A Multicentre Retrospective Analysis of Toxicity in 6-weekly Versus 3-weekly Pembrolizumab. Issue 4 (May 2021)

• Record Type: Journal Article
• Authors: Rowe, Michael; Eastlake, Leonie; Norris, Timothy; Farley, Timothy; Talbot, Toby
• Is Part Of: Journal of immunotherapy. Volume 44:Issue 4(2021)
• Publication Date: 2021-05
• Subjects: pembrolizumab -- 6 weekly -- immune-related adverse events; Immunotherapy -- Periodicals; Immunotherapy -- Periodicals; Neoplasms -- therapy -- Periodicals; Electronic journals; Electronic journals; 615.37
• DOI: 10.1097/CJI.0000000000000361
• Languages: English
• ISSNs: 1524-9557

Abstract

Abstract : Pembrolizumab 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.