Matches in SemOpenAlex for { <https://semopenalex.org/work/W108527077> ?p ?o ?g. }
- W108527077 endingPage "4696" @default.
- W108527077 startingPage "4696" @default.
- W108527077 abstract "Abstract Introduction: Ibrutinib (Imbruvica®), an oral, first-in-class covalent BTK inhibitor, is a new treatment option approved by FDA for chronic lymphocytic leukemia (CLL) patients (pts) with ≥1 prior therapy. We previously reported results from the phase III trial, in which ibrutinib (ibr) significantly improved progression-free and overall survival vs ofatumumab (ofa) in pts with relapsed/refractory CLL or small lymphocytic lymphoma (SLL) (Byrd et al. NEJM, 2014). Here, we report measures of patient well-being, including hematologic, immunologic, and quality of-life parameters, at interim analysis (IA). Methods: Pts with CLL/SLL after ≥1 prior therapy were randomized 1:1 to ibr 420 mg/day until progression or unacceptable toxicity, or to ofa for up to 24 weeks. At IA, secondary efficacy endpoints of hematologic improvement (sustained improvement ≥56 days without transfusions or growth factors) and FACiT-Fatigue (FACiT-F) outcomes were analyzed, along with exploratory endpoints assessing disease-related symptoms (DRS), serum immunoglobulin, patient-reported outcomes (PROs) by EORTC QLQ-C30, and medical resource utilization (MRU). Results: Of 391 enrolled pts (ibr n=195; ofa n=196), 63% had cytopenia(s) at baseline: 45% had anemia (hemoglobin ≤11 g/dL), 35% thrombocytopenia (platelets ≤100×109/L), and 20% neutropenia (absolute neutrophil counts [ANC] ≤1.5×109/L). On the ibr arm, 69% of pts with baseline cytopenias experienced sustained improvement in blood counts compared to 43% on ofa (P<0.0001, table). There was no decrement in serum immunoglobulins (IgA, IgG, IgM) during follow-up. IgA levels increased on the ibrutinib arm only (mean change from baseline: 41% at week 24). Immune cells CD4+ and CD8+ T-cell and NK-cell levels remained relatively stable during treatment. Mean change in FACiT-F score from baseline are shown in the figure for ibr and ofa arms. At week 24, clinically meaningful (≥3 points) improvement in FACiT-F occurred in more pts on ibr than ofa (59% vs 46%, P=0.06); clinically meaningful deterioration was reported by 14% vs 24% (P=0.08), respectively. A larger proportion of ibr vs ofa pts showed clinically meaningful improvement on EORTC-QLQ-C30 global health scores (46% vs 40%). Clinically meaningful improvement (≥10 points) from baseline to week 24 in ibr vs ofa pts was observed for fatigue (median 11 vs 0). A 50% reduction in lymph node based on IRC-assessed CT was observed in 93% (177/190 evaluable) of ibr pts compared with 17% (29/174 evaluable) of ofa pts (P< 0.0001). Splenic response based on IRC-assessed CT was reported for 85% (138/163 evaluable) of ibr pts compared with 54% (82/151 evaluable) of ofa pts. Baseline DRS were comparable between groups; however, improvement by at least 1 grade (G) post-baseline was observed in ibr relative to ofa pts for weight loss (100% vs 93%), fatigue (88% vs 72%), night sweats (95% vs 86%), and anorexia (100% vs 64%), respectively. Cumulative MRU was comparable for growth factors and transfusions, with ibr pts having longer median treatment duration: 8.6 months for ibr vs 5.3 for ofa. Hospitalizations in the first 30 days occurred in 2% ibr vs 15% ofa pts. After adjusting for treatment exposure duration, diarrhea, grade 1-2 bleeding events (e.g petechiae), and atrial fibrillation were among those noted to be more frequent on the ibrutinib arm while events such as fatigue, infusion reaction, and peripheral sensory neuropathy were seen more commonly with ofa. Major hemorrhage events were uncommon, observed in 2 patients on the ibr arm vs 3 on ofa arm without adjusting for exposure time. Exposure-adjusted analysis showed no difference in any-grade infection and a 43% relative reduction for grade 3 or higher infections for ibr. Conclusions: Ibr compared to ofa when administered to previously treated CLL/SLL pts led to improvements in hematologic function and disease burden. A survival benefit with ibr, together with sustained improvements in hematologic endpoints and PRO suggest that ibr enhances quality of life while prolonging survival. Table. Sustained hematologic improvement Parameter, n (%) ITT population Pts with cytopenias at baseline Ibr n=195 Ofa n=196 P value Ibr n=195 Ofa n=196 P value Platelets 60 (31) 19 (10) <0.0001 53/74 (72) 14/64 (22) <0.0001 ANC 52 (27) 19 (10) <0.0001 26/41 (63) 12/38 (32) 0.0047 Hemoglobin 42 (22) 32 (16) 0.1883 42/89 (47) 32/86 (37) 0.1815 Figure. Improvement in FACiT-F by treatment arm. Figure. Improvement in FACiT-F by treatment arm. Disclosures Barrientos: Pharmacyclics: Membership on an entity's Board of Directors or advisory committees, Research Funding. Brown:Sanofi, Onyx, Vertex, Novartis, Boehringer, GSK, Roche/Genentech, Emergent, Morphosys, Celgene, Janssen, Pharmacyclics, Gilead: Consultancy. Kay:Genetech: Research Funding; Pharmacyclics: Research Funding; Hospira: Research Funding; Celgene: Membership on an entity's Board of Directors or advisory committees; Gilead: Membership on an entity's Board of Directors or advisory committees. Coutre:Janssen, Pharmacyclics: Honoraria, Research Funding. Tam:Pharmacyclics and Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees. Mulligan:Roche, Abbvie: Consultancy, Honoraria. Jaeger:Janssen Cilag: Honoraria. Devereux:Pharmacyclics, Janssen: Consultancy, Honoraria. Robak:Janssen: Consultancy, Research Funding. Schuh:Roche, Gilead, GSK, NAPP, Celgene: Honoraria. Bloor:GSK: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees. Dearden:Roche, GSK, Gilead, Janssen, Napp: Honoraria. Jones:Pharmacyclics: Consultancy, Research Funding. Kierschniak:Pharmacyclics, GmbH: Employment. Eckert:Pharmacyclics: Employment. Suzuki:Pharmacyclics: Employment. Hsu:Pharmacyclics: Employment. James:Pharmacyclics: Employment. Byrd:Pharmacyclics: Research Funding. Hillmen:Pharmacyclics, Janssen, Gilead, Roche: Honoraria, Research Funding." @default.
- W108527077 created "2016-06-24" @default.
- W108527077 creator A5000921376 @default.
- W108527077 creator A5001374433 @default.
- W108527077 creator A5001949103 @default.
- W108527077 creator A5002515721 @default.
- W108527077 creator A5011548707 @default.
- W108527077 creator A5015491065 @default.
- W108527077 creator A5016570475 @default.
- W108527077 creator A5025217094 @default.
- W108527077 creator A5027054405 @default.
- W108527077 creator A5027725333 @default.
- W108527077 creator A5030359399 @default.
- W108527077 creator A5033024327 @default.
- W108527077 creator A5034517642 @default.
- W108527077 creator A5036988600 @default.
- W108527077 creator A5037212641 @default.
- W108527077 creator A5047631289 @default.
- W108527077 creator A5056554686 @default.
- W108527077 creator A5057537789 @default.
- W108527077 creator A5059536209 @default.
- W108527077 creator A5069332579 @default.
- W108527077 creator A5072539751 @default.
- W108527077 creator A5074839524 @default.
- W108527077 creator A5075229974 @default.
- W108527077 creator A5076855868 @default.
- W108527077 creator A5080630441 @default.
- W108527077 creator A5081161234 @default.
- W108527077 creator A5085325467 @default.
- W108527077 creator A5087985272 @default.
- W108527077 date "2014-12-06" @default.
- W108527077 modified "2023-10-18" @default.
- W108527077 title "Hematologic and Immunologic Function and Patient Well-Being for the Phase III RESONATETM Study of Ibrutinib Vs Ofatumumab in Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma" @default.
- W108527077 doi "https://doi.org/10.1182/blood.v124.21.4696.4696" @default.
- W108527077 hasPublicationYear "2014" @default.
- W108527077 type Work @default.
- W108527077 sameAs 108527077 @default.
- W108527077 citedByCount "13" @default.
- W108527077 countsByYear W1085270772015 @default.
- W108527077 countsByYear W1085270772016 @default.
- W108527077 countsByYear W1085270772017 @default.
- W108527077 countsByYear W1085270772018 @default.
- W108527077 crossrefType "journal-article" @default.
- W108527077 hasAuthorship W108527077A5000921376 @default.
- W108527077 hasAuthorship W108527077A5001374433 @default.
- W108527077 hasAuthorship W108527077A5001949103 @default.
- W108527077 hasAuthorship W108527077A5002515721 @default.
- W108527077 hasAuthorship W108527077A5011548707 @default.
- W108527077 hasAuthorship W108527077A5015491065 @default.
- W108527077 hasAuthorship W108527077A5016570475 @default.
- W108527077 hasAuthorship W108527077A5025217094 @default.
- W108527077 hasAuthorship W108527077A5027054405 @default.
- W108527077 hasAuthorship W108527077A5027725333 @default.
- W108527077 hasAuthorship W108527077A5030359399 @default.
- W108527077 hasAuthorship W108527077A5033024327 @default.
- W108527077 hasAuthorship W108527077A5034517642 @default.
- W108527077 hasAuthorship W108527077A5036988600 @default.
- W108527077 hasAuthorship W108527077A5037212641 @default.
- W108527077 hasAuthorship W108527077A5047631289 @default.
- W108527077 hasAuthorship W108527077A5056554686 @default.
- W108527077 hasAuthorship W108527077A5057537789 @default.
- W108527077 hasAuthorship W108527077A5059536209 @default.
- W108527077 hasAuthorship W108527077A5069332579 @default.
- W108527077 hasAuthorship W108527077A5072539751 @default.
- W108527077 hasAuthorship W108527077A5074839524 @default.
- W108527077 hasAuthorship W108527077A5075229974 @default.
- W108527077 hasAuthorship W108527077A5076855868 @default.
- W108527077 hasAuthorship W108527077A5080630441 @default.
- W108527077 hasAuthorship W108527077A5081161234 @default.
- W108527077 hasAuthorship W108527077A5085325467 @default.
- W108527077 hasAuthorship W108527077A5087985272 @default.
- W108527077 hasBestOaLocation W1085270771 @default.
- W108527077 hasConcept C126322002 @default.
- W108527077 hasConcept C143998085 @default.
- W108527077 hasConcept C203014093 @default.
- W108527077 hasConcept C2777063308 @default.
- W108527077 hasConcept C2777938653 @default.
- W108527077 hasConcept C2778461978 @default.
- W108527077 hasConcept C2778714382 @default.
- W108527077 hasConcept C2779338263 @default.
- W108527077 hasConcept C2779878957 @default.
- W108527077 hasConcept C2780007613 @default.
- W108527077 hasConcept C2780366003 @default.
- W108527077 hasConcept C2780653079 @default.
- W108527077 hasConcept C29730261 @default.
- W108527077 hasConcept C535046627 @default.
- W108527077 hasConcept C61943457 @default.
- W108527077 hasConcept C71924100 @default.
- W108527077 hasConcept C90924648 @default.
- W108527077 hasConceptScore W108527077C126322002 @default.
- W108527077 hasConceptScore W108527077C143998085 @default.
- W108527077 hasConceptScore W108527077C203014093 @default.
- W108527077 hasConceptScore W108527077C2777063308 @default.
- W108527077 hasConceptScore W108527077C2777938653 @default.
- W108527077 hasConceptScore W108527077C2778461978 @default.
- W108527077 hasConceptScore W108527077C2778714382 @default.
- W108527077 hasConceptScore W108527077C2779338263 @default.
- W108527077 hasConceptScore W108527077C2779878957 @default.