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.

Jian-qiu WU; Yong-ping Song; Li-ping SU; Ming-zhi Zhang; Wei LI; Yu HU; Xiao-hong Zhang; Yu-huan Gao; Zuo-xing Niu; 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-zhi Zhuang; Ji-shi Wang; Zi-min Sun; Hai Bai; Tong-jian Cui; Ji-feng Feng

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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.

Author: Jian-Qiu WU ¹ ; Yong-Ping SONG ² ; Li-Ping SU ³ ; Ming-Zhi ZHANG ⁴ ; Wei LI ⁵ ; Yu HU ⁶ ; Xiao-Hong ZHANG ⁷ ; Yu-Huan GAO ⁸ ; Zuo-Xing NIU ⁹ ; Ru FENG ¹⁰ ; Wei WANG ¹¹ ; Jie-Wen PENG ¹² ; Xiao-Lin LI ¹³ ; Xue-Nong OUYANG ¹⁴ ; Chang-Ping WU ¹⁵ ; Wei-Jing ZHANG ¹⁶ ; Yun ZENG ¹⁷ ; Zhen XIAO ¹⁸ ; Ying-Min LIANG ¹⁹ ; Yong-Zhi ZHUANG ²⁰ ; Ji-Shi WANG ²¹ ; Zi-Min SUN ²² ; Hai BAI ²³ ; Tong-Jian CUI ²⁴ ; Ji-Feng FENG ¹
Author Information

1. Department of Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & Nanjing Medical University Affiliated Cancer Hospital, Nanjing, Jiangsu 210008, China.
2. Department of Hematology, Henan Cancer Hospital, Zhengzhou, Henan 450000, China.
3. Department of Hematology, Shanxi Cancer Hospital, Taiyuan, Shanxi 030013, China.
4. Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan 450000, China.
5. Department of Oncology, Jilin University First Affiliated Hospital, Changchun, Jilin 130000, China.
6. Department of Hematology, Union Hospital Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430072, China.
7. Department of Hematology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang 310009, China.
8. Department of Hematology, Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei 050000, China.
9. Department of Oncology, Affiliated Hospital of Shandong Academy of Medical Sciences, Jinan, Shandong 250000, China.
10. Department of Hematology, Medical University Nanfang Hospital, Guangzhou, Guangdong 510000, China.
11. Department of Oncology, Guangdong Foshan First Hospital, Foshan, Guangdong 528000, China.
12. Department of Oncology, Guangdong Zhongshan People's Hospital, Zhongshan, Guangdong 528403, China.
13. Department of Hematology, Xiangya Hospital Central South University, Changsha, Hunan 410008, China.
14. Department of Oncology, Fuzhou General Hospital of Nanjing Military Command, Fuzhou, Fujian 350001, China.
15. Department of Oncology, Changzhou First People's Hospital, Changzhou, Jiangsu 213000, China.
16. Department of Oncology, 307 Hospital of Chinese People's Liberation Army, Beijing 100070, China.
17. Department of Hematology, First Affiliated Hospital of Kunming Medical University, Kunming, Yunnan 650221, China.
18. Department of Hematology, Affiliated Hospital of Neimenggu Medical College, Hohhot, Huhehaote, Inner Mongolia 010050, China.
19. Department of Hematology, The Fourth Military Medical University Affiliated Tangdu Hospital, Xi'an, Shaanxi 710038, China.
20. Department of Oncology, Daqing General Hospital Group Oilfield General Hospital, Daqing, Heilongjiang 163001, China.
21. Department of Hematology, Affiliated Hospital of Guiyang Medical College, Guiyang, Guizhou 550004, China.
22. Department of Hematology, Anhui Provincial Hospital, Hefei, Anhui 23000, China.
23. Department of Hematology, Lanzhou Military Hospital, Lanzhou, Gansu 730046, China.
24. Department of Oncology, Fujian Provincial Hospital, Fuzhou, Fujian 350001, China.
Publication Type:Clinical Trial
Keywords: Asian; Hematopoietic Malignancy; Hepatitis B Virus; Observational Study; Rituximab
MeSH: Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; therapeutic use; China; Cyclophosphamide; administration & dosage; Doxorubicin; administration & dosage; Female; Follow-Up Studies; Humans; Lymphoma, Follicular; drug therapy; Lymphoma, Large B-Cell, Diffuse; drug therapy; Male; Middle Aged; Prospective Studies; Rituximab; therapeutic use; Vincristine; administration & dosage
From: Chinese Medical Journal 2018;131(15):1767-1775
CountryChina
Language:English
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 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.