| 马忠正,张宁宁,康伟莉,等.氟达拉滨+环磷酰胺+利妥昔单抗治疗慢性淋巴细胞白血病的临床疗效 5年随访观察[J].安徽医药,2020,24(5):993-998. |
| 氟达拉滨+环磷酰胺+利妥昔单抗治疗慢性淋巴细胞白血病的临床疗效 5年随访观察 |
| Five?year follow?up study of fludarabine plus cyclophosphamide and rituximab in the treatment of chronic lymphocytic leukemia |
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| DOI：10.3969/j.issn.1009?6469.2020.05.037 |
| 中文关键词: 白血病，淋巴细胞，慢性， B细胞 氟达拉滨 环磷酰胺 利妥昔单抗 影响因素分析 无病生存 毒性反应 |
| 英文关键词: Leukemia,lymphocytic,chronic,B?cell Fludarabine Cyclophosphamide Rituximab Root cause analysis Disease?free survival Toxicity |
| 基金项目:衡水市科技计划自筹经费基金项目( 20150440) |
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| 中文摘要: |
| 目的比较氟达拉滨 +环磷酰胺( FC)方案与氟达拉滨 +环磷酰胺 +利妥昔单抗( FC+R)方案治疗慢性淋巴细胞白血病(CLL)的临床疗效及安全性差异。方法回顾性收集 2013年 1月至 2016年 6月哈励逊国际和平医院收治的 65例 CLL病例资料，采用 FC方案治疗 34例( FC组)FC+R方案治疗 31例( FC+R组)，比较两组化疗期间药物毒性反应、并发症及化疗结束后临床疗效，对获得客观缓解病例( ORR)，进行独立影响因素分析，比较 ORR获得者及亚组肿瘤无进展生存时间( PFS)与总生存时间( OS)。结果两组均完成 4～6周期诱导化疗，化疗周期构成差异无统计学意义( P＞0.05)。化疗结束后， FC+R组 ORR获得率( 87.1%比 58.8%)、微小病残留( MRD)阴性率( 45.2%比 20.6%)均显著高于 FC组(均 P＜0.05)。 logistic分析表明，化疗后 MRD阳性( OR?＝5.023，95%CI:1.767～8.278)、基因突变或缺失( OR?＝3.743，95%CI:1.868～5.619)是未获得 ORR的独立影响因素(均 P＜0.05)，FC＋R方案则是独立保护因素( OR?＝0.354，95%CI:0.162～0.546)(P＜0.05)。 FC+R组中位 PFS时间长于 FC组(未达到比 47个月， P＞0.05)，两组均未达到中位 OS；ORR病人亚组分析， FC+R组高危遗传学病例及 MRD阳性病例中位 PFS均显著长于 FC组( 45月比 36月； 47月比 39月)(均 P＜0.05)各遗传学亚组与 MRD亚组中位 OS均差异无统计学意义(均 P＞0.05)。 FC+R组血小板减少发生率显著高于 FC组( 35.5%比17，.6%)(P＜0.05)Ⅲ+Ⅳ度白细胞减少( 16.1%比 8.8%)、消化道反应( 19.6%比 8.8%)及 Ⅰ+Ⅱ度贫血( 25.8%比 14.7%)、药物热发生率( 25.8%比，14.7%)均高于 FC组(均 P＞0.05)；两组继发感染等并发症发生率差异无统计学意义( 8.8%比 19.4%)( P＞0.05)。结论 FC＋R方案较 FC方案 ORR获得率更高，能显著延长 ORR病人高危遗传亚组与 MRD阳性亚组 PFS，主要增加血液学毒性、 Ⅲ+Ⅳ度消化道反应及Ⅰ+Ⅱ度药物热。 |
| 英文摘要: |
| Objective Retrospective analysis on clinical efficacy of Fludarabine +Cyclophosphamide and Rituximab(FC + R)for the treatment of chronic lymphocytic leukemia(CLL)，and compare the efficacy and safety of FC scheme versus FC+R scheme.Methods Clinical documents of 65 patients with CLL in Hudson International Peace Hospital from January 2013 to June 2016 were retro?spectively collected，of which 34 cases with FC scheme and 31 cases with RC+R scheme，drug toxicities &complications and clini?cal efficacy were recorded during or after chemotherapy.Logistic regression was introduced to explore the independent factors influ?encing objective remission cases(ORR)， and tumor progression free survival(PFS)and overall survival(OS)of ORR patients and subgroups with genetic and minimal residual disease(MRD)characteristics were compared.Results The two groups complet? ed 4?6 cycles of induction chemotherapy，the composition of chemotherapy cycle with no statistical significance(P＞0.05).The ORR rate(87.1% vs. 58.8%)and MRD negative rate(45.2% vs. 20.6%)in FC+Rgroupafter chemotherapy were significantly high? er than those in FC group(P＜0.05).Logistic analysis showed that MRD positive after chemotherapy(OR?＝5.023，95%CI:1.767?8.278)，gene mutation or deletion(OR?＝3.743，95%CI:1.868?5.619)were independent factors without ORR(P＜0.05).FC+R was an independent protective factor(OR?＝0.354，95%CI:0.162?0.546)(P＜0.05).FC+R group with PFS time was longer than the group FC(not reached vs. 47 months，P＞0.05)， the two groups did not reach the median OS.The analysis of ORR subgroupshowed FC+R scheme could significantly prolong PFS compared with FC scheme for patients with characteristics of high?risk ge?netics and MRD positive results(45 months vs. 36 months；47 months vs. 39 months)( all P＜0.05).The genetics and MRD sub? group with median OS showed no significant differences(P＞0.05).The incidence of thrombocytopenia in FC+R group was signifi?cantly higher than the FC group(35.5% vs. 17.6%)( P＜0.05).The incidence of Ⅲ+Ⅳ leucopenia(16.1% vs. 8.8%)，digestivetract reaction(19.6% vs. 8.8%)and Ⅰ+Ⅱ anemia(25.8% vs. 14.7%)，drug fever(25.8% vs. 14.7%)were higher than the FC group(all P＞0.05).The secondary infection and complications of the two groups were not statistically significant(8.8% vs.19.4%)( P＞0.05).Conclusion Compared with FC scheme，FC+R scheme can get a higher ORR and significantly prolong PFS in ORR patients with high?risk genetic and MRD positive characteristics.The application of Rituximab could increase the incidencesof hematological toxicity，Ⅲ+Ⅳ degree of gastrointestinal reaction and Ⅰ+Ⅱ degree of drug fever. |
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