(UroToday.com) The 2025 GU ASCO annual meeting featured a prostate cancer session and a presentation by Dr. Amit Bahl discussing data from the RECOmMEnD study assessing a prospective real world data evaluation of clinical outcomes in metastatic hormone sensitive prostate cancer (mHSPC) patients treated as part of triplet therapy with darolutamide. Prostate cancer is the most common malignancy in males in the Western world, with approximately 30% of patients presenting with de novo metastatic disease, which is hormone sensitive.
Until 2015, ADT alone was the standard of care for mHSPC. The addition of chemotherapy and, more recently, androgen receptor targeted agents given as a double therapy have improved survival outcomes. Since November 2022, darolutamide has authorization for treatment of mHSPC in combination with docetaxel chemotherapy and ADT (triplet therapy) based on the ARASENS trial results.1 The RECOmMEnD study is a prospective real-world evaluation of clinical outcomes in patients with mHSPC treated with this regimen in the UK.
In this study, there were 318 patients enrolled from 21 UK centers over 20 months from November 2022, with a data cut-off of August 14, 2024. Disease characteristics were evaluated, and descriptive statistics were used for patient demographics, and PSA changes with treatment were analyzed. Physician assessed quality of life classified as “improved,” “stable,” or “declined” from baseline visit were reported.
Among the 318 patients, the median age was 67 (range: 38-84) years, with the majority of the patients having de novo metastatic disease (91.2%). Overall, 68.2% of patients had Gleason score ≥8 prostate cancer, and 76 patients (23.9%) had next generation imaging at diagnosis:
The distribution of metastases was: bone (84.9%), nodal (62.7%), lung (12.6%), and liver (2.5%). The median PSA level was 134 (range: 1 to 5,628) ng/mL at diagnosis. Reduction in median PSA was seen at all stages of treatment: start of darolutamide (11.1 ng/mL), start of docetaxel (6.42 ng/mL), and at the end of docetaxel chemotherapy (0.35 ng/mL):
PSA response in the 226 patients who had completed 6 cycles of docetaxel chemotherapy at the data cut-off included a PSA50 rate of 87.6% and PSA90 rate of 53.2%. PSA responses in those who only completed 4 or 5 cycles of docetaxel (n = 14) did not significantly differ compared to those who completed all 6 cycles (PSA50 p = 0.445 and PSA90 p = 0.664). At 6 months from darolutamide initiation, quality of life data is currently available for 174 patients, of which 88.5% reported either stable or improved quality of life, and 11.5% had a decline in quality of life at the end of chemotherapy.
Dr. Bahl concluded his presentation discussing data from the RECOmMEnD study assessing a prospective real world data evaluation of clinical outcomes in mHSPC patients treated as part of triplet therapy with darolutamide with the following take-home points:
- In this prospective real-world evaluation, mHSPC patients treated with ADT + docetaxel + darolutamide have comparable efficacy and tolerability to that seen in the ARASENS trial
- 88.4% of patients on triplet therapy had stable or improved quality of life at 6 months
- This is an important consideration for clinical teams and patients in the shared decision making regarding treatment options in mHSPC.
Presented by: Amit Bahl, MD, Bristol Hematology and Oncology Centre, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK
Written by: Zachary Klaassen, MD, MSc – Urologic Oncologist, Associate Professor of Urology, Georgia Cancer Center, Wellstar MCG Health, @zklaassen_md on Twitter during the 2025 Genitourinary (GU) American Society of Clinical Oncology (ASCO) Annual Meeting, San Francisco, CA, Thurs, Feb 13 – Sat, Feb 15, 2025.
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