(UroToday.com) The 2023 American Urological Association (AUA) annual meeting held in Chicago, IL between April 28 and May 1st, 2023, was host to an advanced prostate cancer moderated poster session. Dr. Neal Shore presented the results of DEAR, a real-world study on darolutamide, enzalutamide, and apalutamide for non-metastatic castration-resistant prostate cancer (nmCRPC) patients using a United States-based urology network.
Second generation androgen receptor inhibitors (ARIs), darolutamide, enzalutamide, and apalutamide, are approved for nmCRPC patients secondary to their ability to prolong overall survival and metastasis-free survival following results of the ARAMIS,1 PROSPER,2 and SPARTAN3 trials, respectively. Given the non-metastatic, often asymptomatic nature of nmCRPC, drug tolerance, in addition to efficacy, is of utmost importance for these patients. However, real-world outcomes data from the use of different ARIs in clinical practice remain sparse. DEAR is the first study to use a single data source to assess real-world utilization and outcomes of nmCRPC patients treated with darolutamide, enzalutamide, and apalutamide.
This study employed a retrospective chart review using electronic medical records from the Precision Point Specialty network of US urology practices. All eligible patients had nmCRPC, no prior novel hormonal therapy, and initiated first ARI treatment from August 2019 to March 2022. Patients were stratified into 1 of 3 cohorts based on the first prescribed ARI in the nmCRPC stage. This interim report described:
- The proportions of patients who discontinued initial ARI treatment
- Patients who progressed to mCRPC
- The estimated probability of discontinuation/progression at 6-, 12-, 18-, and 24-months using survival analysis with Kaplan-Meier estimates
This analysis included 666 patients, grouped based on their initial ARI use:
- Darolutamide: 276
- Enzalutamide: 280
- Apalutamide: 110
The median patient age was approximately 80 years. 68-74% of men were Caucasian. The median PSA doubling time ranged between 6 and 7.8 months. There were no significant differences in baseline characteristics among patients across the three drug groups, with similar lengths of follow-up.
Overall, fewer patients discontinued treatment in the darolutamide cohort (28%) versus 38% and 46% for enzalutamide and apalutamide, respectively.
Dr. Shore concluded that in this interim analysis of DEAR, despite similar baseline characteristics, fewer darolutamide patients discontinued treatment or progressed to mCRPC compared with patients treated with enzalutamide or apalutamide.
Presented by: Neal Shore, MD, FACS, Urologist, Director, CPI, Carolina Urologic Research Center, Atlantic Urology Clinics, Myrtle Beach, SC
Written by: Rashid K. Sayyid, MD, MSc – Society of Urologic Oncology (SUO) Clinical Fellow at The University of Toronto, @rksayyid on Twitter during the 2023 American Urological Association (AUA) Annual Meeting, Chicago, IL, April 27 – May 1, 2023
References:
3. Smith MR, et al. Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer. N Engl J Med, 2018.