(UroToday.com) The 2024 GU ASCO annual meeting featured a prostate cancer session and a presentation by Dr. Arun Azad discussing patient reported outcomes from patients with novel hormonal therapy pretreatment in the phase 3 TALAPRO-2 study.
In TALAPRO-2, talazoparib + enzalutamide vs placebo + enzalutamide demonstrated significant improvement in radiographic progression-free survival, a manageable adverse event profile, and a delay in time to definitive clinical meaningful deterioration in global health status/quality of life overall and across all pre-specified subgroups.1 The impact of treatment on patients’ health related quality of life is important to consider because maintaining or improving health related quality of life is a major goal of treatment for mCRPC. This post hoc analysis presented at GU ASCO 2024 evaluated patient reported outcomes in patients with prior novel hormonal therapy treatment.
Patient reported outcomes were assessed on day 1 and scheduled visits (every 4 weeks until week 53 then every 8 weeks) until radiographic progression using the EORTC QLQ-C30 and its prostate cancer module, QLQ-PR25. Patient reported outcomes analyses, performed in novel hormonal therapy-pretreated patients for global health status/quality of life functional and symptom scales, included on treatment comparison of overall change from baseline (per longitudinal repeated measures mixed-effects model).
Of the 805 men randomized and treated, 49 patients were included in this subgroup analysis (talazoparib + enzalutamide n= 22; placebo + enzalutamide n= 27):
No statistically significant difference was observed in time to definitive deterioration in global health status/quality of life between arms (HR 0.55, 95% CI 0.22-1.33):
A statistically significant and clinically meaningful estimated overall change from baseline favored talazoparib + enzalutamide in:
- Physical functioning: 20.5, 95% CI 8.8, 32.2; p = 0.0007
- Role functioning: 20.4, 95% CI 4.8, 35.9; p = 0.0103
- Pain: -32.9, 95% CI -50.3, -15.5; p = 0.0002
- Constipation: -12.5, 95% CI -24.4, -0.6; p = 0.040
No statistically significant differences were observed in time to definitive deterioration in urinary symptoms between arms (HR 0.38, 95% CI 0.064-2.30):
Furthermore, there were no statistically significant or clinically meaningful differences in overall change from baseline favoring talazoparib + enzalutamide observed:
Dr. Azad concluded his presentation discussing patient reported outcomes from patients with novel hormonal therapy pretreatment in the phase 3 TALAPRO-2 study with the following take-home points:
- On treatment significant differences favoring talazoparib + enzalutamide were observed in the EORTC QLQ-C30 instrument in physical conditioning, role functioning, pain, and constipation
- On treatment differences in mean scores for each scale available from the EORTC QLQ-PR25 instrument were evaluated, and no statistically significant differences between the treatment arms were found
- Results should be interpreted with caution given the small sample sizes and exploratory nature of this analysis
Presented by: Arun Azad, MD, PhD, Peter MacCallum Cancer Centre; and Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia
Written by: Zachary Klaassen, MD, MSc – Urologic Oncologist, Associate Professor of Urology, Georgia Cancer Center, Wellstar MCG Health, @zklaassen_md on Twitter during the Genitourinary (GU) American Society of Clinical Oncology (ASCO) Annual Meeting, San Francisco, CA, Thurs, Jan 25 – Sat, Jan 27, 2024.
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