硼替佐米联合沙利度胺治疗复发、难治性多发性骨髓瘤的疗效与安全性观察

Efficacy and safety of bortezomib combined with thalidomide for the treatment of relapsed and refractory multiple myeloma

目的:观察硼替佐米联合沙利度胺治疗复发、难治性多发性骨髓瘤的疗效与安全性。方法:收集我院2007年3月至2010年12月采用硼替佐米联合沙利度胺方案治疗复发、难治性多发性骨髓瘤患者的临床资料进行回顾性分析。治疗方法为硼替佐米1.3 mg/m2,于第1、4、8、11天静脉注射;沙利度胺100 mg/d,口服;21 d为1个疗程。依据欧洲血液及骨髓移植组标准判定疗效,按CTCAE Version 3.0标准评价不良反应。结果:共有66例复发、难治性多发性骨髓瘤患者接受硼替佐米联合沙利度胺治疗,除外因个人原因未完成治疗的7例患者,共有59例患者的资料纳入分析。59例中男37例,女22例,中位年龄51(30～64)岁。中位疗程数为6(2～8),中位观察期5(2～10)个月,59例患者中有6例获得完全缓解,12例获得部分缓解,20例获得轻微缓解,总有效率为64.4%。最常见不良反应为胃肠道症状(42例,其中出现不同程度恶心或呕吐36例次,腹泻29例次),其他不良反应为乏力(37例)、血小板减少(23例)、肢端麻木(18例)、发热(15例)、憋气、心慌(5例)、体位性低血压(4例),有1例患者出现视觉障碍。经减少用药剂量或停药及对症治疗后均获缓解。结论:硼替佐米联合沙利度胺是治疗复发、难治性多发性骨髓瘤的有效方法,同时具有较好的安全性。

Objective： To observe the efficacy and safety of bortezomib combined with thalidomide for the treatment of relapsed and refractory multiple myeloma （MM）. Methods： The clinical data from patients with relapsed and refractory multiple myeloma in our hospital between March 2007 and December 2010 were collected and analyzed retrospectively. The treatment regimen was as follows： IV bortezomib 1.3 mg/m2 was given on days 1,4,8,and 11; oral thalidomide 100 mg/d was given every day; each treatment course was 21 days. The efficacy was evaluated according to response criteria from the European Group for Blood and Marrow Transplantation （EMBT） and the adverse drug reactions were evaluated by NCI-CTCAE Version 3.0. Results： A total of 66 patients with relapsed and refractory MM received bortezomib combined with thalidomide and 7 patients were excluded because of their own reasons. At last, 59 patients were entered in this study. Of them, 37 were men and 22 were women with median age of 51 years （ from 30 to 64 ）. The median number of treatment courses was 6 （range ：2-8 ）. The median observation period was 5 months （from 2 to 10 months）. Of the 59 patients, 6 were complete response, 12 were partial response, 20 were minimal response;the total effective rate was 64.4%. The most common adverse reactions were gastrointestinal symptoms （n = 42, 36 cases of nausea or vomiting, 29 of diarrhea）. Other adverse reactions were fatigue （ 37 ）, thrombocytopenia （ 23 ）, acroanesthesia （ 18 ）, fever （ 15 ）, breathlessness and/or palpitation （5）, postural hypotension （4）, vision disorders （1）. The patients＇adverse reaction symptoms were alleviated after dosage reduction or discontinuation of the drugs and symptomatic treatment. Conclusion： Bortezomib combined with thalidomide is an effective and safe regimen for treating patients with relapsed and refractory MM.