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Clinical Trial
. 2018 Aug 5;131(15):1767-1775.
doi: 10.4103/0366-6999.237401.

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  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
Affiliations
Clinical Trial

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 et al. Chin Med J (Engl). .

Abstract
in English, Chinese

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.

利妥昔单抗联合化疗一线治疗初治弥漫大B细胞淋巴瘤和滤泡性淋巴瘤中国患者的疗效与安全性的真实世界3年随访结果：一项前瞻、多中心、非干预性研究摘要背景：关于利妥昔单抗治疗中国弥漫大B细胞淋巴瘤（DLBCL）和滤泡性淋巴瘤 （FL）患者的疗效与安全性的真实世界证据十分有限。本研究通过前瞻性、非干预性的多中心临床研究观察中国真实医疗环境中利妥昔单抗联合化疗（R-Chemo）作为一线方案治疗DLBCL和FL患者的长期疗效与安全性。同时一并观察R-Chemo治疗中乙肝病毒再激活的现状。 方法：研究为前瞻性、多中心、单组的非干预性研究。2011年1月17日至2016年10月31日，纳入国内24个中心的CD20阳性初治DLBCL和FL患者。所有患者在结束最后1次利妥昔单抗治疗后再随访3年。基线收集的数据包括年龄、性别、疾病分期、国际预后指数、滤泡性淋巴瘤国际预后指数、结外侵犯、活动状态和病史等。本研究报道疗效、安全性和乙肝病毒感染的管理现状。 结果：共有来自24个中心的CD20阳性初治的283例DLBCL患者和31例FL患者纳入本研究。DLBCL患者3年无病进展生存率为59％（95％可信区间 50％-67％）；FL患者3年无病进展生存率为46％（95％可信区间 20％-69％）。R-Chemo耐受性良好。在HBsAg阳性患者中，乙肝病毒再激活率为13% (3/24)；在HBsAg阴性/ HBcAb阳性患者中，乙肝病毒再激活率为4% (3/69)。 结论：前瞻非干预性研究证实R-Chemo在中国真实医疗环境中治疗CD20阳性初治DLBCL和FL患者是有效且安全的一线方案。经过积极的预防和治疗，R-Chemo治疗中的乙肝病毒再激活可控。.

Keywords: Asian; Hematopoietic Malignancy; Hepatitis B Virus; Observational Study; Rituximab.

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Conflict of interest statement

There are no conflicts of interest

Figures

Figure 1
Figure 1
Univariate and multivariate analyses using Cox regression for progression-free survival. (a) Univariate analysis. (b) Multivariate analysis. ECOG: Eastern Cooperative Oncology Group performance status; HR: Hazard ratio; CI: Confidence interval; HBsAg: Hepatitis B surface antigen; HBcAb: Hepatitis B core antibody.
Figure 2
Figure 2
Univariate and multivariate analyses using Cox regression for overall survival. (a) Univariate analysis. (b) Multivariate analysis. ECOG: Eastern Cooperative Oncology Group performance status; HR: Hazard ratio; CI: Confidence interval; HBsAg: Hepatitis B surface antigen; HBcAb: Hepatitis B core antibody.
See this image and copyright information in PMC

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