Adverse events need for hospitalization and systemic immunosuppression in very elderly patients (over 80 years) treated with ipilimumab for metastatic melanoma
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Abstract
Background
Checkpoint inhibitors are first-line therapies in melanoma, but safety in older adults has not yet been assessed. Ipilimumab improves survival, but immunologic-related adverse events (AEs) can be threatening, and its use in elderly people raises questions.
Aim
To assess safety in a cohort of very elderly patients treated with ipilimumab.
Methods
All patients over 80 years treated with ipilimumab for melanoma were retrospectively included. AE occurrence, management, and outcome, as well as response rate at week 16 and overall survival were recorded, and compared to data for a group of younger patients treated in our institution during the same period.
Results
In the elderly group, 23 patients were included with a median age of 82 years [80–90]. AEs amounting to 23 occurred in 15 patients (65%) with 5 grade 3 (22%) and 1 grade 5 (opportunistic infection) AEs. Corticosteroids were required for five (22%) patients, additive immunosuppressive therapy for two, hospitalization for four, and definitive interruption of ipilimumab for three. Median overall survival was 14 months. In the younger group, 29 patients were included with a median age of 58 years. AEs occurred in 15/29 (52%) with 4 grade 3 (19%) and 1 grade 4 (7%). Median OS was 17 months.
Conclusion
Serious AEs occurred in 80 + adults at the same rate as observed in our younger patients and as previously reported in younger populations. Ipilimumab can be an option in elderly patients, as patients may benefit from therapy and safety seems to be manageable.
Keywords
Ipilimumab Checkpoint inhibitors Elderly Older adults Adverse events MelanomaAbbreviations
- AE
Adverse events
- anti-TNFα
Anti-tumor-necrosis-factor alpha inhibitors
- BRAF
B-Raf proto-oncogene
- CI
Confidence interval
- CT scan
Computed tomography scan
- ECOG status
Eastern Cooperative Oncology Group status
- HR
Hazard ratio
- irAEs
Immunologic-related adverse events
- LDH
Lactate dehydrogenase
- OS
Overall survival
- PD-1
Programmed-death 1
- PFS
Progression-free survival
- RCT
Randomized clinical trials
- TNM
Tumor node metastasis
Notes
Acknowledgements
We thank Dr Marie-Laure Jullie, Pathology Department, CHU Bordeaux, France, for language editing of the manuscript.
Author contributions
All the authors had full access to all the data in the study. Manuscript was prepared by Vaianu Leroy, Emilie Gerard and Anne Pham-Ledard. Clinical data were prepared and interpreted by Vaianu Leroy, Emilie Gerard, Caroline Dutriaux, Sorilla Prey, Aurelia Gey, Marie Beylot-Barry, Cecile Mertens, and Anne Pham-Ledard. Marie Beylot-Barry and Anne Pham-Ledard reviewed the paper and provided important advice.
Funding
No relevant funding.
Compliance with ethical standards
Conflict of interest
Consulting and advisory role for Bristol-Myers Squibb (Dutriaux, Beylot-Barry); speaker honorarium (Pham-Ledard, Dutriaux, Beylot-Barry) travelling, expenses and accommodation (Pham-Ledard, Dutriaux, Beylot-Barry, Prey). All other authors declare that they have no conflict of interest.
Informed consent
A written informed consent was obtained from all individual participants included in the study, allowing authors to exploit data anonymously.
Ethical approval and ethical standards
This study has been approved by the ethics committee of the University Hospital of Bordeaux, reference number GP-CE2018/11, and has been performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.
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