本妥昔单抗单药及联合化疗治疗复发难治淋巴瘤效果分析

Effect analysis of brentuximab vedotin monotherapy and brentuximab vedotin combined with chemotherapy in treatment of relapsed or refractory lymphoma

目的探讨本妥昔单抗(BV)单药及联合化疗治疗复发难治淋巴瘤的安全性、疗效及患者生存情况。方法2011年10月至2018年12月解放军总医院第一医学中心和解放军总医院第四医学中心共收治复发难治霍奇金淋巴瘤患者47例,其中BV单药治疗组35例,联合化疗组12例;复发难治间变大细胞淋巴瘤8例,BV单药及联合化疗组各4例。比较两种肿瘤在不同组间的安全性、临床疗效及生存情况。结果复发难治霍奇金淋巴瘤BV单药治疗组客观缓解率(ORR)和完全缓解率(CRR)分别为67.7%(21/31)、16.1%(5/31),中位无进展生存(PFS)时间3.5个月(1.5~24.0个月);联合化疗组ORR和CRR分别为81.8%(9/11)与27.3%(3/11),中位PFS时间5.5个月(2.0~24.0个月),两组ORR、CRR比较差异均无统计学意义(χ^2=0.788,P=0.375;χ^2=0.654,P=0.419)。间变大细胞淋巴瘤BV单药治疗组4例中,3例可评估疗效,其中CR 1例,PR 1例,PD 1例;BV联合化疗组4例均可评估疗效,其中CR 2例,PR 2例。BV单药组常见不良反应为贫血、白细胞减低、血小板减少、发热、氨基转移酶升高、乏力、恶心、末梢神经炎、咳嗽等,≥3级不良反应主要为贫血、血小板减少和白细胞减低;联合化疗组常见不良反应与BV单药组相似,在骨髓抑制方面(血小板减少、白细胞减低)两组间差异均有统计学意义(均P<0.05)。结论BV联合化疗较BV单药治疗复发难治淋巴瘤临床疗效提高,生存期延长。BV联合化疗的不良反应主要为骨髓抑制,患者安全性及耐受性可。

Objective To investigate the safety,efficacy and survival of brentuximab vedotin(BV)monotherapy and BV combined with chemotherapy for relapsed or refractory lymphoma.Methods A total of 47 patients with relapsed or refractory Hodgkin's lymphoma(HL)in First Medical Center of PLA general Hospital and Fourth Medical Center of PLA General Hospital from October 2011 to December 2018 were admitted,including 35 cases(BV monotherapy group)and 12 cases(BV combined with chemotherapy group);there were 8 cases of relapsed or refractory anaplastic large cell lymphoma(ALCL),4 cases in BV monotherapy group and 4 cases in BV combined with chemotherapy group.The safety,clinical efficacy and survival of two neoplasms in different groups were compared.Results For relapsed or refractory HL,the objective remission rate(ORR)and complete remission rate(CRR)was 67.7%(21/31)and 16.1%(5/31),and the median progressive-free survival(PFS)time was 3.5 months(1.5-24.0 months)in BV monotherapy group;ORR and CRR was 81.8%(9/11)and 27.3%(3/11),and median PFS time was 5.5 months(2.0-24.0 months)in BV combined with chemotherapy group;there was no statistical difference in ORR and CRR between the both groups(χ^2=0.788,P=0.375;χ^2=0.654,P=0.419).There were 4 cases in BV monotherapy group for ALCL,of which 3 could be evaluated for efficacy,including 1 case of complete remission(CR)and 1 case of partial remission(PR);there were 4 cases in BV combined with chemotherapy group for ALCL,of which 4 could be evaluated for efficacy,including 2 cases of CR and 2 cases of PR.The common adverse events in BV monotherapy group were anemia,leukopenia,thrombocytopenia,fever,elevated transaminase,fatigue,nausea,peripheral neuritis and cough.Grade≥3 adverse events were mainly anemia,thrombocytopenia and leukopenia.The common adverse events of BV combined with chemotherapy group were similar to those of BV monotherapy group,and there were significant differences in bone marrow suppression(thrombocytopenia,leukopenia)between the two groups(all P<0.05).Conclusions The clinical efficacy of BV combined with chemotherapy is better than that of BV monotherapy in treatment of relapsed or refractory lymphoma,and the survival time is prolonged.The adverse reaction of BV combined with chemotherapy is mainly manifested in bone marrow suppression,and the safety and tolerability of patients are acceptable.