BRCA 1/2: Patient-Reported Outcomes in Men With mCRPC Harboring DNA Damage Response Alterations Treated With Talazoparib

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This study evaluated the pain and health-related quality of life (HRQoL) outcomes in patients with metastatic castration-resistant prostate cancer (mCRPC) with DNA damage response (DDR)/homologous recombination repair (HRR) alterations who received talazoparib in the TALAPRO-1 study, with a special interest in the outcomes of patients harboring BRCA1/2 mutations. Overall, 97 men were treated with talazoparib (BRCA1/2, n = 56). The mean EQ-5D-5L index improved in all patients (change from the baseline value, 0.05), including the BRCA1/2 patient subset (change from the baseline value, 0.07). Similarly, the EQ-5D visual analog scale scores improved after the treatment (all patients, 5.42; BRCA1/2 subset, 4.74). An improvement in the overall mean worst pain score was noted in all patients (−1.08) and the BRCA1/2 patient subset (−1.15).

Overall, this study showed that the use of talazoparib was associated with improved HRQoL in all patients with mCRPC with DDR/HHR alterations and in the subset of patients with BRCA1/2 mutations.

– Kamal Sahu, MD

Abstract

This abstract is available on the publisher's site.

BACKGROUND

Talazoparib has shown antitumor activity with a manageable safety profile in men with metastatic castration-resistant prostate cancer (mCRPC) and DNA damage response (DDR)/homologous recombination repair (HRR) alterations.

OBJECTIVE

To evaluate patient-reported health-related quality of life (HRQoL) and pain in patients who received talazoparib in the TALAPRO-1 study, with a special interest in patients harboring breast cancer susceptibility gene 1 or 2 (BRCA1/2) mutations.

DESIGN, SETTING, AND PARTICIPANTS

TALAPRO-1 is a single-arm, phase 2 study in men with mCRPC DDR alterations either directly or indirectly involved in HRR, who previously received one to two taxane-based chemotherapy regimens for advanced prostate cancer and whose mCRPC progressed on one or more novel hormonal agents.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

Men completed the European Quality-of-life Five-dimension Five-level scale (EQ-5D-5L), EQ-5D visual analog scale (VAS), and Brief Pain Inventory-Short Form at predefined time points during the study. The patient-reported outcome (PRO) population included men who completed a baseline and one or more postbaseline assessments before study end. Longitudinal mixed-effect models assuming an unstructured covariance matrix were used to estimate the mean (95% confidence interval [CI]) change from baseline for pain and general health status measurements among all patients and patients with BRCA1/2 mutations.

RESULTS AND LIMITATIONS

In the 97 men in the PRO population treated with talazoparib (BRCA1/2, n = 56), the mean (95% CI) EQ-5D-5L Index improved (all patients, 0.05 [0.01, 0.08]; BRCA1/2 subset, 0.07 [0.03, 0.10]), as did the EQ-5D VAS scores (all patients, 5.42 [2.65, 8.18]; BRCA1/2 subset, 4.74 [1.07, 8.41]). Improvements in the estimated overall change from baseline (95% CI) in the mean worst pain were observed in all patients (-1.08 [-1.52, -0.65]) and the BRCA1/2 subset (-1.15 [-1.67, -0.62]). The probability of not having had experienced deterioration of worst pain by month 12 was 84% for all patients and 83% for the BRCA1/2 subset.

CONCLUSIONS

In heavily pretreated men with mCRPC and DDR/HRR alterations, talazoparib was associated with improved HRQoL in all patients and the BRCA1/2 subset. In both patient groups, worst pain improved from baseline and the probability of not experiencing a deterioration in worst pain with talazoparib was high.

PATIENT SUMMARY

We show that talazoparib was associated at least with no change or improvements in health-related quality of life (HRQoL) and pain burden in men with metastatic castration-resistant prostate cancer and DNA damage response/homologous recombination repair gene alterations in the TALAPRO-1 study. These findings in patient-reported HRQoL and pain complement the antitumor activity and tolerability profile of talazoparib.

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Additional Info

Article Citation

European Urology

Patient-reported Outcomes in Men with Metastatic Castration-resistant Prostate Cancer Harboring DNA Damage Response Alterations Treated with Talazoparib: Results from TALAPRO-1

Eur Urol 2022 Jun 21;[EPub Ahead of Print], F Saad, J de Bono, P Barthélémy, T Dorff, N Mehra, G Scagliotti, A Stirling, JP Machiels, V Renard, M Maruzzo, CS Higano, H Gurney, C Healy, H Bhattacharyya, B Arondekar, A Niyazov, K Fizazi

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

[Purple-Bike]

Interesting study, with the obvious limitation that it is single-arm, it would have been good to have a comparison with olaparib or other PARP inhibitors.