Evidence map›Paper›PMID 35752437›Full record

Observational studyJournal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer2022

Safety and Immunogenicity of mRNA Vaccines Against Severe Acute Respiratory Syndrome Coronavirus 2 in Patients With Lung Cancer Receiving Immune Checkpoint Inhibitors: A Multicenter Observational Study in Japan.

Makoto Hibino, Kiyoaki Uryu, Takayuki Takeda, Yusuke Kunimatsu, Shinsuke Shiotsu, Junji Uchino, Soichi Hirai, Tadaaki Yamada, Asuka Okada, Yoshikazu Hasegawa and 8 more

Open access · bronzeAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
2.1field-weighted citation impact, top 11% 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

11 citing papers in PubMed, 22 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 8 institutions in 1 country.

Makoto HibinoDepartment of Respiratory Medicine, Shonan Fujisawa Tokushukai Hospital, Kanagawa, Japan. Electronic address: m-hibino@ctmc.jp.
Kiyoaki UryuDepartment of Respiratory Medicine, Yao Tokushukai General Hospital, Osaka, Japan.
Takayuki TakedaDepartment of Respiratory Medicine, Japanese Red Cross Kyoto Daini Hospital, Kyoto, Japan.
Yusuke KunimatsuDepartment of Respiratory Medicine, Japanese Red Cross Kyoto Daini Hospital, Kyoto, Japan.
Shinsuke ShiotsuDepartment of Respiratory Medicine, Japanese Red Cross Kyoto Daiichi Hospital, Kyoto, Japan.
Junji UchinoDepartment of Pulmonary Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Soichi HiraiDepartment of Pulmonary Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Tadaaki YamadaDepartment of Pulmonary Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Asuka OkadaDepartment of Respiratory Medicine, Saiseikai Suita Hospital, Osaka, Japan.
Yoshikazu HasegawaDepartment of Medical Oncology, Izumi City General Hospital, Osaka, Japan.
Osamu HiranumaDepartment of Pulmonary Medicine, Otsu City Hospital, Shiga, Japan.
Yusuke ChiharaDepartment of Respiratory Medicine, Uji Tokushukai Medical Center, Kyoto, Japan.
Riko KamadaDepartment of Respiratory Medicine, Shonan Fujisawa Tokushukai Hospital, Kanagawa, Japan.
Shunichi TobeDepartment of Respiratory Medicine, Shonan Fujisawa Tokushukai Hospital, Kanagawa, Japan.
Kazunari MaedaDepartment of Respiratory Medicine, Shonan Fujisawa Tokushukai Hospital, Kanagawa, Japan.
Shigeto HoriuchiDepartment of Respiratory Medicine, Shonan Fujisawa Tokushukai Hospital, Kanagawa, Japan.
Tetsuri KondoDepartment of Respiratory Medicine, Shonan Fujisawa Tokushukai Hospital, Kanagawa, Japan.
Koichi TakayamaDepartment of Pulmonary Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Yokufukai Hospital · JPKyoto Prefectural University of Medicine · JPJapanese Red Cross Society Kyoto Daini Hospital · JPIzumi City General Hospital · JPKyoto first Red Cross hospital · JPOtsu Municipal Hospital · JPSaiseikai Suita Hospital · JPYao Tokushukai General Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPatients with cancer have been prioritized for vaccination against severe acute respiratory syndrome coronavirus 2. Nevertheless, there are limited data regarding the safety, efficacy, and risk of developing immune-related adverse events (irAEs) associated with mRNA vaccines in patients with lung cancer, especially those being actively treated with immune checkpoint inhibitors.

methodsThis multicenter observational study was conducted at nine hospitals in Japan. Patients with lung cancer (≥20 y) actively treated with immune checkpoint inhibitors between 4 weeks prefirst vaccination and 4 weeks postsecond vaccination were enrolled. The primary end point was the incidence of irAEs of any grade on the basis of an assumed incidence without vaccination rate of 35%. Immunogenicity was assessed by measuring anti-spike (S)-IgG antibody levels against severe acute respiratory syndrome coronavirus 2.

resultsA total of 126 patients with lung cancer (median age, 71 y; interquartile range, 65-74) were enrolled from May to November 2021 and followed up until December 2021. There were 26 patients (20.6%, 95% confidence interval: 13.9%-28.8%) and seven patients (5.6%, 95% confidence interval: 2.3%-11.1%) who developed irAEs of any grade pre- and postvaccination, respectively, which was lower than the predicted incidence without vaccination. None of the patients experienced exacerbation of preexisting irAE postvaccination. S-IgG antibodies were seroconverted in 96.7% and 100% of the patients with lung cancer and controls, respectively, but antibody levels were significantly lower in patients with lung cancer (p < 0.001).

conclusionsPatients with lung cancer who were actively treated with ICIs were safely vaccinated without an increased incidence of irAEs; however, their vaccine immunogenicity was lower. This requires further evaluation.

Indexed as

COVID-19Lung NeoplasmsAgedHumansImmune Checkpoint InhibitorsJapanmRNA VaccinesSARS-CoV-2Vaccines, SyntheticImmune Checkpoint InhibitorsmRNA VaccinesVaccines, SyntheticCOVID-19Immune checkpoint inhibitorImmune-related adverse eventImmunoglobulinSARS-CoV-2

Identifiers

PMID35752437
PMCPMC9220466
OpenAlexW4283315173

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.