Background
Immune checkpoint inhibitors [cytotoxic T-lymphocyte antigen 4 (CTLA-4), programmed cell death 1 receptor/ programmed death ligand-1 (PD1/ PD-L1)] have received broad FDA approval in most cancers. As clinical use of these agents proliferates, data for their efficacy and safety in elderly populations, particularly nonagenarians, is sparse [1]. Nonagenarians are commonly excluded from or underrepresented in clinical trials. This occurs despite the fact that the elderly embody the fastest growing portion of the population worldwide [2]. The purpose of this project was to describe the experience of treating veterans >/= 90 years of age with immune checkpoint inhibitors (IPI) for cancer.
Methods
We reviewed drug exposure in Nonagenarians who received IPI within the VA system nationwide between 2016-2017 using CAPRI. We identified 48 veterans and reviewed each patient’s treatment, duration of immunotherapy exposure, response, and toxicity to generate a global review on how those nonagenarians tolerated treatment. Demographic data of study participants and all endpoints have been analyzed using descriptive statistics.
Results
We obtained the record data for 48 veterans who received CPI in the VA health system between 2016 and 2017. Baseline characteristics revealed that the majority of patients (N=26) were ECOG 0-1 at the time of treatment initiation. The most commonly treated malignancies included melanoma (N=19) and NSCLC (N=15) with the majority of cancers being stage IV (N=42). The primary outcome measures are duration of therapy (average 12.2 cycles) and overall survival (average 1.59 years). The secondary outcome is adverse events, with a total rate of 27.1% and grade III/IV events occurring at a rate of 6.3%
Implications
These cases and data points illustrate that immunotherapy is being used in nonagenarians. With close monitoring of toxicities, nonagenarians with acceptable performance status can be treated with immunotherapy with their consent. Future aims will focus on the addition of more data points by expanding to include 2018.
References
1. Lewis JH, Kilgore ML, Goldman DP, Trimble EL, Kaplan R,Montello MJ, et al. Participation of patients 65 years of age or older in cancer clinical trials. J Clin Oncol. 2003;21(7):1383–9. 2. Sgambato S, Casaluce F, Gridelli C. The role of checkpoint inhibitors immunotherapy in advanced non-small cell lung cancer in the elderly. Expert Opin Biol Ther. 2017;17(5):565-571.