https://m2.mtmt.hu/ hun 2026-09-22 01:36 JournalArticle 32153193 VALIDATED true 0 false 2026-07-21T07:49:50.878+0000 2021-08-23T12:55:56.647+0000 2021-08-23T12:48:00.922+0000 true 10062250 Molnár-Taga Márta /api/admin/10062250 Admin true 10062250 2021-10-18T09:11:36.193+0000 2021-10-18T09:11:36.193+0000 2021-08-23T12:55:56.662+0000 true 10062250 Molnár-Taga Márta /api/admin/10062250 Admin true 10062250 true false true 24 24 /api/publicationtype/24 PublicationType 1 true 24 JournalArticle true 10000059 Article true 24 24 /api/publicationtype/24 PublicationType 1 true 24 JournalArticle /api/subtype/10000059 Szakcikk SubType 101 true 10000059 true 1 /api/category/1 Category true 1 Döhner, H. Adjunctive Volasertib in Patients with Acute Myeloid Leukemia not Eligible for Standard Induction Therapy: A Randomized, Phase 3 Trial true true /api/journal/20066828 REVIEWED true false false 20066828 true 2572-9241 Journal FOREIGN 5 8 617 617 10 2021 In this phase 3 trial, older patients with acute myeloid leukemia ineligible for intensive chemotherapy were randomized 2:1 to receive the polo-like kinase inhibitor, volasertib (V; 350 mg intravenous on days 1 and 15 in 4-wk cycles), combined with low-dose cytarabine (LDAC; 20 mg subcutaneous, twice daily, days 1-10; n = 444), or LDAC plus placebo (P; n = 222). Primary endpoint was objective response rate (ORR); key secondary endpoint was overall survival (OS). Primary ORR analysis at recruitment completion included patients randomized ≥5 months beforehand; ORR was 25.2% for V+LDAC and 16.8% for P+LDAC (n = 371; odds ratio 1.66 [95% confidence interval (CI), 0.95-2.89]; P = 0.071). At final analysis (≥574 OS events), median OS was 5.6 months for V+LDAC and 6.5 months for P+LDAC (n = 666; hazard ratio 0.97 [95% CI, 0.8-1.2]; P = 0.757). The most common adverse events (AEs) were infections/infestations (grouped term; V+LDAC, 81.3%; P+LDAC, 63.5%) and febrile neutropenia (V+LDAC, 60.4%; P+LDAC, 29.3%). Fatal AEs occurred in 31.2% with V+LDAC versus 18.0% with P+LDAC, most commonly infections/infestations (V+LDAC, 17.1%; P+LDAC, 6.3%). Lack of OS benefit with V+LDAC versus P+LDAC may reflect increased early mortality with V+LDAC from myelosuppression and infections. © 2021 Lippincott Williams and Wilkins. 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class="authors"> <img title="Forrásközlemény" style="float: left" src="/frontend/resources/grid/publication-core-icon.png"> <img title="Idézőközlemény" style="float: left" src="/frontend/resources/grid/publication-citation-icon.png"> <div class="autype autype0"> <span class="author-name" >Döhner H. ✉ </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Symeonidis A. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Deeren D. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" mtid="10005206"><a href="/gui2/?type=authors&mode=browse&sel=10005206" target="_blank">Demeter J. (<span class="authorship-author-name">Demeter Judit</span> <span class="authorAux-mtmt"> Hematológia</span>) </a> </span> <span class="author-affil"><span title="Semmelweis Egyetem">SE</span>/<span title="Általános Orvostudományi Kar">AOK</span>/<span title="Klinikum">K</span>/Belgyógyászati és Onkológiai Klinika</span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Sanz M.A. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Anagnostopoulos A. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Esteve J. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Fiedler W. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Porkka K. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Kim H.-J. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Lee J.-H. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Usuki K. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >D'Ardia S. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Won Jung C. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Salamero O. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Horst H.-A. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Recher C. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Rousselot P. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Sandhu I. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Theunissen K. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Thol F. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Döhner K. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Teleanu V. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Deangelo D.J. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Naoe T. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Sekeres M.A. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Belsack V. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Ge M. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Taube T. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Ottmann O.G. </span> </div> </div> <div class="title"><a href="/gui2/?mode=browse&params=publication;32153193" target="_blank">Adjunctive Volasertib in Patients with Acute Myeloid Leukemia not Eligible for Standard Induction Therapy: A Randomized, Phase 3 Trial</a></div> <div> <span class="journal-title">HEMASPHERE</span> <span class="journal-issn">( <a target="_blank" href="https://portal.issn.org/resource/ISSN/2572-9241">2572-9241</a>)</span>: <span class="journal-volume">5</span> <span class="journal-issue">8</span> <span class="page"> Paper 617. 10 p. </span> <span class="year">(2021)</span> </div> <div class="pub-footer"> <span class="language" xmlns="http://www.w3.org/1999/html">Nyelv: Angol | </span> <span class="identifiers"> <span class="id identifier oa_GOLD" title=" Gold "> <a style="color:blue" title="10.1097/HS9.0000000000000617" target="_blank" href="https://doi.org/10.1097/HS9.0000000000000617"> DOI </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="000682773000010" target="_blank" href="https://www.webofscience.com/wos/woscc/full-record/000682773000010"> WoS </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:black" title="85112389393" target="_blank" href="http://www.scopus.com/record/display.url?origin=inward&eid=2-s2.0-85112389393"> Scopus </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="34350385" target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=34350385&dopt=Abstract"> PubMed </a> </span> </span> <OnlyViewableByAuthor><div class="ratings"> <div class="journal-subject">Folyóirat szakterülete: Scopus - Hematology&nbsp;&nbsp;&nbsp;SJR indikátor:&nbsp;Q1</div> </div></OnlyViewableByAuthor> <div class="publication-citation" style="margin-left: 0.5cm;"> <span title="Nyilvános idézőközlemények összesen, említések nélkül" class="citingPub-count">Nyilvános idéző összesen: 31</span> | Független: 27 | Függő: 4 | Nem jelölt: 0 | WoS jelölt: 29 | Scopus jelölt:&nbsp;29 | WoS/Scopus jelölt:&nbsp;31 | DOI jelölt:&nbsp;31 </div> <div class="publication-citation"> <a target="_blank" href="/api/publication?cond=citations.related;eq;32153193&sort=publishedYear,desc&sort=title"> Idézett közlemények száma: 1 </a> </div> <div class="mtid"><span class="long-pub-mtid">Közlemény: 32153193</span> | <span class="status-data status-VALIDATED"> Egyeztetett </span> Forrás Idéző | <span class="type-subtype">Folyóiratcikk ( Szakcikk ) </span> | <span class="pub-category">Tudományos</span> | <span class="publication-sourceOfData">Scopus</span> </div> <div class="lastModified">Utolsó módosítás: 2021.08.23. 14:55 Molnár-Taga Márta (SE 4-es admin) </div> </div></div>