Dose-Dense Rituximab-CHOP versus Standard Rituximab-CHOP in Newly Diagnosed Chinese Patients with Diffuse Large B-Cell Lymphoma: A Randomized, Multicenter, Open-Label Phase 3 Trial
机构：[1]Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in Southern China, and Collaborative Innovation Center of Cancer Medicine, Guangzhou, China.临床科室其他部门内科华南肿瘤学国家重点实验室中山大学肿瘤防治中心[2]Department of Medical Oncology, The Seventh Affiliated Hospital, Sun Yat-sen University, Shenzhen, China.[3]Department of Hematology, The First Affiliated Hospital of Xiamen University, Xiamen, China.[4]Department of Hematology, Nanfang Hospital of Southern Medical University, Guangzhou, China.[5]Department of Medical Oncology, Henan Cancer Hospital, Zhengzhou, China.内科第一医学部肿瘤内科河南省肿瘤医院[6]Department of Medical Oncology, Cancer Hospital, Shantou University Medical College, Shantou, China.[7]Department of Medical Oncology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.其他科室肿瘤科中山大学附属第一医院[8]Department of Medical Oncology, Red Cross Hospital of Guangzhou, Guangzhou, China.[9]Department of Lymphoma, Guangdong General Hospital, Guangzhou, China.肿瘤治疗中心淋巴瘤科广东省人民医院[10]Department of Medical Oncology, The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.[11]Cancer Center of The First People's Hospital of Foshan, Foshan, China.[12]Department of Medical Oncology, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China.[13]Department of Medical Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.[14]Cancer Center of People's Hospital of Zhongshan, Zhongshan, China.[15]Cancer Center of Kiang Wu Hospital, Macau, China.[16]Department of Medical Oncology, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.[17]Department of Pathology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in Southern China, and Collaborative Innovation Center of Cancer Medicine, Guangzhou, China.临床科室其他部门病理科华南肿瘤学国家重点实验室中山大学肿瘤防治中心[18]Department of Epidemiology and Biostatistics, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in Southern China, and Collaborative Innovation Center of Cancer Medicine, Guangzhou, China.其他部门华南肿瘤学国家重点实验室中山大学肿瘤防治中心
Purpose Rituximab with cyclophosphamide, doxorubicin, vincristine, and prednisone administered every 3 weeks (R-CHOP-21) is the standard care for diffuse large B-cell lymphoma (DLBCL). It is unknown whether the dose-dense R-CHOP (R-CHOP-14) could improve the outcome of the disease in Asian population. Materials and Methods Newly diagnosed DLBCL patients were centrally, randomly assigned (1:1) to receive R-CHOP-14 or R-CHOP-21. R-CHOP-14 was administered every 2 weeks, and R-CHOP-21 was administered every 3 weeks. Primary end point was disease-free survival (DFS). Secondary end points included overall survival (OS), progression-free survival (PFS), response rate and toxicities. Results Seven hundred and two patients were randomly assigned to receive R-CHOP-14 (n=349) or R-CHOP-21 (n=353). With a median follow-up of 45.6 months, the two groups did not differ significantly in 3-year DFS (79.6% for R-CHOP-14 vs. 83.2% for R-CHOP-21, p=0.311), 3-year OS (77.5% for R-CHOP-14 vs. 77.6% for R-CHOP-21, p=0.903), or 3-year PFS (63.2% for R-CHOP-14 vs. 66.1% for R-CHOP-21, p=0.447). Patients with an International Prognostic Index (IPI) score >= 2 had a poorer prognosis compared to those with an IPI score < 2. Grade 3/4 hematologic and non-hematologic toxicities were manageable and similar between R-CHOP-14 and R-CHOP-21. Conclusion R-CHOP-14 did not improve the outcome of DLBCL compared to R-CHOP-21 in Asian population. With manageable and similar toxicities, both of the two regimens were suitable for Asian DLBCL patients. For high-risk patients with IPI >= 2, new combination regimens based on R-CHOP deserve further investigation to improve efficacy.
基金：
This study was supported by the grant from the Foundation of
5010 Clinical Trials of Sun Yat-sen University.
语种：
外文
被引次数：
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PubmedID：
中科院(CAS)分区：
出版当年[2019]版：
大类|3 区医学
小类|3 区肿瘤学
最新[2023]版：
大类|2 区医学
小类|3 区肿瘤学
第一作者：
第一作者机构：[1]Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in Southern China, and Collaborative Innovation Center of Cancer Medicine, Guangzhou, China.[2]Department of Medical Oncology, The Seventh Affiliated Hospital, Sun Yat-sen University, Shenzhen, China.
共同第一作者：
通讯作者：
通讯机构：[1]Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in Southern China, and Collaborative Innovation Center of Cancer Medicine, Guangzhou, China.[*1]Department of Medical Oncology,Sun Yat-sen University Cancer Center,State Key Laboratory of Oncology in Southern China, and Collaborative Innovation Center of Cancer Medicine, 651 Dongfeng Road East,Guangzhou 510060, China
推荐引用方式(GB/T 7714)：
Li Xueying,Huang He,Xu Bing,et al.Dose-Dense Rituximab-CHOP versus Standard Rituximab-CHOP in Newly Diagnosed Chinese Patients with Diffuse Large B-Cell Lymphoma: A Randomized, Multicenter, Open-Label Phase 3 Trial[J].CANCER RESEARCH AND TREATMENT.2019,51(3):919-932.doi:10.4143/crt.2018.230.
APA：
Li Xueying,Huang He,Xu Bing,Guo Hongqiang,Lin Yingcheng...&Lin Tongyu.(2019).Dose-Dense Rituximab-CHOP versus Standard Rituximab-CHOP in Newly Diagnosed Chinese Patients with Diffuse Large B-Cell Lymphoma: A Randomized, Multicenter, Open-Label Phase 3 Trial.CANCER RESEARCH AND TREATMENT,51,(3)
MLA：
Li Xueying,et al."Dose-Dense Rituximab-CHOP versus Standard Rituximab-CHOP in Newly Diagnosed Chinese Patients with Diffuse Large B-Cell Lymphoma: A Randomized, Multicenter, Open-Label Phase 3 Trial".CANCER RESEARCH AND TREATMENT 51..3(2019):919-932
