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
- Author:
Xueying LI
1
;
He HUANG
;
Bing XU
;
Hongqiang GUO
;
Yingcheng LIN
;
Sheng YE
;
Jiqun YI
;
Wenyu LI
;
Xiangyuan WU
;
Wei WANG
;
Hongyu ZHAN
;
Derong XIE
;
Jiewen PENG
;
Yabing CAO
;
Xingxiang PU
;
Chengcheng GUO
;
Huangming HONG
;
Zhao WANG
;
Xiaojie FANG
;
Yong ZHOU
;
Suxia LIN
;
Qing LIU
;
Tongyu LIN
Author Information
- Publication Type:Multicenter Study
- Keywords: R-CHOP-14; R-CHOP-21; Diffuse large B-cell lymphoma
- MeSH: Asian Continental Ancestry Group; B-Lymphocytes; Cyclophosphamide; Disease-Free Survival; Doxorubicin; Follow-Up Studies; Humans; Lymphoma, B-Cell; Prednisone; Prognosis; Rituximab; Vincristine
- From:Cancer Research and Treatment 2019;51(3):919-932
- CountryRepublic of Korea
- Language:English
- Abstract: 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.
