Evidence map›Paper›PMID 30058572›Full record

Trial reportChinese medical journal2018

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 and 15 more

Registry-linked trialOpen access · goldAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Chinese medical journal, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01340443 (A Multi Centre, Single Arm, Observational Study on Safety and Efficacy of MabThera Plus Chemotherapy as 1st Line Treatment in Patients With DLBCL or FL), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.3field-weighted citation impact, top 39% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01340443 completednot on this map

A Multi Centre, Single Arm, Observational Study on Safety and Efficacy of MabThera Plus Chemotherapy as 1st Line Treatment in Patients With DLBCL or FL

TypeobservationalSponsorHoffmann-La RocheRan2011 to 2016Enrolled314ConditionsDiffuse Large B-Cell Lymphoma
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 27 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors at 12 institutions in 1 country.

Jian-Qiu WuDepartment of Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & Nanjing Medical University Affiliated Cancer Hospital, Nanjing, Jiangsu 210008, China.
Yong-Ping SongDepartment of Hematology, Henan Cancer Hospital, Zhengzhou, Henan 450000, China.
Li-Ping SuDepartment of Hematology, Shanxi Cancer Hospital, Taiyuan, Shanxi 030013, China.
Ming-Zhi ZhangDepartment of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan 450000, China.
Wei LiDepartment of Oncology, Jilin University First Affiliated Hospital, Changchun, Jilin 130000, China.
Yu HuDepartment of Hematology, Union Hospital Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430072, China.
Xiao-Hong ZhangDepartment of Hematology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang 310009, China.
Yu-Huan GaoDepartment of Hematology, Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei 050000, China.
Zuo-Xing NiuDepartment of Oncology, Affiliated Hospital of Shandong Academy of Medical Sciences, Jinan, Shandong 250000, China.
Ru FengDepartment of Hematology, Medical University Nanfang Hospital, Guangzhou, Guangdong 510000, China.
Wei WangDepartment of Oncology, Guangdong Foshan First Hospital, Foshan, Guangdong 528000, China.
Jie-Wen PengDepartment of Oncology, Guangdong Zhongshan People's Hospital, Zhongshan, Guangdong 528403, China.
Xiao-Lin LiDepartment of Hematology, Xiangya Hospital Central South University, Changsha, Hunan 410008, China.
Xue-Nong OuyangDepartment of Oncology, Fuzhou General Hospital of Nanjing Military Command, Fuzhou, Fujian 350001, China.
Chang-Ping WuDepartment of Oncology, Changzhou First People's Hospital, Changzhou, Jiangsu 213000, China.
Wei-Jing ZhangDepartment of Oncology, 307 Hospital of Chinese People's Liberation Army, Beijing 100070, China.
Yun ZengDepartment of Hematology, First Affiliated Hospital of Kunming Medical University, Kunming, Yunnan 650221, China.
Zhen XiaoDepartment of Hematology, Affiliated Hospital of Neimenggu Medical College, Hohhot, Huhehaote, Inner Mongolia 010050, China.
Ying-Min LiangDepartment of Hematology, The Fourth Military Medical University Affiliated Tangdu Hospital, Xi'an, Shaanxi 710038, China.
Yong-Zhi ZhuangDepartment of Oncology, Daqing General Hospital Group Oilfield General Hospital, Daqing, Heilongjiang 163001, China.
Ji-Shi WangDepartment of Hematology, Affiliated Hospital of Guiyang Medical College, Guiyang, Guizhou 550004, China.
Zi-Min SunDepartment of Hematology, Anhui Provincial Hospital, Hefei, Anhui 23000, China.
Hai BaiDepartment of Hematology, Lanzhou Military Hospital, Lanzhou, Gansu 730046, China.
Tong-Jian CuiDepartment of Oncology, Fujian Provincial Hospital, Fuzhou, Fujian 350001, China.
Ji-Feng FengDepartment of Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & Nanjing Medical University Affiliated Cancer Hospital, Nanjing, Jiangsu 210008, China.
Nanjing Medical University · CNHenan Cancer Hospital · CNJiangsu Cancer Hospital · CNFirst Affiliated Hospital of Zhengzhou University · CNShanxi Provincial Cancer Hospital · CNFirst People's Hospital of Foshan · CNFourth Hospital of Hebei Medical University · CNFujian Provincial Hospital · CNHuazhong University of Science and Technology · CNJilin University · CNSecond Affiliated Hospital of Zhejiang University · CNShandong First Medical University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundProspective 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.

methodsA 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.

resultsIn 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.

conclusionsR-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 registrationClinicalTrials.gov, NCT01340443; https://clinicaltrials.gov/ct2/show/NCT01340443.

Indexed as

AgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsChinaCyclophosphamideDoxorubicinFemaleFollow-Up StudiesHumansLymphoma, FollicularLymphoma, Large B-Cell, DiffuseMaleMiddle AgedProspective StudiesRituximabVincristineCyclophosphamideDoxorubicinRituximabVincristineAsianHematopoietic MalignancyHepatitis B VirusObservational StudyRituximab

Identifiers

PMID30058572
PMCPMC6071449
OpenAlexW2884315001

What OpenQuestion holds

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LicenceCC BY-NC-SA
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.