FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W3097133248> ?p ?o ?g. }

• W3097133248 endingPage "31" @default.
• W3097133248 startingPage "30" @default.
• W3097133248 abstract "Background Maintenance therapy improves PFS in NDMM pts. Additional active, well-tolerated treatment options that are suitable for long-term administration are required. The international, multicenter, double-blind, placebo-controlled, phase 3 TOURMALINE-MM4 trial (NCT02312258) of the oral PI ixazomib as maintenance therapy post-induction in non-transplant NDMM pts met its primary endpoint of PFS. Ixazomib demonstrated a significant and clinically meaningful benefit vs placebo, with a manageable and well-tolerated toxicity profile. Feasible, tolerable options for long-term therapy are particularly important in this setting, as pts are often elderly and/or frail. We report herein a subgroup analysis of TOURMALINE-MM4 according to age and frailty status. Methods Pts who achieved ≥partial response (PR) after 6-12 months of standard-of-care induction therapy were randomized 3:2 to ixazomib or placebo maintenance for up to 24 months. The sum of 4 components - age (&lt;75 vs 75-80 vs &gt;80 years; score 0 vs 1 vs 2), the Katz Index of Independence in Activities of Daily Living (ADL; &gt;4 vs ≤4, score 0 vs 1), the Lawton Instrumental ADL Scale (&gt;5 vs ≤5, score 0 vs 1), and the Charlson Comorbidity Index (≤1 vs ≥2, score 0 vs 1) - was used to classify pts as fit (total score: 0), unfit (score: 1), or frail (score: ≥2). Analyses of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and MY20 modules were conducted to evaluate the effects of treatment on QoL within subgroups defined by frailty status and age. Results In the ixazomib (n=425) vs placebo (n=281) arms, there were similar proportions of pts aged &lt;65, 65-74, and ≥75 years and of pts classified as fit, unfit, and frail (Table 1). Baseline disease and treatment characteristics were generally balanced in ixazomib vs placebo pts across the different age and frailty groups, with some numerical differences observed. In pts aged &lt;65 years, higher rates of International Staging System (ISS) stage III disease and fit pts and a lower rate of complete (CR) or very good partial (VGPR) response post-induction were seen (Table 1). Across frailty groups, a higher rate of CR or VGPR was seen in fit pts, a lower rate of ISS stage III disease was seen in unfit pts, and a higher rate of ISS stage III disease and a lower rate of CR or VGPR were seen in frail pts (Table 1). PFS benefit with ixazomib vs placebo was seen across age groups, with hazard ratios (HRs) of 0.576 (95% confidence interval [CI] 0.299-1.108, p=0.095, median 11.0 vs 9.3 months) in pts aged &lt;65 years, 0.615 (95% CI 0.467-0.810, p&lt;0.001, median 17.9 vs 9.3 months) in pts aged 65-74, and 0.740 (95% CI 0.537-1.019, p=0.064, median 16.7 vs 10.2 months) in pts aged ≥75 years. HRs for time to progression (TTP) were similar to those for PFS. PFS benefit with ixazomib vs placebo was also seen across frailty groups (Figure), with similar HRs for TTP. Rates of grade ≥3 treatment-emergent adverse events (TEAEs), serious TEAEs, and discontinuation due to TEAEs were higher or similar with ixazomib vs placebo across age and frailty subgroups (Table 2). Rates were generally somewhat higher in older age groups and in unfit/frail pts in both arms; nevertheless, rates of discontinuation due to TEAEs across groups were &lt;20%, even in pts aged ≥75 years and frail pts (Table 2). With ixazomib, rates of common gastrointestinal TEAEs were similar across age groups; rash and liver impairment appeared less common and peripheral neuropathy more common in older pts (Table 2). Covariate-adjusted changes in QoL subscales from baseline were estimated at each cycle using repeated measures linear mixed models stratified by frailty status. In all frailty groups, the mean changes in each treatment arm were small over time (&lt;10 points on a 0-100 scale) and similar between arms, indicating that continued treatment with ixazomib vs placebo maintenance did not adversely affect pts' QoL. Analyses by age were generally consistent with the results by frailty. Conclusions Ixazomib as post-induction maintenance therapy in non-transplant NDMM pts results in PFS benefits vs placebo regardless of age or frailty status. Ixazomib appeared generally well tolerated across groups, with TEAE rates in both arms generally elevated in elderly/frail vs younger/fit pts. Ixazomib is a feasible and effective maintenance option for prolonging PFS across this heterogeneous pt population. Disclosures Bringhen: Takeda: Consultancy; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Bristol-Myers Squibb: Honoraria; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Karyopharm: Membership on an entity's Board of Directors or advisory committees. Vorog:Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Current Employment. Labotka:Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Current Employment. Wang:Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Current Employment. Cherepanov:Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Current Employment. Cain:Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Current Employment. Manne:Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Current Employment. Dimopoulos:Celgene: Honoraria; Janssen: Honoraria; Takeda: Honoraria; Bristol-Myers Squibb: Honoraria; Beigene: Honoraria; Amgen: Honoraria. OffLabel Disclosure: Use of the oral proteasome inhibitor ixazomib as maintenance therapy in patients with newly diagnosed multiple myeloma not undergoing stem cell transplantation" @default.
• W3097133248 created "2020-11-09" @default.
• W3097133248 creator A5012247336 @default.
• W3097133248 creator A5012405296 @default.
• W3097133248 creator A5013290620 @default.
• W3097133248 creator A5026840856 @default.
• W3097133248 creator A5034751203 @default.
• W3097133248 creator A5049967785 @default.
• W3097133248 creator A5051969814 @default.
• W3097133248 creator A5056184409 @default.
• W3097133248 creator A5062322697 @default.
• W3097133248 creator A5066940168 @default.
• W3097133248 creator A5067110512 @default.
• W3097133248 creator A5068357742 @default.
• W3097133248 creator A5081588608 @default.
• W3097133248 creator A5084003551 @default.
• W3097133248 date "2020-11-05" @default.
• W3097133248 modified "2023-10-17" @default.
• W3097133248 title "Progression-Free Survival (PFS) Benefit Demonstrated and Quality of Life (QoL) Maintained across Age and Frailty Subgroups with the Oral Proteasome Inhibitor (PI) Ixazomib Vs Placebo As Post-Induction Maintenance Therapy in Non-Transplant Newly Diagnosed Multiple Myeloma (NDMM) Patients (Pts): Analysis of the TOURMALINE-MM4 Phase 3 Trial" @default.
• W3097133248 doi "https://doi.org/10.1182/blood-2020-136293" @default.
• W3097133248 hasPublicationYear "2020" @default.
• W3097133248 type Work @default.
• W3097133248 sameAs 3097133248 @default.
• W3097133248 citedByCount "5" @default.
• W3097133248 countsByYear W30971332482021 @default.
• W3097133248 countsByYear W30971332482022 @default.
• W3097133248 countsByYear W30971332482023 @default.
• W3097133248 crossrefType "journal-article" @default.
• W3097133248 hasAuthorship W3097133248A5012247336 @default.
• W3097133248 hasAuthorship W3097133248A5012405296 @default.
• W3097133248 hasAuthorship W3097133248A5013290620 @default.
• W3097133248 hasAuthorship W3097133248A5026840856 @default.
• W3097133248 hasAuthorship W3097133248A5034751203 @default.
• W3097133248 hasAuthorship W3097133248A5049967785 @default.
• W3097133248 hasAuthorship W3097133248A5051969814 @default.
• W3097133248 hasAuthorship W3097133248A5056184409 @default.
• W3097133248 hasAuthorship W3097133248A5062322697 @default.
• W3097133248 hasAuthorship W3097133248A5066940168 @default.
• W3097133248 hasAuthorship W3097133248A5067110512 @default.
• W3097133248 hasAuthorship W3097133248A5068357742 @default.
• W3097133248 hasAuthorship W3097133248A5081588608 @default.
• W3097133248 hasAuthorship W3097133248A5084003551 @default.
• W3097133248 hasConcept C126322002 @default.
• W3097133248 hasConcept C142724271 @default.
• W3097133248 hasConcept C159110408 @default.
• W3097133248 hasConcept C168563851 @default.
• W3097133248 hasConcept C1862650 @default.
• W3097133248 hasConcept C197934379 @default.
• W3097133248 hasConcept C203092338 @default.
• W3097133248 hasConcept C204787440 @default.
• W3097133248 hasConcept C207103383 @default.
• W3097133248 hasConcept C27081682 @default.
• W3097133248 hasConcept C2776364478 @default.
• W3097133248 hasConcept C2776694085 @default.
• W3097133248 hasConcept C2778283404 @default.
• W3097133248 hasConcept C2778367456 @default.
• W3097133248 hasConcept C2779951463 @default.
• W3097133248 hasConcept C2780108899 @default.
• W3097133248 hasConcept C2781098529 @default.
• W3097133248 hasConcept C44249647 @default.
• W3097133248 hasConcept C71924100 @default.
• W3097133248 hasConceptScore W3097133248C126322002 @default.
• W3097133248 hasConceptScore W3097133248C142724271 @default.
• W3097133248 hasConceptScore W3097133248C159110408 @default.
• W3097133248 hasConceptScore W3097133248C168563851 @default.
• W3097133248 hasConceptScore W3097133248C1862650 @default.
• W3097133248 hasConceptScore W3097133248C197934379 @default.
• W3097133248 hasConceptScore W3097133248C203092338 @default.
• W3097133248 hasConceptScore W3097133248C204787440 @default.
• W3097133248 hasConceptScore W3097133248C207103383 @default.
• W3097133248 hasConceptScore W3097133248C27081682 @default.
• W3097133248 hasConceptScore W3097133248C2776364478 @default.
• W3097133248 hasConceptScore W3097133248C2776694085 @default.
• W3097133248 hasConceptScore W3097133248C2778283404 @default.
• W3097133248 hasConceptScore W3097133248C2778367456 @default.
• W3097133248 hasConceptScore W3097133248C2779951463 @default.
• W3097133248 hasConceptScore W3097133248C2780108899 @default.
• W3097133248 hasConceptScore W3097133248C2781098529 @default.
• W3097133248 hasConceptScore W3097133248C44249647 @default.
• W3097133248 hasConceptScore W3097133248C71924100 @default.
• W3097133248 hasIssue "Supplement 1" @default.
• W3097133248 hasLocation W30971332481 @default.
• W3097133248 hasOpenAccess W3097133248 @default.
• W3097133248 hasPrimaryLocation W30971332481 @default.
• W3097133248 hasRelatedWork W1993683096 @default.
• W3097133248 hasRelatedWork W2261920671 @default.
• W3097133248 hasRelatedWork W2781572019 @default.
• W3097133248 hasRelatedWork W2784521119 @default.
• W3097133248 hasRelatedWork W2929187969 @default.
• W3097133248 hasRelatedWork W2979424907 @default.
• W3097133248 hasRelatedWork W3133230829 @default.
• W3097133248 hasRelatedWork W4212819300 @default.
• W3097133248 hasRelatedWork W4243065735 @default.
• W3097133248 hasRelatedWork W4385334256 @default.
• W3097133248 hasVolume "136" @default.
• W3097133248 isParatext "false" @default.
• W3097133248 isRetracted "false" @default.
• W3097133248 magId "3097133248" @default.

• next