mg bid or commercially available LHRH analogue. The primary endpoint is PSA response defined as a ≥ 80% decline at week 24 relative to baseline, in the DARO study arm. The ADT arm is used as an internal control. Secondary endpoints included changes in T levels, safety/tolerability, and quality of life. Results: Among 61 men enrolled, the median (range) age was 72 y (53-86y); 49.2% had metastases; 14.8% and 62.3% had undergone prostatectomy or radiotherapy before study entry. The median (range) of PSA at baseline was 8.9 ng/mL (2.2-333.8). In the DARO arm, the evaluable population with available PSA values at baseline and week 24 consisted of 21 patients. The PSA response rate (>80% PSA decline at wk 24) was 100%, with a median (range) decrease of -99.6% (-94.3, -100) at wk 24 in the DARO arm. Serum T levels increased by a median (range) of 43.4% (5.7-144.0) at wk 24, compared with baseline. In the DARO arm, 45.2% of men reported drug-related AEs (mostly Grade 1 or 2). Most frequent treatment-emergent AEs included gynaecomastia (19.4%), fatigue (12.9%), and hot flush (12.9%). 3.1% of men experienced SAEs, none of which were drug related. HR-QoL measures and ADT arm results will be presented as internal reference. Conclusions: DARO monotherapy (600 mg bid) was associated with significant PSA response in nearly all men with hormone-naïve prostate cancer. Testosterone level changes and most common AEs (gynecomastica, fatigue and hot flush) were consistent with potent AR inhibition. Clinical trial information: NCT02972060 ." @default.
• W4324136952 created "2023-03-15" @default.
• W4324136952 creator A5001474630 @default.
• W4324136952 creator A5004862211 @default.
• W4324136952 creator A5007357362 @default.
• W4324136952 creator A5008091556 @default.
• W4324136952 creator A5012534764 @default.
• W4324136952 creator A5014125093 @default.
• W4324136952 creator A5018433393 @default.
• W4324136952 creator A5019266618 @default.
• W4324136952 creator A5020692060 @default.
• W4324136952 creator A5027991868 @default.
• W4324136952 creator A5045577782 @default.
• W4324136952 creator A5047321862 @default.
• W4324136952 creator A5054677442 @default.
• W4324136952 creator A5059127927 @default.
• W4324136952 creator A5068397630 @default.
• W4324136952 creator A5071019411 @default.
• W4324136952 creator A5083566572 @default.
• W4324136952 date "2023-02-20" @default.
• W4324136952 modified "2023-10-16" @default.
• W4324136952 title "A phase 2 randomized open-label study of oral darolutamide monotherapy vs. androgen deprivation therapy in men with hormone-naive prostate cancer (EORTC-GUCG 1532)." @default.
• W4324136952 doi "https://doi.org/10.1200/jco.2023.41.6_suppl.160" @default.
• W4324136952 hasPublicationYear "2023" @default.
• W4324136952 type Work @default.
• W4324136952 citedByCount "0" @default.
• W4324136952 crossrefType "journal-article" @default.
• W4324136952 hasAuthorship W4324136952A5001474630 @default.
• W4324136952 hasAuthorship W4324136952A5004862211 @default.
• W4324136952 hasAuthorship W4324136952A5007357362 @default.
• W4324136952 hasAuthorship W4324136952A5008091556 @default.
• W4324136952 hasAuthorship W4324136952A5012534764 @default.
• W4324136952 hasAuthorship W4324136952A5014125093 @default.
• W4324136952 hasAuthorship W4324136952A5018433393 @default.
• W4324136952 hasAuthorship W4324136952A5019266618 @default.
• W4324136952 hasAuthorship W4324136952A5020692060 @default.
• W4324136952 hasAuthorship W4324136952A5027991868 @default.
• W4324136952 hasAuthorship W4324136952A5045577782 @default.
• W4324136952 hasAuthorship W4324136952A5047321862 @default.
• W4324136952 hasAuthorship W4324136952A5054677442 @default.
• W4324136952 hasAuthorship W4324136952A5059127927 @default.
• W4324136952 hasAuthorship W4324136952A5068397630 @default.
• W4324136952 hasAuthorship W4324136952A5071019411 @default.
• W4324136952 hasAuthorship W4324136952A5083566572 @default.
• W4324136952 hasConcept C121608353 @default.
• W4324136952 hasConcept C126322002 @default.
• W4324136952 hasConcept C126894567 @default.
• W4324136952 hasConcept C143998085 @default.
• W4324136952 hasConcept C168563851 @default.
• W4324136952 hasConcept C197934379 @default.
• W4324136952 hasConcept C203092338 @default.
• W4324136952 hasConcept C2777899217 @default.
• W4324136952 hasConcept C2778043895 @default.
• W4324136952 hasConcept C2778375690 @default.
• W4324136952 hasConcept C2780192828 @default.
• W4324136952 hasConcept C2781190966 @default.
• W4324136952 hasConcept C2908647359 @default.
• W4324136952 hasConcept C71924100 @default.
• W4324136952 hasConcept C99454951 @default.
• W4324136952 hasConceptScore W4324136952C121608353 @default.
• W4324136952 hasConceptScore W4324136952C126322002 @default.
• W4324136952 hasConceptScore W4324136952C126894567 @default.
• W4324136952 hasConceptScore W4324136952C143998085 @default.
• W4324136952 hasConceptScore W4324136952C168563851 @default.
• W4324136952 hasConceptScore W4324136952C197934379 @default.
• W4324136952 hasConceptScore W4324136952C203092338 @default.
• W4324136952 hasConceptScore W4324136952C2777899217 @default.
• W4324136952 hasConceptScore W4324136952C2778043895 @default.
• W4324136952 hasConceptScore W4324136952C2778375690 @default.
• W4324136952 hasConceptScore W4324136952C2780192828 @default.
• W4324136952 hasConceptScore W4324136952C2781190966 @default.
• W4324136952 hasConceptScore W4324136952C2908647359 @default.
• W4324136952 hasConceptScore W4324136952C71924100 @default.
• W4324136952 hasConceptScore W4324136952C99454951 @default.
• W4324136952 hasIssue "6_suppl" @default.
• W4324136952 hasLocation W43241369521 @default.
• W4324136952 hasOpenAccess W4324136952 @default.
• W4324136952 hasPrimaryLocation W43241369521 @default.
• W4324136952 hasRelatedWork W2501991984 @default.
• W4324136952 hasRelatedWork W2588988563 @default.
• W4324136952 hasRelatedWork W2776594178 @default.
• W4324136952 hasRelatedWork W2907060458 @default.
• W4324136952 hasRelatedWork W2912565296 @default.
• W4324136952 hasRelatedWork W3111556708 @default.
• W4324136952 hasRelatedWork W3157765547 @default.
• W4324136952 hasRelatedWork W3204029969 @default.
• W4324136952 hasRelatedWork W4226040508 @default.
• W4324136952 hasRelatedWork W785005902 @default.
• W4324136952 hasVolume "41" @default.
• W4324136952 isParatext "false" @default.
• W4324136952 isRetracted "false" @default.
• W4324136952 workType "article" @default.