Evidence map›Paper›PMID 29843792›Full record

ArticleCancer communications (London, England)2018

Safety and efficacy of obinutuzumab in Chinese patients with B-cell lymphomas: a secondary analysis of the GERSHWIN trial.

Yan Qin, Yuqin Song, Zhixiang Shen, Xin Du, Wei Ji, Wanling Hsu, Jun Zhu, Yuankai Shi

Registry-linked trialAbstract readClinical Trial, Phase IMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Cancer communications (London, England), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01680991 (A Multi-Center, Open Label, Single Arm, Multiple Dose Study to Assess the Pharmacokinetics of RO5072759 in Chinese Patients With CD20+ Malignant Disease), 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
–field-weighted citation impact
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.

NCT01680991 phase1completednot on this map

A Multi-Center, Open Label, Single Arm, Multiple Dose Study to Assess the Pharmacokinetics of RO5072759 in Chinese Patients With CD20+ Malignant Disease

TypeinterventionalSponsorHoffmann-La RocheRan2012 to 2014Enrolled48ConditionsLymphocytic Leukemia, Chronic, Diffuse Large B-cell Lymphoma, Follicular LymphomaArmsObinutuzumab
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  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

8 authors.

Yan QinDepartment of Medical Oncology, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, P. R. China.
Yuqin SongDepartment of Lymphoma, Beijing Cancer Hospital, Peking University, Beijing, 100142, P. R. China.
Zhixiang ShenDepartment of Hematology, Ruijin Hospital, Shanghai Jiaotong University, Shanghai, 200025, P. R. China.
Xin DuDepartment of Hematology, Guangdong General Hospital/Guangdong Academy of Medical Sciences, Guangzhou, 510030, Guangdong, P. R. China.
Wei JiClinical Science, Shanghai Roche Pharmaceuticals Ltd, Shanghai, 201203, P. R. China.
Wanling HsuStatistics, Roche (China) Holding Ltd, Shanghai, 201203, P. R. China.
Jun ZhuDepartment of Lymphoma, Beijing Cancer Hospital, Peking University, Beijing, 100142, P. R. China.
Yuankai ShiDepartment of Medical Oncology, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, P. R. China. syuankai@cicams.ac.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with relapsed/refractory B-cell lymphomas have limited treatment options. GERSHWIN is an open-label, single-arm, phase Ib study of obinutuzumab monotherapy in Chinese patients with histologically documented CD20

methodsPatients received 1000 mg obinutuzumab intravenously on days 1, 8, and 15 of cycle 1 (CLL patients; first dose split over 2 days), and on day 1 of cycles 2-8. Each cycle lasted for 21 days; the treatment period was 24 weeks. All subjects receiving at least one dose of obinutuzumab were included in the analysis of safety, efficacy, as well as pharmacodynamics.

resultsA total of 48 patients (> 18 years of age) were enrolled (CLL: 12; DLBCL: 23; FL: 13). The subjects received a median of two lines of anticancer treatment prior to the enrollment. Thirty-five patients (72.9%) had at least one adverse event (AE). The most frequent AE was infusion-related reactions (15 patients; 31.3%), followed by pyrexia (11 patients; 22.9%). Treatment-related AEs were reported in 28 patients (58.3%), and included one death (interstitial lung disease). End-of-treatment (EoT) response rate was 33.3%. Best overall response rate was 47.9%. Most CLL patients achieved a partial response at EoT (58.3%). CD19

conclusionsThe safety and efficacy of obinutuzumab monotherapy in Chinese patients with B-cell lymphomas were similar to that observed in previous studies in non-Chinese patients; no new safety signals were observed. Clinical trial registration ID NCT01680991.

Indexed as

Administration, IntravenousAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalAsian PeopleChinaDrug Administration ScheduleDrug Resistance, NeoplasmFemaleHumansLeukemia, Lymphocytic, Chronic, B-CellLymphoma, FollicularLymphoma, Large B-Cell, DiffuseMaleMiddle AgedAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalobinutuzumabB-cell lymphomaChinese patientsChronic lymphocytic leukemiaObinutuzumab

Identifiers

PMID29843792
PMCPMC5993131

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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.