Atakan Tekinalp, Ayfer Gedük, Aydan Akdeniz, Esra Terzi Demirsoy, Vildan Gürsoy, Müzeyyen Aslaner Ak, Metin Bağcı, Sema Seçilmiş, Fatma Keklik Karadağ, Ayşe Oruç Uysal, Ali Doğan, Sinan Demircioğlu, Haşim Atakan Erol, Ceyda Aslan, Fahir Özkalemkaş, Şehmus Ertop, Mehmet Dağlı, Mehmet Sinan Dal, Güray Saydam, Mustafa Merter, Cihan Ural, Özcan Çeneli
{"title":"Daratumumab治疗复发/难治性多发性骨髓瘤的经验:来自土耳其的一项多中心研究","authors":"Atakan Tekinalp, Ayfer Gedük, Aydan Akdeniz, Esra Terzi Demirsoy, Vildan Gürsoy, Müzeyyen Aslaner Ak, Metin Bağcı, Sema Seçilmiş, Fatma Keklik Karadağ, Ayşe Oruç Uysal, Ali Doğan, Sinan Demircioğlu, Haşim Atakan Erol, Ceyda Aslan, Fahir Özkalemkaş, Şehmus Ertop, Mehmet Dağlı, Mehmet Sinan Dal, Güray Saydam, Mustafa Merter, Cihan Ural, Özcan Çeneli","doi":"10.4274/tjh.galenos.2023.2023.0029","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to evaluate patients with relapsed/refractory multiple myeloma (RRMM) who underwent daratumumab (DARA) therapy.</p><p><strong>Materials and methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusion: </strong>Our study provides real-life data in terms of DARA therapy for patients with RRMM and supports the early initiation of DARA therapy.</p>","PeriodicalId":23362,"journal":{"name":"Turkish Journal of Hematology","volume":" ","pages":"242-250"},"PeriodicalIF":1.5000,"publicationDate":"2023-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10701322/pdf/","citationCount":"0","resultStr":"{\"title\":\"Experience of Daratumumab in Relapsed/Refractory Multiple Myeloma: A Multicenter Study from Türkiye\",\"authors\":\"Atakan Tekinalp, Ayfer Gedük, Aydan Akdeniz, Esra Terzi Demirsoy, Vildan Gürsoy, Müzeyyen Aslaner Ak, Metin Bağcı, Sema Seçilmiş, Fatma Keklik Karadağ, Ayşe Oruç Uysal, Ali Doğan, Sinan Demircioğlu, Haşim Atakan Erol, Ceyda Aslan, Fahir Özkalemkaş, Şehmus Ertop, Mehmet Dağlı, Mehmet Sinan Dal, Güray Saydam, Mustafa Merter, Cihan Ural, Özcan Çeneli\",\"doi\":\"10.4274/tjh.galenos.2023.2023.0029\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>This study aimed to evaluate patients with relapsed/refractory multiple myeloma (RRMM) who underwent daratumumab (DARA) therapy.</p><p><strong>Materials and methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusion: </strong>Our study provides real-life data in terms of DARA therapy for patients with RRMM and supports the early initiation of DARA therapy.</p>\",\"PeriodicalId\":23362,\"journal\":{\"name\":\"Turkish Journal of Hematology\",\"volume\":\" \",\"pages\":\"242-250\"},\"PeriodicalIF\":1.5000,\"publicationDate\":\"2023-12-05\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10701322/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Turkish Journal of Hematology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.4274/tjh.galenos.2023.2023.0029\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2023/11/14 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q3\",\"JCRName\":\"HEMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Turkish Journal of Hematology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.4274/tjh.galenos.2023.2023.0029","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/11/14 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"HEMATOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
目的:本研究旨在评估接受达拉单抗(DARA)治疗的RRMM患者。材料和方法:本多中心回顾性研究纳入了2018年2月1日至2022年4月15日期间接受至少两个疗程DARA的134例患者。评估患者的流行病学、疾病和治疗特点以及治疗相关的副作用。进行生存分析。结果:DARA治疗开始时的中位年龄为60岁(35-88岁)。开始DARA的中位时间和中位随访时间分别为41.2(5.1-223)个月和5.7(2.1-24.1)个月。DARA治疗后的ORR为75例(55.9%)，VGPR≥48例(35.8%)。所有患者的总生存期(OS)和无进展生存期(PFS)分别为11.6(7.8-15.5)个月和8.0(5.1-10.9)个月。接受DARA-Vd的患者的OS高于接受DARA-Rd的患者(16.9个月vs 8.3个月;p = 0.014)。在接受Dara-Rd的患者中，无EMD (EMD-)患者的PFS高于有EMD (EMD+)患者(NA vs. 3.7个月;或者,3.4;P < 0.001)。先前治疗的中位数为3(1-8)。早期开始DARA治疗提供OS和PFS优势，尽管统计上不显著。18例(13.4%)患者出现输液相关反应。所有反应均发生在第一次输注时，大部分反应为1-2级(94.5%)。中性粒细胞减少症和血小板减少症的发生率在DARA-Rd组更高(61.9% vs. 24.7%;P < 0.001, 42.9% vs. 15.7%;P < 0.001)。结论:本研究反映了RRMM患者DARA治疗的真实数据，支持DARA治疗的早期启动。
Experience of Daratumumab in Relapsed/Refractory Multiple Myeloma: A Multicenter Study from Türkiye
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.
期刊介绍：
The Turkish Journal of Hematology is published quarterly (March, June, September, and December) by the Turkish Society of Hematology. It is an independent, non-profit peer-reviewed international English-language periodical encompassing subjects relevant to hematology.
The Editorial Board of The Turkish Journal of Hematology adheres to the principles of the World Association of Medical Editors (WAME), International Council of Medical Journal Editors (ICMJE), Committee on Publication Ethics (COPE), Consolidated Standards of Reporting Trials (CONSORT) and Strengthening the Reporting of Observational Studies in Epidemiology (STROBE).
The aim of The Turkish Journal of Hematology is to publish original hematological research of the highest scientific quality and clinical relevance. Additionally, educational material, reviews on basic developments, editorial short notes, images in hematology, and letters from hematology specialists and clinicians covering their experience and comments on hematology and related medical fields as well as social subjects are published. As of December 2015, The Turkish Journal of Hematology does not accept case reports. Important new findings or data about interesting hematological cases may be submitted as a brief report.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
