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https://hdl.handle.net/11499/37063
Title: | Early access program results from Turkey and a literature review on daratumumab monotherapy among heavily pretreated patients with relapsed/refractory myeloma | Authors: | Beksac, M. Aydin, Y. Goker, H. Turgut, Mehmet Besisik, S.K. Cagirgan, S. Tuglular, T. |
Keywords: | EAP Efficacy RRMM Safety Survival bortezomib daratumumab lenalidomide melphalan pomalidomide prednisolone thalidomide adult aged anemia Article cancer diagnosis cancer fatigue cancer recurrence clinical article cohort analysis controlled study coughing drug approval drug efficacy drug safety drug tolerability drug withdrawal dyspnea female fever human lower respiratory tract infection male middle aged monotherapy multiple cycle treatment multiple myeloma nausea neuropathy neutropenia overall survival pneumonia progression free survival prospective study rash throat irritation thrombocytopenia treatment duration treatment response upper respiratory tract infection |
Publisher: | Elsevier Inc. | Abstract: | 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. The 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. © 2020 The Authors | URI: | https://hdl.handle.net/11499/37063 https://doi.org/10.1016/j.clml.2020.02.017 |
ISSN: | 2152-2650 |
Appears in Collections: | PubMed İndeksli Yayınlar Koleksiyonu / PubMed Indexed Publications Collection Scopus İndeksli Yayınlar Koleksiyonu / Scopus Indexed Publications Collection Tıp Fakültesi Koleksiyonu WoS İndeksli Yayınlar Koleksiyonu / WoS Indexed Publications Collection |
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