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难治性多发性骨髓瘤患者使用三氧化二砷:一项前瞻性、II期、单臂研究。

Arsenic trioxide in patients with refractory multiple myeloma: a prospective, phase II, single-arm study.

作者信息

Sanaat Zohreh, Rezazadeh Mahtab, Gharamaleki Jalial Vaez, Ziae Jamal Eivazi, Esfahani Ali

机构信息

Hematology and Oncology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.

出版信息

Acta Med Iran. 2011;49(8):504-8.

PMID:22009804
Abstract

Multiple myeloma (MM) characterized by proliferation of plasma cells in bone marrow and production of monoclonal immunoglobulin's. Recently, arsenic trioxide (ATO), has been considered for treatment refractory MM. We assessed the safety and efficacy of ATO for patients with refractory MM. A phase 2, study of arsenic trioxide was conducted in 12 MM patients, whose refractory to two standard therapy. Patients received arsenic trioxide, 0.25 mg/kg/d for 5 d/week during the first 2 consecutive weeks of each 4-week cycle with 2 week rest. Patients who completed one 4-week cycle were evaluated for response to treatment. Twelve patients with refractory multiple myeloma received ATO. Disease assessment was based the amount of serum proteins electrophoresis. Of the10 patients; stable disease was observed in four patients(33%), progression disease in five patients (41.6%), complete response in one patient (3.8%) and the remaining two patients could not be assessed for a response (because of increased liver enzymes after the first week). Some adverse events: increase liver enzymes and serum creatinine, neutropenia, pruritus, nausea, vomiting, lower extremities edema, noninfectious diarrhea was observed. These results indicate that ATO is active and well tolerated as a single-agent salvage therapy, even in patients with late-stage, refractory MM.

摘要

多发性骨髓瘤(MM)的特征是骨髓中浆细胞增殖并产生单克隆免疫球蛋白。最近,三氧化二砷(ATO)已被考虑用于治疗难治性MM。我们评估了ATO对难治性MM患者的安全性和有效性。对12例对两种标准疗法难治的MM患者进行了一项三氧化二砷的2期研究。患者在每4周周期的前2个连续周内,每周5天接受三氧化二砷,剂量为0.25mg/kg/d,休息2周。完成一个4周周期的患者接受治疗反应评估。12例难治性多发性骨髓瘤患者接受了ATO治疗。疾病评估基于血清蛋白电泳量。在10例患者中,4例(33%)观察到疾病稳定,5例(41.6%)疾病进展,1例(3.8%)完全缓解,其余2例患者无法评估反应(因为第一周后肝酶升高)。观察到一些不良事件:肝酶和血清肌酐升高、中性粒细胞减少、瘙痒、恶心、呕吐、下肢水肿、非感染性腹泻。这些结果表明,即使在晚期难治性MM患者中,ATO作为单药挽救治疗也是有效的且耐受性良好。

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