Trial reportCancer chemotherapy and pharmacology2022
Efficacy and safety exposure-response relationships of apalutamide in patients with metastatic castration-sensitive prostate cancer: results from the phase 3 TITAN study.
Trial report in Cancer chemotherapy and pharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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Who cites it
8 citing papers in PubMed, 13 citations in OpenAlex.
- Effect of apalutamide dosage on the incidence of cutaneous adverse events and prostate-specific antigen reduction in patients with prostate cancer.Oncology letters · 2026Article
- Apalutamide-induced rash and relative dose intensity in metastatic castration-sensitive prostate cancer: a multicenter Japanese cohort study.Translational andrology and urology · 2025Article
- Skin rash in metastatic hormone sensitive prostate cancer patients treated with apalutamide: a retrospective multicenter study in Korea.Prostate international · 2025Article
- Liquid chromatography-tandem mass spectrometry assay for the simultaneous determination of apalutamide and its active metabolite N-desmethyl apalutamide, and its application in real-world patients with castration-resistant prostate cancer.Frontiers in pharmacology · 2025Article
- Severe neutropenia caused by palliative radiation therapy in a case of metastatic hormone-sensitive prostate cancer.IJU case reports · 2024Article
- Cutaneous Adverse Reactions to Apalutamide: Case Series with Clinical and Pathological Correlations.Acta dermato-venereologica · 2024Article
- Real-world analysis of apalutamide-associated skin rash in Chinese patients with prostate cancer.World journal of urology · 2024Article
- Comparison of standard-dose and reduced-dose treatment of metastatic prostate cancer with enzalutamide, apalutamide or darolutamide: a rapid review.BMJ oncology · 2024Article
Corrections and comments
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Authors and funding
11 authors at 6 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeApalutamide plus androgen-deprivation therapy (ADT) has been approved for treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC) based on data from phase 3 TITAN study. This analysis was conducted to describe pharmacokinetics of apalutamide and N-desmethyl-apalutamide and explore relationships between apalutamide exposure and selected clinical efficacy and safety observations.
methods1052 patients were randomized to apalutamide + ADT (n = 525) or placebo + ADT (n = 527). A previously developed population pharmacokinetic model was applied. Cox regression analysis investigated the relationships between apalutamide exposure and overall survival (OS; n = 1004) and radiographic progression-free survival (rPFS; n = 1003). Logistic regression analysis assessed the relationships between apalutamide exposure and selected clinically relevant adverse events (n = 1051).
resultsApalutamide + ADT treatment was efficacious in extending rPFS and OS versus placebo + ADT. Within a relatively narrow apalutamide exposure range (coefficient of variation: 22%), no statistical association was detected between rPFS, OS and apalutamide exposure quartiles. Incidence of skin rash and pruritus increased significantly with increasing apalutamide exposure.
conclusionsDifferences in apalutamide exposure were not associated with clinically relevant differences in rPFS or OS in patients with mCSPC. Patients with increased apalutamide exposure are more likely to develop skin rash and pruritus. Dose reductions may improve these adverse events, based on an individual risk-benefit approach.
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