PMID- 30058572
OWN - NLM
STAT- MEDLINE
DCOM- 20181217
LR  - 20240329
IS  - 2542-5641 (Electronic)
IS  - 0366-6999 (Print)
IS  - 0366-6999 (Linking)
VI  - 131
IP  - 15
DP  - 2018 Aug 5
TI  - 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 Clinical Settings in China: A Prospective, 
      Multicenter, Noninterventional Study.
PG  - 1767-1775
LID - 10.4103/0366-6999.237401 [doi]
AB  - 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 of rituximab 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.
FAU - Wu, Jian-Qiu
AU  - Wu JQ
AD  - Department of Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer 
      Research & Nanjing Medical University Affiliated Cancer Hospital, Nanjing, 
      Jiangsu 210008, China.
FAU - Song, Yong-Ping
AU  - Song YP
AD  - Department of Hematology, Henan Cancer Hospital, Zhengzhou, Henan 450000, China.
FAU - Su, Li-Ping
AU  - Su LP
AD  - Department of Hematology, Shanxi Cancer Hospital, Taiyuan, Shanxi 030013, China.
FAU - Zhang, Ming-Zhi
AU  - Zhang MZ
AD  - Department of Oncology, The First Affiliated Hospital of Zhengzhou University, 
      Zhengzhou, Henan 450000, China.
FAU - Li, Wei
AU  - Li W
AD  - Department of Oncology, Jilin University First Affiliated Hospital, Changchun, 
      Jilin 130000, China.
FAU - Hu, Yu
AU  - Hu Y
AD  - Department of Hematology, Union Hospital Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, Hubei 430072, China.
FAU - Zhang, Xiao-Hong
AU  - Zhang XH
AD  - Department of Hematology, The Second Affiliated Hospital of Zhejiang University 
      School of Medicine, Hangzhou, Zhejiang 310009, China.
FAU - Gao, Yu-Huan
AU  - Gao YH
AD  - Department of Hematology, Fourth Hospital of Hebei Medical University, 
      Shijiazhuang, Hebei 050000, China.
FAU - Niu, Zuo-Xing
AU  - Niu ZX
AD  - Department of Oncology, Affiliated Hospital of Shandong Academy of Medical 
      Sciences, Jinan, Shandong 250000, China.
FAU - Feng, Ru
AU  - Feng R
AD  - Department of Hematology, Medical University Nanfang Hospital, Guangzhou, 
      Guangdong 510000, China.
FAU - Wang, Wei
AU  - Wang W
AD  - Department of Oncology, Guangdong Foshan First Hospital, Foshan, Guangdong 
      528000, China.
FAU - Peng, Jie-Wen
AU  - Peng JW
AD  - Department of Oncology, Guangdong Zhongshan People's Hospital, Zhongshan, 
      Guangdong 528403, China.
FAU - Li, Xiao-Lin
AU  - Li XL
AD  - Department of Hematology, Xiangya Hospital Central South University, Changsha, 
      Hunan 410008, China.
FAU - Ouyang, Xue-Nong
AU  - Ouyang XN
AD  - Department of Oncology, Fuzhou General Hospital of Nanjing Military Command, 
      Fuzhou, Fujian 350001, China.
FAU - Wu, Chang-Ping
AU  - Wu CP
AD  - Department of Oncology, Changzhou First People's Hospital, Changzhou, Jiangsu 
      213000, China.
FAU - Zhang, Wei-Jing
AU  - Zhang WJ
AD  - Department of Oncology, 307 Hospital of Chinese People's Liberation Army, Beijing 
      100070, China.
FAU - Zeng, Yun
AU  - Zeng Y
AD  - Department of Hematology, First Affiliated Hospital of Kunming Medical 
      University, Kunming, Yunnan 650221, China.
FAU - Xiao, Zhen
AU  - Xiao Z
AD  - Department of Hematology, Affiliated Hospital of Neimenggu Medical College, 
      Hohhot, Huhehaote, Inner Mongolia 010050, China.
FAU - Liang, Ying-Min
AU  - Liang YM
AD  - Department of Hematology, The Fourth Military Medical University Affiliated 
      Tangdu Hospital, Xi'an, Shaanxi 710038, China.
FAU - Zhuang, Yong-Zhi
AU  - Zhuang YZ
AD  - Department of Oncology, Daqing General Hospital Group Oilfield General Hospital, 
      Daqing, Heilongjiang 163001, China.
FAU - Wang, Ji-Shi
AU  - Wang JS
AD  - Department of Hematology, Affiliated Hospital of Guiyang Medical College, 
      Guiyang, Guizhou 550004, China.
FAU - Sun, Zi-Min
AU  - Sun ZM
AD  - Department of Hematology, Anhui Provincial Hospital, Hefei, Anhui 23000, China.
FAU - Bai, Hai
AU  - Bai H
AD  - Department of Hematology, Lanzhou Military Hospital, Lanzhou, Gansu 730046, 
      China.
FAU - Cui, Tong-Jian
AU  - Cui TJ
AD  - Department of Oncology, Fujian Provincial Hospital, Fuzhou, Fujian 350001, China.
FAU - Feng, Ji-Feng
AU  - Feng JF
AD  - Department of Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer 
      Research & Nanjing Medical University Affiliated Cancer Hospital, Nanjing, 
      Jiangsu 210008, China.
LA  - eng
SI  - ClinicalTrials.gov/NCT01340443
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PL  - China
TA  - Chin Med J (Engl)
JT  - Chinese medical journal
JID - 7513795
RN  - 4F4X42SYQ6 (Rituximab)
RN  - 5J49Q6B70F (Vincristine)
RN  - 80168379AG (Doxorubicin)
RN  - 8N3DW7272P (Cyclophosphamide)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use
MH  - China
MH  - Cyclophosphamide/administration & dosage
MH  - Doxorubicin/administration & dosage
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Lymphoma, Follicular/*drug therapy
MH  - Lymphoma, Large B-Cell, Diffuse/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Rituximab/*therapeutic use
MH  - Vincristine/administration & dosage
PMC - PMC6071449
OTO - NOTNLM
OT  - Asian
OT  - Hematopoietic Malignancy
OT  - Hepatitis B Virus
OT  - Observational Study
OT  - Rituximab
COIS- There are no conflicts of interest
EDAT- 2018/07/31 06:00
MHDA- 2018/12/18 06:00
PMCR- 2018/08/05
CRDT- 2018/07/31 06:00
PHST- 2018/07/31 06:00 [entrez]
PHST- 2018/07/31 06:00 [pubmed]
PHST- 2018/12/18 06:00 [medline]
PHST- 2018/08/05 00:00 [pmc-release]
AID - ChinMedJ_2018_131_15_1767_237401 [pii]
AID - CMJ-131-1767 [pii]
AID - 10.4103/0366-6999.237401 [doi]
PST - ppublish
SO  - Chin Med J (Engl). 2018 Aug 5;131(15):1767-1775. doi: 10.4103/0366-6999.237401.