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沙利度胺联合每月一次高剂量地塞米松治疗化疗难治性骨髓瘤。一项II期临床研究的结果

Thalidomide plus monthly high-dose dexamethasone in chemorefractory myeloma. Results of a phase II clinical study.

作者信息

Bernardeschi P, Giustarini G, Montenora I, Turrisi G, Dentico P, Rossi S, Turano E, Fiorentini G

机构信息

Istituto Toscano Tumori, Oncology Department and Clinical Laboratory Department, S. Giuseppe Hospital, Empoli, Florence, Italy.

出版信息

In Vivo. 2006 Nov-Dec;20(6A):719-20.

PMID:17203753
Abstract

Thalidomide is a potent anti-myeloma drug which can produce up to a 30-50% overall response rate (ORR) in pre-treated, chemorefractory multiple myeloma. Most authors agree with using 200 mg/daily with associated high dose dexamethasone (40 mg/daily x 4 days, 3 times monthly) considering lower doses investigational. We report our experience using thalidomide 100 mg/daily plus dexamethasone 40 mg/daily once a month, in 27 pre-treated patients. Thalidomide dose excalation and/or association with other drugs were established on the basis of the patient's response. Median age was 69 years (range 50-83 years) and 16 male and 11 female patients were treated. All patients had received more than 1 treatment line (range 1-5). Thalidomide was increased up to 300 mg/daily in 10 patients and 1 patient received up to 400 mg/daily. Two patients were not evaluable because of early death, 1 did not tolerate thalidomide because of pulmonary and neurological side-effects. Sixteen patients responded to this treatment, with an ORR of 66%. The combination of low-dose thalidomide plus monthly high-dose dexamethasone in chemorefractory myeloma showed interesting palliative results. According to our data, increasing thalidomide dosage and/or adding further drugs does not generally produce significant improvement.

摘要

沙利度胺是一种强效抗骨髓瘤药物,对于预处理的、化疗难治性多发性骨髓瘤,其总体缓解率(ORR)可达30%-50%。大多数作者认为,鉴于较低剂量尚处于研究阶段,应使用200毫克/日并联合高剂量地塞米松(40毫克/日×4天,每月3次)。我们报告了对27例预处理患者使用沙利度胺100毫克/日加地塞米松40毫克/日每月1次的经验。沙利度胺剂量递增和/或与其他药物联合应用是根据患者的反应确定的。中位年龄为69岁(范围50-83岁),治疗的患者中有16例男性和11例女性。所有患者均接受过1条以上治疗线(范围1-5)。10例患者的沙利度胺剂量增至300毫克/日,1例患者的剂量增至400毫克/日。2例患者因早期死亡无法评估,1例因肺部和神经副作用不耐受沙利度胺。16例患者对该治疗有反应,ORR为66%。低剂量沙利度胺联合每月高剂量地塞米松用于化疗难治性骨髓瘤显示出了令人感兴趣的姑息治疗效果。根据我们的数据,增加沙利度胺剂量和/或添加其他药物一般不会产生显著改善。

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