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硼替佐米、马法兰和地塞米松静脉注射治疗难治性和复发性多发性骨髓瘤。

Intravenous injection of bortezomib, melphalan and dexamethasone in refractory and relapsed multiple myeloma.

机构信息

Department of Clinical and Molecular Biomedicine, Section of Haematology, University of Catania, Italy.

出版信息

Ann Oncol. 2013 Apr;24(4):1038-44. doi: 10.1093/annonc/mds531. Epub 2012 Nov 7.

DOI:10.1093/annonc/mds531
PMID:23136226
Abstract

BACKGROUND

A combination of bortezomib (1.3 mg/m(2)), melphalan (5 mg/m(2)), and dexamethasone (40 mg) (BMD), with all three drugs given as a contemporary intravenous administration, was retrospectively evaluated.

PATIENTS AND METHODS

Fifty previously treated (median 2 previous lines) patients with myeloma (33 relapsed and 17 refractory) were assessed. The first 19 patients were treated with a twice-a-week (days 1, 4, 8, 11, 'base' schedule) administration while, in the remaining 31 patients, the three drugs were administered once a week (days 1, 8, 15, 22, 'weekly' schedule).

RESULTS

Side-effects were predictable and manageable, with prominent haematological toxicity, and a better toxic profile in 'weekly' schedule (36% versus 66% in 'base' schedule). The overall response rate was 62%. After median follow-up of 24.5 months (range 2.7-50 months), the median progression-free survival (PFS) was 21.6 with no difference between the two schedules and the median overall survival (OS) was 33.8 months. Independently from the adopted schedule, we found that also in a cohort of relapsed/refractory patients achieving at least partial remission improved PFS (35.2 versus 9 months) and OS (unreached median versus 18 months).

CONCLUSION

Taken together, our observations suggest that BMD is an effective regimen in advanced myeloma patients with acceptable toxicity.

摘要

背景

硼替佐米(1.3mg/m²)、美法仑(5mg/m²)和地塞米松(40mg)联合用药(BMD),三种药物均采用当代静脉给药方式,进行回顾性评估。

患者和方法

评估了 50 名先前接受治疗(中位数为 2 线治疗)的骨髓瘤患者(33 例复发和 17 例难治)。前 19 名患者接受每周两次(第 1、4、8、11 天,“基础”方案)给药,而在其余 31 名患者中,三种药物每周一次给药(第 1、8、15、22 天,“每周”方案)。

结果

副作用可预测且可管理,主要为血液学毒性,“每周”方案的毒性谱更好(“基础”方案为 66%,“每周”方案为 36%)。总体缓解率为 62%。中位随访 24.5 个月(范围 2.7-50 个月)后,无进展生存期(PFS)的中位数为 21.6 个月,两种方案之间无差异,总生存期(OS)的中位数为 33.8 个月。独立于采用的方案,我们发现,在至少达到部分缓解的复发/难治性患者队列中,PFS(35.2 个月与 9 个月)和 OS(未达到中位值与 18 个月)也得到改善。

结论

综上所述,我们的观察结果表明,BMD 是一种在晚期骨髓瘤患者中具有可接受毒性的有效方案。

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