Evidence map›Paper›PMID 35534642›Full record

Trial reportInternational journal of clinical oncology2022

Pembrolizumab in advanced NSCLC patients with poor performance status and high PD-L1 expression: OLCSG 1801.

Shinobu Hosokawa, Eiki Ichihara, Daijiro Harada, Shoichi Kuyama, Koji Inoue, Kenichi Gemba, Hirohisa Ichikawa, Yuka Kato, Naohiro Oda, Isao Oze and 8 more

Abstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in International journal of clinical oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed, 10 citations in OpenAlex.

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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

18 authors at 10 institutions in 1 country.

Shinobu HosokawaDepartment of Respiratory Medicine, Japanese Red Cross Okayama Hospital, Okayama, Japan.
Eiki IchiharaDepartment of Allergy and Respiratory Medicine, Okayama University Hospital, 2-5-1 Shikata-cho Kita-ku, Okayama City, Okayama, 700-8558, Japan. ichiha-e@md.okayama-u.ac.jp.ORCID http://orcid.org/0000-0002-2966-106X
Daijiro HaradaDepartment of Thoracic Oncology, NHO Shikoku Cancer Center, Matsuyama, Japan.
Shoichi KuyamaDepartment of Respiratory Medicine, NHO Iwakuni Clinical Center, Iwakuni, Japan.
Koji InoueDepartment of Respiratory Medicine, Ehime Prefectural Central Hospital, Matsuyama, Japan.
Kenichi GembaDepartment of Respiratory Medicine, Chugoku Central Hospital, Fukuyama, Japan.
Hirohisa IchikawaDepartment of Respiratory Medicine, KKR Takamatsu Hospital, Takamatsu, Japan.
Yuka KatoCenter for Innovative Clinical Medicine, Okayama University Hospital, Okayama, Japan.
Naohiro OdaDepartment of Respiratory Medicine, Fukuyama City Hospital, Fukuyama, Japan.
Isao OzeDivision of Cancer Epidemiology and Prevention, Department of Preventive Medicine, Aichi Cancer Center Research Institute, Nagoya, Japan.
Tomoki TamuraDepartment of Respiratory Medicine, NHO Iwakuni Clinical Center, Iwakuni, Japan.
Toshiyuki KozukiDepartment of Thoracic Oncology, NHO Shikoku Cancer Center, Matsuyama, Japan.
Takahiro UmenoDepartment of Respiratory Medicine, Japanese Red Cross Okayama Hospital, Okayama, Japan.
Toshio KuboCenter for Clinical Oncology, Okayama University Hospital, Okayama, Japan.
Katsuyuki HottaCenter for Innovative Clinical Medicine, Okayama University Hospital, Okayama, Japan.
Akihiro BesshoDepartment of Respiratory Medicine, Japanese Red Cross Okayama Hospital, Okayama, Japan.
Yoshinobu MaedaDepartment of Hematology and Oncology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan.
Katsuyuki KiuraDepartment of Allergy and Respiratory Medicine, Okayama University Hospital, 2-5-1 Shikata-cho Kita-ku, Okayama City, Okayama, 700-8558, Japan.
Okayama University Hospital · JPOkayama Red Cross General Hospital · JPIwakuni Medical Center · JPShikoku Cancer Center · JPAichi Cancer Center · JPChugoku Central Hospital · JPEhime Prefectural Central Hospital · JPFukuyama City Hospital · JPNational Hospital Organization Takamatsu Medical Center · JPOkayama University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe role of pembrolizumab in the treatment of poor performance status (PS) patients remains unclear. PATIENTS AND

methodsWe conducted a phase II trial to investigate the efficacy and safety of pembrolizumab as first-line therapy for non-small-cell lung cancer (NSCLC) patients with PSs of 2-3 and programmed cell death ligand 1 (PD-L1) expression ≥ 50%. The primary endpoint of this study was the objective response rate (ORR).

resultsFourteen patients treated at eight institutions were enrolled. Most patients had PS 2 (12/14; 86%) and others had PS 3 (2/14; 14%). The ORR was 57.1% (95% confidence interval 28.9-82.3%), which met the primary endpoint. The median progression-free survival (PFS) and 1-year PFS rates were 5.8 months and 20.0%, respectively. At the time of data cut-off, one patient had received treatment for more than 1 year; another patient had received treatment for more than 2 years. Nine patients had improved PS with treatment (Wilcoxon signed-rank test, p = 0.003). Two patients had immune-related adverse events ≥ grade 3: grades 5 and 3 elevation in alanine and aspartate aminotransferases. Two PS 3-stage patients were diagnosed with clinically progressive disease prior to initial computed tomography; both died within 2 months.

conclusionPembrolizumab was effective for the treatment of NSCLC patients with a poor PS and PD-L1 level ≥ 50%. However, given the poor outcomes of the PS 3 patients, the drug is not indicated for such patients. Adverse events, including liver dysfunction, should be carefully monitored. REGISTRATION ID: UMIN000030955.

Indexed as

Antibodies, Monoclonal, HumanizedCarcinoma, Non-Small-Cell LungLung NeoplasmsB7-H1 AntigenHumansAntibodies, Monoclonal, HumanizedB7-H1 AntigenpembrolizumabImmune checkpoint inhibitorNSCLCPD-L1PembrolizumabPerformance status

Identifiers

PMID35534642
OpenAlexW4229456179

What OpenQuestion holds

Textmetadata
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.