(UroToday.com) The 2022 ESMO annual meeting featured a prostate cancer session, including a presentation by Dr. Sumati Gupta discussing real-world first-line treatment patterns in patients with high-risk nmCRPC. nmCRPC affects approximately 100,000 men in the US, with an annual estimated incidence of 50,000-60,000 cases/year. Patients with nmCRPC are at high risk of developing metastases if they have a PSA doubling time of ≤10 months or Gleason score ≥8. Combining androgen deprivation therapy (ADT) with novel hormone therapies (apalutamide, darolutamide, or enzalutamide) prolongs metastasis-free survival (MFS)1-3 and overall survival (OS)4-6 in nmCRPC, but data on the use of these therapies in real-world settings are minimal. Dr. Gupta and colleagues assessed the real-world use of novel hormone therapies in men with high-risk nmCRPC in the United States.
This retrospective study used the Optum electronic health records database from 2007–2020. Eligible patients were adult men (≥18 years) with nonmetastatic prostate cancer from 2007–2019 who had surgical castration or use of ADT for ≥6 months post-prostate cancer diagnosis. The nmCRPC index date was defined as the date of the first PSA value ≥2 ng/mL and ≥25% above the nadir that occurred during ADT or after surgical castration. Patients with metastasis within 12 months pre-index were excluded. High-risk patients had a PSA doubling time of ≤10 months or Gleason score ≥8. First-line treatment included agents received within 90 days post index. Patient characteristics and first-line treatment distributions were analyzed descriptively.
Of 1,572 patients with high-risk nmCRPC, 48.2% received ADT only, 32.9% received ADT + first-generation nonsteroidal antiandrogens, 8.8% received ADT + novel hormone therapy (including abiraterone), and 10.1% received other regimens as first-line treatment. Patient characteristics were generally similar across treatment groups:
By 2018–2020, use of ADT + novel hormone therapy increased but remained <25% of first-line treatment regimens:
Importantly, in 2018–2020 after approvals of novel hormone therapies, most patients received ADT ± nonsteroidal antiandrogens, including those with a PSA doubling time ≤4 months.
Dr. Gupta concluded this study discussing real-world first-line treatment patterns in patients with high-risk nmCRPC with the following take-home messages:
- Despite level 1 evidence showing improved MFS and OS with ADT + novel hormone therapy, these regimens were underutilized in patients with high-risk nmCRPC, even in those with a PSA doubling time ≤4 months and as recently as 2018–2020
- This study emphasizes the need for real-world data to help highlight deviations from guidelines and quality metrics. Further studies are needed to assess the obstacles behind treatment intensification in patients with high-risk nmCRPC
Presented by: Sumati Gupta, MD, Department of Medicine, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT
Written by: Zachary Klaassen, MD, MSc – Urologic Oncologist, Assistant Professor of Urology, Georgia Cancer Center, Augusta University/Medical College of Georgia, @zklaassen_md on Twitter during the 2022 European Society of Medical Oncology (ESMO) Annual Hybrid Meeting, Paris, FR, Fri, Sept 9 – Tues, Sept 13, 2022.
References:
- Smith MR, Saad F, Chowdhury S, et al. Apalutamide treatment and metastasis-free survival in prostate cancer. N Engl J Med 2018;378(15):1408-1418.
- Fizazi K, Shore N, Tammela TL, et al. Darolutamide in nonmetastatic castration-resistant prostate cancer. N Engl J Med. 2019;380(13):1235-1246.
- Hussain M, Fizazi K, Saad F, et al. Enzalutamide in men with nonmetastatic, castration-resistant prostate cancer. N Engl J Med. 2018 Jun 28;378(26):2465-2474.
- Smith MR, Saad F, Chowdhury S, et al. Apalutamide and Overall Survival in Prostate Cancer. Eur Urol. 2021 Jan;79(1):150-158.
- Fizazi K, Shore N, Tammela TL, et al. Nonmetastatic, Castration-Resistant Prostate Cancer and Survival with Darolutamide. N Engl J Med. 2020 Sep 10;383(11):1040-1049.
- Sternberg CN, Fizazi K, Saad F, et al. Enzalutamide and Survival in Nonmetastatic, Castration-Resistant Prostate Cancer. N Engl J Med. 2020 Jun 4;382(23):2197-2206.