BiRd方案治疗复发难治多发性骨髓瘤的回顾性研究

A retrospective study of the BiRd regimen in the treatment of relapsed/ refractory multiple myeloma

目的探讨BiRd方案（克拉霉素＋来那度胺＋地塞米松）治疗复发难治多发性骨髓瘤（RRMM）的疗效。方法回顾性研究2013年9月至2016年8月于6家医院接受BiRd方案治疗的30例RRMM患者的临床资料，分析总体反应率（ORR）、临床获益率（CBR）、无进展生存（PFS）、总体生存（os）及不良反应资料。结果30例患者中27例可评价疗效，ORR、CBR分别为51．9％（14／27）、66．7％（18／27），其中包括严格意义上的完全缓解（sCR）1例（3．7％）、CR3例（11．1％）、非常好的部分缓解（VGPR）3例（11．1％）、部分缓解（PR）7例（25．9％）。13例既往接受过Rd方案（来那度胺＋地塞米松）治疗的患者（其中9例治疗过程出现疾病进展）中，BiRd方案的ORR和CBR分别为38．5％（5／13）和61．5％（8／13），其中包括5例同时伴有高危[17p-或t（4；14）]和其他不良预后细胞遗传学改变（13q-、1q21＋）的患者。24例既往接受硼替佐米治疗的患者中，BiRd方案治疗的ORR和CBR分别为45．8％（11／24）和62．5％（15／24）。30例患者中位随访时间为14．9（1．0～33．8）个月，至随访截止，20例存活，中位PFS期和预期中位OS期分别为12．0（95％C111．6—12．4）个月和27．6（95％C115．1～40．1）个月。大多数患者对BiRd方案治疗的耐受性良好。结论BiRd方案治疗RRMM安全有效，与硼替佐米无交叉耐药，可能克服Rd耐药和高危细胞遗传学改变。

Objective To evaluate efficacy of the BiRd regimen, a combination of clarithromycin, lenalidomide, and dexamethasone, in the treatment of patients with relapsed/refractory multiple myeloma （RRMM）. Methods Patients with RRMM treated with BiRd between September 11, 2013 and August 1, 2016 at six centers were included to evaluate overall survival rate （ORR）, clinical benefit rate （CBR）, progression-free survival （PFS）, overall survival （OS）, as well as adverse events. Results Of 30 patients with RRMM, 27 patients were evaluable, and ORR and CBR were 51.9% （14/27） and 66.7% （18/27） respectively, including 1 sCR （3.7%）, 3 CR （11.1%）, 3 VGPR （11.1%）, and 7 PR （25.6%）. In 13 patients with prior Rd, ORR and CBR were 38.5% （5/13） and 61.5%（8/13） respectively, of which 5 patients with i〉 MR carried high-risk cytogenetic [ （e.g.17p- or t （4;14） ] together with at least one of other adverse- prognostic cytogenetic （e.g. 13 q- and/or 1 q21 ＋ ）. In 24 patients with prior bortezomib-based therapy, ORR and CBR were 45.8 and 62.5%, respectively. With a median follow-up time of 14.9 （range 1.0-33,8） months, the median PFS and OS were 12.0 （95% C1 11.6-12.4） and 27.6 （95% C1 15.1-40.1） months,respectively. The BiRd regimen was well tolerated. Conclusion The BiRd regimen is an effective and safety protocol for RRMM, including those carrying high-risk cytogenetic markers.