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硼替佐米标准剂量与减量剂量联合阿霉素和地塞米松治疗多发性骨髓瘤患者的疗效比较

[Efficacy comparison between standard and reduced doses of bortezomib combined with adriamycin and dexamethasone in the treatment of patients with multiple myeloma].

作者信息

Gu Hong-tao, Shu Mi-mi, Gao Guang-xun, Dong Bao-xia, Liang Rong, Yang Lan, Bai Qing-xian, Zhang Tao, Zhang Yong-qing, Chen Xie-qun

机构信息

Department of Hematology, Xijing Hospital, Fourth Military Medical University, Xi'an 710032, China.

出版信息

Zhonghua Xue Ye Xue Za Zhi. 2013 Jul;34(7):622-5. doi: 10.3760/cma.j.issn.0253-2727.2013.07.014.

Abstract

OBJECTIVE

To compare the efficacy and safety of standard or reduced doses of bortezomib combined with adriamycin and dexamethasone (PAD) in patients with multiple myeloma (MM).

METHODS

Eighty-two newly diagnosed or refractory/relapsed patients received bortezomib [either 1.2-1.3 mg/m(2) (standard dose) or 1.0-1.1 mg/m(2) (reduced dose) on day 1, 4, 8 and 11], and adriamycin (10 mg/m(2)) plus dexamethasone (40 mg/m(2)) on day 1-4 at 3-week intervals for 1 to 6 courses. The International Myeloma Working Group Criteria were used to evaluate the response. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (Version 3.0).

RESULTS

Two courses of standard dose of PAD resulted in a similar response rate of partial and very good partial complete remissions (PR) compared with reduced dose (80.0% vs 80.8%, P=0.728). Grade III- Ⅳ neutropenia and thrombocytopenia were higher with standard dose than that with reduced doses of PAD (21.1% vs11.1%, P=0.270; 10.5% vs 6.3%, P=0.619, respectively). Grade III-Ⅳ bortezomib-induced peripheral neuropathy, herpes zoster, fatigue or abdominal distention were significantly higher with standard dose than that with reduced dose of PAD (15.8% vs 1.6%, P=0.037; 26.3% vs 6.3%, P=0.028; 36.8% vs 14.3%, P=0.046; 15.8% vs 1.6%, P=0.037, respectively).

CONCLUSION

Reduced dose of PAD appears to result in a similar overall response rate, but a better tolerance and safety compared with standard dose.

摘要

目的

比较标准剂量或降低剂量的硼替佐米联合阿霉素及地塞米松(PAD)治疗多发性骨髓瘤(MM)患者的疗效及安全性。

方法

82例新诊断或难治/复发患者接受硼替佐米治疗[第1、4、8和11天剂量为1.2 - 1.3mg/m²(标准剂量)或1.0 - 1.1mg/m²(降低剂量)],并于第1 - 4天接受阿霉素(10mg/m²)加地塞米松(40mg/m²)治疗,每3周为1个疗程,共进行1至6个疗程。采用国际骨髓瘤工作组标准评估疗效。不良事件按照美国国立癌症研究所通用毒性标准(第3.0版)进行分级。

结果

与降低剂量相比,两个疗程的标准剂量PAD治疗后部分缓解和非常好的部分完全缓解(PR)的缓解率相似(80.0%对80.8%,P = 0.728)。标准剂量PAD导致的Ⅲ - Ⅳ级中性粒细胞减少和血小板减少高于降低剂量(分别为21.1%对11.1%,P = 0.270;10.5%对6.3%,P = 0.619)。标准剂量PAD导致的Ⅲ - Ⅳ级硼替佐米诱导的周围神经病变、带状疱疹、疲劳或腹胀显著高于降低剂量(分别为15.8%对1.6%,P = 0.037;26.3%对6.3%,P = 0.028;36.8%对14.3%,P = 0.046;15.8%对1.6%,P = 0.037)。

结论

与标准剂量相比,降低剂量的PAD似乎能产生相似的总体缓解率,但耐受性和安全性更好。

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