PAD方案治疗初治多发性骨髓瘤的疗效研究

目的:观察硼替佐米联合脂质体多柔比星及地塞米松(PAD)方案治疗初治多发性骨髓瘤(MM)的疗效和不良反应。方法:初治MM患者19例,其中男11例,女8例,中位年龄66(43～77)岁。均给予PAD方案为一线治疗:硼替佐米1.3mg/m2,静脉注射,第1、4、8、11天;脂质体多柔比星20mg,静脉滴注,第1、4、8天;地塞米松20mg/d,静脉滴注,第1、4、8、11天,每4周为一个周期。采用国际骨髓瘤工作组(IMWG)标准观察疗效,并按国际肿瘤组织毒副作用统一命名法的标准(NCICTCAE)(第3版)判断不良反应。结果:平均(3.9±1.1)(2～6)个疗程后的疗效观察,总有效率为89%,其中完全缓解(CR)8例(42%),非常好的部分缓解(VGPR)2例(11%),部分缓解(PR)6例(31%),轻微反应(MR)1例(5%),疾病稳定(SD)2例(11%)。可见初始疗效的中位时间为2.8(1～5)周,最佳疗效的中位时间为2.7(1～4)个月。骨髓瘤细胞、血清单克隆蛋白量、红细胞沉降率均较治疗前下降。中位随访期19(6～35)个月,所有患者目前均生存。最常见的不良反应为胃肠道症状,其中便秘7例(37%),腹泻1例(5%),恶心2例(11%),黏膜炎1例(5%)。其次为血液学改变,中性粒细胞减少6例(32%),贫血3例(16%),血小板减少5例(26%)。另外,周围神经病变(PN)较为多见,1～2级4例(21%),3级1例(5%)。3例(16%)患者出现手足综合征,3例(16%)患者出现乏力。结论:PAD方案治疗初治MM疗效明确,不良反应较少。

PAD (bortezomib,pegylated liposomal doxorubicin and dexamethasone)regimen for the treatment of patients with newly diagnosed multiple myeloma

Objective To study the efficacy and adverse effects of PAD（bortezomib,pegylated liposomal doxorubicin and dexamethasone） regimen in the treatment of patients with newly diagnosed multiple myeloma（MM）.Methods Nineteen patients [11 males,8 females,median age 66（43-77） years] with newly diagnosed MM were treated with PAD regimen as first line therapy：bortezomib 1.3 mg/m2 intravenous injection on day 1,4,8,11;pegylated liposomal doxorubicin 20 mg intravenously on day 1,4,8;dexamethasone 20 mg intravenously on day 1,4,8,11.Every 4 week as a course.Response was evaluated according to the International Uniform Response Criteria for MM.Adverse events were assessed according to the National Cancer Institute Common Toxicity Criteria,version 3.0.Results After 2-6（3.9±1.1）courses of treatment,the overall response rate was 89%：complete response 8 cases（42 %）,very good partial response 2 cases（11%）,partial response 6 cases（31%）,minimal 1 case（5%）.Two cases（11%） were kept in stable disease.The median time to initial response was 2.8（1-5） weeks and the median time to best response was 2.7（1-4） months.Bone marrow plasma cells,serum monoclonal protein,and erythrocyte sedimentation rate were decreased.After a medium of 19（6-35） months follow-up,all the patients were alive.The most common adverse events were gastrointestinal symptoms [constipation in 7（37%）,diarrhea in 1（5%）,mucositis in 1（5%）,and nausea in 2（11%） patients].Hematologic adverse effects included neutropenia in 6 patients,anemia in 3 patients and thrombocytopenia in 5 patients.Peripheral neuropathy was relatively commom,grade 1/2 in 4 and grade 3 in 1 patient.Hand-foot syndrome occurred in 3 patients.Fatigue was observed in 3 patients.Conclusions PAD regimen is an effective therapy with a high response rate and manageable adverse effects for patients with newly diagnosed MM.