Dr. Tombal, one of the co-authors, presented the patient-reported outcomes (PROs) from the study. The emphasis is on health-related quality of life (HRQOL), as it has been demonstrated to be associated with overall and progression-free survival – even in the setting of prostate cancer (TERRAIN and PREVAIL trials). As metastatic prostate cancer can be associated with significant symptoms, patient reported outcomes is just as important as oncologic outcomes.
PRO measures were assessed at baseline and every 16 weeks (4 months) while on treatment. HRQOL assessments included Brief Pain Inventory Short Form (BPI-SF), Functional Assessment of Cancer Therapy – Prostate (FACT-P), and EQ-5D-5L (a validated European QOL assessment). The analysis was done all patients in the intent-to-treat population (all patients randomized, whether they got assigned treatment or not).
Herein, the baseline data is presented. While much of the information is in tables on the poster, key findings are below.
- Median age of the population was 74, but ~50% of the population was older than 75
- Patients were predominantly from Europe
- >75% had ECOG 0 – fully functional, no limitations
- Majority (89%) did not use bone targeting agents at baseline
- These were high-risk patients, >75% had PSADT <6 months
- 54% had prior prostate surgical procedure, 45% did not
- 73.5% were asymptomatic at baseline, and only 14.6% were severely symptomatic
- Median score was 0 (scored from 0-10)
- Total and 4 sub-section (physical well-being, social/family well-being, functional well-being, emotional well-being) all indicated that patients had HRQOL at baseline
- Median total score 121.2 (scored from 0-156, range 39.2-155)
- Baseline scores comparable to non-metastatic CRPC and mCRPC chemo-naïve patients in STRIVE, TERRAIN, PREVAIL studies
- Also demonstrated high baseline function
- Median utility index score was 0.94 (0-1.0)
- 36.7% actually reported the best possible health score – compares favorably to 47.6% in a general population assessment
Ultimately, this assessment of the baseline characteristics demonstrate that, for the most part, cM0 CRPC patients are quite asymptomatic and have good baseline HRQOL. Treatment strategies should aim to effectively treat disease without compromising this QOL.
Presented by: Bernard Tombal, MD
Co-Authors: Hussain M., Penson D., Attard G., Sternberg C.N., Phung D., Naidoo S., Modelska K., Demirhan E., Ramaswamy K., Ivanescu C., Saad F.
Written by: Thenappan Chandrasekar, MD Clinical Fellow, University of Toronto, twitter: @tchandra_uromd at the 2018 European Association of Urology Meeting EAU18, 16-20 March, 2018 Copenhagen, Denmark
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