Evidence map›Paper›PMID 34830983›Full record

ArticleCancers2021

Safety of COVID-19 mRNA Vaccines in Patients with Cancer Enrolled in Early-Phase Clinical Trials.

Pamela Trillo Aliaga, Dario Trapani, José Luis Sandoval, Edoardo Crimini, Gabriele Antonarelli, Grazia Vivanet, Stefania Morganti, Chiara Corti, Paolo Tarantino, Alex Friedlaender and 6 more

Open access · goldAbstract read
In one paragraph

Article in Cancers, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.7field-weighted citation impact, top 26% 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

7 citing papers in PubMed, 12 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

16 authors at 3 institutions in 2 countries.

Pamela Trillo AliagaDivision of New Drugs and Early Drug Development, European Institute of Oncology IRCCS, 20141 Milan, Italy.
Dario TrapaniDivision of New Drugs and Early Drug Development, European Institute of Oncology IRCCS, 20141 Milan, Italy.
José Luis SandovalUnit of Population Epidemiology, Division and Department of Primary Care Medicine, Geneva University Hospitals, 1205 Geneva, Switzerland.ORCID 0000-0002-6256-7083
Edoardo CriminiDivision of New Drugs and Early Drug Development, European Institute of Oncology IRCCS, 20141 Milan, Italy.
Gabriele AntonarelliDivision of New Drugs and Early Drug Development, European Institute of Oncology IRCCS, 20141 Milan, Italy.ORCID 0000-0002-9758-3665
Grazia VivanetDivision of New Drugs and Early Drug Development, European Institute of Oncology IRCCS, 20141 Milan, Italy.
Stefania MorgantiDivision of New Drugs and Early Drug Development, European Institute of Oncology IRCCS, 20141 Milan, Italy.
Chiara CortiDivision of New Drugs and Early Drug Development, European Institute of Oncology IRCCS, 20141 Milan, Italy.ORCID 0000-0002-0359-0267
Paolo TarantinoDivision of New Drugs and Early Drug Development, European Institute of Oncology IRCCS, 20141 Milan, Italy.ORCID 0000-0001-8686-0228
Alex FriedlaenderDepartment of Oncology, Geneva University Hospitals, 1205 Geneva, Switzerland.
Carmen BelliDivision of New Drugs and Early Drug Development, European Institute of Oncology IRCCS, 20141 Milan, Italy.ORCID 0000-0001-7067-7496
Ida MinchellaDivision of New Drugs and Early Drug Development, European Institute of Oncology IRCCS, 20141 Milan, Italy.
Marzia LocatelliDivision of New Drugs and Early Drug Development, European Institute of Oncology IRCCS, 20141 Milan, Italy.
Angela EspositoDivision of New Drugs and Early Drug Development, European Institute of Oncology IRCCS, 20141 Milan, Italy.
Carmen CriscitielloDivision of New Drugs and Early Drug Development, European Institute of Oncology IRCCS, 20141 Milan, Italy.ORCID 0000-0001-9064-0113
Giuseppe CuriglianoDivision of New Drugs and Early Drug Development, European Institute of Oncology IRCCS, 20141 Milan, Italy.ORCID 0000-0003-1781-2518
University of Milan · ITEuropean Institute of Oncology · ITUniversity Hospital of Geneva · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Pivotal trials of COVID-19 vaccines did not include cancer patients, with questions remaining about their safety and efficacy in this population. Patients enrolled in early-phase clinical trials receive novel treatments with unknown efficacy and safety profiles. Studies on the safety of COVID-19 vaccines in these patients are urgently required. This is a retrospective, real-world, cohort study of patients receiving anticancer treatments and COVID-19 vaccines between 1 February and 25 June 2021 at the Division of New Drugs Development for Innovative Therapies of the European Institute of Oncology. One hundred thirteen patients were enrolled, 40 in early-phase clinical trials, and 20 under novel immunotherapy agents. Nearly three-quarters of the patients experienced at least one adverse event (AE) after the first dose (1D) (74.3%) and second dose (2D) (72.6%). Most of the AEs were local (67.3% 1D and 61.9% after 2D), while 31.8% (1D) and 38.1% (2D) of the patients had systemic AEs. No AEs above grade 2 were observed. Therefore, COVID-19 vaccines appear to be safe in patients enrolled in early-phase clinical trials, including patients receiving novel immunotherapy compounds. All cancer patients should be prioritized for COVID-19 vaccination, regardless of ongoing treatments or enrollment in early-phase trials.

Indexed as

COVID-19COVID-19 vaccineCOVID and cancerearly-phase clinical trialsnovel immunotherapyphase one trialSARS-CoV-2solid tumorstargeted therapy

Identifiers

PMID34830983
PMCPMC8616209
OpenAlexW3215897431

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.