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首页> 外文期刊>The New England journal of medicine >Daratumumab-Based Treatment for Immunoglobulin Light-Chain Amyloidosis
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Daratumumab-Based Treatment for Immunoglobulin Light-Chain Amyloidosis

机译：基于免疫球蛋白轻链淀粉样蛋白病的基于Daratumumab的治疗方法

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Background Systemic immunoglobulin light-chain (AL) amyloidosis is characterized by deposition of amyloid fibrils of light chains produced by clonal CD38+ plasma cells. Daratumumab, a human CD38-targeting antibody, may improve outcomes for this disease. Methods We randomly assigned patients with newly diagnosed AL amyloidosis to receive six cycles of bortezomib, cyclophosphamide, and dexamethasone either alone (control group) or with subcutaneous daratumumab followed by single-agent daratumumab every 4 weeks for up to 24 cycles (daratumumab group). The primary end point was a hematologic complete response. Results A total of 388 patients underwent randomization. The median follow-up was 11.4 months. The percentage of patients who had a hematologic complete response was significantly higher in the daratumumab group than in the control group (53.3% vs. 18.1%) (relative risk ratio, 2.9; 95% confidence interval [CI], 2.1 to 4.1; P<0.001). Survival free from major organ deterioration or hematologic progression favored the daratumumab group (hazard ratio for major organ deterioration, hematologic progression, or death, 0.58; 95% CI, 0.36 to 0.93; P=0.02). At 6 months, more cardiac and renal responses occurred in the daratumumab group than in the control group (41.5% vs. 22.2% and 53.0% vs. 23.9%, respectively). The four most common grade 3 or 4 adverse events were lymphopenia (13.0% in the daratumumab group and 10.1% in the control group), pneumonia (7.8% and 4.3%, respectively), cardiac failure (6.2% and 4.8%), and diarrhea (5.7% and 3.7%). Systemic administration-related reactions to daratumumab occurred in 7.3% of the patients. A total of 56 patients died (27 in the daratumumab group and 29 in the control group), most due to amyloidosis-related cardiomyopathy. Conclusions Among patients with newly diagnosed AL amyloidosis, the addition of daratumumab to bortezomib, cyclophosphamide, and dexamethasone was associated with higher frequencies of hematologic complete response and survival free from major organ deterioration or hematologic progression. (Funded by Janssen Research and Development; ANDROMEDA ClinicalTrials.gov number, .)
机译：背景：系统性免疫球蛋白轻链淀粉样变（AL）的特征是克隆性CD38+浆细胞产生的轻链淀粉样纤维沉积。达拉图单抗是一种人类CD38靶向抗体，可以改善这种疾病的预后。方法我们随机将新诊断的AL淀粉样变性患者分为两组，分别接受硼替佐米、环磷酰胺和地塞米松6个周期的治疗（对照组）或皮下注射达鲁单抗，然后每4周接受一次达鲁单抗，最多24个周期（达鲁单抗组）。主要终点是血液学完全反应。结果388例患者随机分组。中位随访时间为11.4个月。达拉单抗组血液学完全缓解的患者百分比显著高于对照组（53.3%对18.1%）（相对风险比，2.9；95%可信区间[CI]，2.1至4.1；P<0.001）。无主要器官恶化或血液学进展的存活率有利于达拉单抗组（主要器官恶化、血液学进展或死亡的风险比为0.58；95%可信区间为0.36至0.93；P=0.02）。6个月时，达拉单抗组的心脏和肾脏反应发生率高于对照组（分别为41.5%和22.2%，53.0%和23.9%）。四种最常见的3级或4级不良事件是淋巴细胞减少（达鲁单抗组为13.0%，对照组为10.1%）、肺炎（分别为7.8%和4.3%）、心力衰竭（6.2%和4.8%）和腹泻（5.7%和3.7%）。7.3%的患者出现了与达鲁单抗有关的全身给药反应。共有56名患者死亡（达鲁单抗组27名，对照组29名），大部分死于淀粉样变性相关心肌病。结论在新诊断的AL淀粉样变性患者中，在硼替佐米、环磷酰胺和地塞米松的基础上加用达鲁单抗与血液学完全反应和无主要器官恶化或血液学进展的存活率较高有关。（由杨森研发部资助；ANDROMEDA ClinicalTrials.gov编号，）

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