In a recent study presented at ESMO Virtual Congress 2020, data reported on apalutamide (APA) administered in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) is comparable between real-world data from an international named patient program (NPP) and phase 3 SPARTAN clinical trial results.
For the NPP, a total of 556 patients with nmCRPC received APA pre-approval administration. After a follow-up of 10 months for both cohorts, APA treatment continuation was evaluated and compared using Kaplan Meier analyses and multivariable Cox proportional hazard regression.
The researchers found that the median age for both NPP and SPARTAN was 74, with the age range being 49-93 for NPP and 48-94 for SPARTAN. The number of patients still on APA at 10 months was greater in the NPP cohort compared with the SPARTAN group (83% vs 78.8%). The primary reasons for treatment discontinuation in the first 10 months in NPP vs SPARTAN included investigator-assessed progressive disease (28.1% vs 28.2%, respectively), adverse events (31.4% vs 42.4%), or withdrawal by patient (21.9% vs 22.9%). Overall, patients at a higher age were more likely to discontinue treatment with APA.
"This is the first report on real world nmCRPC [patients] administered with APA. This report demonstrates a trend towards improved rates of APA continuation after [the] first 10 [month] follow up compared with those previously reported in a large phase III study," concluded the study authors, led by Heather Payne, MBBS, FRCP, FRCR, Consultant in Clinical Oncology at the University College Hospital in London, England. "The reasons for APA discontinuation during [the] first 10 [months] of APA administration also appear to be comparable."
For More Information
Payne HA, Bulbul M, Hatzimouratidis S, et al (2020). Apalutamide for non-metastatic castration resistant prostate cancer (NMCRPC): a comparison of real-life experience from an international named patient program (NPP) vs the prior phase III clinical study. Ann Oncol (ESMO Annual Meeting Abstracts), 30(suppl_4):S507-S549. Abstract 630P. DOI:10.1016/annonc/annonc275
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