A recent clinical trial analysis has demonstrated that health-related quality of life (HRQOL) outcomes remain consistent across different treatment combinations involving Erleada (apalutamide) in patients with advanced castration-sensitive prostate cancer.
The study, published in JAMA Network Open, compared three treatment regimens: androgen-deprivation therapy (ADT) plus Zytiga (abiraterone acetate) and Deltasone (prednisone) (AAP), Erleada alone (APA), and Erleada combined with Zytiga and Deltasone (APA plus AAP).
Quality of Life Assessment Results
Researchers utilized the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire to evaluate patient quality of life, with scores ranging from 0 to 156 (higher scores indicating better quality of life). Baseline mean FACT-P total scores showed minimal variation across groups: 118.5 for ADT plus AAP, 116.1 for APA alone, and 114.9 for AAP plus APA.
At the 25-week mark, quality of life measurements remained stable, with mean FACT-P total scores of 122.3, 119.5, and 119.9 for the respective groups. Notably, the Erleada monotherapy group demonstrated a 63% reduction in risk for emotional well-being score deterioration compared to 44% in the ADT plus AAP group.
Treatment Efficacy Markers
The study revealed promising efficacy outcomes across all treatment arms. PSA response rates, defined as levels of 0.2 ng/mL or lower at week 25, were achieved in:
- 75.6% of patients receiving ADT plus AAP
- 60% of patients on Erleada alone
- 79.5% of patients receiving the Erleada plus AAP combination
Two-year overall survival rates remained robust across all groups, with 92.5% for ADT plus AAP, 87.9% for Erleada alone, and 92.7% for the combination therapy.
Safety Profile and Side Effects
Treatment-related adverse events were observed across all groups, with similar overall incidence rates:
- 71.4% in the ADT plus AAP group
- 81% in the Erleada monotherapy group
- 81.8% in the combination therapy group
Severe to life-threatening (Grade 3-4) side effects occurred in 19%, 16.7%, and 22.7% of patients across the respective groups. The Erleada monotherapy group showed lower rates of hot flashes and hypertension but experienced higher rates of gynecomastia (54.8%) and breast pain (14.3%).
The findings hold particular significance for patients with castration-sensitive disease, where quality of life considerations are crucial due to the extended treatment duration and potential lifetime requirement for testosterone suppression therapy. The study authors emphasized the importance of these results given the various treatment options available and their distinct side effect profiles.
