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ESMO 2021

ESMO 2021: Patient-Reported Pain in Men With Metastatic Castration-Resistant Prostate Cancer Receiving Talazoparib: TALAPRO-1

(UroToday.com) In the on-demand poster session of the European Society for Medical Oncology (ESMO) Annual Congress, Dr. Fred Saad presented a secondary analysis of the change in patient-reported pain among patients treated with talazoparib for metastatic castration-resistant prostate cancer (mCRPC) in the TALAPRO-1 trial (NCT03148795). This trial enrolled men with progressive mCRPC and an 11-gene panel assessing tumor DNA Damage Response Alterations (DDRm) involved either directly or indirectly in homologous recombination repair (HRR). In the context of the trial, included men had received 1–2 taxane-based chemotherapy and progressed on ≥1 novel hormonal therapy before inclusion. The primary study endpoint was objective response rate ([ORR] per RECIST v.1.1; central review).



While previously published, to briefly summarize, 1-arm phase II study, men with mCRPC and DNA Damage Repair alteration (DDRm) either directly or indirectly involved in homologous recombination repair (HRR) who had previously received taxane-based chemotherapy (CT) and progressed on ≥1 novel hormonal agent (NHT) (abiraterone and/or enzalutamide) received talazoparib (1mg/d). In this analysis of the secondary outcome, the authors assessed the change from baseline in patient-reported pain, measured by the Brief Pain Inventory-Short Form (BPI-SF). The patients completed the BPI-SF at baseline, every (q) 2 weeks until week 9, q4 weeks until week 25, and q12 weeks until disease progression. They then used a longitudinal mixed-effects model to estimate the mean overall change from baseline for pain burden (worst, severity, and interference). Kaplan-Meier method estimated time to deterioration (TTD) for worst pain, pain severity and time to 1st opioid use. TTD was defined as ≥ 2-point increase from baseline for 2 consecutive visits at least 4 weeks apart without a decrease in WHO analgesic usage score.

The authors included 97 patients with a baseline and ≥ 1 post baseline assessment. Among these patients, 56 had BRCA1/2 alterations. Improvements in the overall change from baseline in pain burden were observed in both groups.

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In the TTD analysis for worst pain, 84.0% of the overall analytic cohort and 82.9% of those with BRCA1/2 mutations had not deteriorated by month 12. In the TTD analysis for pain severity, 89.2% of the overall analytic cohort and 89.1% of the BRCA1/2 subset had not deteriorated by month 12.

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Additionally, the probability of remaining opioid free at 12-months was 56.6% for the overall analytic cohort and 56.7% for those with BRCA1/2 mutations.

The authors concluded that talazoparib improved pain burden in men with mCRPC harboring HRR/DDR alterations pretreated with taxanes and NHT.

Presented by: Fred Saad, MD, FRCS, Professor and Chief of Urology, Director of GU Oncology, Raymond Garneau Chair in Prostate Cancer, University of Montreal Hospital Centre (CHUM), Director, Prostate Cancer Research, Institut du cancer de Montréal/CRCHUM