Hormone-naive prostate cancer: Enzalutamide monotherapy provides some disease suppression
The androgen receptor inhibitor Enzalutamide ( Xtandi ) is approved for the treatment of metastatic castration-resistant prostate cancer that has progressed on Docetaxel.
A study has assessed the activity and safety of Enzalutamide monotherapy in men with hormone-naive prostate cancer.
This trial is a open-label, single-arm, phase 2 study, done across 12 European sites. Men aged over 18 years, with hormone-naive prostate cancer for whom hormone therapy was indicated, and who had non-castration levels of testosterone and prostate-specific antigen ( PSA ) of 2 ng/mL or greater at screening, and an Eastern Cooperative Oncology Group ( ECOG ) score of 0, received oral Enzalutamide 160 mg/day.
The primary outcome was the proportion of patients with an 80% or greater decline in PSA at week 25. All analyses included all patients who had received at least one dose of the study drug.
67 men were enrolled into the study. 62 patients ( 92.5% ) had a decline in PSA of 80% or greater at week 25.
The most commonly reported treatment-emergent adverse events up to week 25 were gynaecomastia ( n=24 ), fatigue ( n=23 ), nipple pain ( n=13 ), and hot flush ( n=12 ), all of which were of mild to moderate severity.
Nine patients had a treatment-emergent adverse event of grade 3 or higher, most of which were reported in one patient each, except for pneumonia ( grade 3, two patients ) and hypertension ( grade 3, four patients ).
Five patients reported serious adverse events, none of which were deemed to be treatment related.
The findings suggest that Enzalutamide monotherapy in men with hormone-naive prostate cancer of varying severity provides a level of disease suppression, and was generally well tolerated. ( Xagena )
Tombal B et al, The Lancet Oncology 2014; 15: 592-600
Apalutamide has significantly improved overall survival in patients with metastatic hormone-sensitive prostate cancer
The results from the final analysis of the phase 3 TITAN study, which has demonstrated the continued statistically significant benefit...
Rubraca as monotherapy treatment for patients with BRCA1/2-mutant, metastatic castration-resistant prostate cancer, treated with androgen receptor-directed therapy and a taxane-based chemotherapy
The FDA ( U.S. Food and Drug Administration ) has approved Rubraca ( Rucaparib ) tablets for the treatment...
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...
Genome-wide transcriptional analysis has identified a unique subset of androgen receptor (AR)+, estrogen receptor ( ER ) / progesterone receptor...
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...
PROSPER trial: Enzalutamide reduces the risk of metastasis or death by 71% in men with non-metastatic castration-resistant prostate cancer
The results from the phase 3 PROSPER trial in patients with non-metastatic ( M0 ) castration-resistant prostate cancer ( CRPC...
SPARTAN trial, Apalutamide, an androgen receptor inhibitor, improves median metastasis-free survival by more than two years in patients with non-metastatic castration-resistant prostate cancer
New findings were presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium ( ASCO GU ) in San...
TERRAIN trial: Enzalutamide increases the progression-free survival compared to Bicalutamide in metastatic castration-resistant prostate cancer
The results from the phase 2 TERRAIN trial of Enzalutamide ( Xtandi ) compared to Bicalutamide ( Casodex ) in...
STRIVE trial: Enzalutamide increases progression-free survival compared to Bicalutamide in castration-resistant prostate cancer
The results from the STRIVE trial of Enzalutamide ( Xtandi ) compared to Bicalutamide ( Casodex ) in men with...