Enzalutamide prolongs urinary and bowel symptom control in men with non-metastatic castration-resistant prostate cancer
The PROSPER trial has shown a clinically and statistically significant improvement in metastasis-free survival ( hazard ratio, HR=0.292 [ 95% CI 0.241, 0.352 ], p less than 0.0001 ) with Enzalutamide ( Xtandi; n = 933 ) versus placebo ( n = 468 ) in asymptomatic men with non-metastatic castration-resistant prostate cancer ( nmCRPC ) and prostate-specific antigen doubling time less than or equal to 10 months.
All men without prior orchiectomy continued androgen deprivation therapy.
Researchers have assessed the impact of Enzalutamide on prostate cancer symptoms and health-related quality of life ( HRQoL ).
Prostate cancer symptoms and HRQoL were assessed at baseline and subsequently every 16 weeks, using the EORTC Quality of Life Questionnaire-Prostate 25 ( QLQ-PR25 ) and the EuroQol 5-domain 5-level ( EQ-5D-5L ).
Clinically meaningful symptom worsening in prostate cancer symptoms scores was defined using thresholds derived as 1/2 standard deviation at baseline.
Clinically meaningful deterioration in EQ-5D-5L visual analogue scale was defined using the pre-established threshold of 7.
Time to first confirmed ( at two consecutive visits ) and unconfirmed ( one visit ) deterioration in QLQ-PR25 and EQ-5D-5L scores were assessed using Kaplan-Meier estimates and Cox models.
Completion rates were high for patients remaining on study ( more than 85% for all visits ).
Baseline scores were similar between arms and showed low symptom burden ( including urinary and bowel symptoms ) and high HRQoL.
The proportion of patients reporting either no change or improvement in HRQoL and prostate cancer symptoms scores at week 49 was higher with Enzalutamide ( 67 − 87% ) than placebo ( 62 − 81% ).
Over the course of treatment, Enzalutamide significantly delayed worsening of symptoms including urinary and bowel symptoms / function.
In contrast, Enzalutamide significantly increased the risk of worsening of hormonal treatment related symptoms compared to placebo.
In conclusion, in addition to delayed disease progression in the PROSPER trial, Enzalutamide prolonged urinary and bowel symptom control and delayed decline in HRQoL scores versus placebo. ( Xagena )
Source: European Society of Medical Oncology - ESMO Congress, 2018
Castration-resistant prostate cancer ( CRPC ) is defined as disease progression during ADT ( androgen deprivation therapy ), with serum...
Apalutamide vs placebo in patients with non-metastatic castration-resistant prostate cancer receiving androgen deprivation therapy: health-related quality of life at final analysis of the SPARTAN study
The phase III SPARTAN study evaluated Apalutamide ( Erleada ) vs Placebo in patients with non-metastatic castration-resistant prostate cancer (...
European Union: Lynparza approved for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer
Lynparza ( Olaparib ) has been approved in the European Union ( EU ) for patients with metastatic castration-resistant prostate...
European Commission has approved expanded use of Erleada for treatment of patients with metastatic hormone-sensitive prostate cancer
The European Commission ( EC ) has granted marketing authorisation for the expanded use of Erleada ( Apalutamide ) to...
Apalutamide versus placebo in patients with nonmetastatic castration-resistant prostate cancer: final survival results from SPARTAN, a phase III trial
SPARTAN has evaluated Apalutamide ( Erleada ) versus placebo in patients with nonmetastatic castration-resistant prostate cancer ( nmCRPC ) and...
Darolutamide added to androgen deprivation therapy for nonmetastatic castration-resistant prostate cancer: overall survival results of phase III ARAMIS study
Darolutamide ( Nubeqa ) is a structurally distinct androgen receptor inhibitor with a favorable safety profile, approved for treating men...
IPATential150 study: Ipatasertib in combination with Abiraterone and Prednisone / Prednisolone met its co-primary endpoint of radiographic progression free survival in patients with PTEN loss tumours
Tthe phase III IPATential150 study met its co-primary endpoint of radiographic progression-free survival ( rPFS ) in patients with metastatic...
Erleada for non-metastatic castration-resistant prostate cancer patients who are at high risk of developing metastatic disease, European Commission approved
The European Commission ( EC ) has granted marketing authorisation for Erleada ( Apalutamide ), a next generation oral androgen...
Apalutamide improves overall survival and radiographic progression-free survival in patients with metastatic castration-sensitive prostate cancer
Results from the phase 3 TITAN study were presented in an oral session at the American Society of Clinical...
For patients with prostate cancer, treating the disease with androgen deprivation therapy ( ADT ) is linked to a...