Estetrol Prevents Hot Flushes and Improves Quality of Life in Patients with Advanced Prostate Cancer Treated with Androgen Deprivation Therapy: The PCombi Study

Parker, 2020, Prostate cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up, Ann Oncol, 31, 1119, 10.1016/j.annonc.2020.06.011 Ng, 2020, Metastatic hormone-sensitive prostate cancer (mHSPC): advances and treatment strategies in the first-line setting, Oncol Ther, 8, 209, 10.1007/s40487-020-00119-z Desai, 2021, Hormonal therapy for prostate cancer, Endocr Rev, 42, 354, 10.1210/endrev/bnab002 Cornford, 2021, EAU-EANM-ESTRO-ESUR-SIOG guidelines on prostate cancer. Part II—2020 update: treatment of relapsing and metastatic prostate cancer, Eur Urol, 79, 263, 10.1016/j.eururo.2020.09.046 Hammes, 2019, Impact of estrogens in males and androgens in females, J Clin Invest, 129, 1818, 10.1172/JCI125755 Frisk, 2010, Managing hot flushes in men after prostate cancer—a systematic review, Maturitas, 65, 15, 10.1016/j.maturitas.2009.10.017 Guise, 2007, Estrogenic side effects of androgen deprivation therapy, Rev Urol, 9, 163 Freedland, 2009, Androgen deprivation therapy and estrogen deficiency induced adverse effects in the treatment of prostate cancer, Prostate Cancer Prostat Dis, 12, 333, 10.1038/pcan.2009.35 Mawet, 2015, Unique effects on hepatic function, lipid metabolism, bone and growth endocrine parameters of estetrol in combined oral contraceptives, Eur J Contracept Reprod Health Care, 20, 463 Douxfils, 2020, Evaluation of the effect of a new oral contraceptive containing estetrol and drospirenone on hemostasis parameters, Contraception, 102, 396, 10.1016/j.contraception.2020.08.015 Coelingh Bennink, 2008, Oral bioavailability and bone-sparing effects of estetrol in an osteoporosis model, Climacteric, 11, 2, 10.1080/13697130701798692 Coelingh Bennink, 2021, Estetrol cotreatment of androgen deprivation therapy in infiltrating or metastatic, castration-sensitive prostate cancer: a randomized, double-blind, phase II trial (PCombi), Eur Urol Open Sci, 28, 52, 10.1016/j.euros.2021.04.005 Gerard, 2022, Profile of estetrol, a promising native estrogen for oral contraception and the relief of climacteric symptoms of menopause, Expert Rev Clin Pharmacol, 15, 121, 10.1080/17512433.2022.2054413 Coelingh Bennink, 2008, Estetrol review: profile and potential clinical applications, Climacteric, 11, 47, 10.1080/13697130802073425 Azam, 2019, Performance status assessment by using ECOG (Eastern Cooperative Oncology Group) score for cancer patients by oncology healthcare professionals, Case Rep Oncol, 12, 728, 10.1159/000503095 Esper, 1997, Measuring quality of life in men with prostate cancer using the Functional Assessment of Cancer Therapy-Prostate instrument, Urology, 50, 920, 10.1016/S0090-4295(97)00459-7 Cella, 2009, Estimating clinically meaningful changes for the Functional Assessment of Cancer Therapy-Prostate: results from a clinical trial of patients with metastatic hormone-refractory prostate cancer, Value Health, 12, 124, 10.1111/j.1524-4733.2008.00409.x Shore, 2020, Optimizing the role of androgen deprivation therapy in advanced prostate cancer: challenges beyond the guidelines, Prostate, 80, 527, 10.1002/pros.23967 Iversen, 2011, Hot flushes in prostatic cancer patients during androgen-deprivation therapy with monthly dose of degarelix or leuprolide, Prostate Cancer Prostat Dis, 14, 184, 10.1038/pcan.2011.11 Dearnaley, 2020, Eur Urol, 78, 184, 10.1016/j.eururo.2020.03.001 Shore, 2020, Oral relugolix for androgen-deprivation therapy in advanced prostate cancer, N Engl J Med, 382, 2187, 10.1056/NEJMoa2004325 Nishiyama, 2004, Influence of hot flashes on quality of life in patients with prostate cancer treated with androgen deprivation therapy, Int J Urol, 11, 735, 10.1111/j.1442-2042.2004.00896.x Langley, 2013, Cardiovascular outcomes in patients with locally advanced and metastatic prostate cancer treated with luteinising-hormone-releasing-hormone agonists or transdermal oestrogen: the randomised, phase 2 MRC PATCH trial (PR09), Lancet Oncol, 14, 306, 10.1016/S1470-2045(13)70025-1 Gilbert, 2017, Quality-of-life outcomes from the Prostate Adenocarcinoma: TransCutaneous Hormones (PATCH) trial evaluating luteinising hormone-releasing hormone agonists versus transdermal oestradiol for androgen suppression in advanced prostate cancer, BJU Int, 119, 667, 10.1111/bju.13687 Dobbs, 2019, Estrogens and prostate cancer, Prostate Cancer Prostat Dis, 22, 185, 10.1038/s41391-018-0081-6 Holzbeierlein, 2006, Managing complications of androgen deprivation therapy for prostate cancer, Urol Clin North Am, 33, 181, 10.1016/j.ucl.2005.12.008 Harle, 2006, Endocrine complications of androgen-deprivation therapy in men with prostate cancer, Clin Adv Hematol Oncol, 4, 687 Cook, 1973, Pre-estrogen irradiation of the breast to prevent gynecomastia, Am J Roentgenol, 117, 662, 10.2214/ajr.117.3.662 Hutton, 2020, Comparing interventions for management of hot flashes in patients with breast and prostate cancer: a systematic review with meta-analyses, Oncol Nurs Forum, 47, E86 Ahmadi, 2014, Androgen deprivation therapy for prostate cancer: long-term safety and patient outcomes, Patient Relat Outcome Meas, 5, 63 Yu, 2015, Selective estrogen receptor alpha agonist GTx-758 decreases testosterone with reduced side effects of androgen deprivation therapy in men with advanced prostate cancer, Eur Urol, 67, 334, 10.1016/j.eururo.2014.06.011 Allan, 2014, Androgen deprivation therapy complications, Endocr Relat Cancer, 21, T119, 10.1530/ERC-13-0467 Coelingh Bennink, 2018, A dose-escalating study with the fetal estrogen estetrol in healthy men, J Clin Endocrinol Metab, 103, 3239, 10.1210/jc.2018-00147