(UroToday.com) The 2024 European Association of Urology (EAU) annual meeting featured a session on metastatic prostate cancer, and a presentation by Dr. Rossella Nicoletti discussing preliminary results from PIONEER, the development of a predictive model for death among patients with metastatic hormone sensitive prostate cancer (mHSPC). ADT was the standard of care for patients with mHSPC for decades.
Recently, emerging therapies (ARTA, taxane-based chemotherapy, and their combinations) associated with ADT have proven to be more effective than ADT alone. However, metastatic disease is still a clinical state that remains poorly understood and real-world data may have the potential for generating real-world evidence for designing and conducting confirmatory trials and answering questions that may not be addressed otherwise. The aim of this study presented at EAU 2024 was to develop and present preliminary results of a predictive model for death amongst patients with mHSPC treated with one of the approved treatment plans based on characteristics present at admission using real-world data under the PIONEER project.
Data of patients with mHSPC across a distributed network of observational databases were collected. Male patients without prior orchiectomy with mHSPC were enrolled in Cohort 1, while Cohort 2 was defined as the start of ADT as surrogate definition of mHSPC disease, both in the metachronous and synchronous setting. The study design for PIONEER is as follows:
Overall, 94,261 mHSPC patients were included of which 77,123 patients received treatment. The number of deaths by year after the index date is as follows:
The variables increasing odds of mortality were:
- Age > 90 years
- Non-ADC variants
- M1c disease
- liver metastasis
The variables decreasing odds of mortality were:
- Age < 80 years
- Adenocarcinoma of the prostate
- M1a-M1b disease
- Grade Group 3 or lower
- cT1 disease
Overall, 60% of deaths occurred in the first two years after date of diagnosis. The model can only predict death with reasonable certainty in the first year after diagnosis, with an accuracy of 74.3%:
This may be due to many factors, primarily the non-uniform mHSPC disease state, thus there is a need to better risk stratify these patients.
Dr. Nicoletti concluded this presentation discussing preliminary results from PIONEER with the following conclusions:
- This is the largest study in Europe with real-world data in the mHSPC setting
- The landscape of prostate cancer treatment is constantly evolving, so it is important to understand the behavior of the disease in real-world setting
- This prediction model shows promising results, however, a large validation cohort is needed to confirm the reliability of these findings
Presented by: Rossella Nicoletti, MD, University of Florence, Florence, Italy
Written by: Zachary Klaassen, MD, MSc - Urologic Oncologist, Associate Professor of Urology, Georgia Cancer Center, WellStar MCG Health, @zklaassen_md on Twitter during the 2024 European Association of Urology (EAU) annual congress, Paris, France, April 5th - April 8th, 2024