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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

癌症 2020年第3期39卷 118-128页

作者： Sung Yong Oh Won Seog Kim Jin Seok Kim Seok Jin Kim Dok Hyun Yoon Deok‑Hwan Yang Won Sik Lee Hyo Jung Kim Ho‑Young Yhim seong Hyun Jeong Jong Ho Won Suee Lee jee Hyun Kong Sung‑Nam lim Jun Ho Ji Kyung A.Kwon Gyeong‑Won Lee Jae Hoon Lee Ho Sup Lee Ho‑Jin Shin Cheolwon Suh Department of Internal Medicine Dong-A University HospitalBusan 49201Republic of Korea Department of Medicine Samsung Medical CenterSungkyunkwan University School of MedicineSeoul 06351Republic of Korea Division of Hematology Department of Internal MedicineYonsei University College of MedicineSeoul 03722Republic of Korea Department of Oncology Asan Medical CenterUniversity of Ulsan College of MedicineSongpa‑guSeoul 05505Republic of Korea Department of Hematology‑Oncology Chonnam National University Hwasun HospitalHwasun 58128Republic of Korea Department of Hematology Busan Paik HospitalInje University College of MedicineBusan 04511Republic of Korea Department of Internal Medicine Hallym University Sacred Heart HospitalHallym University College of MedicineAnyang 14068Republic of Korea Department of Internal Medicine Chonbuk National University HospitalJeonju 54907Republic of Korea Department of Hematology‑Oncology Ajou University School of MedicineSuwon 16499Republic of Korea Department of Internal Medicine Soonchunhyang University Seoul HospitalSoonchunhyang University College of MedicineSeoul 04401Republic of Korea Division of Hematology‑Oncology Department of Internal MedicineWonju Severance Christian HospitalYonsei University College of MedicineWonju 26426Republic of Korea Department of Internal Medicine Haeundae Paik HospitalInje University College of MedicineBusan 48108Republic of Korea Division of Hematology and Oncology Department of Internal MedicineSamsung Changwon HospitalSungkyunkwan University School of MedicineChangwon 51353Republic of Korea Division of Hematology‑Oncology Department of Internal MedicineDongnam Institute of Radiological and Medical SciencesBusan 46033Republic of Korea Division of Hematology‑Oncology Department of Internal MedicineGyeongsang National University HospitalGyeongsang National University College of MedicineJinju 52727Republic of Korea Department of Internal Medicine Gachon University Gil Medical CenterIncheon 21565Republic of

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... 详细信息

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/m^2)、环磷酰胺(750 mg/m^2)和长春新碱(1.4 mg/m^2;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375mg/m^2,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。

关键词：边缘区淋巴瘤晚期利妥昔单抗环磷酰胺长春新碱维持多中心开放标签生存

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Phase Ⅱ study of R-CVP followed by rituximab maintenance therapy for patients with advanced marginal zone lymphoma:consortium for improving survival of lymphoma(CISL)study

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Cancer Communications 2019年第1期39卷 526-535页

作者： Sung Yong Oh Won Seog Kim Jin Seok Kim Seok Jin Kim Dok Hyun Yoon Deok-Hwan Yang Won Sik Lee Hyo Jung Kim Ho-Young Yhim seong Hyun Jeong Jong Ho Won Suee Lee jee Hyun Kong Sung-Nam lim Jun Ho Ji Kyung A.Kwon Gyeong-Won Lee Jae Hoon Lee Ho Sup Lee Ho-Jin Shin Cheolwon Suh Department of Internal Medicine Dong-A University HospitalBusan 49201Republic of Korea Department of Medicine Samsung Medical CenterSungkyunkwan University School of MedicineSeoul 06351Republic of Korea Division of Hematology Department of Internal MedicineYonsei University College of MedicineSeoul 03722Republic of Korea Department of Oncology Asan Medical CenterUniversity of Ulsan College of MedicineSongpa-guSeoul 05505Republic of Korea Department of Hematology-Oncology Chonnam National University Hwasun HospitalHwasun 58128Republic of Korea Department of Hematology Busan Paik HospitalInje University College of MedicineBusan 04511Republic of Korea Department of Internal Medicine Hallym University Sacred Heart HospitalHallym University College of MedicineAnyang 14068Republic of Korea Department of Internal Medicine Chonbuk National University HospitalJeonju 54907Republic of Korea Department of Hematology-Oncology Ajou University School of MedicineSuwon 16499Republic of Korea Department of Internal Medicine Soonchunhyang University Seoul HospitalSoonchunhyang University College of MedicineSeoul 04401Republic of Korea Division of Hematology-Oncology Department of Internal MedicineWonju Severance Christian HospitalYonsei University College of MedicineWonju 26426Republic of Korea Department of Internal Medicine Haeundae Paik HospitalInje University College of MedicineBusan 48108Republic of Korea Division of Hematology and Oncology Department of Internal MedicineSamsung Changwon HospitalSungkyunkwan University School of MedicineChangwon 51353Republic of Korea Division of Hematology-Oncology Department of Internal MedicineDongnam Institute of Radiological and Medical SciencesBusan 46033Republic of Korea Division of Hematology-Oncology Department of Internal MedicineGyeongsang National University HospitalGyeongsang National University College of MedicineJinju 52727Republic of Korea Department of Internal Medicine Gachon University Gil Medical CenterIncheon 21565Republic of

Background:The response rate and survival improvement for rituximab,a CD20-targeting monoclonal antibody,have been demonstrated in marginal zone lymphoma(MZL)as monotherapy and in combination with chemotherapeutic regimens,yet relapses still occur despite treatment ***,extending the period of remission in MZL patients remains an essential *** multicenter,single-arm,open-label phase II study evaluated the survival efficacy of 2 years of rituximab-maintenance therapy in patients with stage III-IV CD20-positive MZL who had responded to first-line R-CVP(rituximab,cyclophosphamide,vincristine,and prednisolone).The objective of this study was to determine whether rituximab maintenance following R-CVP warrants further ***:Prior to rituximab-maintenance therapy,patients received 6-8 cycles of first-line R-CVP therapy for stage III-IV ***(375 mg/m^(2)),cyclophosphamide(750 mg/m^(2)),and vincristine(1.4 mg/m^(2);maximum 2 mg)were administered via an intravenous infusion on day 1 of each 3-week cycle,while oral prednisolone(100 mg)was given on days 1-5 of each 3-week *** patients who achieved complete response(CR),partial response(PR),or stable disease(SD)to R-CVP treatment,were prescribed rituximab-maintenance therapy which was administered intravenously at a dose of 375 mg/m^(2) every 8 weeks for up to 12 *** primary endpoint was progression-free survival(PFS).Secondary endpoints were overall survival(OS)and treatment ***:47 patients were enrolled,of whom,45(96%)received rituximab-maintenance ***(33%)patients had nodal *** R-CVP first-line therapy,20(44%),22(49%),and 3(7%)patients achieved CR,PR,and SD,*** a median follow-up of 38.2 months,their observed 3-year PFS rate was 81%.During the rituximab-maintenance,6 PR and 1 SD patients achieved CR following the administration of *** LDH and the presence of B symptoms were found to be significant prognostic fac

关键词： Marginal zone Lymphoma Advanced stage Rituximab Cyclophosphamide Vincristine Maintenance Multicenter Open label Survival

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