dc.contributor.author | Favara, DM | |
dc.contributor.author | Spain, L | |
dc.contributor.author | Au, L | |
dc.contributor.author | Clark, J | |
dc.contributor.author | Daniels, E | |
dc.contributor.author | Diem, S | |
dc.contributor.author | Chauhan, D | |
dc.contributor.author | Turajlic, S | |
dc.contributor.author | Powell, N | |
dc.contributor.author | Larkin, JM | |
dc.contributor.author | Yousaf, N | |
dc.coverage.spatial | England | |
dc.date.accessioned | 2022-08-22T13:15:36Z | |
dc.date.available | 2022-08-22T13:15:36Z | |
dc.date.issued | 2020-07-01 | |
dc.identifier | ARTN e000585 | |
dc.identifier | S2059-7029(20)32633-8 | |
dc.identifier.citation | ESMO Open, 2020, 5 (4), pp. e000585 - | |
dc.identifier.issn | 2059-7029 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/5295 | |
dc.identifier.eissn | 2059-7029 | |
dc.identifier.eissn | 2059-7029 | |
dc.identifier.doi | 10.1136/esmoopen-2019-000585 | |
dc.description.abstract | BACKGROUND: Immune-related diarrhoea/colitis (ir-D/C) is a common adverse event of immune checkpoint inhibitor (ICI) therapy. Guidelines recommend corticosteroid (CS) treatment; however, the average treatment duration for ir-D/C remains poorly defined. METHODS: All advanced melanoma patients treated with ICI therapy at the Royal Marsden Hospital between 2011 and 2016 were reviewed to identify ir-D/C cases alongside clinical variables. RESULTS: 117 any-grade ir-D/C episodes occurred in 109 (21%) patients out of a total of 519 patients treated (ipilimumab=77 episodes, anti-PD1=17 (nivolumab or pembrolizumab), ipilimumab and nivolumab=23 (ipi+nivo)) (seven patients had ir-D/C more than once on different lines of treatment) and >/=grade 3 ir-D/C occurred most frequently (63/519 patients (12%) vs 29/519 (5%) grade 1, and 25/519 (5%) grade 2). Median onset (days) of all-grade ir-D/C after starting ICI therapy was 41 for ipilimumab (IQR 24 to 59, n=77), 91 for anti-PD1 (IQR 46 to 355, n=17) and 45 for ipi+nivo (IQR 24 to 67, n=23). In 71/117 (61%) patients, ir-D/C episodes were treated with CS (17% grade 2; 79% grade 3/4): 54 being steroid-responsive; 17 being steroid-refractory and received additional anti-tumor necrosis factor (TNF) treatment. Median grade 3 ir-D/C CS duration was similar across treatments, averaging 58 days. Median overall CS duration (days) was longer in the grade 3/4 D/C steroid-refractory group (94 vs 45 days). Infection developed in 11/71 (15%) CS recipients and in 6/17 (35%) anti-TNF recipients. In 65/117 (55%) patients, ir-D/C episodes were investigated with flexible sigmoidoscopy. Of these patients, 38/65 (58%) had macroscopic colitis and 12/65 (18%) had microscopic colitis. The steroid-refractory group had more macroscopic changes, 13/17 (76%), than the steroid-responsive group, 22/41 (54%). CONCLUSION: Rates of grade 3 ir-D/C were higher than reported in clinical trials. The 58-day median duration of CS therapy for grade 3 ir-D/C places a significant number of patients at risk of complications. We demonstrate that microscopic colitis is an important subgroup, advocating biopsies in ir-D/C even with macroscopically normal bowel. | |
dc.format | Print | |
dc.format.extent | e000585 - | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | ELSEVIER | |
dc.relation.ispartof | ESMO Open | |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ | |
dc.subject | corticosteroids | |
dc.subject | immunotherapy related diarrhoea/colitis | |
dc.subject | immunotherapy toxicity | |
dc.subject | infliximab | |
dc.subject | Adrenal Cortex Hormones | |
dc.subject | Colitis | |
dc.subject | Diarrhea | |
dc.subject | Female | |
dc.subject | Humans | |
dc.subject | Immune Checkpoint Inhibitors | |
dc.subject | Male | |
dc.subject | Melanoma | |
dc.subject | Middle Aged | |
dc.subject | Skin Neoplasms | |
dc.subject | Tumor Necrosis Factor Inhibitors | |
dc.title | Five-year review of corticosteroid duration and complications in the management of immune checkpoint inhibitor-related diarrhoea and colitis in advanced melanoma. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2020-01-14 | |
dc.date.updated | 2022-08-22T13:15:09Z | |
rioxxterms.version | VoR | |
rioxxterms.versionofrecord | 10.1136/esmoopen-2019-000585 | |
rioxxterms.licenseref.startdate | 2020-07-01 | |
rioxxterms.type | Journal Article/Review | |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/32641348 | |
pubs.issue | 4 | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Melanoma and Kidney Cancer | |
pubs.organisational-group | /ICR/Primary Group/Royal Marsden Clinical Units | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Melanoma and Kidney Cancer/Melanoma and Kidney Cancer (hon.) | |
pubs.organisational-group | /ICR/Students | |
pubs.organisational-group | /ICR/Students/PhD and MPhil | |
pubs.organisational-group | /ICR/Students/PhD and MPhil/17/18 Starting Cohort | |
pubs.publication-status | Published | |
pubs.volume | 5 | |
icr.researchteam | Melanoma & Kidney Cancer | |
dc.contributor.icrauthor | Au, Lewis | |
icr.provenance | Deposited by Mr Arek Surman on 2022-08-22. Deposit type is initial. No. of files: 1. Files: Five-year review of corticosteroid duration and complications in the management of immune checkpoint inhibitor-related diarr.pdf | |