Experience of Daratumumab in Relapsed/Refractory Multiple Myeloma: A Multicenter Study from T�rkiye

Experience of Daratumumab in Relapsed/Refractory Multiple Myeloma: A Multicenter Study from T�rkiye [Turk J Hematol]

Turk J Hematol. 2023; 40(4): 242-250 | DOI: 10.4274/tjh.galenos.2023.2023.0029

Experience of Daratumumab in Relapsed/Refractory Multiple Myeloma: A Multicenter Study from T�rkiye

Atakan Tekinalp¹, Ayfer Ged�k², Aydan Akdeniz³, Esra Terzi Demirsoy⁴, Vildan G�rsoy⁵, M�zeyyen Aslaner Ak⁶, Metin Ba�c�⁷, Sema Se�ilmi�⁸, Fatma Keklik Karada�⁹, Ay�e Oru� Uysal¹⁰, Ali Do�an¹¹, Sinan Demircio�lu¹, Ha�im Atakan Erol², Ceyda Aslan⁴, Fahir �zkalemka�¹², �ehmus Ertop⁶, Mehmet Da�l�⁷, Mehmet Sinan Dal⁸, G�ray Saydam⁹, Mustafa Merter¹⁰, Cihan Ural¹¹, �zcan �eneli¹
¹Necmettin Erbakan University Meram Faculty of Medicine, Department of Hematology, Division of Internal Medicine, Konya, T�rkiye
²Kocaeli University Faculty of Medicine, Department of Hematology, Division of Internal Medicine, Kocaeli, T�rkiye
³Mersin University Faculty of Medicine, Department of Hematology, Division of Internal Medicine, Mersin, T�rkiye
⁴University of Health Sciences T�rkiye, Derince Training and Research Hospital, Clinic of Hematology, Kocaeli, T�rkiye
⁵Bursa City Hospital, Clinic of Hematology, Bursa, T�rkiye
⁶B�lent Ecevit University Faculty of Medicine, Department of Hematology, Division of Internal Medicine, Zonguldak, T�rkiye
⁷Sel�uk University Faculty of Medicine, Department of Hematology, Division of Internal Medicine, Konya, T�rkiye
⁸Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital, Clinic of Hematology, Ankara, T�rkiye
⁹Ege University Faculty of Medicine, Department of Hematology, Division of Internal Medicine, �zmir, T�rkiye
¹⁰F�rat University Faculty of Medicine, Department of Hematology, Division of Internal Medicine, Elaz��, T�rkiye
¹¹Van Y�z�nc� Y�l University Faculty of Medicine, Department of Hematology, Division of Internal Medicine, Van, T�rkiye
¹²Bursa Uluda� University Faculty of Medicine, Department of Hematology, Division of Internal Medicine, Bursa, T�rkiye

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 progressionfree 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.

Keywords: Daratumumab, Relapsed/refractory multiple myeloma, Real-world data

Relaps/Refrakter Multipl Myelomda Daratumumab Deneyemi: T�rkiye�den �ok Merkezli Bir �al��ma

Ama�: Bu �al��man�n amac�, relaps/refrakter multipl myelom (RRMM) tan�s� ile daratumumab (DARA) kullanan hastalar�n de�erlendirilmesidir.
Gere� ve Y�ntem: �al��ma, �ok merkezli ve retrospektif olarak tasarland�. 01.02.2018-15.04.2022 tarifleri aras�nda en az iki k�r DARA kullanm�� olan 134 hasta �al��maya dahil edildi. Hastalar�n epidemiyolojik, hastal�k ve tedavi ile ili�kili �zellikleri ve tedavi ili�kili yan etkileri de�erlendirildi. Sa� kal�m analizleri yap�ld�.
Bulgular: DARA tedavisine ba�lama ya��n�n ortancas� 60 (35-88) olup, hastalar�n 56�s� (%41,8) kad�n ve 48�i (%58,2) erkekti. DARA tedavisine ba�lama ve takip s�relerinin ortanca de�erleri s�ras�yla 41,2 (5,1-223) ve 5,7 (2,1-24,1) ayd�. DARA tedavisi sonras� genel yan�t oran� hastalar�n 75�inde (%55,9) ve �ok iyi k�smi yan�t veya daha iyisi hastalar�n 48�inde (%35,8) g�zlendi. T�m hastalar i�in genel sa�kal�m (OS) ve progresyonsuz sa�kal�m (PFS) s�ras�yla 11,6 (7,8-15,5) ve 8,0 (5,1-10,9) ayd�. DARA ve bortezomib-deksametazon (DARA-Vd) ile tedavi g�ren hastalarda OS, DARA ve lenalidomid-deksametazon (DARA-Rd) ile tedavi g�renlere g�re daha y�ksek bulundu (s�ras�yla 16,9 ve 8,3 ay; p=0,014). DARA-Rd tedavisi g�ren hastalar aras�nda, ekstramed�ller hastal�� olmayanlarda PFS, ekstramed�ller hastal�� olanlara g�re daha y�ksekti (NA�ya kar��l�k 3,7 ay; OR: 3,4; p<0,001). �nceki tedavilerin ortanca say�s� 3 (1-8) idi. DARA tedavisine erken d�nemde ba�laman�n OS ve PFS i�in bir avantaj sa�lad��, ancak istatistiksel olarak anlaml� olmad�� g�r�ld�. �nf�zyonla ili�kili reaksiyonlar 18 (%13,4) hastada g�zlendi. T�m reaksiyonlar ilk inf�zyon s�ras�nda meydana geldi ve reaksiyonlar�n �o�u 1 veya 2. derecedeydi (%94,5). N�tropeni ve trombositopeni s�kl�� DARA-Rd grubunda daha y�ksekti (%61,9�a kar�� %24,7, p<0,001 ve %42,9�a kar�� %15,7, p<0,001).
Sonu�: �al��mam�z, RRMM hastalar�nda DARA kullan�m�yla ili�kin gerek ya�am verisi niteli�ini ta��maktad�r ve DARA�n�n erken d�nemde kullan�lmas�n� destekler niteliktedir.

Anahtar Kelimeler: Daratumumab, Relaps/refrakter multipl myelom, Ger�ek ya�am deneyimi

Atakan Tekinalp, Ayfer Ged�k, Aydan Akdeniz, Esra Terzi Demirsoy, Vildan G�rsoy, M�zeyyen Aslaner Ak, Metin Ba�c�, Sema Se�ilmi�, Fatma Keklik Karada�, Ay�e Oru� Uysal, Ali Do�an, Sinan Demircio�lu, Ha�im Atakan Erol, Ceyda Aslan, Fahir �zkalemka�, �ehmus Ertop, Mehmet Da�l�, Mehmet Sinan Dal, G�ray Saydam, Mustafa Merter, Cihan Ural, �zcan �eneli. Experience of Daratumumab in Relapsed/Refractory Multiple Myeloma: A Multicenter Study from T�rkiye. Turk J Hematol. 2023; 40(4): 242-250

Corresponding Author: Atakan Tekinalp, T�rkiye

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