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

BMC Cancer

Research Article

Weijing Zhang¹  Jishi Wang²  Zuoxing Niu³  Zhen Xiao⁴  Zimin Sun⁵  Changping Wu⁶  Yongzhi Zhuang⁷  Yun Zeng⁸  Yuhuan Gao⁹  Tongjian Cui^1,10  Xuenong Ouyang^1,11  Wei Wang^1,12  Jiewen Peng^1,13  Yongping Song^1,14  Jianqiu Wu^1,15  Jifeng Feng^1,15  Wei Li^1,16  Hai Bai^1,17  Ru Feng^1,18  Zhiyun Zhao^1,19  Li Xu^1,19  Tingchao Chen^1,19  Liping Su^2,20  Mingzhi Zhang^2,21  Yingmin Liang^2,22  Xiaohong Zhang^2,23  Yu Hu^2,24  Xiaolin Li^2,25 

[1] 307 Hospital of PLA, Beijing, China;Affiliated Hospital of Guiyang Medical College, Guiyang, China;Affiliated Hospital of Shandong Academy of Medical Sciences, Jinan, China;Affiliated hospital of Neimenggu Medical College, Huhehaote, China;Anhui Provincial Hospital, Hefei, China;Changzhou First People’s Hospital, Changzhou, China;Daqing General Hospital Group Oilfield General Hospital, Daqing, China;First Affiliated Hospital of Kunming Medical University, Kunming, China;Fourth Hospital of Hebei Medical University, Shijiazhuang, China;Fujian provincial hospital, Fuzhou, China;Fuzhou General Hospital of Nanjing Military Command, Fuzhou, China;Guangdong Foshan First Hospital, Foshan, China;Guangdong Zhongshan People’s Hospital, Zhongshan, China;Henan Cancer Hospital, Zhengzhou, China;Jiangsu Cancer Hospital, 210000, Nanjing, China;Jilin University First Affiliated Hospital, Changchun, China;Lanzhou Military Hospital, Lanzhou, China;Nanfang Medical University Nanfang Hospital, Guangzhou, China;Shanghai Roche Pharmaceuticals Ltd, Shanghai, China;Shanxi Cancer Hospital, Taiyuan, China;The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China;The Fourth Military Medical University Affiliated Tangdu Hospital, Xi’an, China;The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China;Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, China;Xiangya Hospital Central South University, Changsha, China;

关键词: DLBCL;    R-CHOP;    Chemotherapy;    HBV infection;    HBsAg;   

DOI  :  10.1186/s12885-016-2523-7

 received in 2015-03-30, accepted in 2016-07-05,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundThe 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.MethodsTreatment-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.ResultsOverall, 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.ConclusionsThis 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.Trial registrationClinicalTrials.gov #NCT01340443, April 20, 2011.

【 授权许可】

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© Wu et al. 2016