Evidence map›Paper›PMID 37760942›Full record

ArticleBiomedicines2023

A Prospective Cohort Study Assessing the Relationship between Plasma Levels of Osimertinib and Treatment Efficacy and Safety.

Tatsuro Fukuhara, Kazuhiro Imai, Taku Nakagawa, Ryotaro Igusa, Hayato Yokota, Kana Watanabe, Aya Suzuki, Mami Morita, Ren Onodera, Akira Inoue and 3 more

Abstract read
In one paragraph

Article in Biomedicines, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–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

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. 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

13 authors.

Tatsuro FukuharaDepartment of Respiratory Medicine, Miyagi Cancer Center, Natori 981-1239, Japan.ORCID 0000-0003-0440-470X
Kazuhiro ImaiDepartment of Thoracic Surgery, Akita University Graduate School of Medicine, Akita 010-8543, Japan.ORCID 0000-0003-4490-7862
Taku NakagawaDepartment of Thoracic Surgery, Omagari Kosei Medical Center, Daisen 014-0027, Japan.
Ryotaro IgusaDepartment of Respiratory Medicine, Osaki Citizen Hospital, Osaki 989-6136, Japan.
Hayato YokotaDepartment of Pharmacy, Akita University Hospital, Akita 010-8543, Japan.ORCID 0000-0003-1389-435X
Kana WatanabeDepartment of Respiratory Medicine, Miyagi Cancer Center, Natori 981-1239, Japan.
Aya SuzukiDepartment of Respiratory Medicine, Miyagi Cancer Center, Natori 981-1239, Japan.
Mami MoritaDepartment of Respiratory Medicine, Miyagi Cancer Center, Natori 981-1239, Japan.
Ren OnoderaDivision of Pulmonary Medicine, Department of Internal Medicine, Iwate Medical University School of Medicine, Yahaba 028-3694, Japan.
Akira InoueDepartment of Palliative Medicine, Tohoku University Graduate School of Medicine, Sendai 980-8575, Japan.
Masatomo MiuraDepartment of Pharmacokinetics, Akita University Graduate School of Medicine, Akita 010-8543, Japan.ORCID 0000-0001-7120-2425
Yoshihiro MinamiyaDepartment of Thoracic Surgery, Akita University Graduate School of Medicine, Akita 010-8543, Japan.
Makoto MaemondoDivision of Pulmonary Medicine, Department of Medicine, Jichi Medial University, Shimotsuke 329-0498, Japan.ORCID 0000-0002-1950-1943

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Osimertinib is a standard treatment for patients with EGFR-mutated non-small cell lung carcinoma (NSCLC). We evaluated the relationship between plasma osimertinib concentrations and treatment outcome in patients with NSCLC for this cohort study. The plasma levels of osimertinib and its metabolite AZ5104 were measured a week after the start of treatment (P1). The primary endpoint was to evaluate the correlation between plasma concentration and adverse events (AEs). The correlation with treatment efficacy was one of the secondary endpoints. In patients with CNS metastases, the concentration in the cerebrospinal fluid was also measured. Forty-one patients were enrolled. The frequency of AEs was highest for rash, followed by anorexia and thrombocytopenia. Thirty-eight cases provided measurements for P1. The median plasma concentration of osimertinib was 227 ng/mL, and that of AZ5104 was 16.5 ng/mL. The mean CNS penetration rate of two cases was 3.8%. The P1 in the group with anorexia was significantly higher than that in the group without anorexia (385.0 ng/mL vs. 231.5 ng/mL,

Indexed as

EGFRnon-small cell lung cancerosimertinibtrough level

Identifiers

PMID37760942
PMCPMC10526408

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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.