低剂量硼替佐米联合沙利度胺及化疗治疗多发性骨髓瘤35例

目的 观察低剂量硼替佐米联合沙利度胺及化疗治疗多发性骨髓瘤(MM)患者的疗效及安全性.方法 35例初治及难治复发MM患者,硼替佐米1.1 mg/m2,第0、3、7、10天,静脉注射;沙利度胺从50 mg/d开始逐渐加量至150 mg/d或患者能够耐受的最大剂量;化疗方案根据每疗程患者情况选择MP、VAD或AD方案.28 d为1个疗程,每例患者至少接受2个疗程以上治疗.达到部分缓解(PR)及以上疗效的患者应用沙利度胺150 mg/d或患者能够耐受的最大剂量维持治疗.采用2006年MM国际统一疗效标准观察疗效,根据国际癌症研究中心不良事件通用命名标准评估不良反应.结果 中位随访20个月,35例患者治疗总有效率82.8%,其中完全缓解(CR)率48.6%,良好的部分缓解(VGPR)率17.1%,PR率17.1%.3年预计无进展生存(PFS)和总生存(OS)率分别为60.92%和72.41%.达PR以上疗效患者的OS率高于未达PR患者,差异有统计学意义(P=0.004).初治及难治复发患者客观缓解率(ORR)及OS率差异无统计学意义.Ⅲ～Ⅳ度非血液学毒性主要包括乏力(3/35)、恶心、呕吐(8/35)、便秘(4/35)和周围神经病变(3/35).Ⅲ～Ⅳ度血液学毒性为粒细胞缺乏(10/35)和血小板减少(8/35).结论 低剂量硼替佐米联合沙利度胺及化疗治疗MM具有较好的疗效及安全性,沙利度胺维持治疗可延长患者PFS时间.

Effects of low-dose bortezomib plus thalidomide and chemotherapy in treatment of multiple myeloma

Objective To observe the curative effects and toxicity of low-dose bortezomib plus thalidomide and chemotherapy in treatment of multiple myeloma. Methods 35 patients with initial, refractory or relapsed MM received at least two cycles of treatment with bortezomib at 1.1 mg/m2 intravenously on days 0,3, 7, and 10, and by daily oral thalidomide escalated from 50mg to 150 mg and chemotherapy. The chemotherapy regimens included MP, VAD and AD regimen which was chosen according to the status of patients. Results After a median follow-up of 20 months, the overall response rate was 82.8 %, complete remission (CR)48.6 %, very good partial remission (VEPR) 17.1%, and partial remission 17.1%. The 3-year PFS and OS were 60.92 % and 72.41% separately. ORR and OS were same in initial and refractory or relapsed MM patients. Grade 3 or 4 adverse events including debility (3/35), nausing and vomiting (8/35), constipation (4/35), peripheral sensory neuropathy (3/35), neutropenia (10/35) and thrombocytopenia (12 %) were observed.Conclusion The regimen of low-dose bortezomib plus thalidomide and chemotherapy is a highly effective and safety regimen for MM patients. The maintenane therapy with thalidomide may prolong PFS.