FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W4212982113> ?p ?o ?g. }

• W4212982113 endingPage "90" @default.
• W4212982113 startingPage "90" @default.
• W4212982113 abstract "90 Background: Darolutamide, a structurally distinct and highly potent androgen receptor inhibitor, had a consistently favorable safety and tolerability profile in patients with nonmetastatic castration-resistant prostate cancer in ARAMIS, and discontinuation rates due to adverse events (AEs) remained consistently low after longer follow-up. In previously reported phase 1/2 studies in patients with metastatic castration-resistant prostate cancer (mCRPC), darolutamide was well tolerated for up to 25 months. We report the safety and tolerability of extended treatment with darolutamide in these mCRPC studies. Methods: Data from three phase 1/2 studies (NCT02363855, NCT01317641/NCT01429064, and NCT01784757) in patients with mCRPC were pooled for analysis of long-term safety. Results are summarized descriptively. Results: Of 173 patients with mCRPC evaluable for safety in the 3 studies, 13 patients received > 2 years of darolutamide treatment; median duration of treatment was 38 months (range 24–90). Six patients received > 4 years of darolutamide treatment. Nine of 13 patients with > 2 years of darolutamide therapy initially received 600 mg BID; others received 200 mg (n = 1), 300 mg (n = 1), or 700 mg (n = 2) BID. Median age was 68 years in the > 2-years group, and most patients were white. Patients were enrolled from France (n = 4), Latvia (n = 3), United Kingdom (n = 3), Finland (n = 2), and Japan (n = 1). Most patients had normal renal function (n = 10) and hepatic function (n = 10), 12 patients had Eastern Cooperative Oncology Group performance status of 0, and 9 patients had a Gleason score ≥7. Prior systemic anticancer treatments taken by more than 1 patient were bicalutamide (n = 10); cyproterone (n = 3); and triptorelin and leuprorelin (n = 2 each). No patient received prior chemotherapy. All 13 patients reported AEs, most grade 1 or 2; 6 reported grade 3 AEs. Treatment-related AEs were reported in 5 patients, and all were grade 1 in severity. Serious AEs were reported in 6 patients, and all were judged not related to darolutamide. One patient treated with darolutamide for > 2 years had an AE (new neoplasm; not related to darolutamide) that led to treatment discontinuation. Conclusions: Extended darolutamide treatment > 2 years in this small group of patients with mCRPC was generally well tolerated, with safety and tolerability consistent with that previously reported. Clinical trial information: NCT02363855, NCT01317641/NCT01429064, and NCT01784757." @default.
• W4212982113 created "2022-02-24" @default.
• W4212982113 creator A5000159955 @default.
• W4212982113 creator A5004786708 @default.
• W4212982113 creator A5006874570 @default.
• W4212982113 creator A5007779528 @default.
• W4212982113 creator A5011425417 @default.
• W4212982113 creator A5014625956 @default.
• W4212982113 creator A5022378006 @default.
• W4212982113 creator A5024937203 @default.
• W4212982113 creator A5033272736 @default.
• W4212982113 creator A5034014576 @default.
• W4212982113 creator A5040519604 @default.
• W4212982113 creator A5056587248 @default.
• W4212982113 creator A5057183350 @default.
• W4212982113 creator A5059303252 @default.
• W4212982113 creator A5062742458 @default.
• W4212982113 creator A5085352169 @default.
• W4212982113 creator A5090618504 @default.
• W4212982113 date "2022-02-20" @default.
• W4212982113 modified "2023-10-05" @default.
• W4212982113 title "Long-term safety of darolutamide in patients with metastatic castration-resistant prostate cancer." @default.
• W4212982113 doi "https://doi.org/10.1200/jco.2022.40.6_suppl.090" @default.
• W4212982113 hasPublicationYear "2022" @default.
• W4212982113 type Work @default.
• W4212982113 citedByCount "0" @default.
• W4212982113 crossrefType "journal-article" @default.
• W4212982113 hasAuthorship W4212982113A5000159955 @default.
• W4212982113 hasAuthorship W4212982113A5004786708 @default.
• W4212982113 hasAuthorship W4212982113A5006874570 @default.
• W4212982113 hasAuthorship W4212982113A5007779528 @default.
• W4212982113 hasAuthorship W4212982113A5011425417 @default.
• W4212982113 hasAuthorship W4212982113A5014625956 @default.
• W4212982113 hasAuthorship W4212982113A5022378006 @default.
• W4212982113 hasAuthorship W4212982113A5024937203 @default.
• W4212982113 hasAuthorship W4212982113A5033272736 @default.
• W4212982113 hasAuthorship W4212982113A5034014576 @default.
• W4212982113 hasAuthorship W4212982113A5040519604 @default.
• W4212982113 hasAuthorship W4212982113A5056587248 @default.
• W4212982113 hasAuthorship W4212982113A5057183350 @default.
• W4212982113 hasAuthorship W4212982113A5059303252 @default.
• W4212982113 hasAuthorship W4212982113A5062742458 @default.
• W4212982113 hasAuthorship W4212982113A5085352169 @default.
• W4212982113 hasAuthorship W4212982113A5090618504 @default.
• W4212982113 hasConcept C121608353 @default.
• W4212982113 hasConcept C126322002 @default.
• W4212982113 hasConcept C143998085 @default.
• W4212982113 hasConcept C197934379 @default.
• W4212982113 hasConcept C2776551883 @default.
• W4212982113 hasConcept C2777899217 @default.
• W4212982113 hasConcept C2778375690 @default.
• W4212982113 hasConcept C2778715236 @default.
• W4212982113 hasConcept C2780192828 @default.
• W4212982113 hasConcept C61367390 @default.
• W4212982113 hasConcept C71924100 @default.
• W4212982113 hasConceptScore W4212982113C121608353 @default.
• W4212982113 hasConceptScore W4212982113C126322002 @default.
• W4212982113 hasConceptScore W4212982113C143998085 @default.
• W4212982113 hasConceptScore W4212982113C197934379 @default.
• W4212982113 hasConceptScore W4212982113C2776551883 @default.
• W4212982113 hasConceptScore W4212982113C2777899217 @default.
• W4212982113 hasConceptScore W4212982113C2778375690 @default.
• W4212982113 hasConceptScore W4212982113C2778715236 @default.
• W4212982113 hasConceptScore W4212982113C2780192828 @default.
• W4212982113 hasConceptScore W4212982113C61367390 @default.
• W4212982113 hasConceptScore W4212982113C71924100 @default.
• W4212982113 hasIssue "6_suppl" @default.
• W4212982113 hasLocation W42129821131 @default.
• W4212982113 hasOpenAccess W4212982113 @default.
• W4212982113 hasPrimaryLocation W42129821131 @default.
• W4212982113 hasRelatedWork W2309274182 @default.
• W4212982113 hasRelatedWork W2776594178 @default.
• W4212982113 hasRelatedWork W2891268463 @default.
• W4212982113 hasRelatedWork W3014214351 @default.
• W4212982113 hasRelatedWork W3023947295 @default.
• W4212982113 hasRelatedWork W3132581442 @default.
• W4212982113 hasRelatedWork W3183248075 @default.
• W4212982113 hasRelatedWork W4226040508 @default.
• W4212982113 hasRelatedWork W4251402126 @default.
• W4212982113 hasRelatedWork W4291017293 @default.
• W4212982113 hasVolume "40" @default.
• W4212982113 isParatext "false" @default.
• W4212982113 isRetracted "false" @default.
• W4212982113 workType "article" @default.