Immune checkpoint inhibitor effects on male reproduction.

Abstract

e16528 Background: Immune checkpoint inhibitors (ICI) have been shown to improve overall survival (OS) in patients with metastatic renal cell carcinoma (RCC) as compared to previous therapy with multi-kinase inhibitors (MKI). However, little is known about the effects of these drugs on male reproductive capacity and the current data regarding effects of MKI and ICI therapies on gonadal function and fertility are both limited and conflicting. We sought to evaluate effects of MKI and ICI on male reproductive function in patients with RCC. Methods: Male patients with RCC receiving MKI or ICI for a period of at least 3 months were identified. Inclusion criteria included age ≤ 50 years, no prior history of chemotherapy, and no prior history of medical or surgical conditions that would affect spermatogenesis such as hypogonadism, Klinefelter syndrome, or vasectomies. Patients were instructed to abstain from ejaculation 2 to 7 days prior to study collection. Follicle-stimulating hormone (FSH), luteinizing hormone (LH), morning testosterone, and a semen analysis was obtained for each patient and analyzed. Results: Of 10 patients, 5 (50%) were on ICI and 5 (50%) were on MKI. Of the patients on ICI, 2 (40%) exhibited abnormal semen morphology, motility, and sperm concentration. Of the patients on ICI, one exhibited elevated LH and FSH levels and one exhibited elevated LH levels only. Of the patients on MKI, 2 (40%) exhibited abnormal semen morphology, motility, and sperm concentration. One patient on MKI exhibited elevated LH and FSH levels. All patients had normal testosterone levels. Conclusions: Our preliminary descriptive data analysis suggests that both ICI and MKI may affect semen morphology and motility, sperm concentration, and LH and FSH levels, but does not affect testosterone levels. Due to the currently limited sample size, abnormal semen analysis and hormone levels may be attributable to confounding factors, such as performance status, the metastatic disease itself, comorbidities, etc. Study recruitment and analysis are ongoing.