(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 podium session. Dr. Jason Hafron presented the results of the REAL ADT ORAL study, an analysis of a US EMR database that attempts to provide a real-world characterization of patients receiving relugolix or ADT injections in combination with oral anti-androgens.
Relugolix was FDA approved in December 2020 and became commercially available in January 2021 following the results of the HERO trial that demonstrated:1
- Superior castration rates through 48 weeks with relugolix versus leuprolide (97% versus 89%)
- Improved castration potency (Castrate levels at day 4: 56% versus 0%)
- Enhanced testosterone recovery (Mean testosterone levels 90 days after treatment discontinuation: 288.4 ng/dL versus 58.6 ng/dL)
- Lower incidence of major adverse CV events (3% versus 6%).
While ADT is often combined with androgen receptor signaling inhibitors (ARSIs) in practice, the combination of relugolix with the ARSI enzalutamide was shown to have similar efficacy and safety as other cohorts. Based on these findings, some current guidelines do not recommend the use of combination ARSIs and relugolix. The real-world use of combined relugolix with ARSIs in real-world practice remains unknown. As such, the objective of this study was to describe the demographic and clinical characteristics of patients prescribed oral relugolix in combination with other prostate cancer medications in a real-world setting.
This was a cross-sectional analysis using de-identified EMR data from 536,539 patients representing 89 community urology practices in the US (PPS Analytics). This analysis captured all patients on ADT in 2021, the first year of Relugolix’s availability. The study flow chart is demonstrated below. Starting with 150,000 patients, the investigators identified 3,096 patients using relugolix, of whom 542 used combination relugolix/ARSI.
Interestingly, the proportion of patients on combination ADT/ARSI did not vary by underlying ADT drug (relugolix, degarelix, or leuprolide) and was between 16.2 and 17.5%. Interestingly, there appears to be an increased uptake of relugolix, compared to degarelix and leuprolide, for patients receiving radiation therapy, likely secondary to the enhanced testosterone recovery observed in patients on reluoglix.1
The investigators next examined the ARSIs most frequently used in combination with the ADT agents. In all three groups (relugolix, degarelix, and leuprolide), enzalutamide was the most frequently co-prescribed ARSI, followed by apalutamide and abiraterone acetate.
Dr. Hafron concluded his presentation as follows:
- In this real-world analysis, oral relugolix in combination with an ARSI is prescribed by urologists in relatively large numbers and similar percentages, compared with injectable ADTs
- As additional data become available, future studies will focus on the duration of ADT in combination with other prostate cancer medications and associated outcomes
Presented by: Jason Hafron, MD, Professor of Urology, William Beaumont School of Medicine, Oakland University, Royal Oak, Michigan
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
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