Evidence map›Paper›PMID 30796151›Full record

Observational studyThe oncologist2019

Clinical Outcomes of Patients with Advanced Cancer and Pre-Existing Autoimmune Diseases Treated with Anti-Programmed Death-1 Immunotherapy: A Real-World Transverse Study.

Alessio Cortellini, Sebastiano Buti, Daniele Santini, Fabiana Perrone, Raffaele Giusti, Marcello Tiseo, Melissa Bersanelli, Maria Michiara, Antonino Grassadonia, Davide Brocco and 35 more

Abstract readComparative StudyMulticenter StudyObservational Study
In one paragraph

Observational study in The oncologist, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 108 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
108citing papers in PubMed, 11 pooled it
–field-weighted citation impact
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

108 citing papers in PubMed, 11 syntheses or guidelines pooled it.

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  9. Preexisting autoimmune disease is a risk factor for immune-related adverse events: a meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2021
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48 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

45 authors.

Alessio CortelliniMedical Oncology, St. Salvatore Hospital, L'Aquila, Italy alessiocortellini@gmail.com.ORCID 0000-0002-1209-5735
Sebastiano ButiMedical Oncology, University Hospital of Parma, Parma, Italy.
Daniele SantiniMedical Oncology, Campus Bio-Medico University, Rome, Italy.
Fabiana PerroneMedical Oncology, University Hospital of Parma, Parma, Italy.
Raffaele GiustiDepartment of Clinical and Molecular Medicine, Sant'Andrea Hospital, Sapienza University of Rome, Rome, Italy.
Marcello TiseoMedical Oncology, University Hospital of Parma, Parma, Italy.
Melissa BersanelliMedical Oncology, University Hospital of Parma, Parma, Italy.
Maria MichiaraMedical Oncology, University Hospital of Parma, Parma, Italy.
Antonino GrassadoniaDepartment of Medical, Oral & Biotechnological Sciences, University G. D'Annunzio, Chieti-Pescara, Italy.
Davide BroccoClinical Oncology Unit, S.S. Annunziata Hospital, Chieti, Italy.
Nicola TinariDepartment of Medical, Oral & Biotechnological Sciences, University G. D'Annunzio, Chieti-Pescara, Italy.
Michele De TursiDepartment of Medical, Oral & Biotechnological Sciences, University G. D'Annunzio, Chieti-Pescara, Italy.
Federica ZorattoMedical Oncology, Santa Maria Goretti Hospital, Latina, Italy.
Enzo VeltriMedical Oncology, Santa Maria Goretti Hospital, Latina, Italy.
Riccardo MarconciniDepartment of Oncology, University Hospital of Pisa, Istituto Toscano Tumori, Pisa, Italy.
Francesco MalorgioMedical Oncology, "Santo Spirito" Hospital, Pescara, Italy.
Carlo GarufiMedical Oncology, "Santo Spirito" Hospital, Pescara, Italy.
Marco RussanoMedical Oncology, Campus Bio-Medico University, Rome, Italy.
Cecilia AnesiMedical Oncology, Campus Bio-Medico University, Rome, Italy.
Tea ZeppolaMedical Oncology, Campus Bio-Medico University, Rome, Italy.
Marco FilettiDepartment of Clinical and Molecular Medicine, Sant'Andrea Hospital, Sapienza University of Rome, Rome, Italy.
Paolo MarchettiDepartment of Clinical and Molecular Medicine, Sant'Andrea Hospital, Sapienza University of Rome, Rome, Italy.
Andrea BotticelliDepartment of Clinical and Molecular Medicine, Sant'Andrea Hospital, Sapienza University of Rome, Rome, Italy.
Gian Carlo Antonini CappelliniIstituto Dermopatico dell'Immacolata, IDI-IRCCS, Rome, Italy.
Federica De GalitiisIstituto Dermopatico dell'Immacolata, IDI-IRCCS, Rome, Italy.
Maria Giuseppa VitaleMedical Oncology, University Hospital of Modena, Modena, Italy.
Roberto SabbatiniMedical Oncology, University Hospital of Modena, Modena, Italy.
Sergio BracardaMedical Oncology, "Santa Maria" Hospital, Terni, Italy.
Rossana BerardiOncology Clinic, Università Politecnica delle Marche, Ospedali Riuniti di Ancona, Ancona, Italy.
Silvia RinaldiOncology Clinic, Università Politecnica delle Marche, Ospedali Riuniti di Ancona, Ancona, Italy.
Marianna TudiniMedical Oncology, AV2 Fabriano ASUR Marche, Fabriano, Italy.
Rosa Rita SilvaMedical Oncology, AV2 Fabriano ASUR Marche, Fabriano, Italy.
Annagrazia PiredduMedical Oncology Unit, University Hospital of Cagliari, Cagliari, Italy.
Francesco AtzoriMedical Oncology Unit, University Hospital of Cagliari, Cagliari, Italy.
Rita ChiariMedical Oncology, Santa Maria della Misericordia Hospital, Perugia, Italy.
Biagio RicciutiMedical Oncology, Santa Maria della Misericordia Hospital, Perugia, Italy.
Daniela IaconoPulmonary Oncology Unit, St. Camillo Forlanini Hospital, Rome, Italy.
Maria Rita MigliorinoPulmonary Oncology Unit, St. Camillo Forlanini Hospital, Rome, Italy.
Antonio RossiMedical Oncology, IRCCS Casa Sollievo della Sofferenza Hospital, San Giovanni Rotondo, Italy.
Giampiero PorzioMedical Oncology, St. Salvatore Hospital, L'Aquila, Italy.
Katia CannitaDepartment of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.
Valeria CiciarelliDermatology, San Salvatore Hospital, L'Aquila, Italy.
Maria Concetta FargnoliDermatology, San Salvatore Hospital, L'Aquila, Italy.
Paolo Antonio AsciertoMelanoma, Cancer Immunotherapy and Development Therapeutics Unit, Istituto Nazionale Tumori-IRCCS Fondazione "G. Pascale", Naples, Italy.
Corrado FicorellaMedical Oncology, St. Salvatore Hospital, L'Aquila, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with a history of autoimmune diseases (AIDs) have not usually been included in clinical trials with immune checkpoint inhibitors. MATERIALS AND

methodsConsecutive patients with advanced cancer, treated with anti-programmed death-1 (PD-1) agents, were evaluated according to the presence of pre-existing AIDs. The incidence of immune-related adverse events (irAEs) and clinical outcomes were compared among subgroups.

resultsA total of 751 patients were enrolled; median age was 69 years. Primary tumors were as follows: non-small cell lung cancer, 492 (65.5%); melanoma, 159 (21.2%); kidney cancer, 94 (12.5%); and others, 6 (0.8%). Male/female ratio was 499/252. Eighty-five patients (11.3%) had pre-existing AIDs, further differentiated in clinically active (17.6%) and inactive (82.4%). Among patients with pre-existing AIDs, incidence of irAEs of any grade was significantly higher when compared with patients without AIDs (65.9% vs. 39.9%). At multivariate analysis, both inactive (

conclusionThis study quantifies the increased risk of developing irAEs in patients with pre-existing AIDs who had to be treated with anti-PD-1 immunotherapy. Nevertheless, the incidence of grade 3/4 irAEs is not significantly higher when compared with control population. The finding of a greater incidence of irAEs among female patients ranks among the "hot topics" in gender-related differences in immuno-oncology. IMPLICATIONS FOR PRACTICE: Patients with a history of autoimmune diseases (AIDs) have not usually been included in clinical trials with immune checkpoint inhibitors but are frequent in clinical practice. This study quantifies the increased risk of developing immune-related adverse events (irAEs) in patients with pre-existing AIDs who had to be treated with anti-programmed death-1 immunotherapy. Nevertheless, their toxicities are mild and the incidence of grade 3/4 irAEs is not significantly higher compared with those of controls. These results will help clinicians in everyday practice, improving their ability to offer a proper counselling to patients, in order to offer an immunotherapy treatment even to patients with pre-existing autoimmune disease.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Agents, ImmunologicalAutoimmune DiseasesDrug-Related Side Effects and Adverse ReactionsFemaleHumansIncidenceMaleMiddle AgedNeoplasmsProgrammed Cell Death 1 ReceptorProgression-Free SurvivalRetrospective StudiesSeverity of Illness IndexAntineoplastic Agents, ImmunologicalPDCD1 protein, humanProgrammed Cell Death 1 ReceptorAnti‐programmed death‐1Autoimmune diseaseImmune checkpoint inhibitorsImmunotherapyPerformance statusSex

Identifiers

PMID30796151
PMCPMC6656514

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