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A study found no significant HRQOL differences between Erleada-based therapies and ADT plus AAP for advanced castration-sensitive prostate cancer.
Study finds Erleada-based prostate cancer therapies showed similar quality of life outcomes compared to standard treatment.
Among patients with advanced castration-sensitive prostate cancer, health-related quality of life (HRQOL) was not statistically different between those receiving Erleada (apalutamide) alone (APA) or APA plus Zytiga (abiraterone acetate) and Deltasone (prednisone) (AAP), compared with those receiving androgen-deprivation therapy (ADT) plus AAP, according to study findings published in JAMA Network Open.
Health-related quality of life was evaluated using the Functional Assessment of Cancer Therapy–Prostate (FACT-P) questionnaire and its subscales. The questionnaire was completed at baseline and every four weeks until week 25. FACT-P scores range from 0 to 156, with higher scores indicating better quality of life, according to study authors.
There were no significant differences in baseline mean FACT-P total scores or subscales across the three treatment groups: ADT plus AAP, 118.5; APA alone, 116.1; and AAP plus APA, 114.9.
Health-related quality of life was maintained during the treatment period, with no statistically significant differences at 25 weeks in mean FACT-P total scores or subscales: ADT plus AAP, 122.3; APA alone, 119.5; and AAP plus APA, 119.9.
Overall Survival: time from treatment to death from any cause.
PSA Level: blood marker for prostate health.
Castration-sensitive: cancer responsive to testosterone suppression.
Gynecomastia: male breast enlargement.
ADT: lowers androgens to slow prostate cancer.
The APA alone and AAP plus APA groups did not lead to meaningful improvements in HRQOL compared to the ADT plus AAP group, except in time to deterioration of the emotional well-being score. This outcome was more favorable in the APA-alone group, with a 63% reduction in risk compared to the ADT plus AAP group, which had a 44% reduction in risk.
“For patients with castration-sensitive disease, HRQOL is particularly relevant due to symptom burden, a prolonged course of disease with potentially life-long treatments that induce testosterone suppression and its well-known consequences, and multiple treatment options with varying adverse event profiles,” study authors wrote.
A prostate-specific antigen (PSA) level of 0.2 nanograms per milliliter or lower at week 25 was observed in 31 of 41 patients (75.6%) in the ADT plus AAP group, 24 of 40 patients (60%) in the APA-alone group and 31 of 39 patients (79.5%) in the APA plus AAP group.
The two-year overall survival rates were 92.5% for the ADT plus AAP group, 87.9% for the APA-alone group and 92.7% for the APA plus AAP group.
Treatment-related side effects of any grade were reported in 30 of 42 patients (71.4%) in the ADT plus AAP group, 34 of 42 patients (81%) in the APA-alone group and 36 of 44 patients (81.8%) in the APA plus AAP group.
Grade 3 (severe) and 4 (life-threatening) treatment-related side effects occurred in eight of 42 patients (19%) in the ADT plus AAP group, seven of 42 patients (16.7%) in the APA-alone group and 10 of 44 patients (22.7%) in the APA plus AAP group. Lower rates of hot flashes and hypertension were reported in the APA-alone group.
Gynecomastia affected 23 of 42 patients (54.8%), and breast pain was reported by six of 42 patients (14.3%) in the APA-alone group, both higher than rates observed in the other two groups. No new safety signals were detected in the study.
Reference:
“Androgen Receptor Pathway Inhibitor Therapy for Advanced Prostate Cancer: Secondary Analysis of a Randomized Clinical Trial” by Dr. Diogo Assed Bastos et al., JAMA Network Open.
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