دورية أكاديمية
أعرض في EDS

Experience of Daratumumab in Relapsed/Refractory Multiple Myeloma: A Multicenter Study from Türkiye

التفاصيل البيبلوغرافية
العنوان: Experience of Daratumumab in Relapsed/Refractory Multiple Myeloma: A Multicenter Study from Türkiye
المؤلفون: Tekinalp A; Necmettin Erbakan University Meram Faculty of Medicine, Department of Hematology, Division of Internal Medicine, Konya, Türkiye, Gedük A; Kocaeli University Faculty of Medicine, Department of Hematology, Division of Internal Medicine, Kocaeli, Türkiye, Akdeniz A; Mersin University Faculty of Medicine, Department of Hematology, Division of Internal Medicine, Mersin, Türkiye, Terzi Demirsoy E; University of Health Sciences Türkiye, Derince Training and Research Hospital, Clinic of Hematology, Kocaeli, Türkiye, Gürsoy V; Bursa City Hospital, Clinic of Hematology, Bursa, Türkiye, Aslaner Ak M; Bülent Ecevit University Faculty of Medicine, Department of Hematology, Division of Internal Medicine, Zonguldak, Türkiye, Bağcı M; Selçuk University Faculty of Medicine, Department of Hematology, Division of Internal Medicine, Konya, Türkiye, Seçilmiş S; Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital, Clinic of Hematology, Ankara, Türkiye, Keklik Karadağ F; Ege University Faculty of Medicine, Department of Hematology, Division of Internal Medicine, İzmir, Türkiye, Oruç Uysal A; Fırat University Faculty of Medicine, Department of Hematology, Division of Internal Medicine, Elazığ, Türkiye, Doğan A; Van Yüzüncü Yıl University Faculty of Medicine, Department of Hematology, Division of Internal Medicine, Van, Türkiye, Demircioğlu S; Necmettin Erbakan University Meram Faculty of Medicine, Department of Hematology, Division of Internal Medicine, Konya, Türkiye, Erol HA; Kocaeli University Faculty of Medicine, Department of Hematology, Division of Internal Medicine, Kocaeli, Türkiye, Aslan C; University of Health Sciences Türkiye, Derince Training and Research Hospital, Clinic of Hematology, Kocaeli, Türkiye, Özkalemkaş F; Bursa Uludağ University Faculty of Medicine, Department of Hematology, Division of Internal Medicine, Bursa, Türkiye, Ertop Ş; Bülent Ecevit University Faculty of Medicine, Department of Hematology, Division of Internal Medicine, Zonguldak, Türkiye, Dağlı M; Selçuk University Faculty of Medicine, Department of Hematology, Division of Internal Medicine, Konya, Türkiye, Dal MS; Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital, Clinic of Hematology, Ankara, Türkiye, Saydam G; Ege University Faculty of Medicine, Department of Hematology, Division of Internal Medicine, İzmir, Türkiye, Merter M; Fırat University Faculty of Medicine, Department of Hematology, Division of Internal Medicine, Elazığ, Türkiye, Ural C; Van Yüzüncü Yıl University Faculty of Medicine, Department of Hematology, Division of Internal Medicine, Van, Türkiye, Çeneli Ö; Necmettin Erbakan University Meram Faculty of Medicine, Department of Hematology, Division of Internal Medicine, Konya, Türkiye
المصدر: Turkish journal of haematology : official journal of Turkish Society of Haematology [Turk J Haematol] 2023 Dec 05; Vol. 40 (4), pp. 242-250. Date of Electronic Publication: 2023 Nov 14.
نوع المنشور: Multicenter Study; Journal Article
اللغة: English
بيانات الدورية: Publisher: Galenos Yayinevi Country of Publication: Turkey NLM ID: 9606065 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1308-5263 (Electronic) Linking ISSN: 13007777 NLM ISO Abbreviation: Turk J Haematol Subsets: MEDLINE
أسماء مطبوعة: Publication: 2012- : Ankara, Turkey : Galenos Yayinevi
Original Publication: Ankara, Türkiye : Turkish Society of Haematology
مواضيع طبية MeSH: Multiple Myeloma*/drug therapy, Female ; Humans ; Male ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Dexamethasone/therapeutic use ; Lenalidomide/therapeutic use ; Neutropenia ; Retrospective Studies ; Adult ; Middle Aged ; Aged ; Aged, 80 and over
مستخلص: Objective: This study aimed to evaluate patients with relapsed/refractory multiple myeloma (RRMM) who underwent daratumumab (DARA) therapy.
Materials and Methods: This multicenter retrospective study included 134 patients who underwent at least two courses of DARA from February 1, 2018, to April 15, 2022. Epidemiological, disease, and treatment characteristics of patients and treatment-related side effects were evaluated. Survival analysis was performed.
Results: The median age at the start of DARA was 60 (range: 35-88), with 56 patients (41.8%) being female and 48 (58.2%) being male. The median time to initiation of DARA and the median follow-up time were 41.2 (5.1-223) and 5.7 (2.1-24.1) months, respectively. The overall response rate after DARA therapy was 75 (55.9%), and very good partial response or better was observed in 48 (35.8%) patients. Overall survival (OS) and progression-free survival (PFS) for all patients were 11.6 (7.8-15.5) and 8.0 (5.1-10.9) months, respectively. OS was higher for patients undergoing treatment with DARA and bortezomib-dexamethasone (DARA-Vd) compared to those undergoing treatment with DARA and lenalidomide-dexamethasone (DARA-Rd) (16.9 vs. 8.3 months; p=0.014). Among patients undergoing DARA-Rd, PFS was higher in those without extramedullary disease compared to those with extramedullary disease (not achieved vs. 3.7 months; odds ratio: 3.4; p<0.001). The median number of prior therapies was 3 (1-8). Initiation of DARA therapy in the early period provided an advantage for OS and PFS, although it was statistically insignificant. Infusion-related reactions were observed in 18 (13.4%) patients. All reactions occurred during the first infusion and most reactions were of grade 1 or 2 (94.5%). The frequency of neutropenia and thrombocytopenia was higher in the DARA-Rd group (61.9% vs. 24.7%, p<0.001 and 42.9% vs. 15.7%, p<0.001).
Conclusion: Our study provides real-life data in terms of DARA therapy for patients with RRMM and supports the early initiation of DARA therapy.
Competing Interests: Conflict of Interest: No conflict of interest was declared by the authors.
(©Copyright 2023 by Turkish Society of Hematology Turkish Journal of Hematology, Published by Galenos Publishing House.)
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فهرسة مساهمة: Keywords: Daratumumab; Relapsed/refractory multiple myeloma; Real-world data
Local Abstract: [Publisher, Turkish] Bu çalışmanın amacı, relaps/refrakter multipl myelom (RRMM) tanısı ile daratumumab (DARA) kullanan hastaların değerlendirilmesidir. [Publisher, Turkish] Çalışma, çok merkezli ve retrospektif olarak tasarlandı. 01.02.2018-15.04.2022 tarifleri arasında en az iki kür DARA kullanmış olan 134 hasta çalışmaya dahil edildi. Hastaların epidemiyolojik, hastalık ve tedavi ile ilişkili özellikleri ve tedavi ilişkili yan etkileri değerlendirildi. Sağ kalım analizleri yapıldı. [Publisher, Turkish] DARA tedavisine başlama yaşının ortancası 60 (35-88) olup, hastaların 56’sı (%41,8) kadın ve 48’i (%58,2) erkekti. DARA tedavisine başlama ve takip sürelerinin ortanca değerleri sırasıyla 41,2 (5,1-223) ve 5,7 (2,1-24,1) aydı. DARA tedavisi sonrası genel yanıt oranı hastaların 75’inde (%55,9) ve çok iyi kısmi yanıt veya daha iyisi hastaların 48’inde (%35,8) gözlendi. Tüm hastalar için genel sağkalım (OS) ve progresyonsuz sağkalım (PFS) sırasıyla 11,6 (7,8-15,5) ve 8,0 (5,1-10,9) aydı. DARA ve bortezomib-deksametazon (DARA-Vd) ile tedavi gören hastalarda OS, DARA ve lenalidomid-deksametazon (DARA-Rd) ile tedavi görenlere göre daha yüksek bulundu (sırasıyla 16,9 ve 8,3 ay; p=0,014). DARA-Rd tedavisi gören hastalar arasında, ekstramedüller hastalığı olmayanlarda PFS, ekstramedüller hastalığı olanlara göre daha yüksekti (NA’ya karşılık 3,7 ay; OR: 3,4; p<0,001). Önceki tedavilerin ortanca sayısı 3 (1-8) idi. DARA tedavisine erken dönemde başlamanın OS ve PFS için bir avantaj sağladığı, ancak istatistiksel olarak anlamlı olmadığı görüldü. İnfüzyonla ilişkili reaksiyonlar 18 (%13,4) hastada gözlendi. Tüm reaksiyonlar ilk infüzyon sırasında meydana geldi ve reaksiyonların çoğu 1 veya 2. derecedeydi (%94,5). Nötropeni ve trombositopeni sıklığı DARA-Rd grubunda daha yüksekti (%61,9’a karşı %24,7, p<0,001 ve %42,9’a karşı %15,7, p<0,001). [Publisher, Turkish] Çalışmamız, RRMM hastalarında DARA kullanımıyla ilişkin gerek yaşam verisi niteliğini taşımaktadır ve DARA’nın erken dönemde kullanılmasını destekler niteliktedir.
المشرفين على المادة: 4Z63YK6E0E (daratumumab)
7S5I7G3JQL (Dexamethasone)
F0P408N6V4 (Lenalidomide)
تواريخ الأحداث: Date Created: 20231114 Date Completed: 20240103 Latest Revision: 20240103
رمز التحديث: 20240103
مُعرف محوري في PubMed: PMC10701322
DOI: 10.4274/tjh.galenos.2023.2023.0029
PMID: 37961952
قاعدة البيانات: MEDLINE
الوصف
تدمد:1308-5263
DOI:10.4274/tjh.galenos.2023.2023.0029