Acalabrutinib Versus Investigator's Choice in Relapsed/Refractory Chronic Lymphocytic Leukemia: Final ASCEND Trial Results
DC Field | Value | Language |
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dc.contributor.author | Ghia, Paolo | - |
dc.contributor.author | Pluta, Andrzej | - |
dc.contributor.author | Wach, Malgorzata | - |
dc.contributor.author | Lysak, Daniel | - |
dc.contributor.author | Simkovic, Martin | - |
dc.contributor.author | Kriachok, Iryna | - |
dc.contributor.author | Illes, Arpad | - |
dc.contributor.author | de la Serna, Javier | - |
dc.contributor.author | Dolan, Sean | - |
dc.contributor.author | Campbell, Philip | - |
dc.contributor.author | Musuraca, Gerardo | - |
dc.contributor.author | Jacob, Abraham | - |
dc.contributor.author | Avery, Eric J. | - |
dc.contributor.author | Lee, Jae Hoon | - |
dc.contributor.author | Usenko, Ganna | - |
dc.contributor.author | Min Hui Wang | - |
dc.contributor.author | Yu, Ting | - |
dc.contributor.author | Jurczak, Wojciech | - |
dc.date.accessioned | 2023-01-19T01:41:47Z | - |
dc.date.available | 2023-01-19T01:41:47Z | - |
dc.date.created | 2023-01-18 | - |
dc.date.issued | 2022-12 | - |
dc.identifier.issn | 2572-9241 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/86686 | - |
dc.description.abstract | Acalabrutinib is a Bruton tyrosine kinase inhibitor approved for patients with chronic lymphocytic leukemia (CLL). ASCEND is the pivotal phase 3 study of acalabrutinib versus investigator's choice of idelalisib plus rituximab (IdR) or bendamustine plus rituximab (BR) in patients with relapsed/refractory (R/R) CLL. In the primary ASCEND analysis (median 16.1-month follow-up), acalabrutinib showed superior efficacy with an acceptable tolerability profile versus IdR/BR; here, we report final similar to 4 year follow-up results. Patients with R/R CLL received oral acalabrutinib 100 mg twice daily until progression or unacceptable toxicity, or investigator's choice of IdR or BR. A total of 310 patients (acalabrutinib, n = 155; IdR, n = 119; BR, n = 36) were enrolled. At median follow-up of 46.5 months (acalabrutinib) and 45.3 months (IdR/BR), acalabrutinib significantly prolonged investigator-assessed progression-free survival (PFS) versus IdR/BR (median, not reached [NR] vs 16.8 months; P < 0.001); 42-month PFS rates were 62% (acalabrutinib) versus 19% (IdR/BR). Median overall survival (OS) was NR (both arms); 42-month OS rates were 78% (acalabrutinib) versus 65% (IdR/BR). Adverse events led to drug discontinuation in 23%, 67%, and 17% of patients in the acalabrutinib, IdR, and BR arms, respectively. Events of clinical interest (acalabrutinib vs IdR/BR) included all-grade atrial fibrillation/flutter (8% vs 3%), all-grade hypertension (8% vs 5%), all-grade major hemorrhage (3% vs 3%), grade >= 3 infections (29% vs 29%), and second primary malignancies excluding nonmelanoma skin cancer (7% vs 2%). At similar to 4 years follow-up, acalabrutinib maintained favorable efficacy versus standard-of-care regimens and a consistent tolerability profile in patients with R/R CLL. | - |
dc.language | 영어 | - |
dc.language.iso | en | - |
dc.publisher | LIPPINCOTT WILLIAMS & WILKINS | - |
dc.relation.isPartOf | HEMASPHERE | - |
dc.title | Acalabrutinib Versus Investigator's Choice in Relapsed/Refractory Chronic Lymphocytic Leukemia: Final ASCEND Trial Results | - |
dc.type | Article | - |
dc.type.rims | ART | - |
dc.description.journalClass | 1 | - |
dc.identifier.wosid | 000893221200010 | - |
dc.identifier.doi | 10.1097/HS9.0000000000000801 | - |
dc.identifier.bibliographicCitation | HEMASPHERE, v.6, no.12, pp.E801 | - |
dc.description.isOpenAccess | Y | - |
dc.identifier.scopusid | 2-s2.0-85143544528 | - |
dc.citation.startPage | E801 | - |
dc.citation.title | HEMASPHERE | - |
dc.citation.volume | 6 | - |
dc.citation.number | 12 | - |
dc.contributor.affiliatedAuthor | Lee, Jae Hoon | - |
dc.type.docType | Article | - |
dc.relation.journalResearchArea | Hematology | - |
dc.relation.journalWebOfScienceCategory | Hematology | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
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