Evidence map›Paper›PMID 37638980›Full record

Observational studyCancer immunology, immunotherapy : CII2023

Systematic vitamin D supplementation is associated with improved outcomes and reduced thyroid adverse events in patients with cancer treated with immune checkpoint inhibitors: results from the prospective PROVIDENCE study.

Melissa Bersanelli, Alessio Cortellini, Alessandro Leonetti, Alessandro Parisi, Marcello Tiseo, Paola Bordi, Maria Michiara, Simona Bui, Agnese Cosenza, Leonarda Ferri and 18 more

Open access · hybridAbstract readObservational Study
In one paragraph

Observational study in Cancer immunology, immunotherapy : CII, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
4.8field-weighted citation impact, top 5% 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

16 citing papers in PubMed, 19 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

28 authors at 6 institutions in 1 country.

Melissa Bersanelli *Medical Oncology Unit, University Hospital of Parma, Parma, Italy.
Alessio Cortellini *Operative Research Unit of Medical Oncology, Fondazione Policlinico Universitario Campus Bio-Medico, Alvaro del Portillo N° 200, 00128, Rome, Italy. alessio.cortellini@gmail.com.
Alessandro LeonettiMedical Oncology Unit, University Hospital of Parma, Parma, Italy.
Alessandro ParisiDepartment of Oncology, Università Politecnica Delle Marche-AOU Delle Marche, 60121, Ancona, Italy.
Marcello TiseoMedical Oncology Unit, University Hospital of Parma, Parma, Italy.
Paola BordiMedical Oncology Unit, University Hospital of Parma, Parma, Italy.
Maria MichiaraMedical Oncology Unit, University Hospital of Parma, Parma, Italy.
Simona BuiMedical Oncology Unit, University Hospital of Parma, Parma, Italy.
Agnese CosenzaMedical Oncology Unit, University Hospital of Parma, Parma, Italy.
Leonarda FerriMedical Oncology Unit, University Hospital of Parma, Parma, Italy.
Giulia Claire GiudiceMedical Oncology Unit, University Hospital of Parma, Parma, Italy.
Irene TestiMedical Oncology Unit, University Hospital of Parma, Parma, Italy.
Elena RapacchiMedical Oncology Unit, University Hospital of Parma, Parma, Italy.
Roberta CamisaMedical Oncology Unit, University Hospital of Parma, Parma, Italy.
Bruno VincenziOperative Research Unit of Medical Oncology, Fondazione Policlinico Universitario Campus Bio-Medico, Alvaro del Portillo N° 200, 00128, Rome, Italy.
Giuseppe CarusoMedical Oncology Unit, University Hospital of Parma, Parma, Italy.
Antonio Natale RautiDepartment of Medicine and Surgery, University of Parma, Parma, Italy.
Federica ArturiDepartment of Medicine and Surgery, University of Parma, Parma, Italy.
Marco TucciDepartment of Interdisciplinary Medicine (DIM), University of Bari "Aldo Moro", Bari, Italy.
Valentina SantoOperative Research Unit of Medical Oncology, Fondazione Policlinico Universitario Campus Bio-Medico, Alvaro del Portillo N° 200, 00128, Rome, Italy.
Valentina RicozziOperative Research Unit of Medical Oncology, Fondazione Policlinico Universitario Campus Bio-Medico, Alvaro del Portillo N° 200, 00128, Rome, Italy.
Vanessa BurtetUOC Farmacia Ospedaliera, Aulss N.1 Dolomiti, Belluno Hospital, Belluno, Italy.
Paolo SgargiCancer Registry of Parma Province, University Hospital of Parma, Parma, Italy.
Renata TodeschiniGruppo Oncologico Italiano Di Ricerca Clinica (GOIRC), Parma, Italy.
Fable ZustovichUOC Oncologia, Aulss N.1 Dolomiti, Belluno Hospital, Belluno, Italy.
Luigia Stefania StucciMedical Oncology Unit, Policlinico Hospital of Bari, Bari, Italy.
Daniele SantiniOncologia Medica A, Policlinico Umberto 1, La Sapienza Università Di Roma, Rome, Italy.
Sebastiano ButiMedical Oncology Unit, University Hospital of Parma, Parma, Italy.
University of Parma · ITCampus Bio Medico University Hospital · ITItalian Oncology Group of Clinical Research · ITMarche Polytechnic University · ITPoliclinico Umberto I · ITUniversity of Bari Aldo Moro · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHypovitaminosis D can have a negative prognostic impact in patients with cancer. Vitamin D has a demonstrated role in T-cell-mediated immune activation. We hypothesized that systematic vitamin D repletion could impact clinical outcomes in patients with cancer receiving immune-checkpoint inhibitors (ICIs).

methodsWe planned a prospective observational study (PROVIDENCE) to assess serum vitamin D levels in patients with advanced cancer receiving ICIs (cohort 1 at treatment initiation, cohort 2 during treatment) and the impact of systematic repletion on survival and toxicity outcomes. In an exploratory analysis, we compared the clinical outcomes of cohort 1 with a control cohort of patients followed at the participating centers who did not receive systematic vitamin D repletion.

resultsOverall, 164 patients were prospectively recruited in the PROVIDENCE study. In cohort 1, consisting of 101 patients with 94.1% hypovitaminosis (≤ 30 ng/ml) at baseline, adequate repletion with cholecalciferol was obtained in 70.1% at the three months re-assessment. Cohort 2 consisted of 63 patients assessed for vitamin D at a median time of 3.7 months since immunotherapy initiation, with no patients having adequate levels (> 30 ng/ml). Even in cohort 2, systematic supplementation led to adequate levels in 77.8% of patients at the three months re-assessment. Compared to a retrospective control group of 238 patients without systematic vitamin D repletion, PROVIDENCE cohort 1 showed longer overall survival (OS, p = 0.013), time to treatment failure (TTF, p = 0.017), and higher disease control rate (DCR, p = 0.016). The Inverse Probability of Treatment Weighing (IPTW) fitted multivariable Cox regression confirmed the significantly decreased risk of death (HR 0.55, 95%CI: 0.34-0.90) and treatment discontinuation (HR 0.61, 95%CI: 0.40-0.91) for patients from PROVIDENCE cohort 1 in comparison to the control cohort. In the context of longer treatment exposure, the cumulative incidence of any grade immune-related adverse events (irAEs) was higher in the PROVIDENCE cohort 1 compared to the control cohort. Nevertheless, patients from cohort 1 experienced a significantly decreased risk of all grade thyroid irAEs than the control cohort (OR 0.16, 95%CI: 0.03-0.85).

conclusionThe PROVIDENCE study suggests the potential positive impact of early systematic vitamin D supplementation on outcomes of patients with advanced cancer receiving ICIs and support adequate repletion as a possible prophylaxis for thyroid irAEs.

Indexed as

Antineoplastic Agents, ImmunologicalNeoplasmsDietary SupplementsHumansImmune Checkpoint InhibitorsProspective StudiesRetrospective StudiesThyroid GlandVitamin DAntineoplastic Agents, ImmunologicalImmune Checkpoint InhibitorsVitamin DCancerCholecalciferolImmune checkpoint inhibitorsImmune related adverse eventsImmunotherapyVitamin D

Identifiers

PMID37638980
PMCPMC10576732
OpenAlexW4386209199

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.