Evidence map›Paper›PMID 35194005›Full record

Trial reportChinese medical journal2021

Efficacy and safety of obinutuzumab for the first-line treatment of follicular lymphoma: a subgroup analysis of Chinese patients enrolled in the phase III GALLIUM study.

Xiaonan Hong, Yuqin Song, Yuankai Shi, Qingyuan Zhang, Wei Guo, Gang Wu, Junmin Li, Jifeng Feng, Anastasiia Kinkolykh, Andrea Knapp and 1 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Chinese medical journal, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01332968 (A Multicenter, Phase III, Open-Label, Randomized Study in Previously Untreated Patients With Advanced Indolent Non-Hodgkin's Lymphoma Evaluating the Benefit of GA101), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.5field-weighted citation impact, top 37% 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.

NCT01332968 phase3completednot on this map

A Multicenter, Phase III, Open-Label, Randomized Study in Previously Untreated Patients With Advanced Indolent Non-Hodgkin's Lymphoma Evaluating the Benefit of GA101 (RO5072759) Plus Chemotherapy Compared With Rituximab Plus Chemotherapy Followed by GA101 or Rituximab Maintenance Therapy in Responders

TypeinterventionalSponsorHoffmann-La RocheRan2011 to 2021Enrolled1,401ConditionsNon-Hodgkin's LymphomaArmsObinutuzumab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. 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

11 authors at 9 institutions in 2 countries.

Xiaonan HongDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai 200032, China.
Yuqin SongKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Beijing 100142, China.
Yuankai ShiNational Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing 100021, China.
Qingyuan ZhangDepartment of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin Medical University, Harbin, Heilongjiang 150081, China.
Wei GuoDepartment of Hematology, The First Hospital of Jilin University, Changchun, Jilin 130015, China.
Gang WuDepartment of Medical Oncology, Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430023, China.
Junmin LiShanghai Institute of Hematology, State Key Laboratory of Medical Genomics, National Research Center for Translational Medicine at Shanghai, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China.
Jifeng FengDepartment of Medical Oncology, Jiangsu Cancer Hospital, Nanjing Medical University Affiliated Cancer Hospital, Nanjing, Jiangsu 210009, China.
Anastasiia KinkolykhConsultant to F. Hoffmann-La Roche Ltd, Basel, Switzerland, via GCE Solutions - an IQVIA business, Switzerland.
Andrea KnappProduct Development Oncology, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
Tongyu LinDepartment of Medical Oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, and Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong 510075, China.
Roche (Switzerland) · CHChinese Academy of Medical Sciences & Peking Union Medical College · CNFudan University Shanghai Cancer Center · CNHuazhong University of Science and Technology · CNJilin University · CNNanjing Medical University · CNPeking University Cancer Hospital · CNShanghai Institute of Hematology · CNThird Affiliated Hospital of Harbin Medical University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundsGALLIUM is a global phase III study that demonstrated significant improvements in progression-free survival (PFS) for obinutuzumab plus chemotherapy (G-chemo) vs. rituximab plus chemotherapy (R-chemo) in previously untreated patients with follicular lymphoma (FL). This study aimed to report the results of a subgroup of patients in China.

methodsPatients were randomized to G-chemo or R-chemo. Responders received maintenance therapy for 2 years or until disease progression. The primary endpoint was investigator (INV)-assessed PFS. Secondary endpoints included the overall response rate (ORR) and complete response rate (CRR) at the end of induction chemotherapy, overall survival (OS), and safety.

resultsOverall, 58 patients with FL were randomized to the G-chemo (n = 25) and R-chemo arms (n = 33). The INV-assessed PFS rate at 3 years was 81.8% in the G-chemo arm, vs. 70.2% in the R-chemo arm (hazard ratio 0.35; 95% confidence interval: 0.09-1.34; P = 0.1120). The INV-assessed CRRs (without positron emission tomography [PET]) in these arms were 24.0% and 21.2%, respectively, whereas the ORRs were 80.0% and 90.9%, respectively. INV-assessed CRR-PET was 52.6% in the G-chemo, vs. 60.9% in the R-chemo. Median OS was not reached in either arm. Grade 3 to 5 adverse events were more frequent in the R-chemo arm (97.0% vs. 88.0%).

conclusionsThe results of this subgroup analysis were consistent with those of the global population, and they suggest that G-chemo has a positive benefit-risk profile in patients from China with FL.

trial registrationClinicalTrials.gov, No. NCT01332968.

Indexed as

GalliumLymphoma, FollicularAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsHumansRituximabAntibodies, Monoclonal, HumanizedGalliumobinutuzumabRituximab

Identifiers

PMID35194005
PMCPMC8869628
OpenAlexW3201325637

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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.