{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,11]],"date-time":"2026-07-11T11:56:04Z","timestamp":1783770964096,"version":"3.55.0"},"reference-count":23,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2021,8,3]],"date-time":"2021-08-03T00:00:00Z","timestamp":1627948800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,8,3]],"date-time":"2021-08-03T00:00:00Z","timestamp":1627948800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["J Transl Med"],"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Severe immune-related Adverse Events (irAEs) develop in 10\u201327% of patients treated with Immune-Oncology (IO) [Powles (Lancet 391:748\u2013757, 2018); Galsky (Lancet 395:1547\u20131557, 2020); Haanen (Ann Oncol 28:119\u2013142, 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We 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\u2013G4 toxicities have been included as control group.<\/jats:p>\n                    <jats:p>Primary endpoint was to evaluate 6\u00a0months Progression Free Survival (PFS) after early treatment interruption for Grade (G) 3\u20134 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).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>18\/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\u00a0months since IO interruption, TTF was 1.6\u00a0months (95% CI 1.6\u20132.1), mPFS was 7.4\u00a0months (95% CI 3.16\u201311.6) and mOS was 15.5\u00a0months (5.1\u201325.8). In the control group 111\/184 (60.3%) patients were free from progression at 6\u00a0months, TTF was 4.6\u00a0months (95% CI 3.5\u20135.6), mPFS was 4.6\u00a0months (95% CI 3.5\u20135.6) and mOS was 19.6\u00a0months (95% CI 15.1\u201324.0). In the overall population, mPFS was 5.0\u00a0months (95% CI 4.0\u20135.9) and mOS was 19.6\u00a0months (95% CI 15.1\u201324.0).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>ICIs seem to maintain efficacy even after early interruption due to severe irAE.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s12967-021-03008-9","type":"journal-article","created":{"date-parts":[[2021,8,3]],"date-time":"2021-08-03T04:03:28Z","timestamp":1627963408000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["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"],"prefix":"10.1186","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0993-7540","authenticated-orcid":false,"given":"Marco","family":"Stellato","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giuseppe","family":"Procopio","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ugo","family":"De Giorgi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marco","family":"Maruzzo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Davide","family":"Bimbatti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessia","family":"Mennitto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Sbrana","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giandomenico","family":"Roviello","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chiara","family":"Casadei","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pierangela","family":"Sepe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandro","family":"Pignata","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniele","family":"Santini","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,8,3]]},"reference":[{"issue":"10","key":"3008_CR1","doi-asserted-by":"publisher","first-page":"1370","DOI":"10.1016\/S1470-2045(19)30413-9","volume":"20","author":"RJ Motzer","year":"2019","unstructured":"Motzer RJ, Rini BI, McDermott DF, Ar\u00e9n Frontera O, Hammers HJ, Carducci MA, et al. 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All patients signed informed consent to participate to the study.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Authors received consent for publication.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Sandro Pignata received honoraria from MSD AZ ROCHE Pfizer GSK Clovis pharmamar and research funding MSD AZ ROCHE PFIZER. Ugo De Giorgi has served as consultant\/advisory board member for Astellas, Bayer, BMS, Ipsen, Janssen, Merck, Pfizer and Sanofi; has received travel support from BMS, Ipsen, Janssen and Pfizer; and has received research funding from AstraZeneca, Roche and Sanofi (Inst). All the other authors have no conflict of interest. Daniele Santini received honoraria from MSD, Pfizer, Astellas, Eisai, Janssen, Merck-Serono, Ipsen, Sanofi, BMS.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"328"}}