Evidence map›Paper›PMID 34344414›Full record

ArticleJournal of translational medicine2021

Clinical outcome of renal cancer patients who early interrupted immunotherapy due to serious immune-related adverse events. Meet-Uro 13 trial on behalf of the MeetUro investigators.

Marco Stellato, Giuseppe Procopio, Ugo De Giorgi, Marco Maruzzo, Davide Bimbatti, Alessia Mennitto, Andrea Sbrana, Giandomenico Roviello, Chiara Casadei, Pierangela Sepe and 2 more

Abstract read
In one paragraph

Article in Journal of translational medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–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

6 citing papers in PubMed.

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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

12 authors.

Marco StellatoDepartment of Medical Oncology, Campus Bio-Medico University of Rome, Via Alvaro del Portillo 200, 00128, Rome, Italy. m.stellato@unicampus.it.ORCID 0000-0002-0993-7540
Giuseppe ProcopioMedical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Ugo De GiorgiIRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori, Meldola, Italy.
Marco MaruzzoMedical Oncology Unit 1, Department of Oncology, Istituto Oncologico Veneto IOV IRCCS, Padua, Italy.
Davide BimbattiMedical Oncology Unit 1, Department of Oncology, Istituto Oncologico Veneto IOV IRCCS, Padua, Italy.
Alessia MennittoDivision of Oncology, University Hospital "Maggiore Della Carità", Novara, Italy.
Andrea SbranaDepartment of Surgical, Medical and Molecular Pathology and Critical Area Medicine, University of Pisa, Pisa, Italy.
Giandomenico RovielloDepartment of Health Sciences, University of Florence, Florence, Italy.
Chiara CasadeiIRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori, Meldola, Italy.
Pierangela SepeMedical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Sandro PignataDepartment of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale", Naples, Italy.
Daniele SantiniDepartment of Medical Oncology, Campus Bio-Medico University of Rome, Via Alvaro del Portillo 200, 00128, Rome, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSevere immune-related Adverse Events (irAEs) develop in 10-27% of patients treated with Immune-Oncology (IO) [Powles (Lancet 391:748-757, 2018); Galsky (Lancet 395:1547-1557, 2020); Haanen (Ann Oncol 28:119-142, 2017)]. The aim of our study was to evaluate efficacy and clinical outcome of metastatic renal cell carcinoma (mRCC) patients who stopped Immune Checkpoint Inhibitors (ICIs) due to early Grade (G) 3-G4 irAEs.

methodsWe retrospectively collected data from 204 mRCC patients treated with ICIs in 6 Italian referral centers adhering to the Meet-Uro group, between February 2017 and January 2020. To properly weight the results, patients who did not report early G3-G4 toxicities have been included as control group. Primary endpoint was to evaluate 6 months Progression Free Survival (PFS) after early treatment interruption for Grade (G) 3-4 toxicities compared to the control group. Secondary endpoints were to evaluate Time to treatment failure (TTF) and overall survival (OS) in both groups. All statistical analyses were performed using SPSS software (version 19.00, SPSS, Chicago).

results18/204 (8.8%) patients had early treatment interruption for serious (G3-G4) irAEs. Early was defined as interruption of IO after only one or two administrations. Immune related nephritis and pancreatitis were the most common irAE that lead to treatment interruption. 6/18 patients received IO-IO combination whereas 12/18 patients antiPD1. In the study group, 12/18 (66.6%) were free from progression at 6 months since IO interruption, TTF was 1.6 months (95% CI 1.6-2.1), mPFS was 7.4 months (95% CI 3.16-11.6) and mOS was 15.5 months (5.1-25.8). In the control group 111/184 (60.3%) patients were free from progression at 6 months, TTF was 4.6 months (95% CI 3.5-5.6), mPFS was 4.6 months (95% CI 3.5-5.6) and mOS was 19.6 months (95% CI 15.1-24.0). In the overall population, mPFS was 5.0 months (95% CI 4.0-5.9) and mOS was 19.6 months (95% CI 15.1-24.0).

conclusionsICIs seem to maintain efficacy even after early interruption due to severe irAE.

Indexed as

Carcinoma, Renal CellKidney NeoplasmsHumansImmunotherapyItalyRetrospective StudiesImmune-related adverse eventsImmunotherapyRenal cell carcinoma

Identifiers

PMID34344414
PMCPMC8330118

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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.