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Radioimmunotherapy with radretumab in patients with relapsed hematologic malignancies

机译:Radretumab放射免疫治疗复发性血液系统恶性肿瘤患者

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摘要

We present here a systematic analysis of lymphoma and MM patients recruited into 2 clinical trials or treated with radretumab according to compassionate use, describing the biodistribution, dosimetry, safety, and clinical activity of radretumab. Methods: Uptake in lymphoma lesions, safety, and clinical activity of radretumab radioimmunotherapy (R-RIT) were evaluated in 18 relapsed lymphoma or multiple myeloma patients. Results: In 14 of 18 patients, selective tumor uptake was found; 11 of 15 lymphoma patients, including 9 of 11 with Hodgkin lymphoma (HL), were eligible for R-RIT (a priori criteria-based target-tobone marrow ratio > 10:1 for EudraCT no. 2005-000545 or > 4:1 for EudraCT no. 2007-007241-12 at dosimetric imaging). Two HL and 1 diffuse large B cell lymphoma patient achieved complete response; 1 HL patient had partial response. Both multiple myeloma patients receiving R-RIT experienced stabilization of disease. Therefore, the overall objective response rate was 40%. Uncomplicated grade 3-4 thrombocytopenia or leukocytopenia was observed in 5 R-RIT patients, lasting 4-129 d. Conclusion: R-RIT showed a favorable benefit and risk profile in advanced relapsed lymphoma patients and induced complete response in 2 heavily pretreated, relapsed HL patients and in 1 diffuse large B cell lymphoma patient. These results warrant further exploration of R-RIT in larger phase II clinical trials. Copyright © 2012 by the Society of Nuclear Medicine, Inc.
机译:我们在这里提供一项针对淋巴瘤和MM患者的系统分析,该患者入选2个临床试验或根据同情使用radretumab进行治疗,描述了radretumab的生物分布,剂量,安全性和临床活性。方法:对18例复发性淋巴瘤或多发性骨髓瘤患者的radretumab放射免疫疗法(R-RIT)的淋巴瘤病灶摄取,安全性和临床活性进行了评估。结果:18名患者中有14名发现有选择性的肿瘤吸收; 15例淋巴瘤患者中有11例,包括11例霍奇金淋巴瘤(HL)有9例符合R-RIT(EudraCT No.2005-000545的先验标准基于靶标与骨髓的比例> 10:1或> 4:1用于剂量成像的EudraCT No.2007-007241-12)。 2例HL和1例弥漫性大B细胞淋巴瘤患者完全缓解。 1名HL患者有部分反应。接受R-RIT治疗的多发性骨髓瘤患者均经历了疾病稳定。因此,总的客观回应率为40%。在5名R-RIT患者中观察到简单的3-4级血小板减少或白细胞减少,持续4-129 d。结论:R-RIT在晚期复发性淋巴瘤患者中显示出有利的获益和风险状况,并在2例经过高度预处理的复发性HL患者和1例弥漫性大B细胞淋巴瘤患者中引起完全缓解。这些结果值得在较大的II期临床试验中进一步探索R-RIT。核医学协会版权所有©2012。

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