2026-06-14T02:07:31Zhttps://repisalud.isciii.es/rest/oai/request
oai:repisalud.isciii.es:20.500.12105/185702024-09-27T12:08:35Zcom_20.500.12105_15322com_20.500.12105_2051col_20.500.12105_16927
Repisalud author Mehra, Niven author Fizazi, Karim author de Bono, Johann S author Barthélémy, Philippe author Dorff, Tanya author Stirling, Adam author Machiels, Jean-Pascal author Bimbatti, Davide author Kilari, Deepak author Dumez, Herlinde author Buttigliero, Consuelo author van Oort, Inge M author Castro, Elena author Chen, Hsiang-Chun author Di Santo, Nicola author DeAnnuntis, Liza author Healy, Cynthia G author Scagliotti, Giorgio V 2024-02-27T14:57:38Z 2024-02-27T14:57:38Z 2022 10.1093/oncolo/oyac172 1549-490X The oncologist http://hdl.handle.net/10668/19827 36124924 http://hdl.handle.net/20.500.12105/18570 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. 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. 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]). 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. NCT03148795. eng BRCA PARP inhibitor castration-resistant prostatic cancer talazoparib Talazoparib, a Poly(ADP-ribose) Polymerase Inhibitor, for Metastatic Castration-resistant Prostate Cancer and DNA Damage Response Alterations: TALAPRO-1 Safety Analyses. research article