Cancer Res Treat.  2019 Jul;51(3):919-932. 10.4143/crt.2018.230.

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

Affiliations
  • 1Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in Southern China, Collaborative Innovation Center of Cancer Medicine, Guangzhou, China. tongyulin@hotmail.com
  • 2Department of Medical Oncology, The Seventh Affiliated Hospital, Sun Yat-sen University, Shenzhen, China.
  • 3Department of Hematology, The First Affiliated Hospital of Xiamen University, Xiamen, China.
  • 4Department of Hematology, Nanfang Hospital of Southern Medical University, Guangzhou, China.
  • 5Department of Medical Oncology, Henan Cancer Hospital, Zhengzhou, China.
  • 6Department of Medical Oncology, Cancer Hospital, Shantou University Medical College, Shantou, China.
  • 7Department of Medical Oncology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.
  • 8Department of Medical Oncology, Red Cross Hospital of Guangzhou, Guangzhou, China.
  • 9Department of Lymphoma, Guangdong General Hospital, Guangzhou, China.
  • 10Department of Medical Oncology, The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.
  • 11Cancer Center of The First People’s Hospital of Foshan, Foshan, China.
  • 12Department of Medical Oncology, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China.
  • 13Department of Medical Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
  • 14Cancer Center of People’s Hospital of Zhongshan, Zhongshan, China.
  • 15Cancer Center of Kiang Wu Hospital, Macau, China.
  • 16Department of Medical Oncology, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.
  • 17Department 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.
  • 18Department 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.

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.

Keyword

R-CHOP-14; R-CHOP-21; Diffuse large B-cell lymphoma

MeSH Terms

Asian Continental Ancestry Group*
B-Lymphocytes*
Cyclophosphamide
Disease-Free Survival
Doxorubicin
Follow-Up Studies
Humans
Lymphoma, B-Cell*
Prednisone
Prognosis
Rituximab
Vincristine
Cyclophosphamide
Doxorubicin
Prednisone
Rituximab
Vincristine
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