吉西他滨固定剂量率输注联合方案治疗复发难治性弥漫大B细胞淋巴瘤临床观察  

Clinical observation on chemotherapeutic efficacy and safety of gemcitabine in a fixed dose rate containing regimen in treatment of relapsed or refractory diffuse large B-cell lymphoma patients

作　　者：万一元[1] 惠红霞[1] 王晓炜[1] 刘华[1] 万莉[1] 

机构地区：[1]南京医科大学附属淮安第一医院肿瘤内科,江苏淮安223300

出　　处：《中华肿瘤防治杂志》2015年第11期880-884,共5页Chinese Journal of Cancer Prevention and Treatment

摘　　要：目的观察吉西他滨固定剂量率输注联合奥沙利铂、地塞米松方案治疗复发、难治性弥漫大B细胞淋巴瘤（diffuse large B-cell lymphoma,DLBCL）化疗疗效及安全性。方法选取2009-01-01-2013-12-31南京医科大学附属淮安第一医院病理及免疫组化确诊的复发或难治性DLBCL患者共37例,接受吉西他滨（1 000mg/m2,d1、d8）以固定剂量率即10mg/（m2·min）联合奥沙利铂（130mg/m2,d1）、地塞米松（40mg/d,d1~d4）方案化疗,每21d重复,每例患者完成4~6个周期（至少2个周期）化疗,并随访。每2个周期评价化疗疗效,每1个周期后评价毒副作用。结果 37例复发或难治性DLBCL患者中,复发21例,难治16例。其中CR 8例,PR 15例,SD 5例,RR 62.16%（23/37）,临床获益率75.68%（28/37）。分层分析显示,近期疗效仅与病变部位（χ2=4.298,P=0.038）密切相关,而与性别（χ2=0.016,P=0.898）、分期（χ2=1.770,P=0.413）、既往治疗情况（χ2=0.001,P=0.970）、乳酸脱氢酶（LDH）水平（χ2=743,P=0.389）、有无B症状（χ2=0.302,P=0.582）、免疫分型（χ2=0.650,P=0.420）以及Ki-67表达（χ2=2.184,P=0.139）无相关性。中位随访时间43个月（8~59个月）,中位肿瘤进展时间11.9个月（95%CI为9~23个月）。毒副作用,主要为血液学毒性,尤其Ⅲ~Ⅳ级白细胞、血小板减少发生率较高,分别为24.03%和18.83%,无治疗相关死亡病例发生;而非血液学毒副作用发生率低且较轻。结论吉西他滨固定剂量率输注联合奥沙利铂、地塞米松作为复发、难治性DLBCL挽救性化疗方案是有效和安全的,值得进一步研究其临床应用价值。OBJECTIVE To investigate chemotherapeutic efficacy and safety of gemcitabine in a fixed dose rate combined with oxaliplatin and dexamethasone regimens in treatment of relapsed or refractory diffuse large B-cell lymphoma（DLBCL）patients.METHODS A total of 37 patients with relapsed or refractory DLBCL by pathological and immunohistochemical diagnose were recruited from Jan.1,2009 to Dec.31,2013 in the First Hospital of Huai＇an city Affiliated to Nanjing Medical College.The patients were received chemotherapy with gemcitabine in a fixed dose rate of 10mg/m2 per minute（gemcitabine 1 000mg/m2,Day 1,8）combined with oxaliplatin（130mg/m2,Day 1）and dexamethasone（40mg per day Day 1-4）regimens.Each patient was received four-six cycles,at least two cycles chemotherapy every 21 days and followed up until disease progression or lost.The objective response rate（RR）and time to tumor progression（TTP）were evaluated.Toxicities were documented after each cycle.RESULTS Among 37 enrolled relapsed or refractory DLBCL patients,relapsed patients were 21,refractory patients were 16.Complete response（CR）was 8patients,partial response（PR）was 15 patients,stable disease（SD）was 5patients.RR was 62.16%（23/37）,clinical benefit rate was 75.68%（28/37）.Stratified analyses showed that chemotherapeutic efficacy was only associated with site of lesion（χ2=4.298,P=0.038）.It was not related to genders（χ2=0.016,P=0.898）,clinical stage（χ2=1.770,P=0.413）,experience of previous therapy（χ2=0.001,P=0.970）,level of LDH（χ2=0.743,P=0.389）,whether or not there was B＇symptom（χ2=0.302,P=0.582）,immunologic classification（χ2=0.650,P=0.420）and expression of Ki-67（χ2=2.184,P=0.139）.The median follow-up time was 43months（from 8to 59months）.The median TTP was 11.9months（95%CI：9-23months）.With respect to adverse events,the major side effect was hematological toxicity.The rate of gradeⅢ/Ⅳleucocytopenia and thrombocytopenia was remarkably high,24.03%,18.83%,respectively.There

关 键 词：吉西他滨 固定剂量率 复发或难治性 弥漫大B细胞淋巴瘤 抗肿瘤联合方案 治疗结果 

分 类 号：R733.1[医药卫生—肿瘤]