{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,7]],"date-time":"2026-03-07T19:12:42Z","timestamp":1772910762328,"version":"3.50.1"},"reference-count":45,"publisher":"Oxford University Press (OUP)","issue":"10","license":[{"start":{"date-parts":[[2022,9,19]],"date-time":"2022-09-19T00:00:00Z","timestamp":1663545600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,10,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>The phase II TALAPRO-1 study (NCT03148795) demonstrated durable antitumor activity in men with heavily pretreated metastatic castration-resistant prostate cancer (mCRPC). Here, we detail the safety profile of talazoparib.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Patients and Methods<\/jats:title>\n                  <jats:p>Men received talazoparib 1 mg\/day (moderate renal impairment 0.75 mg\/day) orally until radiographic progression, unacceptable toxicity, investigator decision, consent withdrawal, or death. Adverse events (AEs) were evaluated: incidence, severity, timing, duration, potential overlap of selected AEs, dose modifications\/discontinuations due to AEs, and new clinically significant changes in laboratory values and vital signs.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>In the safety population (N = 127; median age 69.0 years), 95.3% (121\/127) experienced all-cause treatment-emergent adverse events (TEAEs). Most common were anemia (48.8% [62\/127]), nausea (33.1% [42\/127]), decreased appetite (28.3% [36\/127]), and asthenia (23.6% [30\/127]). Nonhematologic TEAEs were generally grades 1 and 2. No grade 5 TEAEs or deaths were treatment-related. Hematologic TEAEs typically occurred during the first 4-5 months of treatment. The median duration of grade 3-4 anemia, neutropenia, and thrombocytopenia was limited to 7-12 days. No grade 4 events of anemia or neutropenia occurred. Neither BRCA status nor alteration origin significantly impacted the safety profile. The median (range) treatment duration was 6.1 (0.4-24.9) months; treatment duration did not impact the incidence of anemia. Only 3 of the 15 (11.8% [15\/127]) permanent treatment discontinuations were due to hematologic TEAEs (thrombocytopenia 1.6% [2\/127]; leukopenia 0.8% [1\/127]).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>Common TEAEs associated with talazoparib could be managed through dose modifications\/supportive care. Demonstrated efficacy and a manageable safety profile support continued evaluation of talazoparib in mCRPC.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>ClinicalTrials.gov identifier<\/jats:title>\n                  <jats:p>NCT03148795<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/oncolo\/oyac172","type":"journal-article","created":{"date-parts":[[2022,9,20]],"date-time":"2022-09-20T10:12:31Z","timestamp":1663668751000},"page":"e783-e795","source":"Crossref","is-referenced-by-count":16,"title":["Talazoparib, a Poly(ADP-ribose) Polymerase Inhibitor, for Metastatic Castration-resistant Prostate Cancer and DNA Damage Response Alterations: TALAPRO-1 Safety Analyses"],"prefix":"10.1093","volume":"27","author":[{"given":"Niven","family":"Mehra","sequence":"first","affiliation":[{"name":"Department of Medical Oncology, Radboud University Medical Center , Nijmegen , The 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Therapeutics, City of Hope Comprehensive Cancer Center , Duarte, CA , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adam","family":"Stirling","sequence":"additional","affiliation":[{"name":"ICON Cancer Centre , Queensland , Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jean-Pascal","family":"Machiels","sequence":"additional","affiliation":[{"name":"Medical Oncology, Cliniques Universitaires Saint-Luc , Brussels , Belgium"},{"name":"Medical Oncology, Universit\u00e9 catholique de Louvain (UCLouvain) , Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Davide","family":"Bimbatti","sequence":"additional","affiliation":[{"name":"Medical Oncology 1 Unit, Department of Oncology, Istituto Oncologico Veneto IOV IRCCS , Padova , Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Deepak","family":"Kilari","sequence":"additional","affiliation":[{"name":"Division of Hematology and Oncology, Medical 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Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3691-6454","authenticated-orcid":false,"given":"Elena","family":"Castro","sequence":"additional","affiliation":[{"name":"Hospital Universitario Virgen de la Victoria, Instituto de Investigaci\u00f3n Biom\u00e9dica de M\u00e1laga (IBIMA) , M\u00e1laga , Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hsiang-Chun","family":"Chen","sequence":"additional","affiliation":[{"name":"Biostatistics, Pfizer Inc ., La Jolla, CA , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7210-734X","authenticated-orcid":false,"given":"Nicola","family":"Di Santo","sequence":"additional","affiliation":[{"name":"Global Product Development, Pfizer Inc ., Durham, NC , 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