GU Symposium 2021: Final TITAN Trial Results in Metastatic Prostate Cancer
Posted: Monday, February 22, 2021
Patients with metastatic castration-sensitive prostate cancer who were undergoing androgen-deprivation therapy appeared to derive an overall survival benefit from treatment with apalutamide compared with a placebo, according to Kim N. Chi, MD, of the BC Cancer and Vancouver Prostate Centre, Canada, and colleagues. The final analysis of efficacy and safety results from the phase III TITAN trial were presented during the virtual edition of the 2021 Genitourinary (GU) Cancers Symposium (Abstract 11).
“Based on these data, androgen-deprivation therapy alone should no longer be considered sufficient for patients with advanced, castration-sensitive disease,” Dr. Chi commented in a press release.
In this trial, a total of 1,052 patients were randomly assigned in a 1:1 ratio to receive androgen-deprivation therapy in combination with apalutamide or a placebo. Follow-up data were provided for a median of 44 months.
After the results were unblinded, 39.5% of the placebo group crossed over to apalutamide. The median duration of treatment was longer with apalutamide than with the placebo (39.3 vs. 20.2 months, respectively); in patients who crossed over to apalutamide, the median duration of treatment was 15.4 months. The median duration of overall survival was not estimable with apalutamide and was 52.2 months with the placebo (P < .0001). After crossover adjustments were made, the median duration of overall survival was not estimable with apalutamide and was 39.8 months with the placebo (P < .0001).
The 48-month survival rates were 65% and 52% with apalutamide and the placebo, respectively. The time to second disease progression (both not estimable; P < .0001) and castration resistance (not estimable vs. 11.4 months; P < .0001) favored apalutamide versus the placebo. Health-related quality of life was maintained in patients treated with apalutamide and was not different from those treated with the placebo. The safety profile appeared to be congruent with previous reports.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.