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dc.contributor.authorRowe, Michael
dc.contributor.authorEastlake, Leonie
dc.contributor.authorNorris, Timothy
dc.contributor.authorFarley, Timothy
dc.contributor.authorTalbot, Toby
dc.identifier.citationRowe, M. et al. (2021) ‘A Multicentre Retrospective Analysis of Toxicity in 6-weekly Versus 3-weekly Pembrolizumab.’, Journal of immunotherapy (Hagerstown, Md. : 1997), 44(4), pp. 175–178. doi: 10.1097/CJI.0000000000000361.
dc.description.abstractPembrolizumab is an anti-programmed cell death protein 1 immune checkpoint inhibitor with a dosing schedule of 200 mg 3 weekly (q3w). Dose of 400 mg 6 weekly (q6w) was approved based on simulation of dose/exposure relationships and predicted no difference in toxicity. We present real-world comparative toxicity data. Patients receiving pembrolizumab for any indication between March and December 2019 were included across 3 regional centers. Toxicity data were collected retrospectively using Common Terminology Criteria for Adverse Events, v5.0. Clinically significant immune-related adverse events (CSirAE) were defined as immune-related events and grade ≥3 rash. Data were analyzed using incidence (Poisson distribution) and incidence ratio. Overall, 63 patients started on q6w and 110 patients received q3w. There were 3 (q6w) and 8 (q3w) grade 3-5 CSirAE and 13 (q6w) and 31 (q3w) grade 1-2 CSirAE. The incidence of grade 3-5 CSirAE was 0.77 (95% confidence interval: 0.16-2.24) per 100 patient-months in q6w and 0.68 (95% confidence interval: 0.29-1.34) per 100 patient-months in q3w (incidence ratio of 1.13; 95% confidence interval: 0.19-4.70). Low-grade toxicity was common (fatigue, pruritus, rash; q6w 46%, q3w 42%). Incidence of CSirAEs was low but low-grade toxicity was common. Despite a limited number of events, there is the suggestion that the q6w schedule has a similar toxicity profile to q3w and therefore consideration should be given to the reduced burden to patients and health services when deciding treatment.
dc.rightsCopyright © 2021 Elsevier Inc. All rights reserved.
dc.titleA Multicentre Retrospective Analysis of Toxicity in 6-weekly Versus 3-weekly Pembrolizumab
dc.typeJournal Article
dc.identifier.journalJournal of immunotherapy
dc.description.noteThe article is available via Open Access. Click on the 'Additional link' above to access the full-text.
dc.description.admin-notePublished version, accepted version

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Copyright © 2021 Elsevier Inc. All rights reserved.
Except where otherwise noted, this item's license is described as Copyright © 2021 Elsevier Inc. All rights reserved.