FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2951482013> ?p ?o ?g. }

• W2951482013 endingPage "526" @default.
• W2951482013 startingPage "525" @default.
• W2951482013 abstract "Background: Duvelisib (DUV), a first-in-class oral dual PI3K-δ,γ inhibitor, is approved for treatment of relapsed/refractory (R/R) CLL/SLL after ≥ 2 prior therapies. In the phase 3 DUO trial, DUV 25 mg BID significantly improved efficacy vs ofatumumab (OFA; mPFS, 13.3 vs 9.9 mo; HR, 0.52 [P < .0001]; ORR, 74% vs 45% [P < .0001]) in pts with R/R CLL/SLL (Flinn et al. Blood 2018). Treatment-emergent AEs (TEAEs) of special interest (AESIs) such as infections, diarrhea, colitis, neutropenia, rash, ALT/AST elevation, and pneumonitis, were moderate and manageable with early intervention and dose modification. Aims: To examine dose-modification patterns and their impact on response to DUV in the DUO trial. Methods: TEAEs were assessed according to the NCI CTCAE v4.03. Dose interruptions (DI) or reductions (DR) to 15, 10, or 5 mg BID were permitted per study protocol to manage TEAEs. Responses were assessed by an independent review committee before and after dose modifications and were analyzed using descriptive statistics. Results: Among 158 DUV-treated pts, median duration of DUV exposure was 11.6 mo (vs 5.3 mo, OFA). DI and DR occurred in 80% (126/158) and 27% (43/158) of pts, respectively. The most common cause of DI was diarrhea (23%), followed by neutropenia (12%) and pneumonia or colitis (11% each). Among responders (n = 118), median time to first response on DUV was 1.9 mo and estimated median duration of response was 11.1 mo. Median time to first DI was 3.9 mo and median duration of DI was 15 d (range, 1–133 d). Response to DUV was improved or maintained in most pts evaluated for response who had ≥ 1 DI for > 1 wk (84% [42/50]) or > 2 wk (82% [31/38]) followed by ≥ 3 wk on DUV. In a landmark analysis, median PFS was similar in pts with DI and those without DI for > 1 wk (17.8 vs 16.3 mo) or > 2 wk (17.8 vs 16.3 mo) within the first 3 mo. The median time to DR after CR/PR was 5.6 mo (n = 25) and median duration was 3.4 mo. Median time to onset across AESIs after starting DUV ranged from 2.2 to 4.3 mo; median time to resolution was within 4 wk across AESIs. Proportions of pts experiencing AESIs were stable or decreased over time after 3–6 mo: 0–3 mo, 64% (101/158); > 3–6 mo, 63% (86/137); > 6–9 mo, 47% (54/114); > 9–12 mo, 52% (52/100), and seldom led to discontinuation of DUV (≤ 10%). Summary/Conclusion: DI/DR can contribute to the effective management of TEAEs with DUV. These findings suggest that DI of > 1–2 weeks or more do not appear to significantly impact response to DUV or PFS." @default.
• W2951482013 created "2019-06-27" @default.
• W2951482013 creator A5007320360 @default.
• W2951482013 creator A5011758516 @default.
• W2951482013 creator A5017461150 @default.
• W2951482013 creator A5023759811 @default.
• W2951482013 creator A5024663060 @default.
• W2951482013 creator A5031410374 @default.
• W2951482013 creator A5041971719 @default.
• W2951482013 creator A5046511952 @default.
• W2951482013 creator A5047306889 @default.
• W2951482013 creator A5065468755 @default.
• W2951482013 creator A5071809163 @default.
• W2951482013 creator A5078357327 @default.
• W2951482013 creator A5081280216 @default.
• W2951482013 creator A5086041553 @default.
• W2951482013 creator A5088930384 @default.
• W2951482013 date "2019-06-01" @default.
• W2951482013 modified "2023-09-27" @default.
• W2951482013 title "PS1158 IBRUTINIB PLUS RITUXIMUB IN STEROID REFRACTORY AUTOIMMUNE HEMOLYTIC ANEMIA: ELABORATION OF TREATMENT APPROACH (ISRAEL): AN INTERIM ANALYSIS OF THE ROHS TRIAL" @default.
• W2951482013 doi "https://doi.org/10.1097/01.hs9.0000562916.18980.8c" @default.
• W2951482013 hasPublicationYear "2019" @default.
• W2951482013 type Work @default.
• W2951482013 sameAs 2951482013 @default.
• W2951482013 citedByCount "0" @default.
• W2951482013 crossrefType "journal-article" @default.
• W2951482013 hasAuthorship W2951482013A5007320360 @default.
• W2951482013 hasAuthorship W2951482013A5011758516 @default.
• W2951482013 hasAuthorship W2951482013A5017461150 @default.
• W2951482013 hasAuthorship W2951482013A5023759811 @default.
• W2951482013 hasAuthorship W2951482013A5024663060 @default.
• W2951482013 hasAuthorship W2951482013A5031410374 @default.
• W2951482013 hasAuthorship W2951482013A5041971719 @default.
• W2951482013 hasAuthorship W2951482013A5046511952 @default.
• W2951482013 hasAuthorship W2951482013A5047306889 @default.
• W2951482013 hasAuthorship W2951482013A5065468755 @default.
• W2951482013 hasAuthorship W2951482013A5071809163 @default.
• W2951482013 hasAuthorship W2951482013A5078357327 @default.
• W2951482013 hasAuthorship W2951482013A5081280216 @default.
• W2951482013 hasAuthorship W2951482013A5086041553 @default.
• W2951482013 hasAuthorship W2951482013A5088930384 @default.
• W2951482013 hasBestOaLocation W29514820131 @default.
• W2951482013 hasConcept C126322002 @default.
• W2951482013 hasConcept C197934379 @default.
• W2951482013 hasConcept C2777063308 @default.
• W2951482013 hasConcept C2778248108 @default.
• W2951482013 hasConcept C2778496288 @default.
• W2951482013 hasConcept C2778570526 @default.
• W2951482013 hasConcept C2779802037 @default.
• W2951482013 hasConcept C29730261 @default.
• W2951482013 hasConcept C71924100 @default.
• W2951482013 hasConcept C90924648 @default.
• W2951482013 hasConceptScore W2951482013C126322002 @default.
• W2951482013 hasConceptScore W2951482013C197934379 @default.
• W2951482013 hasConceptScore W2951482013C2777063308 @default.
• W2951482013 hasConceptScore W2951482013C2778248108 @default.
• W2951482013 hasConceptScore W2951482013C2778496288 @default.
• W2951482013 hasConceptScore W2951482013C2778570526 @default.
• W2951482013 hasConceptScore W2951482013C2779802037 @default.
• W2951482013 hasConceptScore W2951482013C29730261 @default.
• W2951482013 hasConceptScore W2951482013C71924100 @default.
• W2951482013 hasConceptScore W2951482013C90924648 @default.
• W2951482013 hasIssue "S1" @default.
• W2951482013 hasLocation W29514820131 @default.
• W2951482013 hasLocation W29514820132 @default.
• W2951482013 hasOpenAccess W2951482013 @default.
• W2951482013 hasPrimaryLocation W29514820131 @default.
• W2951482013 hasRelatedWork W1541193958 @default.
• W2951482013 hasRelatedWork W2039636470 @default.
• W2951482013 hasRelatedWork W2137432312 @default.
• W2951482013 hasRelatedWork W2243375749 @default.
• W2951482013 hasRelatedWork W2378568667 @default.
• W2951482013 hasRelatedWork W2379233625 @default.
• W2951482013 hasRelatedWork W2423595795 @default.
• W2951482013 hasRelatedWork W2480155873 @default.
• W2951482013 hasRelatedWork W4210639517 @default.
• W2951482013 hasRelatedWork W4300573830 @default.
• W2951482013 hasVolume "3" @default.
• W2951482013 isParatext "false" @default.
• W2951482013 isRetracted "false" @default.
• W2951482013 magId "2951482013" @default.
• W2951482013 workType "article" @default.