Evidence map›Paper›PMID 34789537›Full record

Trial reportCancer discovery2022

Fasting-Mimicking Diet Is Safe and Reshapes Metabolism and Antitumor Immunity in Patients with Cancer.

Claudio Vernieri, Giovanni Fucà, Francesca Ligorio, Veronica Huber, Andrea Vingiani, Fabio Iannelli, Alessandra Raimondi, Darawan Rinchai, Gianmaria Frigè, Antonino Belfiore and 29 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial
In one paragraph

Trial report in Cancer discovery, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 192 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
192citing papers in PubMed, 3 pooled it
24.7field-weighted citation impact, top 1% 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.

NCT05703997 phase2not yet recruitingnot on this mapstarted 2023, after this paper: background citation

FASTing-like Approach to Improve the Efficacy of Maintenance IMMunotherapy in Extensive-stage Small Cell Lung Cancer Patients Not Progressing on Chemoimmunotherapy Induction: the FASTIMMUNE Trial

TypeinterventionalSponsorFondazione IRCCS Istituto Nazionale dei Tumori, MilanoRan2023 to 2029Enrolled20ConditionsSmall Cell Lung CarcinomaArmsCyclic, 5-day calorie restriction, Atezolizumab
NCT05763992 phase2unknown statusnot on this mapstarted 2023, after this paper: background citation

Targeting Triple Negative BREAst Cancer Metabolism With a Combination of Chemoimmunotherapy and a FASTing-like Approach in the Preoperative Setting: the BREAKFAST 2 Trial

TypeinterventionalSponsorFondazione IRCCS Istituto Nazionale dei Tumori, MilanoRan2023 to 2026Enrolled145ConditionsBreast Cancer, Triple Negative Breast Cancer, Dietary Exposure, FastingArmsControl diet (ARM A) or Fasting-Like Approach (FLA, ARM B)
3 · Its place in the literature

Who cites it

192 citing papers in PubMed, 3 syntheses or guidelines pooled it, 288 citations in OpenAlex.

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  15. Autophagy modulation in cancer.Nature reviews. Drug discovery · 2026
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132 more citing papers are in PubMed but not listed here.

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

39 authors at 9 institutions in 3 countries.

Claudio VernieriMedical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. claudio.vernieri@istitutotumori.mi.it claudio.vernieri@ifom.eu licia.rivoltini@istitutotumori.mi.it.
Giovanni FucàMedical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.ORCID 0000-0002-1560-2253
Francesca LigorioMedical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Veronica HuberUnit of Immunotherapy of Human Tumors, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Andrea VingianiOncology and Haemato-Oncology Department, University of Milan, Milan, Italy.ORCID 0000-0002-9827-3976
Fabio IannelliIFOM, The FIRC Institute of Molecular Oncology, Milan, Italy.
Alessandra RaimondiMedical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Darawan RinchaiImmunology Department, Cancer Program, Sidra Medicine, Doha, Qatar.ORCID 0000-0001-8851-7730
Gianmaria FrigèDepartment of Experimental Oncology, European Institute of Oncology (IEO), IRCCS, Milan, Italy.ORCID 0000-0003-3253-7091
Antonino BelfioreDeparment of Pathology and Laboratory Medicine, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.ORCID 0000-0002-8011-6382
Luca LalliUnit of Immunotherapy of Human Tumors, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.ORCID 0000-0002-4472-628X
Claudia ChiodoniMolecular Immunology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.ORCID 0000-0002-7644-9969
Valeria CancilaTumor Immunology Unit, Department of Health Sciences, University of Palermo, Palermo, Italy.
Federica ZanardiIFOM, The FIRC Institute of Molecular Oncology, Milan, Italy.ORCID 0000-0003-2261-4911
Arta AjaziIFOM, The FIRC Institute of Molecular Oncology, Milan, Italy.
Salvatore CortellinoIFOM, The FIRC Institute of Molecular Oncology, Milan, Italy.
Viviana VallacchiUnit of Immunotherapy of Human Tumors, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.ORCID 0000-0002-2819-0630
Paola SquarcinaUnit of Immunotherapy of Human Tumors, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Agata CovaUnit of Immunotherapy of Human Tumors, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Samantha PesceUnit of Immunotherapy of Human Tumors, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Paola FratiUnit of Immunotherapy of Human Tumors, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Raghvendra MallQatar Computing Research Institute, Hamad Bin Khalifa University, Doha, Qatar.
Paola Antonia CorsettoDepartment of Pharmacological and Biomolecular Sciences, University of Milan, Milan, Italy.
Angela Maria RizzoDepartment of Pharmacological and Biomolecular Sciences, University of Milan, Milan, Italy.
Cristina FerrarisBreast Unit, Fondazione IRCCS Istituto Nazionale dei Tumori. Milan 20133, Italy.
Secondo FolliBreast Unit, Fondazione IRCCS Istituto Nazionale dei Tumori. Milan 20133, Italy.
Marina Chiara GarassinoMedical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Giuseppe CapriMedical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Giulia BianchiMedical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Mario Paolo ColomboMolecular Immunology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.ORCID 0000-0003-0042-7955
Saverio MinucciDepartment of Experimental Oncology, European Institute of Oncology (IEO), IRCCS, Milan, Italy.
Marco FoianiIFOM, The FIRC Institute of Molecular Oncology, Milan, Italy.
Valter Daniel LongoIFOM, The FIRC Institute of Molecular Oncology, Milan, Italy.ORCID 0000-0002-0946-7534
Giovanni ApoloneScientific Directorate, Fondazione IRCCS Istituto Nazionale dei Tumori. Milan, Italy.ORCID 0000-0001-5179-104X
Valter TorriLaboratory of Methodology for Biomedical Research, Istituto di Ricerche Farmacologiche "Mario Negri" IRCCS, Milan, Italy.
Giancarlo PruneriOncology and Haemato-Oncology Department, University of Milan, Milan, Italy.
Davide Bedognetti *Immunology Department, Cancer Program, Sidra Medicine, Doha, Qatar.
Licia Rivoltini *Unit of Immunotherapy of Human Tumors, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. claudio.vernieri@istitutotumori.mi.it claudio.vernieri@ifom.eu licia.rivoltini@istitutotumori.mi.it.
Filippo de Braud *Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Fondazione IRCCS Istituto Nazionale dei Tumori · ITUniversity of Milan · ITIFOM · ITQatar Airways (Qatar) · QAEuropean Institute of Oncology · ITHamad bin Khalifa University · QAMario Negri Institute for Pharmacological Research · ITUniversity of Palermo · ITUniversity of Southern California · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In tumor-bearing mice, cyclic fasting or fasting-mimicking diets (FMD) enhance the activity of antineoplastic treatments by modulating systemic metabolism and boosting antitumor immunity. Here we conducted a clinical trial to investigate the safety and biological effects of cyclic, five-day FMD in combination with standard antitumor therapies. In 101 patients, the FMD was safe, feasible, and resulted in a consistent decrease of blood glucose and growth factor concentration, thus recapitulating metabolic changes that mediate fasting/FMD anticancer effects in preclinical experiments. Integrated transcriptomic and deep-phenotyping analyses revealed that FMD profoundly reshapes anticancer immunity by inducing the contraction of peripheral blood immunosuppressive myeloid and regulatory T-cell compartments, paralleled by enhanced intratumor Th1/cytotoxic responses and an enrichment of IFNγ and other immune signatures associated with better clinical outcomes in patients with cancer. Our findings lay the foundations for phase II/III clinical trials aimed at investigating FMD antitumor efficacy in combination with standard antineoplastic treatments. SIGNIFICANCE: Cyclic FMD is well tolerated and causes remarkable systemic metabolic changes in patients with different tumor types and treated with concomitant antitumor therapies. In addition, the FMD reshapes systemic and intratumor immunity, finally activating several antitumor immune programs. Phase II/III clinical trials are needed to investigate FMD antitumor activity/efficacy.

Indexed as

FastingAntineoplastic AgentsBreast NeoplasmsColorectal NeoplasmsFemaleHumansMaleMiddle AgedProspective StudiesTreatment OutcomeAntineoplastic Agents

Identifiers

PMID34789537
PMCPMC9762338
OpenAlexW3212242980

What OpenQuestion holds

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Registered trials

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.