摘要
目的:分析硼替佐米为主化疗方案治疗初治与复发难治多发性骨髓瘤(MM)患者的临床疗效和不良反应。方法:初治MM患者11例,复发、难治MM患者7例均采用VD方案化疗:硼替佐米1.0~1.3mg/m2第1、4、8和11天快速静脉注射,地塞米松20mg第1~4天(7例复发难治予地塞米松40mg)静脉滴注,3周为1疗程,所有患者分别接受1~6个疗程的治疗,继以沙利度胺100mg/d口服维持治疗,另有2例初治患者联用脂质体阿霉素60mg,d 1。根据EBMT标准观察疗效,按NCI-CTCAE(第3版)标准判断不良反应。结果:平均随访8(2~15)个月,11例初治患者对治疗均有反应,其中CR/nCR 5例(45%),PR 5例(45%),MR 1例(10%)。7例复发难治患者中,CR 1例(13%),PR 2例(29%),MR 2例(29%),PD 2例(29%),初治组总体缓解率(CR/nCR加PR)高于复发难治组,P<0.05。不良反应主要表现为乏力、胃肠道症状和周围神经病变。初治组3/11例出现腹胀、腹泻,5/11例发生Ⅰ~Ⅱ级周围神经病变;复发难治组4/7例出现腹胀(1例伴腹痛)、腹泻,3/7例发生Ⅱ级周围神经病变。结论:硼替佐米联合地塞米松与沙利度胺治疗初治MM起效快,总体反应率及完全缓解率高;该方案用于复发、难治性MM亦有较高治疗反应率,但疗效逊于初治患者,其远期疗效有待进一步观察评价。不良反应程度轻微,可控制和预测,总体耐受性良好。
Objective:To investigate the efficacy and adverse effects of bortezomib in the treatment of multiple myeloma.Method:Eleven newly diagnosed multiple myeloma patients and 7 relapsed or refractory multiple myeloma(RRMM) patients were treated with bortezomib(1.0-1.3 mg/ m2) by rapid intravenous injection(day 1,4,8,11) and dexamethasone 20 mg/d(40 mg/d for RRMM) by intravenous drip(day 1-4).This regimen was repeated every 21 days as one cycle.All the patients received one to six courses,followed by oral thalidomaide(100 mg/d)for maintenance treatment.In addition,2 newly diagnosed patients received the combination of liposomes doxorubicin 60mg,d1 and bortezomib.Response was evaluated according to EBMT criteria and adverse effects were graded according to NCI-CTCAE(version 3.0).Result:The 8-month(2-15 months)median follow-up showed that clinical response in 11 newly diagnosed patients was 100 %,including CR/nCR 5(45%),PR 5(45%) and MR 1(10%);In 7 patients with RRMM CR 1(13%),PR 2(29%),MR 2(29%),PD 2(29%) were achieved.The overall response rate(CR/nCR+PR) in newly diagnosed group was significantly higher than that in RRMM group,P0.05.The most common adverse events were fatigue,gastrointestinal symptoms and peripheral neuropathy.In the newly diagnosed group adverse events were observed as following: abdominal distension/ diarrhea(3/11),peripheral neuropathy(5/11),and distension(4/7,1 with abdominal pain),peripheral neuropathy(3/7) in RRMM group.Conclusion:Bortezomib in combination with dexamethasone is an effective therapy for newly diagnosed multiple myeloma patients.The overall response rate and the CR rate are high.This regimen also contributes to a high response rate for RRMM,but the effect is inferior to newly diagnosed ones.The long-term efficacy needs further investigation.The adverse events are mild,controllable,predictive and tolerable.
出处
《临床血液学杂志》
CAS
2011年第3期290-292,共3页
Journal of Clinical Hematology