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转载 两种疗法治疗新诊断多发性骨髓瘤,孰优孰劣?

田卫伟 副主任医师 山西白求恩医院 血液科
2016-03-20 220人已读
田卫伟 副主任医师
山西白求恩医院

马法兰、强的松和沙利度胺被认为是新诊断多发性骨髓瘤不适宜接受造血干细胞移植的标准治疗方案。但由于长期使用沙利度胺会导致周围神经病变限制其使用。来拉度胺的化学结构与沙利度胺相似,被认为是二代的免疫调节剂,它取代沙利度胺后疗效如何。发表于《BLOOD》杂志的一项临床研究,比较了马法兰+强的松+来那度胺(后来那度胺维持治疗)与马法兰+强的松+沙利度胺(后沙利度胺维持治疗)的疗效。该研究表明:马法兰+强的松+来那度胺在临床疗效上较马法兰+强松+沙利度胺无显著优势,但不良反应,如周围神经病变明显减少。因此,马法兰+强的松+来那度胺(后来那度胺维持治疗)是更佳的治疗选择。山西白求恩医院血液科田卫伟

The combination of melphalan, prednisone, and thalidomide (MPT) is considered standard therapy for newly diagnosed patients with multiple myeloma who are ineligible for stem cell transplantation. Long-term treatment with thalidomide is hampered by neurotoxicity. Melphalan, prednisone, and lenalidomide, followed by lenalidomide maintenance therapy, showed promising results without severe neuropathy emerging. We randomly assigned 668 patients between nine 4-week cycles of MPT followed by thalidomide maintenance until disease progression or unacceptable toxicity (MPT-T) and the same MP regimen with thalidomide being replaced by lenalidomide (MPR-R). This multicenter, open-label, randomized phase  3 trial was undertaken by Dutch-Belgium Cooperative Trial Group for Hematology Oncology and the Nordic Myeloma Study Group (the HOVON87/NMSG18 trial). The primary end point was progression-free survival (PFS). A total of 318 patients were randomly assigned to receive MPT-T, and 319 received MPR-R. After a median follow-up of 36 months, PFS with MPT-T was 20 months (95% confidence interval [CI], 18-23 months) vs 23 months (95% CI, 19-27 months) with MPR-R (hazard ratio, 0.87; 95% CI, 0.72-1.04; P = .12). Response rates were similar, with at least a very good partial response of 47% and 45%, respectively. Hematologic toxicity was more pronounced with MPR-R, especially grades 3 and 4 neutropenia: 64% vs 27%. Neuropathy of at least grade 3 was significantly higher in the MPT-T arm: 16% vs  2% in MPR-R, resulting in a significant shorter duration of maintenance therapy (5 vs 17 months in MPR-R), irrespective of age. MPR-R has no advantage over MPT-T concerning efficacy. The toxicity profile differed with clinically significant neuropathy during thalidomide maintenance vs myelosuppression with MPR.

Zweegman, S., et al., Melphalan, prednisone, and lenalidomide versus melphalan, prednisone, and thalidomide in untreated multiple myeloma. Blood, 2016. 127(9): p. 1109-16.


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田卫伟 副主任医师

山西白求恩医院 血液科

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