Positron emission tomography-adapted therapy in low-risk diffuse large B-cell lymphoma:results of a randomized,phase Ⅲ,non-inferiority trial  被引量:3

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作  者:Qing Shi Yang He Hong-Mei Yi Rong-Ji Mu Xu-Feng Jiang Di Fu Lei Dong Wei Qin Peng-Peng Xu Shu Cheng Qi Song Sai-Juan Chen Li Wang Wei-Li Zhao 

机构地区:[1]State Key Laboratory of Medical Genomics,National Research Center for Translational Medicine at Shanghai,Shanghai Institute of Hematology,Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,Shanghai,P.R.China [2]Department of Pathology,Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,Shanghai,P.R.China [3]Clinical Research Institute,Shanghai Jiao Tong University School of Medicine,Shanghai,P.R.China [4]Department of Nuclear Medicine,Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,Shanghai,P.R.China [5]Department of Radiology,Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine,Shanghai,P.R.China [6]Laboratory of Molecular Pathology,Pole de Recherches Sino-Francis en Science du Vivant et Génomique,Shanghai,China

出  处:《Cancer Communications》2023年第8期896-908,共13页癌症通讯(英文)

基  金:National Natural Science Foundation of China,Grant/Award Numbers:81830007,82130004,82170178,82200201,82070204;National Key Research and Development Program of China,Grant/Award Number:2022YFC2502600;Chang Jiang Scholars Program;Shanghai Municipal Education Commission Gaofeng Clinical Medicine Grant Support,Grant/Award Numbers:20152206,20152208;Clinical Research Plan of Shanghai Hospital Development Center,Grant/Award Numbers:SHDC2020CR1032B,SHDC2022CRD033;Multicenter Clinical Research Project by Shanghai Jiao Tong University School of Medicine,Grant/Award Number:DLY201601;Collaborative Innovation Center of Systems Biomedicine;Samuel Waxman Cancer Research Foundation。

摘  要:Background:The current standard of care for non-bulky diffuse large B-cell lymphoma(DLBCL)patients with an International Prognostic Index(IPI)of 0 is four cycles of rituximab plus cyclophosphamide,doxorubicin,vincristine and prednisone(R-CHOP)but whether the same efficacy can be achieved with reduced chemotherapy regimen of four cycles for non-bulky DLBCL patients with an IPI of 1 remains unclear.This study compared four cycles versus six cycles of chemotherapy in non-bulky low-risk DLBCL patients with negative interim positron emission tomography with computed tomography(PET-CT,Deauville 1-3),irrespective of age and other IPI risk factors(IPI 0-1).Methods:This was an open-label,randomized,phaseⅢ,non-inferiority trial.Patients aged 14-75 years with newly diagnosed low-risk DLBCL,according to IPI,achieving PET-CT confirmed complete response(CR)after four cycles of R-CHOPwere randomized(1:1)between four cycles of rituximab(4R-CHOP+4R arm)or two cycles of R-CHOP plus two cycles of rituximab(6R-CHOP+2R arm).The primary endpoint was 2-year progression-free survival(PFS),conducted in the intention-to-treat population.Safety was assessed in patients with at least one cycle of assigned treatment.The non-inferiority margin was-8%.Results:A total of 287 patients were included in the intention-to-treat analysis,the median follow-up was 47.3 months,and the 2-year PFS rate was 95%(95%confidence interval[CI],92%to 99%)and 94%(95%CI,91%to 98%)for the 4R-CHOP+4R and 6R-CHOP+2R arm.The absolute difference in 2-year PFS between the two arms was 1%(95%CI,-5%to 7%),supporting the non-inferiority of 4R-CHOP+4R.Grade 3-4 neutropenia was lower in the last four cycles of rituximab alone in the 4R-CHOP+4R arm(16.7%versus 76.9%),with decreased risk of febrile neutropenia(0.0%versus 8.4%)and infection(2.1%versus 14.0%).Conclusions:For newly diagnosed low-risk DLBCL patients,interim PET-CT after four cycles of R-CHOP was effective in identifying patients with Deauville 1-3 who would have a good response and Deauville 4-5 patients who migh

关 键 词:diffuse large B-cell lymphoma LOW-RISK positron emission tomography randomized phaseⅢtrial 

分 类 号:R733.4[医药卫生—肿瘤]

 

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