dc.contributor.author | Saad, F | |
dc.contributor.author | de Bono, J | |
dc.contributor.author | Barthélémy, P | |
dc.contributor.author | Dorff, T | |
dc.contributor.author | Mehra, N | |
dc.contributor.author | Scagliotti, G | |
dc.contributor.author | Stirling, A | |
dc.contributor.author | Machiels, J-P | |
dc.contributor.author | Renard, V | |
dc.contributor.author | Maruzzo, M | |
dc.contributor.author | Higano, CS | |
dc.contributor.author | Gurney, H | |
dc.contributor.author | Healy, C | |
dc.contributor.author | Bhattacharyya, H | |
dc.contributor.author | Arondekar, B | |
dc.contributor.author | Niyazov, A | |
dc.contributor.author | Fizazi, K | |
dc.coverage.spatial | Switzerland | |
dc.date.accessioned | 2022-09-06T13:29:50Z | |
dc.date.available | 2022-09-06T13:29:50Z | |
dc.date.issued | 2022-06-21 | |
dc.identifier | S0302-2838(22)02407-1 | |
dc.identifier.citation | European Urology, 2022, pp. S0302-2838(22)02407-1 - | |
dc.identifier.issn | 0302-2838 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/5430 | |
dc.identifier.eissn | 1873-7560 | |
dc.identifier.eissn | 1873-7560 | |
dc.identifier.doi | 10.1016/j.eururo.2022.05.030 | |
dc.description.abstract | 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. | |
dc.format | Print-Electronic | |
dc.format.extent | S0302-2838(22)02407-1 - | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | ELSEVIER | |
dc.relation.ispartof | European Urology | |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/4.0/ | |
dc.subject | BRCA1/2 status | |
dc.subject | Brief Pain Inventory | |
dc.subject | DNA damage response alteration | |
dc.subject | Metastatic castration-resistant prostate cancer | |
dc.subject | Patient-reported outcomes | |
dc.subject | Poly(ADP-ribose) polymerase inhibitor | |
dc.subject | TALAPRO-1 trial | |
dc.subject | Talazoparib | |
dc.title | Patient-reported Outcomes in Men with Metastatic Castration-resistant Prostate Cancer Harboring DNA Damage Response Alterations Treated with Talazoparib: Results from TALAPRO-1. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2022-05-28 | |
dc.date.updated | 2022-09-06T13:24:47Z | |
rioxxterms.version | VoR | |
rioxxterms.versionofrecord | 10.1016/j.eururo.2022.05.030 | |
rioxxterms.licenseref.startdate | 2022-06-21 | |
rioxxterms.type | Journal Article/Review | |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/35750582 | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Prostate Cancer Targeted Therapy Group | |
pubs.publication-status | Published online | |
pubs.publisher-url | http://dx.doi.org/10.1016/j.eururo.2022.05.030 | |
icr.researchteam | PrCa Targeted Therapy | |
dc.contributor.icrauthor | De Bono, Johann | |
icr.provenance | Deposited by Mr Arek Surman on 2022-09-06. Deposit type is initial. No. of files: 1. Files: 1-s2.0-S0302283822024071-main.pdf | |