FHINCH study: Fertility and sexual health effects of cancer therapy in young women with lung cancer and melanoma.

Abstract

e20081 Background: Recent clinical trials support the efficacy of neoadjuvant and adjuvant immune checkpoint inhibitors (ICIs) or tyrosine kinase inhibitors (TKIs) for patients (pts) with non-small cell lung cancer (NSCLC) and melanoma. Despite broader use and potential adverse events, their impact on women’s fertility and sexual health remains unclear. We report preliminary baseline results evaluating ICIs and TKIs’ effects on fertility biomarkers and sexual health in premenopausal women with NSCLC or melanoma. Methods: FHINCHis aprospective single-center cohort study of premenopausal (<50 years) women with NSCLC or melanoma receiving a neoadjuvant or adjuvant ICI or TKI for early-stage or metastatic disease. Serum anti-mullerian hormone (AMH), follicle-stimulating hormone (FSH), estradiol, and progesterone levels, with or without a pelvic antral-follicle count (AFC) ultrasound, and self-reported menses logs are collected within 3 months of treatment initiation (T0), 6 (T1), 12 (T2) and 24 (T3) months post-treatment initiation, and a sexual health and fertility-related concerns and experiences questionnaire at T0, T2, and T3. Results: Among 8 pts enrolled from 6/24-12/24, 6 pts with T0 biological results had AMH, FSH, estradiol, and progesterone results that deviated from expected ranges based on age and timing in menstrual cycle. AMH ranged from <0.08- 3.94 (expected: 1.52 - 9.95 ng/mL), FSH from 3- 84.3 (expected: 4.7- 21.5 IU/L; postmenopausal: 23.0-116.3), estradiol from <0.20- 169 (expected: 30-400 pg/mL; postmenopausal: 0 – 24), and progesterone from <0.20- 13 (expected follicular phase: 0.1 to 0.7 ng/mL; expected luteal phase: 2-25; postmenopausal: < 1). Two patients, ages 24 and 44, had AFC evaluated; follicle counts were 15-20 and 0-1, respectively (expected counts of 12-30 and 3-10, respectively). Most (6/8) survey respondents reported discussing fertility with their oncology team, though 5 were unsure if the risk of premature menopause was discussed. While most (5) women were not concerned about becoming infertile due to treatment, two were a little or somewhat concerned. Only one pt pursued fertility preservation before treatment (oocyte cryopreservation); among the other 7, most (5) did not know fertility preservation was an option. Seven pts reported that fertility concerns did not affect their treatment decisions. Prior to diagnosis, pts reported being a little (1), somewhat (1), quite a bit (3), or very (3) satisfied with their sexual health; sexual health satisfaction at T0 was similar. Most women (6) reported not having discussed the impact of treatment on sexual health with their oncology team. Conclusions: Pre-menopausal women undergoing ICIs or TKIs for NSCLC or melanoma face potential effects on ovarian function and sexual health . This study will help elucidate the longitudinal impact of these therapies to promote informed decision making.