Evidence map›Paper›PMID 36522630›Full record

ArticleBMC cancer2022

Rationale and protocol design of a phase II study of first-line osimertinib treatment for patients with poor performance status and EGFR mutation-positive non-small cell lung cancer (OPEN/TORG2040).

Tomoya Fukui, Jiichiro Sasaki, Satoshi Igawa, Akiko Kada, Toshiki I Saito, Yoshihito Kogure, Hiroaki Okamoto, Katsuhiko Naoki

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 39% 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

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Review
  2. 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

8 authors at 3 institutions in 1 country.

Tomoya FukuiDepartment of Respiratory Medicine, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0374, Japan. tofukui@med.kitasato-u.ac.jp.ORCID http://orcid.org/0000-0003-4814-4401
Jiichiro SasakiResearch and Development Center for New Medical Frontiers, Kitasato University School of Medicine, Kanagawa, Japan.
Satoshi IgawaDepartment of Respiratory Medicine, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0374, Japan.
Akiko KadaClinical Research Center, National Hospital Organization Nagoya Medical Center, Aichi, Japan.
Toshiki I SaitoClinical Research Center, National Hospital Organization Nagoya Medical Center, Aichi, Japan.
Yoshihito KogureDepartment of Respiratory Medicine, National Hospital Organization Nagoya Medical Center, Aichi, Japan.
Hiroaki OkamotoDepartment of Respiratory Medicine and Medical Oncology, Yokohama Municipal Citizen's Hospital, Kanagawa, Japan.
Katsuhiko NaokiDepartment of Respiratory Medicine, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0374, Japan.
Kitasato University · JPNational Hospital Organization · JPYokohama Municipal Citizen's Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCancer chemotherapy indications for patients with poor performance status and advanced lung cancer are limited. Molecular targeted drugs, including epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors, can be used in patients with poor performance status owing to their high efficacy and safety. The third-generation EGFR-tyrosine kinase inhibitor osimertinib has demonstrated effectiveness in the initial treatment of advanced EGFR mutation-positive non-small cell lung cancer in patients with good performance status; however, no evidence exists of the drug's effectiveness in patients with poor performance status in a prospective study. We designed a study that aims to investigate the efficacy and safety of first-line osimertinib treatment in patients with advanced non-small cell lung cancer harboring sensitive EGFR mutations and with poor performance status.

methodsThe OPEN/TORG2040 study is a multicenter, single-arm, phase II trial for patients with unresectable, advanced EGFR mutation-positive non-small cell lung cancer with a poor performance status (≥ 2). Eligible patients will receive osimertinib until disease progression or unacceptable toxicity. The primary endpoint is the objective response rate of the first-line osimertinib treatment. Considering a threshold value of 45%, expected value of 70% for objective response rate, one-sided significance level of 5%, statistical power of 80%, and ineligible patients, the sample size was set to 30. The secondary endpoints are disease control rate, performance status improvement rate, and safety and patient-reported outcomes using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core Quality of Life Questionnaire and Lung Cancer 13. Time to treatment failure, progression-free survival, and overall survival will also be assessed. DISCUSSION: Our study can determine the clinical benefits of osimertinib treatment in patients with poor performance status, since the clinical outcomes of patients with EGFR mutation-positive non-small cell lung cancer with poor performance status treated with this drug as a first-line treatment have not been sufficiently evaluated.

trial registrationJapan Registry of Clinical Trials: jRCTs041200100 (registration date: February 12, 2021).

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsAcrylamidesAniline CompoundsClinical Trials, Phase II as TopicErbB ReceptorsHumansIndolesMulticenter Studies as TopicMutationProspective StudiesProtein Kinase InhibitorsPyrimidinesQuality of LifeAcrylamidesAniline CompoundsEGFR protein, humanErbB ReceptorsIndolesosimertinibProtein Kinase InhibitorsPyrimidinesEpidermal growth factor receptorFirst-line chemotherapyNon-small cell lung cancerOsimertinibPoor performance status

Identifiers

PMID36522630
PMCPMC9753257
OpenAlexW4311934306

What OpenQuestion holds

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LicenceCC BY
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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.