Evidence map›Paper›PMID 33331923›Full record

Trial reportNeuro-oncology2021

Whole-brain radiotherapy with and without concurrent erlotinib in NSCLC with brain metastases: a multicenter, open-label, randomized, controlled phase III trial.

Zhenzhou Yang, Yan Zhang, Rongqing Li, Abulimiti Yisikandaer, Biyong Ren, Jianguo Sun, Jianjun Li, Long Chen, Ren Zhao, Juying Zhang and 3 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neuro-oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01887795 (Phase Ⅲ Trial of WBRT Versus Erlotinib Concurrent Whole-brain Radiation Therapy as first-line Treatment for Patients With Multiple Brain Metastases From Non-small-cell Lung Cancer), which is not on this map. Cited by 22 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 4 pooled it
1.9field-weighted citation impact, top 11% 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.

NCT01887795 phase3completednot on this map

Phase Ⅲ Trial of WBRT Versus Erlotinib Concurrent Whole-brain Radiation Therapy as first-line Treatment for Patients With Multiple Brain Metastases From Non-small-cell Lung Cancer(ENTER): a Multicentre, Open-label, Randomised Study

TypeinterventionalSponsorDaping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityRan2013 to 2016Enrolled224ConditionsMultiple Brain Metastases, Non-small-cell Lung CancerArmsErlotinib, WBRT
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 4 syntheses or guidelines pooled it, 29 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 12 institutions in 2 countries.

Zhenzhou YangCancer Center, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Yan ZhangDepartment of Thoracic Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, China.
Rongqing LiDepartment of Radiation Oncology, The First Affiliated Hospital of Kunming Medical University, Kunming, China.
Abulimiti YisikandaerDepartment of Radiotherapy of the Chest and Abdomen, Affiliated Tumor Hospital of Xinjiang Medical University, Urumqi, China.
Biyong RenInstitute for Cancer Prevention and Treatment, Chongqing Sanxia Central Hospital, Chongqing, China.
Jianguo SunDepartment of Medical Oncology, Xinqiao Hospital, Chongqing, China.
Jianjun LiDepartment of Oncology, Southwest Hospital, Chongqing, China.
Long ChenDepartment of Radiation Oncology, Cancer Hospital, Guangxi Medical University, Nanning, China.
Ren ZhaoDepartment of Radiotherapy, General Hospital of Ningxia Medical University, Yinchuan, China.
Juying ZhangDepartment of Epidemiology and Biostatistics, West China School of Public Health and West China Fourth Hospital, Sichuan University, Chengdu, China.
Xuefeng XiaGenePlus-Beijing Institute, Peking University Medical Industrial Park, Zhongguancun Life Science Park, Beijing, China.
Zhongxing LiaoDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
David P CarboneDepartment of Internal Medicine, Division of Medical Oncology, The Ohio State University Medical Center, Columbus, Ohio, USA.
First Affiliated Hospital of Kunming Medical University · CNGuangxi Medical University · CNNingxia Medical University General Hospital · CNPeking University · CNSecond Affiliated Hospital of Chongqing Medical University · CNSichuan University · CNSouthwest Hospital · CNThe Ohio State University · USThe University of Texas MD Anderson Cancer Center · USWest China Medical Center of Sichuan University · CNXinjiang Medical University · CNXinqiao Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundErlotinib combined with whole-brain radiotherapy (WBRT) demonstrated a favorable objective response rate in a phase II single-arm trial of non-small cell lung cancer (NSCLC) patients with brain metastases. We assessed whether concurrent erlotinib with WBRT is safe and benefits patients in a phase III, randomized trial.

methodsNSCLC patients with two or more brain metastases were enrolled and randomly assigned (1:1) to WBRT (n = 115) or WBRT combined with erlotinib arms (n = 109). The primary endpoint was intracranial progression-free survival (iPFS) and cognitive function (CF) was assessed by the Mini-Mental State Examination (MMSE).

resultsA total of 224 patients from 10 centers across China were randomized to treatments. Median follow-up was 11.2 months. Median iPFS for WBRT concurrent erlotinib was 11.2 months vs 9.2 months for WBRT-alone (P = .601). Median PFS and overall survival (OS) of combination group were 5.3 vs 4.0 months (P = .825) and 12.9 vs 10.0 months (P = .545), respectively, compared with WBRT-alone. In EGFR-mutant patients, iPFS (14.6 vs 12.8 months; P = .164), PFS (8.8 vs 6.4 months; P = .702), and OS (17.5 vs 16.9 months; P = .221) were not significantly improved in combination group over WBRT-alone. Moreover, there were no significant differences in patients experiencing MMSE score change between the treatments.

conclusionConcurrent erlotinib with WBRT didn't improve iPFS and excessive CF detriment either in the intent-to-treat (ITT) population or in EGFR-mutant patients compared with WBRT-alone, suggesting that while safe for patients already taking the drug, there is no justification for adding concurrent EGFR-TKI with WBRT for the treatment of brain metastases. Trial registration: Clinical trials.gov identifier: NCT01887795.

Indexed as

Brain NeoplasmsCarcinoma, Non-Small-Cell LungLung NeoplasmsBrainChinaCranial IrradiationErbB ReceptorsErlotinib HydrochlorideHumansErbB ReceptorsErlotinib Hydrochloridebrain metastasesepidermal growth factor receptorerlotinibnon–small cell lung cancerwhole-brain radiation therapy

Identifiers

PMID33331923
PMCPMC8168818
OpenAlexW3116467632

What OpenQuestion holds

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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.