Evidence map›Paper›PMID 30628188›Full record

Trial reportThoracic cancer2019

Phase II trial of a non-platinum triplet for patients with advanced non-small cell lung carcinoma (NSCLC) overexpressing ERCC1 messenger RNA.

Shinnosuke Takemoto, Yoichi Nakamura, Hiroshi Gyoutoku, Hiroaki Senju, Daiki Ogawara, Takaya Ikeda, Hiroyuki Yamaguchi, Takeshi Kitazaki, Hirofumi Nakano, Katsumi Nakatomi and 5 more

Open access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Thoracic cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.0field-weighted citation impact, top 22% 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

8 citing papers in PubMed, 9 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. MnTnHex-2-PyPAntioxidants (Basel, Switzerland) · 2022
    Article
  5. Article
  6. The Effect of the Kirsten Rat Sarcoma Viral Oncogene Homolog (Genetic testing and molecular biomarkers · 2022
    Article
  7. Review
  8. 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

15 authors at 9 institutions in 2 countries.

Shinnosuke TakemotoDepartment of Respiratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.ORCID 0000-0003-0373-0618
Yoichi NakamuraDivision of Thoracic Oncology, Tochigi Cancer Center, Utsunomiya, Japan.
Hiroshi GyoutokuDepartment of Respiratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
Hiroaki SenjuSecond Department of Medicine, Nagasaki University Hospital, Nagasaki, Japan.
Daiki OgawaraDepartment of Respiratory Medicine, Sasebo City General Hospital, Sasebo, Japan.
Takaya IkedaDepartment of Respiratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.ORCID 0000-0001-9585-1753
Hiroyuki YamaguchiDepartment of Cellular Signaling, The University of Tokyo, Tokyo, Japan.ORCID 0000-0002-9182-5694
Takeshi KitazakiDivision of Respiratory Diseases, Department of Internal Medicine, Japanese Red Cross Nagasaki Genbaku Hospital, Nagasaki, Japan.
Hirofumi NakanoRespiratory Medicine, Ureshino Medical Center, Ureshino, Japan.
Katsumi NakatomiDepartment of Respiratory Medicine, Nagasaki University Hospital, Nagasaki, Japan.
Shinya TomariRespiratory Medicine, Isahaya General Hospital, Isahaya, Japan.
Shuntaro SatoNagasaki University Hospital, Nagasaki, Japan.
Seiji NagashimaDepartment of Medicine, National Hospital Organization Nagasaki Medical Center, Nagasaki, Japan.
Minoru FukudaClinical Oncology Center, Nagasaki University Hospital, Nagasaki, Japan.ORCID 0000-0002-5321-1843
Hiroshi MukaeDepartment of Respiratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
Nagasaki University · JPNagasaki University Hospital · JPAsahi General Hospital · JPJapanese Red Cross Society, Japan · JPNagasaki Medical Center · JPSasebo City General Hospital · JPTochigi Cancer Center · JPToxicologie, Pharmacologie et Signalisation Cellulaire · FRUreshino Medical Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe prospectively evaluated the efficacy and toxicity of a non-platinum triplet regimen for patients with advanced non-small cell lung cancer (NSCLC) expected to be platinum-resistant.

methodsPatients were diagnosed with NSCLC using endobronchial ultrasonography with a guide sheath as a core biopsy. RNA was immediately isolated from unfixed biopsy specimens, and quantitative real-time reverse transcription-PCR assays were performed to determine ERCC1 messenger RNA expression. Patients with advanced, untreated NSCLC showing high ERCC1 levels (ΔCt ≧ 6.5) were assigned a non-platinum triplet regimen of irinotecan and paclitaxel plus bevacizumab. The primary end point was the objective response rate (ORR).

resultsA total of 141 untreated patients were evaluated and 30 patients were entered into this phase II trial. The ORR was 66.7% (95% confidence interval [CI] 47.2-82.7) and median progression-free survival (PFS) was 215 days. Grade 4 thrombosis occurred in one patient, but other toxicities were mild and controllable. Fifty-six patients were treated with platinum-containing regimens and 24 patients responded (ORR 42.8%, 95% CI 29.7-56.7). Twenty-nine of these patients had high ERCC1 levels, of which 6 patients responded; 27 patients had low ERCC1 levels, 18 patients responded (P = 0.0053 by Fisher's exact test).

conclusionThe triplet combination might be effective for patients with advanced, untreated NSCLC overexpressing ERCC1. ERCC1 messenger RNA levels may be a predictive factor for response to platinum-containing regimens.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBiomarkers, TumorCarcinoma, Non-Small-Cell LungDisease-Free SurvivalDNA-Binding ProteinsEndonucleasesFemaleHumansIrinotecanMaleMiddle AgedNeoplasm StagingPaclitaxelBevacizumabBiomarkers, TumorDNA-Binding ProteinsEndonucleasesERCC1 protein, humanIrinotecanPaclitaxelRNA, MessengerBevacizumabexcision repair cross-complementation group 1irinotecannon-small cell lung cancerpaclitaxel

Identifiers

PMID30628188
PMCPMC6397920
OpenAlexW2910641388

What OpenQuestion holds

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LicenceCC BY-NC
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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.