Evidence map›Paper›PMID 32315488›Full record

Trial reportClinical and translational science2020

Phase I/II Study of Erlotinib to Determine the Optimal Dose in Patients With Non-Small Cell Lung Cancer Harboring Only EGFR Mutations.

Yuichiro Takeda, Naoki Ishizuka, Kazumi Sano, Satoshi Hirano, Manabu Suzuki, Go Naka, Haruhito Sugiyama

Abstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Clinical and translational science, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Theranostics · 2024
    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

7 authors.

Yuichiro TakedaDepartment of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan.
Naoki IshizukaDepartment of Clinical Trial Planning and Management, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.
Kazumi SanoLaboratory of Drug Metabolism and Disposition, Meiji Pharmaceutical University, Tokyo, Japan.
Satoshi HiranoDepartment of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan.
Manabu SuzukiDepartment of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan.
Go NakaDepartment of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan.
Haruhito SugiyamaDepartment of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The recommended daily dose of erlotinib was determined for patients with all types of non-small cell lung cancer (NSCLC). We determined the optimal dose (OD) in patients with NSCLC harboring only epidermal growth factor receptor (EGFR) sensitizing mutations. EGFR-tyrosine kinase inhibitor-naïve patients with sensitizing mutations were eligible. Clinical OD was determined in a phase I/II study based on the continual re-assessment method (CRM) of both disease control and dose-limiting toxicity, defined as any toxicity of grade 2 (G2) or higher within 8 weeks. We also determined the pharmacologic OD via a pharmacokinetic (PK) study. Thirty-eight patients were enrolled. Clinical OD was 25 mg/day by the CRM. Median progression-free survival (mPFS) was 9.3 months. In receiver operating characteristic (ROC) analysis of mPFS, the trough concentration (

Indexed as

AgedAged, 80 and overCarcinoma, Non-Small-Cell LungDose-Response Relationship, DrugErbB ReceptorsErlotinib HydrochlorideFemaleHumansKaplan-Meier EstimateLung NeoplasmsMaleMiddle AgedMutationProgression-Free SurvivalProspective StudiesProtein Kinase InhibitorsEGFR protein, humanErbB ReceptorsErlotinib HydrochlorideProtein Kinase Inhibitors

Identifiers

PMID32315488
PMCPMC7719385

What OpenQuestion holds

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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.