title: Rituximab plus chemotherapy as first-line treatment in Chinese patients with diffuse large B-cell lymphoma in routine practice: a prospective, multicentre, non-interventional study.
abstract: The efficacy and safety of rituximab-based chemotherapy (R-chemo), the standard regimen for patients with diffuse large B-cell lymphoma (DLBCL), which is more common in Asia than in Western countries, are well confirmed in randomized controlled trials (RCTs). However, the safety and effectiveness of R-chemo in patients who are largely excluded from RCTs have not been well characterized. This real-world study investigated the safety and effectiveness of R-chemo as first-line treatment in Chinese patients with DLBCL.
  
  
  
  Treatment-naive DLBCL patients who were CD20 positive and eligible to receive R-chemo were enrolled with no specific exclusion criteria. Data collected at baseline included age, gender, disease stage, international prognostic index (IPI), B symptoms, extranodal involvement, performance status, and medical history. In the present study, data on safety, treatment effectiveness, and HBV infection management were collected 120 days after the last R-chemo administration.
  
  
  
  Overall, R-chemo was well tolerated. The safety profile of R-chemo in patients with a history of heart or liver disease was well described without any additional unexpected safety concerns. The overall response rate (ORR) in the Chinese patients from this study was 94.2 % (complete response [CR], 55.0 %; CR unconfirmed [CRu] 18.2 %; and partial response [PR], 20.9 %). Compared to patients with no history of disease, the CR and PR rates of patients with a history of heart or liver disease were lower and higher, respectively; this tendency could be in part explained by treatment interruptions in patients with heart or liver diseases. HBsAg positivity and a maximum tumor diameter of ≥7.5 cm negatively correlated with CR + CRu, whereas age and HBsAg positivity negatively correlated with CR.
  
  
  
  This study further validated the safety and effectiveness of R-chemo in Chinese patients with DLBCL. Patients with a history of heart or liver disease may further benefit from R-chemo if preventive measures are taken to reduce hepatic and cardiovascular toxicity. In addition to IPI and tumor diameter, HBsAg positivity could also be a poor prognostic factor for CR in Chinese patients with DLBCL.
  
  
  
  ClinicalTrials.gov # NCT01340443 , April 20, 2011.
authors.affiliation: Jiangsu Cancer Hospital, Nanjing, 210000, China.
authors.forename: Jianqiu
authors.initials: J
authors.lastname: Wu
authors.affiliation: Henan Cancer Hospital, Zhengzhou, China.
authors.forename: Yongping
authors.initials: Y
authors.lastname: Song
authors.affiliation: Shanxi Cancer Hospital, Taiyuan, China.
authors.forename: Liping
authors.initials: L
authors.lastname: Su
authors.affiliation: Shanghai Roche Pharmaceuticals Ltd, Shanghai, China.
authors.forename: Li
authors.initials: L
authors.lastname: Xu
authors.affiliation: Shanghai Roche Pharmaceuticals Ltd, Shanghai, China.
authors.forename: Tingchao
authors.initials: T
authors.lastname: Chen
authors.affiliation: Shanghai Roche Pharmaceuticals Ltd, Shanghai, China.
authors.forename: Zhiyun
authors.initials: Z
authors.lastname: Zhao
authors.affiliation: The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
authors.forename: Mingzhi
authors.initials: M
authors.lastname: Zhang
authors.affiliation: Jilin University First Affiliated Hospital, Changchun, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Li
authors.affiliation: Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, China.
authors.forename: Yu
authors.initials: Y
authors.lastname: Hu
authors.affiliation: The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.
authors.forename: Xiaohong
authors.initials: X
authors.lastname: Zhang
authors.affiliation: Fourth Hospital of Hebei Medical University, Shijiazhuang, China.
authors.forename: Yuhuan
authors.initials: Y
authors.lastname: Gao
authors.affiliation: Affiliated Hospital of Shandong Academy of Medical Sciences, Jinan, China.
authors.forename: Zuoxing
authors.initials: Z
authors.lastname: Niu
authors.affiliation: Nanfang Medical University Nanfang Hospital, Guangzhou, China.
authors.forename: Ru
authors.initials: R
authors.lastname: Feng
authors.affiliation: Guangdong Foshan First Hospital, Foshan, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Wang
authors.affiliation: Guangdong Zhongshan People's Hospital, Zhongshan, China.
authors.forename: Jiewen
authors.initials: J
authors.lastname: Peng
authors.affiliation: Xiangya Hospital Central South University, Changsha, China.
authors.forename: Xiaolin
authors.initials: X
authors.lastname: Li
authors.affiliation: Fuzhou General Hospital of Nanjing Military Command, Fuzhou, China.
authors.forename: Xuenong
authors.initials: X
authors.lastname: Ouyang
authors.affiliation: Changzhou First People's Hospital, Changzhou, China.
authors.forename: Changping
authors.initials: C
authors.lastname: Wu
authors.affiliation: 307 Hospital of PLA, Beijing, China.
authors.forename: Weijing
authors.initials: W
authors.lastname: Zhang
authors.affiliation: First Affiliated Hospital of Kunming Medical University, Kunming, China.
authors.forename: Yun
authors.initials: Y
authors.lastname: Zeng
authors.affiliation: Affiliated hospital of Neimenggu Medical College, Huhehaote, China.
authors.forename: Zhen
authors.initials: Z
authors.lastname: Xiao
authors.affiliation: The Fourth Military Medical University Affiliated Tangdu Hospital, Xi'an, China.
authors.forename: Yingmin
authors.initials: Y
authors.lastname: Liang
authors.affiliation: Daqing General Hospital Group Oilfield General Hospital, Daqing, China.
authors.forename: Yongzhi
authors.initials: Y
authors.lastname: Zhuang
authors.affiliation: Affiliated Hospital of Guiyang Medical College, Guiyang, China.
authors.forename: Jishi
authors.initials: J
authors.lastname: Wang
authors.affiliation: Anhui Provincial Hospital, Hefei, China.
authors.forename: Zimin
authors.initials: Z
authors.lastname: Sun
authors.affiliation: Lanzhou Military Hospital, Lanzhou, China.
authors.forename: Hai
authors.initials: H
authors.lastname: Bai
authors.affiliation: Fujian provincial hospital, Fuzhou, China.
authors.forename: Tongjian
authors.initials: T
authors.lastname: Cui
authors.affiliation: Jiangsu Cancer Hospital, Nanjing, 210000, China. fjif@medmail.com.cn.
authors.forename: Jifeng
authors.initials: J
authors.lastname: Feng
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018951:Antigens, CD20 / Q000378:metabolism; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002681:China / Q000453:epidemiology; D018572:Disease-Free Survival; D006331:Heart Diseases / Q000150:complications; D006514:Hepatitis B Surface Antigens / Q000097:blood; D006801:Humans; D008107:Liver Diseases / Q000150:complications; D016403:Lymphoma, Large B-Cell, Diffuse / Q000188:drug therapy* / Q000378:metabolism / Q000401:mortality; D008875:Middle Aged; D064792:Pragmatic Clinical Trials as Topic; D011446:Prospective Studies; D000069283:Rituximab / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018951:Antigens, CD20; D006514:Hepatitis B Surface Antigens; D000069283:Rituximab
keywords: Chemotherapy; DLBCL; HBV infection; HBsAg; R-CHOP