Thalidomide, dexamethasone, and pegylated liposomal doxorubicin (ThaDD) for patients older than 65 years with newly diagnosed multiple myelorna
Thalidomide, dexamethasone, and pegylated liposomal doxorubicin (ThaDD) for patients older than 65 years with newly diagnosed multiple myelorna
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DOI：
10.1182/blood-2006-03-013086
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发表时间：
2006-10-01
期刊：
影响因子：
20.3
通讯作者：
Leoni, Pietro
中科院分区：
文献类型：
--
作者：
Offidani, Massimo;Corvatta, Laura;Leoni, Pietro
我们介绍了一项使用沙利度胺、地塞米松和聚乙二醇脂质体阿霉素 (ThaDD) 治疗 50 名 65 岁以上新诊断多发性骨髓瘤患者的 2 期研究结果。在28天的周期中，睡前连续口服沙利度胺100 mg，第1至4天和第9至12天口服地塞米松40 mg，并在第1天静脉注射聚乙二醇化脂质体阿霉素40 mg/m(2)。根据 EBMT 标准评估疗效。 17 名 (34%) 名患者实现 CR，7 名 (14%) 名 nCR，5 名 (10%) 名 VGPR，15 名 (30%) 名 PR 和 5 名 (10%) 名 MR，ORR 为 98%。只有 1 名患者 (2%) 出现疾病进展。预计 3 年的进展时间 (TTP)、无事件生存期 (EFS) 和总生存期 (OS) 分别为 60%、57% 和 74%，这些参数在达到至少 VGPR 缓解的患者中显着高于未达到缓解的患者。 3级和4级非血液学不良事件为便秘（10%）、疲劳（6%）、震颤（4%）、粘膜炎（4%）和掌跖红肿感觉（2%）。 12% 的患者出现 3 级和 4 级中性粒细胞减少症。分别有 22% 和 14% 的患者出现 3 级和 4 级感染以及血栓栓塞事故。在治疗新诊断的多发性骨髓瘤老年患者中，ThaDD 是一种非常有效的治疗方案，且毒性可控。
We present the results of a phase 2 study using thalidomide, dexamethasone, and pegylated liposomal doxorubicin (ThaDD) in the treatment of 50 patients older than 65 years with newly diagnosed multiple myeloma. Thalidomide 100 mg was administered orally at bedtime continuously, dexamethasone 40 mg was administered orally on days 1 to 4 and 9 to 12, and pegylated liposomal doxorubicin 40 mg/m(2) was administered intravenously on day 1 over the 28-day cycle. Response was assessed according to the EBMT criteria. Seventeen (34%) patients achieved CR, 7 (14%) nCR, 5 (10%) VGPR, 15 (30%) PR, and 5 (10%) MR, resulting in an ORR of 98%. Only 1 patient (2%) presented progressive disease. Time to progression (TTP), event-free survival (EFS), and overall survival (OS) projected at 3 years were 60%, 57%, and 74%, respectively, and these parameters were significantly higher in those patients achieving a response of at least VGPR versus those who did not. Grade 3 and 4 nonhematologic adverse events were constipation (10%), fatigue (6%), tremors (4%), mucositis (4%), and palmar-plantar erythrodysesthesia (2%). Grade 3 and 4 neutropenia occurred in 12% of patients. Grade 3 and, 4 infections and thromboembolic accidents were observed in 22% and 14% of patients, respectively. In the treatment of elderly patients with newly diagnosed multiple myeloma, ThaDD is a very effective regimen with manageable toxicity.