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bortezomib: with longer follow-up: Myeloma: after failure of thalidomide

机译:硼替佐米:随访时间更长:骨髓瘤:沙利度胺治疗失败后

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In patients with multiple myeloma who are not eligible for haematopoietic stem cell transplantation, standard treatment consists of the melphalan + pred-nisone + thalidomide combination. Thalidomide monotherapy is a second-line option for some patients who relapse after initial chemotherapy.? In 2013, marketing authorisation for subcutaneous bortezomib (Velcade0, Janssen Cilag) provides an opportunity to examine data on its use in multiple myeloma with longer follow-up.? Bortezomib has still not been compared directly with thalidomide in previously untreated patients. The final results of the initial assessment confirmed thatsurvival is prolonged by about one year when bortezomib is added to melphalan + prednisone, a benefit similar to that of thalidomide. 9 In second-line treatment, the final results of the initial assessment showed that bortezomib prolonged median survival by about 6 months compared with dexamethasone (29.8 months versus 23.7 months). A trial of thalidomide versus bortezomib showed no difference in overall survival (about 21 months).? In an unblinded, randomised, controlled trial, adding bortezomib to the thalidomide + dexamethasone combination did not improve the 2-year survival rate. The median time to disease progression was increased by about 6 months, but there were more cases of severe peripheral neuropathy, severe infections, and severe thrombocytopenia.? In another randomised trial, subcutaneous administration of bortezomib appeared to be as effective as intravenous administration. Subcutaneous administration was also less toxic: 57% of patients experienced serious adverse reactions, compared to 71% of patients treated intravenously.? Bortezomib is a neurotoxic drug: it has been linked to reversible posterior leukoencephalopathy syndrome and to dozens of cases of optic neuropathy. In the comparative trial, bortezomib was associated with an excess of neurological disorders and severe infections, while thalidomide was linked to an excess of venous thrombosis and stroke. There is a higher risk of pharmacokinetic interactions with bortezomib than with thalidomide,? In practice, in late 2013, the melphalan + prednisone + thalidomide combination remains the standard treatment for multiple myeloma when haematopoietic stem cell transplantation is not feasible. Bortezomib, preferably by the subcutaneous route, is an option for patients in whom thalidomide fails.
机译:对于不适合进行造血干细胞移植的多发性骨髓瘤患者,标准治疗包括美法仑+泼尼松+沙利度胺的组合。沙利度胺单药治疗是一些初次化疗后复发的患者的第二线选择。在2013年,皮下注射硼替佐米(Velcade0,Janssen Cilag)的销售授权书提供了一个机会,可检查其在多发性骨髓瘤中的使用情况,并进行更长的随访。在先前未治疗的患者中,尚未将硼替佐米与沙利度胺直接进行比较。初步评估的最终结果证实,将硼替佐米加到美法仑+泼尼松中,生存期延长了大约一年,其益处与沙利度胺相似。 9在二线治疗中,初步评估的最终结果表明,与地塞米松相比,硼替佐米将中位生存期延长了约6个月(29.8个月对23.7个月)。沙利度胺和硼替佐米的试验显示总生存期(约21个月)无差异。在一项无盲的随机对照试验中,在沙利度胺和地塞米松联合用药中加入硼替佐米不能提高2年生存率。疾病进展的中位时间增加了约6个月,但还有更多的病例出现严重的周围神经病变,严重的感染和严重的血小板减少症。在另一项随机试验中,硼替佐米皮下给药似乎与静脉内给药一样有效。皮下给药的毒性也较小:57%的患者出现严重不良反应,而静脉注射的患者为71%。硼替佐米是一种神经毒性药物:它与可逆性后脑白质脑病综合征以及数十例视神经病变病例有关。在一项比较试验中,硼替佐米与神经系统疾病和严重感染过多有关,而沙利度胺与静脉血栓形成和中风过多有关。硼替佐米与沙利度胺相比具有更高的药代动力学相互作用风险。实际上,2013年末,当造血干细胞移植不可行时,美法仑+泼尼松+沙利度胺联合治疗仍是多发性骨髓瘤的标准治疗方法。对于沙利度胺治疗失败的患者,选择硼替佐米,最好通过皮下途径。

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    《Prescrire international》 |2014年第147期|共1页
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  • 正文语种 eng
  • 中图分类 药学;
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