Bortezomib in combination with pegylated liposomal doxorubicin and thalidomide is an effective steroid independent salvage regimen for patients with relapsed or refractory multiple myeloma: results of a phase II clinical trial
Bortezomib in combination with pegylated liposomal doxorubicin and thalidomide is an effective steroid independent salvage regimen for patients with relapsed or refractory multiple myeloma: results of a phase II clinical trial
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DOI：
10.1080/10428190902912460
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发表时间：
2009-01-01
影响因子：
2.6
通讯作者：
Czuczman, Myron S.
中科院分区：
文献类型：
--
作者：
Chanan-Khan, Asher;Miller, Kena C.;Czuczman, Myron S.
新型抗骨髓瘤药物与其他抗骨髓瘤药物特别是地塞米松联合使用时，疗效得到了增强。骨髓瘤治疗方案中使用的类固醇剂量通常耐受性差。因此，在一项II期临床试验中，我们研究了包括硼替佐米、聚乙二醇化脂质体阿霉素和沙利度胺（VDT方案）在内的无类固醇联合治疗的疗效。23例复发或难治性骨髓瘤或其他浆细胞癌患者接受VDT方案治疗。患者既往治疗的中位数为5次，65.2%的患者对最后一次治疗方案难治性。总有效率分别为55.5%和22%。中位无进展生存期为10.9个月（95% CI: 7.3-15.8），中位总生存期为15.7个月（95% CI: 9.1-未达到）。疲劳和感觉神经病变是最常见的副作用。我们观察到VDT是一种有效的无类固醇方案，即使在难治性骨髓瘤患者中也能诱导持久缓解。
Novel agents have demonstrated enhanced efficacy when combined with other antimyeloma agents especially dexamethasone. The steroid doses employed in myeloma regimens are often poorly tolerated. Therefore, in a phase II clinical trial we investigated the efficacy of a steroid-free combination including bortezomib, pegylated liposomal doxorubicin and thalidomide (VDT regimen). Twenty-three patients with relapsed or refractory myeloma or other plasma cell cancers were treated with the VDT regimen. Patient had a median of five prior therapies and 65.2% were refractory to their last regimen. The overall response rates were 55.5% and 22%, respectively. The median progression free survival was 10.9 months (95% CI: 7.3-15.8) and the median overall survival was 15.7 months (95% CI: 9.1-not reached). Fatigue and sensory neuropathy were the most common side effects noted. We observe that VDT is an effective steroid-free regimen with ability to induce durable remission even in patients with refractory myeloma.