不同剂量来那度胺治疗初治多发性骨髓瘤患者的疾病控制效果、生存时间及安全性

Disease Control Efficacy,Survival Time and Safety in Treatment of Newly Diagnosed Multipe Mycloma Patients with Different Doses of Lenalidomide Regimens

目的:探讨常规剂量和低剂量来那度胺治疗初治多发性骨髓瘤患者的疾病控制效果、生存时间及安全性。方法:收集并回顾性分析2011年6月-2015年6月收治的初治多发性骨髓瘤患者116例临床资料,在地塞米松+来那度胺基础上,按来那度胺给药剂量不同分为常规剂量组(58例)和低剂量组(58例)。比较2组ORR、随访3年PFS率和OS率、治疗前后KPS评分、RNS评分、免疫表型指标水平及毒副作用的发生率。结果:低剂量组2个疗程ORR显著低于常规剂量组(P <0.05);2组4个和6个疗程ORR比较无显著性差异(P> 0.05);2组随访3年PFS率和OS率比较无显著性差异(P> 0.05);低剂量组患者治疗后KPS评分和RNS评分均显著优于治疗前(P <0.05);2组患者治疗后免疫表型指标水平均显著优于治疗前(P <0.05);但2组治疗后免疫表型指标水平组间比较无显著性差异(P> 0.05);同时2组III-IV度白细胞减少、周围神经病变、消化道反应、肺部感染及疱疹发生率比较无显著性差异(P> 0.05);低剂量组中性粒细胞减少和血小板减少发生率均显著低于常规剂量组(P <0.05)。结论:常规剂量和低剂量来那度胺方案用于初治多发性骨髓瘤患者治疗具有相近疾病控制效果和生存时间;其中低剂量来那度胺方案尽管早期起效相对缓慢,但有助于提高总体生存质量,减低毒副作用发生风险。

Objective:To investigate the efficacy of disease control,survival time and safely in treatment of newly diagnosed multiple mycloma patients with different dose of tenalidomide regimens.Methods:The clinical data of 116 patients with multiple myeloma from June 2011 to June 2015 were collected and analyzed retrospectively.According to doses of used lenalidomide based on dexamethasone plus lenalidomide regimen 116 patients were divided into 2 groups:conventional dose group(58 cases)and low dose group(58 cases).The ORR,PFS rate and OS rate during followed-up for 3 years,KPS score,RNS score and immunophenotypic index before and after treatment and drug toxicity incidence were compared between 2 groups.Results:The ORR for 2 treatment courses of low dose group was significantly lower than that in conventienal dose group(P<0.05).The ORR for 4 and 6 treatment courses was not significantly different between 2 groups(P>0.05).The PFS rate and OS rate during followed-up for 3 years was no significantly different between 2 groups(P>0.05).The KPS score and RNS score after treatment of low dose group were significantly better than those in conventional dose group and before treatment(P<0.05).The levels of immunophenotypic index after treatment of both groups were significantly better than those before treatment(P<0.05).The incidence of III-IV grade hematological toxicity,pulmonary infection and herpes were not significantly different between 2 groups(P>0.05).The incidence of peripheral neuropathy and gastrointestinal reactions in the low dose group were significantly lower than that in conventional dose group(P<0.05).Conclusion:Conventional and low doses of lenalidomide possess the same control effects and survival time for treatment of newly dingnosed patients with multiple myeloma;Despite,the initiation of effects from the low dose lenalidomide is relatively slower,it contributes to raise the overall quality of life and reduce the risk of drug toxicity.