Apalutamide Boosts 24-Month OS in Real-World Population With Metastatic Castration-Sensitive Prostate Cancer
- kenashman
- May 13
- 2 min read
Onclive 14 April 2025 : Ashley Chan
Treatment with apalutamide (Erleada) demonstrated consistent 24-month overall survival (OS) data between real-world patients with metastatic castration-sensitive prostate cancer (mCSPC) and those treated in the phase 3 TITAN trial (NCT02489318).
The rationale of the real-world study was to compare the 24-month OS outcomes in the proportion of ARPI-naive patients with mCSPC who recently initiated apalutamide vs enzalutamide or apalutamide vs abiraterone acetate.
In the study, patients were evaluated as having mCSPC if they had a diagnosis code or clinical indicator for bone, nodal, or visceral metastasis, without castration resistance before or on the index date. Patients were also naive to ARPIs and were not previously treated with estrogens, immunotherapy, PARP inhibitors, or radiopharmaceutical therapy. Notably, castration resistance was evaluated based on a previously published algorithm that incorporated the presence of ADT—identified in both Precision Point Specialty (PPS) Analytics and the Komodo Research Claims Database (KRD)—and prostate-specific antigen (PSA) levels with clinical notes from the electronic medical record by PPS.
Limitations of this real-world study included the potential for selection and information bias because of miscoding or misclassification in clinical records or claims data, a sole database reflection of a community urology perspective, missing deaths from KRD despite high capture rates of 90% or greater, residual differences post-IPTW associated with a high-risk indication for abiraterone acetate, and the confinement that the regression analysis could only adjust for measured covariates with the potential of remaining confounding variables.
“In phase 3 trials, OS was assessed at prespecified time points. In these real-world studies, OS was assessed [for] 24 months for evaluation of statistical comparison. Longer follow-up may better estimate the full clinical benefit of apalutamide,” the poster authors concluded.
