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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(Open Access)

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机构: [1]Jiangsu Cancer Hospital, Nanjing 210000, China [2]Henan Cancer Hospital, Zhengzhou, China [3]Shanxi Cancer Hospital, Taiyuan, China [4]Shanghai Roche Pharmaceuticals Ltd, Shanghai, China [5]The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China [6]Jilin University First Affiliated Hospital, Changchun, China [7]Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, China [8]The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China [9]Fourth Hospital of Hebei Medical University, Shijiazhuang, China [10]Affiliated Hospital of Shandong Academy of Medical Sciences, Jinan, China [11]Nanfang Medical University Nanfang Hospital, Guangzhou, China [12]Guangdong Foshan First Hospital, Foshan, China [13]Guangdong Zhongshan People’s Hospital, Zhongshan, China [14]Xiangya Hospital Central South University, Changsha, China [15]Fuzhou General Hospital of Nanjing Military Command, Fuzhou, China [16]Changzhou First People’s Hospital, Changzhou, China [17]307 Hospital of PLA, Beijing, China [18]First Affiliated Hospital of Kunming Medical University, Kunming, China [19]Affiliated hospital of Neimenggu Medical College, Huhehaote, China [20]The Fourth Military Medical University Affiliated Tangdu Hospital, Xi’an, China [21]Daqing General Hospital Group Oilfield General Hospital, Daqing, China [22]Affiliated Hospital of Guiyang Medical College, Guiyang, China [23]Anhui Provincial Hospital, Hefei, China [24]Lanzhou Military Hospital, Lanzhou, China [25]Fujian provincial hospital, Fuzhou, China
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关键词: Chemotherapy DLBCL HBsAg HBV infection R-CHOP

摘要:
Background: 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. Methods: 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. Results: 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. Conclusions: 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. Trial registration: ClinicalTrials.gov # NCT01340443 , April 20, 2011. © 2016 Wu et al.

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出版当年[2016]版:
大类 | 2 区 医学
小类 | 3 区 肿瘤学
最新[2025]版:
大类 | 3 区 医学
小类 | 3 区 肿瘤学
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出版当年[2016]版:
Q2 ONCOLOGY
最新[2023]版:
Q2 ONCOLOGY

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第一作者机构: [1]Jiangsu Cancer Hospital, Nanjing 210000, China
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