Evidence map›Paper›PMID 33205587›Full record

Trial reportThoracic cancer2021

Osimertinib combined with bevacizumab for leptomeningeal metastasis from EGFR-mutation non-small cell lung cancer: A phase II single-arm prospective clinical trial.

Zhi-Qin Lu, Jing Cai, Xia Wang, Jian-Ping Wei, Zhi-Min Zeng, Long Huang, An-Wen Liu

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Thoracic cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04944069 (Almonertinib Combined With Bevacizumab for EGFR-Mutant NSCLC Patients With Leptomeningeal Metastasis), which is not on this map. Cited by 30 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 1 pooled it
3.0field-weighted citation impact, top 6% 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.

NCT04944069 naunknown statusnot on this map

Almonertinib Combined With Bevacizumab for EGFR-Mutant NSCLC Patients With Leptomeningeal Metastasis: A Prospective, Open-label, Multi-center, Single-arm Study

TypeinterventionalSponsorSecond Affiliated Hospital of Nanchang UniversityRan2021 to 2025Enrolled69ConditionsNSCLC, Leptomeningeal Metastasis, EGFR Activating MutationArmsAlmonertinib, Bevacizumab
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 1 synthesis or guideline pooled it, 42 citations in OpenAlex.

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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

7 authors at 1 institution in 2 countries.

Zhi-Qin Lu *Department of Oncology, The Second Affiliated Hospital of Nanchang University, Nanchang, China.ORCID 0000-0001-9159-9562
Jing Cai *Department of Oncology, The Second Affiliated Hospital of Nanchang University, Nanchang, China.
Xia WangDepartment of Oncology, The Second Affiliated Hospital of Nanchang University, Nanchang, China.ORCID 0000-0002-6986-0979
Jian-Ping WeiDepartment of Oncology, The Second Affiliated Hospital of Nanchang University, Nanchang, China.
Zhi-Min ZengDepartment of Oncology, The Second Affiliated Hospital of Nanchang University, Nanchang, China.
Long HuangDepartment of Oncology, The Second Affiliated Hospital of Nanchang University, Nanchang, China.
An-Wen LiuDepartment of Oncology, The Second Affiliated Hospital of Nanchang University, Nanchang, China.
Nanchang University · CN

Funding

2018CSCO Qilu Research Foundation Y-Q201802-009Jiangxi Postgraduate Innovation Special Fund Project YC2019-S087Jiangxi Provincial key Laboratory of Cancer Clinical Transformation 20171BCD40022
6 · The paper itself

Abstract

backgroundLeptomeningeal metastasis (LM) is associated with poor prognosis in non-small cell lung cancer (NSCLC). The aim of this study was to investigate the efficacy and safety of osimertinib combined with bevacizumab for LM from epidermal growth factor receptor mutation (EGFRm) NSCLC.

methodsWe conducted a phase II single-arm prospective clinical trial of EGFRm NSCLC with LM treated with osimertinib combined with bevacizumab. LM response assessment was based on the modified RANO LM radiological criteria; CNS and extra-CNS response was evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The primary end points included LM progression-free survival (PFS) and objective response rate (ORR); the secondary end points included safety and LM overall survival (OS).

resultsA total of 14 patients were included in the study, with a median age of 61 years, and they were predominantly female (64%). EGFR mutations were reported in exons 19 del (n = 7) and 21 L858R (n = 7). When LM was diagnosed, 12 (85.7%) patients had clinical symptoms, 71.4% (10/14) of patients were diagnosed with LM by cytology, and five (35.7%) patients had a performance status (PS) score > 2. The median LM PFS was 9.3 months (95% CI: 8.2-10.4), and the LM ORR was 50%. The safety findings in the present study were consistent with the known profile of osimertinib with bevacizumab; the median LM OS was 12.6 months, and the one-year survival rate was 35.7%.

conclusionsOsimertinib combined with bevacizumab is an appropriate treatment option for patients with LM from EGFRm NSCLC. KEY POINTS: SIGNIFICANT FINDINGS OF THE STUDY: To date, there is no prospective clinical study on the treatment of osimertinib combined with bevacizumab in EGFRm NSCLC with LM. WHAT THIS STUDY ADDS: The median LM PFS was 9.3 months (95% CI: 8.2-10.4), and the LM ORR was 50%, the median LM OS was 12.6 months, and the one-year survival rate was 35.7%. Osimertinib combined with bevacizumab is an appropriate treatment option for patients with LM from EGFRm NSCLC.

Indexed as

AcrylamidesAgedAniline CompoundsBevacizumabCarcinoma, Non-Small-Cell LungFemaleHumansIndolesLung NeoplasmsMaleMeningeal CarcinomatosisMiddle AgedNeoplasm MetastasisProspective StudiesPyrimidinesSurvival RateAcrylamidesAniline CompoundsBevacizumabIndolesosimertinibPyrimidinesBevacizumabEGFR mutationleptomeningeal metastasisnon-small cell lung cancerosimertinib

Identifiers

PMID33205587
PMCPMC7812067
OpenAlexW3099381320

What OpenQuestion holds

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LicenceCC BY
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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.