首页|期刊导航|中华医学杂志（英文版）|Three-year Follow—up on the Safety and Effectiveness
of Rituximab Plus Chemotherapy as First．Line
Treatment of Diffuse Large B．Cell Lymphoma
and Follicular Lymphoma in Real．World ClinicaI
Settings in China：A Prospective．Multicenter,
N0ninIerVenlional Study
Three-year Follow—up on the Safety and Effectiveness of Rituximab Plus Chemotherapy as First．Line Treatment of Diffuse Large B．Cell Lymphoma and Follicular Lymphoma in Real．World ClinicaI Settings in China：A Prospective．Multicenter, N0ninIerVenlional Study
Jian-Qiu Wu Ru Feng Wei Wang Jie-Wen Peng Xiao-Lin Li Xue-Nong Ouyang Chang-Ping Wu Wei-Jing Zhang Yun Zeng Zhen Xiao Ying-Min Liang Yong-Ping Song Yong-Zhi Zhuang Ji-Shi Wang Zi-Min Sun Hai Bai Tong-Jian Cui Ji-Feng Feng Li-Ping Su Ming-Zhi Zhang Wei Li Yu Hu Xiao-Hong Zhang Yu-Huan Gao Zuo-Xing Niu
中华医学杂志（英文版）2018，Vol.131Issue(15)：1767-1775,9.
中华医学杂志（英文版）2018，Vol.131Issue(15)：1767-1775,9.DOI:10.4103/0366-6999.237401
Three-year Follow—up on the Safety and Effectiveness of Rituximab Plus Chemotherapy as First．Line Treatment of Diffuse Large B．Cell Lymphoma and Follicular Lymphoma in Real．World ClinicaI Settings in China：A Prospective．Multicenter, N0ninIerVenlional Study
摘要
Abstract
Background:Prospective real-life data on the safety and effectiveness of rituximab in Chinese patients with diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) are limited.This real-world study aimed to evaluate long-term safety and effectiveness outcomes ofrituximab plus chemotherapy (R-chemo) as first-line treatment in Chinese patients with DLBCL or FL.Hepatitis B virus (HBV) reactivation management was also investigated.Methods:A prospective,multicenter,single-arm,noninterventional study of previously untreated CD20-positive DLBCL or FL patients receiving first-line R-chemo treatment at 24 centers in China was conducted between January 17,2011 and October 31,2016.Enrolled patients underwent safety and effectiveness assessments after the last rituximab dose and were followed up for 3 years.Effectiveness endpoints included progression-free survival (PFS) and overall survival (OS).Safety endpoints were adverse events (AEs),serious AEs,drug-related AEs,and AEs of special interest.We also reported data on the incidence of HBV reactivation.Results:In total,283 previously untreated CD20-positive DLBCL and 31 FL patients from 24 centers were enrolled.Three-year PFS was 59％ (95％ confidence interval [CI]:50-67％) for DLBCL patients and 46％ (95％ CI:20-69％) for FL patients.For DLBCL patients,multivariate analyses showed that PFS was not associated with international prognostic index,tumor maximum diameter,HBV infection status,or number of rituximab treatment cycles,and OS was only associated with age ＞60 years (P ＜ 0.05).R-chemo was well tolerated.The incidence of HBV reactivation in hepatitis B surface antigen (HBsAg)-positive and HBsAg-negative/hepatitis B core antibody-positive patients was 13％ (3/24) and 4％ (3/69),respectively.Conclusions:R-chemo is effective and safe in real-world clinical practice as first-line treatment for DLBCL and FL in China,and that HBV reactivation during R-chemo is manageable with preventive measures and treatment.Trial Registration:ClinicalTrials.gov,NCT01340443;https://clinicaltrials.gov/ct2/show/NCT01340443.关键词
Asian/Hematopoietic Malignancy/Hepatitis B Virus/Observational Study/RituximabKey words
Asian/Hematopoietic Malignancy/Hepatitis B Virus/Observational Study/Rituximab引用本文复制引用
Jian-Qiu Wu,Ru Feng,Wei Wang,Jie-Wen Peng,Xiao-Lin Li,Xue-Nong Ouyang,Chang-Ping Wu,Wei-Jing Zhang,Yun Zeng,Zhen Xiao,Ying-Min Liang,Yong-Ping Song,Yong-Zhi Zhuang,Ji-Shi Wang,Zi-Min Sun,Hai Bai,Tong-Jian Cui,Ji-Feng Feng,Li-Ping Su,Ming-Zhi Zhang,Wei Li,Yu Hu,Xiao-Hong Zhang,Yu-Huan Gao,Zuo-Xing Niu..Three-year Follow—up on the Safety and Effectiveness of Rituximab Plus Chemotherapy as First．Line Treatment of Diffuse Large B．Cell Lymphoma and Follicular Lymphoma in Real．World ClinicaI Settings in China：A Prospective．Multicenter, N0ninIerVenlional Study[J].中华医学杂志（英文版）,2018,131(15):1767-1775,9.基金项目
This study was supported by grants from the National Natural Science Foundation of China (No.81570186) and the Health and Family Planning Commission of Jiangsu Province (No.H201511). （No.81570186）
