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边缘区淋巴瘤晚期患者R-CVP后利妥昔单抗维持治疗的II期研究:一项改善淋巴瘤生存协会(CISL)的研究

摘要:

背景与目的 利妥昔单抗是一种靶向CD20的单克隆抗体,在治疗边缘区淋巴瘤(marginal zone lymphoma,MZL)中可以单药或联合化疗使用,可提高缓解率和生存率,但治疗后仍可能会复发.因此,仍需探索如何延长MZL患者的缓解期的治疗方案.这项多中心、单臂、开放标签的II期研究评估了对一线R-CVP(rituximab,cyclophosphamide,vincristine,and prednisolone;利妥昔单抗、环磷酰胺、长春新碱和泼尼松龙)治疗有反应的Ⅲ-Ⅳ期CD20阳性MZL患者进行利妥昔单抗维持治疗2年的生存率.本研究旨在明确R-CVP后利妥昔单抗维持治疗的策略是否有进一步研究的价值.方法 在利妥昔单抗维持治疗之前,Ⅲ-Ⅳ期MZL患者应接受6-8周期的R-CVP一线治疗.每个周期为3周,第1 d静脉输注利妥昔单抗(375 mg/m2)、环磷酰胺(750 mg/m2)和长春新碱(1.4 mg/m2;最大2 mg),第1-5 d口服泼尼松龙(100 mg).对R-CVP治疗达到完全缓解(complete response,CR)、部分缓解(part response,PR)或疾病稳定(stable response,SD)的患者进行利妥昔单抗维持治疗,每8周静脉注射利妥昔单抗375 mg/m2,直到12个周期.主要终点为无进展生存期(progression-free surviva,PFS),次要终点为总生存期(overall survival,OS)和治疗安全性.结果 共纳入47例患者,其中45(96%)例接受了利妥昔单抗维持治疗.15(33%)例患者有淋巴结MZL.在进行R-CVP一线治疗后,分别有20(44%)例、22(49%)例和3(7%)例的患者达到了CR、PR和SD.中位随访38.2个月后,患者的3年PFS率为81%.在利妥昔单抗维持治疗期间,R-CVP治疗后有6例PR和1例SD患者获得CR.LDH升高和B症状是PFS的重要预后因素(P=0.003),3年OS率为90%.利妥昔单抗维持治疗的耐受性良好,常见的治疗性不良事件为感觉性神经病(18%)、肌痛(13%)、疲劳(9%)和中性粒细胞减少(9%).结论 一线R-CVP治疗后利妥昔单抗维持治疗在Ⅲ-Ⅳ期MZL患者中不仅表现出较好的PFS,而且药物毒性反应评价良好.

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作者: Sung Yong Oh [1] Won Seog Kim [2] Jin Seok Kim [3] Seok Jin Kim [2] Dok Hyun Yoon [4] Deok-Hwan Yang [5] Won Sik Lee [6] Hyo Jung Kim [7] Ho-Young Yhim [8] Seong Hyun Jeong [9] Jong Ho Won [10] Suee Lee [1] Jee Hyun Kong [11] Sung-Nam Lim [12] Jun Ho Ji [13] Kyung A.Kwon [14] Gyeong-Won Lee [15] Jae Hoon Lee [16] Ho Sup Lee [17] Ho-Jin Shin [18] Cheolwon Suh [4]
作者单位: Department of Internal Medicine,Dong-A University Hospital,Busan 49201,Republic of Korea [1] Department of Medicine,Samsung Medical Center,Sungkyunkwan University School of Medicine,Seoul 06351,Republic of Korea [2] Division of Hematology,Department of Internal Medicine,Yonsei University College of Medicine,Seoul 03722,Republic of Korea [3] Department of Oncology,Asan Medical Center,Universityof Ulsan College of Medicine,Songpa-gu,Seoul 05505,Republic of Korea [4] Department of Hematology-Oncology,Chonnam National University Hwasun Hospital,Hwasun 58128,Republic of Korea [5] Department of Hematology,Busan Paik Hospital,Inje University College of Medicine,Busan 04511,Republic of Korea [6] Department of Internal Medicine,Hallym University Sacred Heart Hospital,Hallym University College of Medicine,Anyang 14068,Republic of Korea [7] Department of Internal Medicine,Chonbuk National University Hospital,Jeonju 54907,Republic of Korea [8] Department of Hematology-Oncology,Ajou University School of Medicine,Suwon 16499,Republic of Korea [9] Department of Internal Medicine,Soonchunhyang University Seoul Hospital,Soonchunhyang University College of Medicine,Seoul 04401,Republic of Korea [10] Division of Hematology-Oncology,Department of Internal Medicine,Wonju Severance Christian Hospital,Yonsei University College of Medicine,Wonju 26426,Republic of Korea [11] Department of Internal Medicine,Haeundae Paik Hospital,Inje University College of Medicine,Busan 48108,Republic of Korea [12] Division of Hematology and Oncology,Department of Internal Medicine,Samsung Changwon Hospital,Sungkyunkwan University School of Medicine,Changwon 51353,Republic of Korea [13] Division of Hematology-Oncology,Department of Internal Medicine,Dongnam Instituteof Radiological and Medical Sciences,Busan 46033,Republic of Korea [14] Division of Hematology-Oncology,Department of Internal Medicine,Gyeongsang National University Hospital,Gyeongsang National University College of Medicine,Jinju 52727,Republic of Korea [15] Department of Internal Medicine,Gachon University Gil Medical Center,Incheon 21565,Republic of Korea [16] Department of Internal Medicine,Kosin University Gospel Hospital,Kosin University College of Medicine,Busan 49267,Republic of Korea [17] Division of Oncology,Department of Internal Medicine,Pusan National University Hospital,Busan 49241,Republic of Korea [18]
期刊: 《癌症》2020年39卷3期 118-128页 MEDLINEISTICCSCDBP
栏目名称: 原创论著
发布时间: 2020-07-14
基金项目:
东亚大学研究基金的资助.利妥昔单抗由罗氏韩国公司捐赠
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