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Anti-programmed death ligand 1 immunotherapies in cancer patients with pre-existing systemic sclerosis: A
Marion Panhaleux1, Olivier Espitia2, Benjamin Terrier3
1Faculté de Médecine, Université de Lille, France.
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.
Insights
Immune checkpoint inhibitors like anti-PD1/PD-L1 therapies show promise for cancer patients with systemic sclerosis (SSc). While some SSc flare-ups and immune-related events occurred, the therapies were generally suitable.
Area of Science:
- Oncology
- Immunology
- Rheumatology
Background:
- Cancer patients with autoimmune diseases like systemic sclerosis (SSc) are often excluded from clinical trials.
- Limited data exists on the safety and efficacy of immune checkpoint inhibitors (ICIs) in this population.
Purpose of the Study:
- To investigate the tolerability and efficacy of anti-programmed death ligand 1 (PD-L1) immunotherapies in cancer patients with pre-existing SSc.
- To assess the incidence of SSc flare-ups and immune-related adverse events (irAEs) in SSc patients receiving ICIs.
Main Methods:
- A multicentre, nationwide, open-label, phase IV observational study (Scleronco-01) conducted from 2019 to 2021.
- Seventeen patients with SSc and various cancers (lung, head and neck, melanoma, colorectal) were treated with anti-PD1 or anti-PD-L1 therapies.
- Median follow-up was 12 months.
Main Results:
- The overall response rate (ORR) was 41% (7/17 patients).
- Four patients (24%) experienced SSc flare-ups.
- Ten patients (59%) developed irAEs (grade I-II in 11 patients [65%], grade III-IV in one [6%]).
- Median overall survival was 15.8 months.
Conclusions:
- Anti-PD1 or PD-L1 immunotherapies appear to be suitable options for cancer patients with pre-existing SSc.
- Longer follow-up periods are necessary for comprehensive long-term safety analyses.
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