Anti-programmed death ligand 1 immunotherapies in cancer patients with pre-existing systemic sclerosis: A postmarketed phase IV safety assessment study.

Abstract

OBJECTIVES:

Cancer patients with pre-existing autoimmune disease, such as systemic sclerosis (SSc), are excluded from clinical trials, so the data on tolerability and efficacy of immune checkpoint inhibitors in these patients are limited. This study investigated the tolerability and efficacy of anti-programmed death ligand 1 (PD (L)1) immunotherapies in patients with pre-existing SSc.

METHODS:

Scleronco-01 was a multicentre, nationwide, open-label, phase IV observational study, from 2019 to 2021.

RESULTS:

Seventeen SSc patients receiving treatment for lung carcinoma (n = 13, 77%), head and neck cancer (n = 2, 12%), melanoma (n = 1, 6%), and colorectal carcinoma (n = 1, 6%) were included. The median (interquartile range) patient age was 60 (34-82) years. Fifteen (88%) patients received anti-PD1 (nivolumab and pembrolizumab) and two (12%) anti-PD-L1 (durvalumab). The median follow-up duration was 12 (range, 2-38) months. Four patients (24%) experienced flare-up of SSc symptoms. Ten patients (59%) developed an immune-related adverse event (grade I-II in 11 patients [65%], grade III-IV in one [6%]) without grade V. The overall response rate was 41% (7/17 patients). The median overall survival was 15.8 (95% confidence interval: 7.3 to not reached) months.

CONCLUSION:

Anti-PD1 or PD-L1 immunotherapies are suitable options for cancer patients with pre-existing SSc. Longer follow-up periods are required for long-term safety analyses.

• Authors: Marion Panhaleux, Olivier Espitia, Benjamin Terrier, Guillaume Manson, Alexandre Maria, Sébastien Humbert, Benoît Godbert, Julie Perrin, Aurélie Achille, Jennifer Arrondeau, Marie Kostine, Vincent Fallet, Grégory Pugnet, Benjamin Chaigne, Stéphane Champiat, Ariane Laparra, Francois-Xavier Danlos, David Launay, Nicolas Penel, Olivier Lambotte, Jean-Marie Michot, Alexandra Forestier
• Journal: European journal of cancer (Oxford, England : 1990) (Eur J Cancer) Vol. 160 Pg. 134-139 (01 2022) ISSN: 1879-0852 [Electronic] England
• PMID: 34810048 (Publication Type: Clinical Trial, Phase IV, Journal Article, Multicenter Study)
• Copyright: Copyright © 2021 Elsevier Ltd. All rights reserved.

Chemical References

• Programmed Cell Death 1 Receptor

Topics

• Adult
• Aged
• Aged, 80 and over
• Female
• Humans
• Immunotherapy (methods)
• Male
• Middle Aged
• Programmed Cell Death 1 Receptor (antagonists & inhibitors)
• Retrospective Studies
• Scleroderma, Systemic (drug therapy, etiology)