Evidence map›Paper›PMID 32629391›Full record

Trial reportEBioMedicine2020

Evaluation of plasma EGFR mutation as an early predictor of response of erlotinib plus bevacizumab treatment in the NEJ026 study.

Tatsuro Fukuhara, Haruhiro Saito, Naoki Furuya, Kana Watanabe, Shunichi Sugawara, Shunichiro Iwasawa, Yoshio Tsunezuka, Ou Yamaguchi, Prof Morihito Okada, Kozo Yoshimori and 15 more

Open access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in EBioMedicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 3 pooled it
2.8field-weighted citation impact, top 7% 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

25 citing papers in PubMed, 3 syntheses or guidelines pooled it, 28 citations in OpenAlex.

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  15. Liquid biopsies, are we ready for prime time?Journal for immunotherapy of cancer · 2023
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  17. Dynamic Assessment of Tissue and PlasmaInternational journal of molecular sciences · 2022
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

25 authors at 20 institutions in 1 country.

Tatsuro FukuharaMiyagi Cancer Center, Natori, Japan.
Haruhiro SaitoKanagawa Cancer Center, Yokohama, Japan.
Naoki FuruyaSt. Marianna University School of Medicine, Kawasaki, Japan.
Kana WatanabeMiyagi Cancer Center, Natori, Japan.
Shunichi SugawaraSendai Kousei Hospital, Sendai, Japan.
Shunichiro IwasawaChiba University, Chiba, Japan.
Yoshio TsunezukaIshikawa Prefectural Central Hospital, Kanazawa, Japan.
Ou YamaguchiSaitama Medical University International Medical Center, Hidaka, Japan.
Prof Morihito OkadaHiroshima University Hospital, Hiroshima, Japan.
Kozo YoshimoriFukujuji Hospital, Tokyo, Japan.
Ichiro NakachiSaiseikai Utsunomiya Hospital, Utsunomiya, Japan.
Prof Akihiko GemmaNippon Medical School, Tokyo, Japan.
Koichi AzumaKurume University, Kurume, Japan.
Futoshi KurimotoSaitama Cancer Center, Ina, Japan.
Yukari TsubataShimane University, Shimane, Japan.
Yuka FujitaNational Hospital Organization Asahikawa Medical Center, Asahikawa, Japan.
Hiromi NagashimaDivision of Pulmonary Medicine, Allergy, and Rheumatology, Department of Internal Medicine, Iwate Medical University School of Medicine, 2-1-1, Idaidori, Yahaba-cho, Shiwa-gun, Iwate 028-3695, Japan.
Gyo AsaiOkazaki City Hospital, Okazaki, Japan.
Satoshi WatanabeNiigata University Medical and Dental Hospital, Niigata, Japan.
Masaki MiyazakiSuita Municipal Hospital, Suita, Japan.
Prof Koichi HagiwaraJichi Medical University, Shimotsuke, Japan.
Prof Toshihiro NukiwaTohoku University, Sendai, Japan.
Prof Satoshi MoritaKyoto University, Kyoto, Japan.
Prof Kunihiko KobayashiSaitama Medical University International Medical Center, Hidaka, Japan.
Prof Makoto MaemondoDivision of Pulmonary Medicine, Allergy, and Rheumatology, Department of Internal Medicine, Iwate Medical University School of Medicine, 2-1-1, Idaidori, Yahaba-cho, Shiwa-gun, Iwate 028-3695, Japan. Electronic address: maemondo-ma693@aioros.ocn.ne.jp.
Iwate Medical University · JPMiyagi Prefectural Hospital Organization · JPSaitama Medical University · JPAsahikawa Medical University · JPChiba University · JPFukujuji Hospital · JPHiroshima University Hospital · JPIshikawa Prefectural Central Hospital · JPJichi Medical University · JPKanagawa Prefectural Hospital Organization · JPKurume University · JPKyoto University · JPNiigata University Medical and Dental Hospital · JPNippon Medical School · JPOkazaki City Hospital · JPSaiseikai Utsunomiya hospital · JPSaitama Cancer Center · JPSendai Kousei Hospital · JPShimane University · JPSt. Marianna University School of Medicine · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe NEJ026 Phase 3 study demonstrated that erlotinib and bevacizumab (BE)-treated NSCLC patients with EGFR mutations had significantly better progression-free survival (PFS) than those treated with erlotinib alone (E). This study included a prospective analysis of the relationship between the mutational status of EGFR in plasma circulating tumor DNA (ctDNA) and the efficacy of TKI monotherapy or combination therapy. We describe these results herein.

methodsPlasma samples were collected from patients enrolled in NEJ026 at the start of treatment (P0), 6 weeks after the start of treatment (P1), and upon confirmation of progressive disease (P2). Plasma ctDNA was analyzed using a modified PNA-LNA PCR clamp method. PFS and OS according to EGFR status at the time of plasma collection were evaluated.

findingsPlasma activating EGFR mutation (aEGFR) at P0 was detected in 68% of cases; patients without plasma aEGFR had longer PFS. The frequency of T790M mutation at P2 was similar in both arms: 8 (19.0%) in BE and 11 (20.8%) in E. Based on the aEGFR profiles, PFS was evaluated among three groups: type A [P0(-), P1(-)], type B [P0(+), P1(-)], and type C [P0(+), P1(+)]. This revealed that BE was more efficacious than E, and that BE was associated with improved PFS in all types.

interpretationPre-treatment plasma aEGFR status have a potential of early predictor of response of TKI efficacy. Monitoring plasma aEGFR mutation will contribute to selection and continuation of treatment with BE or E.

fundingChugai Pharmaceutical.

Indexed as

AgedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabDrug Resistance, NeoplasmErbB ReceptorsErlotinib HydrochlorideFemaleHumansLung NeoplasmsMaleMiddle AgedMutationProgression-Free SurvivalProtein Kinase InhibitorsBevacizumabEGFR protein, humanErbB ReceptorsErlotinib HydrochlorideProtein Kinase Inhibitors

Identifiers

PMID32629391
PMCPMC7334809
OpenAlexW3040127550

What OpenQuestion holds

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LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.