Early Access Program Results From Turkey and a Literature Review on Daratumumab Monotherapy Among Heavily Pretreated Patients With Relapsed/Refractory Myeloma

Basit Öğe Kaydı
dc.contributor.authorBeksac, Meral
dc.contributor.authorAydin, Yildiz
dc.contributor.authorGoker, Hakan
dc.contributor.authorTurgut, Mehmet
dc.contributor.authorBesisik, Sevgi Kalayoglu
dc.contributor.authorCagirgan, Seckin
dc.contributor.authorTekgunduz, Emre
dc.date.accessioned2020-12-01T11:58:47Z
dc.date.available2020-12-01T11:58:47Z
dc.date.issued2020
dc.departmentEge Üniversitesien_US
dc.description.abstractThe present study investigated the efficacy and safety profile of daratumumab monotherapy in 42 patients with relapsed refractory multiple myeloma through a Turkish early access program. the current findings have confirmed the efficacy of daratumumab monotherapy in heavily pretreated patients with refractory multiple myeloma because of the deep and durable responses and favorable safety and tolerability profile. Background: in countries where frontline drug approval is limited to first-generation proteasome inhibitors or immunomodulatory drugs, relapses have been both more frequent and less durable. We investigated real world data on the efficacy and safety of daratumumab monotherapy among patients with relapsed refractory multiple myeloma (RRMM) from Turkey using a prospective early access program. Patients and Methods: A total of 42 patients with RRMM after a minimum of 3 previous lines of proteasome inhibitor/immunomodulatory drug-based treatments were included from 25 centers across Turkey. Daratumumab monotherapy was administered intravenously at a dose of 16 mg/kg weekly (cycles 1-2), on alternate weeks (cycles 3-6), and monthly thereafter. Results: the median daratumumab monotherapy duration was 5.5 months (range, 0.2-28.7 months). the overall response rate was 45.2%, including 14 (33.3%) partial responses, 4 (9.5%) very good partial responses, and 1 (2.4%) complete response. the median duration of response was 4.9 months. the median progression-free survival (PFS) was 5.5 (95% confidence interval, 2.6-8.4 months) with 12- and 18-month PFS rates of 35.7% and 31.0%, respectively. the median overall survival was not reached; the 12- and 18-month overall survival rates were 64.3% and 59.5%, respectively. the depth of response had a significant effect on PFS (log-rank test, P = .026). Overall, of the 76 adverse events reported, 33 (43.4%) were grade >= 3; only 4 (9.52%) were grade 3 infusion-related reactions. No infusion-related reactions or adverse events led to treatment discontinuation. Conclusion: the present findings from our daratumumab early access program have confirmed the efficacy and safety profile of daratumumab monotherapy in heavily pretreated Turkish patients with RRMM.en_US
dc.description.sponsorshipJanssen Pharmaceutica Turkeyen_US
dc.description.sponsorshipThe present daratumumab EAP was funded by Janssen Pharmaceutica Turkey. the authors would like to thank to Professor Sule Oktay, MD, PhD, and Cagla Ayhan, MD, from KAPPA Consultancy Training Research Ltd (Istanbul, Turkey), who contributed to the manuscript writing and statistical analyses.en_US
dc.identifier.doi10.1016/j.clml.2020.02.017en_US
dc.identifier.endpageE484en_US
dc.identifier.issn2152-2650
dc.identifier.issn2152-2669
dc.identifier.issue8en_US
dc.identifier.pmid32482539en_US
dc.identifier.scopus2-s2.0-85085602296en_US
dc.identifier.scopusqualityQ2en_US
dc.identifier.startpageE474en_US
dc.identifier.urihttps://doi.org/10.1016/j.clml.2020.02.017
dc.identifier.urihttps://hdl.handle.net/11454/62108
dc.identifier.volume20en_US
dc.identifier.wosWOS:000552071100004en_US
dc.identifier.wosqualityQ3en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherCig Media Group, Lpen_US
dc.relation.ispartofClinical Lymphoma Myeloma & Leukemiaen_US
dc.relation.publicationcategoryMakale - Ulusal Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectEAPen_US
dc.subjectEfficacyen_US
dc.subjectRRMMen_US
dc.subjectSafetyen_US
dc.subjectSurvivalen_US
dc.titleEarly Access Program Results From Turkey and a Literature Review on Daratumumab Monotherapy Among Heavily Pretreated Patients With Relapsed/Refractory Myelomaen_US
dc.typeReview Articleen_US

Dosyalar

Koleksiyon

WoS İndeksli Yayınlar Koleksiyonu
PubMed İndeksli Yayın Koleksiyonu
Scopus İndeksli Yayınlar Koleksiyonu