Patient-Reported Outcomes and Changes in PSA in Patients With Advanced Prostate Cancer Treated With Apalutamide in the SPARTAN and TITAN Studies

Transcript:

Background

• In phase 3 placebo-controlled trials using androgen deprivation therapy (ADT), the addition of apalutamide in patients with nonmetastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-sensitive prostate cancer (mCRPC) resulted in the following:
  • Improved overall survival
  • Reduced risk of disease progression
  • Preserved health-related quality of life
• In many patients, prostate-specific antigen (PSA) responses were rapid and deep, with reduction to 0.2 ng/mL or less or 90% or greater reduction compared with baseline.
• Reduction was associated with extended metastasis-free survival or radiographic progression-free survival.
• The objective of this post hoc analysis of the SPARTAN (NCT01946204) and TITAN (NCT02489318) trials was to explore the relationship between rapid and deep PSA decline with health-related quality of life following apalutamide treatment.

Methods

• Patients were randomized to 28-day cycles of apalutamide 240 mg every day or placebo.
• Patient-reported outcomes were assessed at baseline, specific cycles during treatment, and postprogression up to 1 year via paper or electronic surveys.
• A month 3 landmark analysis and a month 6 landmark analysis evaluated PSA decline and time to subsequent deterioration in patient-reported outcomes.
• Time-to-event end points were analyzed by Kaplan-Meier method and Cox proportional hazards model

Results and Conclusions

• At months 3 and 6, PSA decline correlated with health-related quality of life measures.
• Patients with advanced prostate cancer who had rapid and deep declines in PSA following treatment with apalutamide had more favorable health-related quality of life, physical wellbeing, and less pain and fatigue.
• These data show that early PSA response indicates benefits in patient-relevant end points in conjunction with oncological outcomes.
• These data may help guide care and counsel for patients with nmCRPC or mCSPC.