Alegre Adrián, de la Rubia Javier, Sureda Balari Anna, Encinas Rodríguez Cristina, Suárez Alexia, Blanchard María Jesús, Bargay Lleonart Joan, Rodríguez-Otero Paula, Insunza Andrés, Palomera Luis, Peñarrubia María Jesús, Ríos-Tamayo Rafael, Casado Montero Luis Felipe, González Marta Sonia, Potamianou Anna, Couturier Catherine, Pei Huiling, Hevia Henar, Milionis Iordanis, Gaudig Maren, Mateos María-Victoria
Hospital Universitario de La Princesa, Madrid, Spain.
Hospital Dr. Peset and School of Medicine and Dentistry, Catholic University of Valencia, Valencia, Spain.
Hemasphere. 2020 Jun 3;4(3):e380. doi: 10.1097/HS9.0000000000000380. eCollection 2020 Jun.
Daratumumab is a human CD38-targeted monoclonal antibody approved as monotherapy for heavily pretreated relapsed and refractory multiple myeloma. We report findings for the Spanish cohort of an open-label treatment protocol that provided early access to daratumumab monotherapy and collected safety and patient-reported outcomes data for patients with relapsed or refractory multiple myeloma. At 15 centers across Spain, intravenous daratumumab (16 mg/kg) was administered to 73 patients who had ≥3 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory drug, or who were double refractory to both. The median duration of daratumumab treatment was 3.3 (range: 0.03-13.17) months, with a median number of 12 (range: 1-25) infusions. Grade 3/4 treatment-emergent adverse events were reported in 74% of patients and included lymphopenia (28.8%), thrombocytopenia (27.4%), neutropenia (21.9%), leukopenia (19.2%), and anemia (15.1%). Common (>5%) serious treatment-emergent adverse events included respiratory tract infection (9.6%), general physical health deterioration (6.8%), and back pain (5.5%). Infusion-related reactions occurred in 45% of patients. The median change from baseline in all domains of the EQ-5D-5L and EORTC QLQ-C30 was mostly 0. A total of 18 (24.7%) patients achieved a partial response or better, with 10 (13.7%) patients achieving a very good partial response or better. Median progression-free survival was 3.98 months. The results of this early access treatment protocol are consistent with previously reported trials of daratumumab monotherapy and confirm its safety and antitumoral efficacy in Spanish patients with heavily treated relapsed or refractory multiple myeloma. European Clinical Trials Database number: 2015-002993-19.
达雷妥尤单抗是一种靶向人CD38的单克隆抗体，被批准作为单一疗法用于治疗经过大量前期治疗的复发难治性多发性骨髓瘤。我们报告了一项开放标签治疗方案的西班牙队列研究结果，该方案使患者能够尽早接受达雷妥尤单抗单一疗法治疗，并收集复发或难治性多发性骨髓瘤患者的安全性数据及患者报告的结局数据。在西班牙的15个中心，对73例患者静脉注射达雷妥尤单抗（16mg/kg），这些患者既往接受过≥3线治疗，包括蛋白酶体抑制剂和免疫调节药物，或对两者均双重耐药。达雷妥尤单抗治疗的中位持续时间为3.3（范围：0.03 - 13.17）个月，中位输注次数为12次（范围：1 - 25次）。74%的患者报告了3/4级治疗中出现的不良事件，包括淋巴细胞减少（28.8%）、血小板减少（27.4%）、中性粒细胞减少（21.9%）、白细胞减少（19.2%）和贫血（15.1%）。常见（>5%）的严重治疗中出现的不良事件包括呼吸道感染（9.6%）、总体健康状况恶化（6.8%）和背痛（5.5%）。45%的患者发生了输液相关反应。EQ - 5D - 5L和EORTC QLQ - C30所有领域从基线的中位变化大多为0。共有18例（24.7%）患者获得部分缓解或更好疗效，其中10例（13.7%）患者获得非常好的部分缓解或更好疗效。中位无进展生存期为3.98个月。该早期准入治疗方案的结果与先前报道的达雷妥尤单抗单一疗法试验一致，并证实了其在西班牙经过大量治疗的复发或难治性多发性骨髓瘤患者中的安全性和抗肿瘤疗效。欧洲临床试验数据库编号：2015 - 002993 - 19。
