DEAR study: 使用Darolutamide、Enzalutamide及Apalutamide治療非轉移性去勢抗性攝護腺癌病患之真實世界數據: 以美國泌尿科病例回溯性研究

陳忠信¹, Neal D. Shore,² Nasreen Khan,³ Niculae Constantinovici,⁴ Javeed Khan,⁵ Guifang Chen,³ Julie Xu,⁶ Vlasta Hlebec,³ Alicia K. Morgans,⁷ Daniel J. George⁸

¹國立臺灣大學醫學院附設醫院, ²Carolina Urologic Research Center, Myrtle Beach, SC, USA; ³Bayer HealthCare, Whippany, NJ, USA; ⁴Bayer Consumer Care AG, Basel, Switzerland; ⁵Bayer plc, Reading, United Kingdom; ⁶Bayer Canada, Mississauga, ON, Canada; ⁷Dana-Farber Cancer Institute, Boston, MA, USA; ⁸Duke University Cancer Institute, Durham, NC, USA

Real-world Study on Darolutamide, Enzalutamide, and Apalutamide for Nonmetastatic Castration-Resistant Prostate Cancer Patients Using a Urology Network in the United States (DEAR Study)

Chung-Hsin Chen,¹ presenting on behalf of Neal D. Shore,² Nasreen Khan,³ Niculae Constantinovici,⁴ Javeed Khan,⁵ Guifang Chen,³ Julie Xu,⁶ Vlasta Hlebec,³ Alicia K. Morgans,⁷ Daniel J. George⁸

¹National Taiwan University Hospital, Taipei City, Taiwan; ²Carolina Urologic Research Center, Myrtle Beach, SC, USA; ³Bayer HealthCare, Whippany, NJ, USA; ⁴Bayer Consumer Care AG, Basel, Switzerland; ⁵Bayer plc, Reading, United Kingdom; ⁶Bayer Canada, Mississauga, ON, Canada; ⁷Dana-Farber Cancer Institute, Boston, MA, USA; ⁸Duke University Cancer Institute, Durham, NC, USA

Purpose: Second-generation androgen receptor inhibitors (ARIs) are recommended for patients with nonmetastatic castration-resistant prostate cancer (nmCRPC) due to their ability to prolong overall survival and metastasis-free survival. Besides efficacy, drug tolerance is also important, especially as these patients are often asymptomatic from their disease. However, there is limited information on real-world (RW) outcomes from the use of different ARIs. DEAR is the first study using a single data source to assess RW utilization and outcomes of darolutamide (daro), enzalutamide (enza), and apalutamide (apa) in patients with nmCRPC.

Materials and Methods: This is a retrospective chart review study using electronic medical records from the Precision Point Specialty network of US urology practices. Eligible patients had nmCRPC, no prior novel hormonal therapy, and were initiated on first ARI treatment from August 2019 to March 2022. Patients were stratified into 3 cohorts based on the first prescribed ARI in the nmCRPC stage. This report describes the proportions of patients who discontinued initial ARI treatment, patients who progressed to metastatic CRPC (mCRPC), and the estimated probability of discontinuation/progression at 6, 12, 18, and 24 months using Kaplan-Meier estimates.

Results: In total, 870 patients were included (daro/enza/apa, n=362/382/126). Median age (80/79/80 years), White race (66%/66%/74%), and median prostate-specific antigen doubling time (6.8/6.4/7.4 months) were similar in the daro/enza/apa cohorts at baseline. Median length of follow-up was similar (Table). Overall, a lower proportion of patients discontinued treatment in the daro cohort (30.4%) vs 40.8%/46.0% for enza/apa, and a lower proportion of patients progressed to mCRPC in the daro cohort (17.7%) compared with enza or apa (28.3%/27.8%). Generally, the estimated probability of discontinuation/progression was numerically lower for daro compared with enza or apa. 

Conclusions: Despite similar baseline characteristics and duration of follow-up, a lower proportion of daro patients discontinued treatment or progressed to mCRPC compared with enza or apa.