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.

Autor:	Li X; Department 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.; Department of Medical Oncology, The Seventh Affiliated Hospital, Sun Yat-sen University, Shenzhen, China., Huang H; Department 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., Xu B; Department of Hematology, The First Affiliated Hospital of Xiamen University, Xiamen, China.; Department of Hematology, Nanfang Hospital of Southern Medical University, Guangzhou, China., Guo H; Department of Medical Oncology, Henan Cancer Hospital, Zhengzhou, China., Lin Y; Department of Medical Oncology, Cancer Hospital, Shantou University Medical College, Shantou, China., Ye S; Department of Medical Oncology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China., Yi J; Department of Medical Oncology, Red Cross Hospital of Guangzhou, Guangzhou, China., Li W; Department of Lymphoma, Guangdong General Hospital, Guangzhou, China., Wu X; Department of Medical Oncology, The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, China., Wang W; Cancer Center of The First People's Hospital of Foshan, Foshan, China., Zhan H; Department of Medical Oncology, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China., Xie D; Department of Medical Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China., Peng J; Cancer Center of People's Hospital of Zhongshan, Zhongshan, China., Cao Y; Cancer Center of Kiang Wu Hospital, Macau, China., Pu X; Department of Medical Oncology, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China., Guo C; Department 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., Hong H; Department 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., Wang Z; Department 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., Fang X; Department 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., Zhou Y; Department of Hematology, The First Affiliated Hospital of Xiamen University, Xiamen, China., Lin S; 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., Liu Q; 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., Lin T; Department 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.
Jazyk:	angličtina
Zdroj:	Cancer research and treatment [Cancer Res Treat] 2019 Jul; Vol. 51 (3), pp. 919-932. Date of Electronic Publication: 2018 Oct 02.
DOI:	10.4143/crt.2018.230
Abstrakt:	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.
Databáze:	MEDLINE
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