Evidence map›Paper›PMID 35488720›Full record

Trial reportThoracic cancer2022

Phase 2 study of first-line pembrolizumab monotherapy in elderly patients with non-small-cell lung cancer expressing high PD-L1.

Takeshi Masuda, Kazunori Fujitaka, Tomoko Suzuki, Kosuke Hamai, Naoko Matsumoto, Mirai Matsumura, Shoko Isoyama, Sayaka Ueno, Mineyo Mito, Kakuhiro Yamaguchi and 7 more

Open access · goldAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Thoracic cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 3 pooled it
0.7field-weighted citation impact, top 29% 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

9 citing papers in PubMed, 3 syntheses or guidelines pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Article
  6. Article
  7. Review
  8. Review
  9. 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

17 authors at 6 institutions in 1 country.

Takeshi MasudaDepartment of Respiratory Medicine, Hiroshima University Hospital, Hiroshima, Japan.ORCID 0000-0003-3557-0049
Kazunori FujitakaDepartment of Respiratory Medicine, Hiroshima University Hospital, Hiroshima, Japan.
Tomoko SuzukiDepartment of Respiratory Internal Medicine, JA Onomichi General Hospital, Hiroshima, Japan.
Kosuke HamaiDepartment of Respiratory Medicine, Hiroshima Prefectural Hospital, Hiroshima, Japan.ORCID 0000-0002-8654-5532
Naoko MatsumotoDepartment of Respiratory Internal Medicine, Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital, Hiroshima, Japan.
Mirai MatsumuraDepartment of Respiratory Medicine, Hiroshima University Hospital, Hiroshima, Japan.
Shoko IsoyamaDepartment of Respiratory Medicine, Hiroshima University Hospital, Hiroshima, Japan.
Sayaka UenoDepartment of Respiratory Medicine, Hiroshima Prefectural Hospital, Hiroshima, Japan.
Mineyo MitoDepartment of Respiratory Internal Medicine, Kure Medical Center, Hiroshima, Japan.
Kakuhiro YamaguchiDepartment of Respiratory Medicine, Hiroshima University Hospital, Hiroshima, Japan.ORCID 0000-0002-9117-1934
Shinjiro SakamotoDepartment of Respiratory Medicine, Hiroshima University Hospital, Hiroshima, Japan.
Reo KawanoDepartment of Clinical Research Center in Hiroshima, Hiroshima University Hospital, Hiroshima, Japan.
Ken MasudaDepartment of Respiratory Internal Medicine, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan.
Ryohei NishinoDepartment of Respiratory Internal Medicine, Hiroshima City Asa Citizens Hospital, Hiroshima, Japan.
Nobuhisa IshikawaDepartment of Respiratory Medicine, Hiroshima Prefectural Hospital, Hiroshima, Japan.ORCID 0000-0002-0208-2180
Masahiro YamasakiDepartment of Respiratory Internal Medicine, Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital, Hiroshima, Japan.
Noboru HattoriDepartment of Respiratory Medicine, Hiroshima University Hospital, Hiroshima, Japan.
Hiroshima University Hospital · JPHiroshima Prefectural Hospital · JPHiroshima City Asa Citizens Hospital · JPHiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital · JPKure Medical Center · JPOnomichi General Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPembrolizumab is the recommended first-line therapy for patients with advanced non-small-cell lung cancer (NSCLC) and a programmed death ligand-1 (PD-L1) tumor proportion score (TPS) of ≥50% without driver mutations. However, its efficacy and safety for patients ≥75 years have not been prospectively investigated; this was the aim of this study.

methodsThis multicenter and open-label single-arm phase II study was conducted at 12 institutions. Chemotherapy-naïve patients with advanced NSCLC and a PD-L1 TPS of ≥50% without EGFR mutations or translocation of the ALK received pembrolizumab every 3 weeks. The primary endpoint was progression-free survival (PFS) with a threshold of 4.3 months. The secondary endpoints were overall survival (OS), objective response rate (ORR), disease control rate (DCR), safety, and quality of life.

resultsTwenty-six patients were enrolled between October 2017 and March 2020. The median PFS was 9.6 (95% confidence interval [CI] 2.1-20.6) months. The lower limit of the 95% CI did not exceed the target. The median OS was 21.6 months. The ORR and DCR were 41.7% and 70.8%, respectively. The proportion of patients with grade ≥3 treatment-related adverse events was 15.4%. The quality of life score did not change significantly during treatment.

conclusionWhile this study showed that pembrolizumab was a tolerable treatment for elderly patients, the safety requires further confirmation in a larger study. Although the primary endpoint, the median PFS (9.6 months), was slightly shorter than that (10.3 months) of the previous phase III study (KEYNOTE-024 study), the median PFS did not achieve the expected value.

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsAgedAntibodies, Monoclonal, HumanizedB7-H1 AntigenHumansQuality of LifeAntibodies, Monoclonal, HumanizedB7-H1 AntigenCD274 protein, humanpembrolizumabelderly patientsnon-small-cell lung cancerpembrolizumabprogrammed death ligand-1

Identifiers

PMID35488720
PMCPMC9161325
OpenAlexW4225141849

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.