Evidence map›Paper›PMID 36451343›Full record

Trial reportCancer2023

A randomized Phase 2 study to compare erlotinib with or without bevacizumab in previously untreated patients with advanced non-small cell lung cancer with EGFR mutation.

Youngjoo Lee, Hye Ryun Kim, Min Hee Hong, Ki Hyeong Lee, Keon Uk Park, Geon Kook Lee, Hyae Young Kim, Soo-Hyun Lee, Kun Young Lim, Sung Jin Yoon and 2 more

Open access · hybridAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase II
In one paragraph

Trial report in Cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 5 pooled it
2.6field-weighted citation impact, top 9% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 5 syntheses or guidelines pooled it, 20 citations in OpenAlex.

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  19. Targeting of endothelial cells in brain tumours.Clinical and translational medicine · 2023
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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

12 authors at 4 institutions in 1 country.

Youngjoo LeeCenter for Lung Cancer, National Cancer Center, Goyang, Republic of Korea.ORCID 0000-0003-0180-189X
Hye Ryun KimDivision of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea.
Min Hee HongDivision of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea.ORCID 0000-0003-3490-2195
Ki Hyeong LeeDepartment of Internal Medicine, Chungbuk National University Hospital, Cheongju, Republic of Korea.
Keon Uk ParkDepartment of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, Republic of Korea.ORCID 0000-0002-6902-7063
Geon Kook LeeDepartment of Pathology, National Cancer Center, Goyang, Republic of Korea.
Hyae Young KimDepartment of Radiology, National Cancer Center, Goyang, Republic of Korea.
Soo-Hyun LeeDepartment of Radiology, National Cancer Center, Goyang, Republic of Korea.
Kun Young LimDepartment of Radiology, National Cancer Center, Goyang, Republic of Korea.
Sung Jin YoonCenter for Lung Cancer, National Cancer Center, Goyang, Republic of Korea.
Byoung Chul ChoDivision of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea.
Ji-Youn HanCenter for Lung Cancer, National Cancer Center, Goyang, Republic of Korea.
National Cancer Center · KRYonsei University · KRChungbuk National University Hospital · KRKeimyung University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study evaluated whether an addition of bevacizumab to erlotinib improves clinical outcomes in patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC).

methodsThis is an open-label, multicenter, randomized Phase 2 study in South Korea. Chemonaïve patients with Stage IIIB/IV NSCLC with EGFR 19 deletion or L858R mutation were eligible. Asymptomatic brain metastasis (BM) was enrolled without local treatment. Patients received either erlotinib plus bevacizumab or erlotinib.

resultsBetween December 2016 and March 2019, 127 patients were randomly assigned to receive erlotinib plus bevacizumab (n = 64) or erlotinib (n = 63). Fifty-nine (46.5%) patients had baseline BM. Fewer patients in the erlotinib plus bevacizumab arm received radiotherapy for BM than in the erlotinib arm (10.3% vs. 40.0%). A trend toward longer progression-free survival (PFS) was observed in the erlotinib plus bevacizumab arm compared with the erlotinib alone arm; however, it was not statistically significant (median PFS, 17.5 months vs. 12.4 months; hazard ratio [HR], 0.74; 95% CI, 0.51-1.08; p = .119). The unplanned subgroup analysis showed a longer PFS with erlotinib plus bevacizumab in patients with BM (median PFS, 18.6 months vs. 10.3 months; HR, 0.54; 95% CI, 0.31-0.95; p = .032). Grade 3 or worse adverse events occurred in 56.6% of the erlotinib plus bevacizumab arm and 20.6% of the erlotinib arm.

conclusionsAlthough it was not statistically significant, a trend to improvement in PFS was observed in patients with erlotinib plus bevacizumab compared to erlotinib alone. PLAIN LANGUAGE SUMMARY: A randomized Phase 2 study compared erlotinib with or without bevacizumab in previously untreated patients with advanced non-small cell lung cancer with EGFR mutation. The erlotinib plus bevacizumab failed to improve median progression-free survival compared with the erlotinib alone. However, the progression-free survival benefit from erlotinib plus bevacizumab was found in patients with brain metastasis with no severe hemorrhagic adverse effects.

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsBevacizumabDisease-Free SurvivalErbB ReceptorsErlotinib HydrochlorideHumansMutationProtein Kinase InhibitorsBevacizumabEGFR protein, humanErbB ReceptorsErlotinib HydrochlorideProtein Kinase Inhibitorsanti-angiogenesisbrain metastasisEGFR mutationnonsmall cell lung cancertargeted therapy

Identifiers

PMID36451343
PMCPMC10100207
OpenAlexW4310573171

What OpenQuestion holds

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Registered trials

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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.