Neoadjuvant Hormone Therapy Before Prostatectomy in Locally Advanced Prostate Cancer
Posted: Wednesday, June 5, 2019
There is an increased risk of cancer recurrence for patients with locally advanced prostate cancer. In a phase II trial, as reported in the Journal of Clinical Oncology, it was concluded that neoadjuvant hormone therapy followed by radical prostatectomy in men showed improved outcomes in patients who received enzalutamide and leuprolide (EL) with abiraterone and prednisone (ELAP). Mary-Ellen Taplin, MD, of the Dana-Farber Cancer Institute in Boston, and colleagues cautioned that longer follow-up is needed to assess the impact of therapy on recurrence rates.
The study focused on 75 patients who had a biopsy Gleason score of 4 + 3 = 7 or greater, prostate-specific antigen(PSA) level higher than 20 ng/mL, or T3 disease. Lymph nodes had to be smaller than 2 mm. The patients were randomly given 2:1 ELAP or EL for 24 weeks followed by radical prostatectomy. The primary endpoint was pathologic complete response or minimal residual disease with a residual tumor of up to 5 mm.
The minimal residual disease rate was 30% in the ELAP group versus 15% in the EL group. The rates of ypT3 disease, positive margins, and positive lymph nodes were similar between the groups as well as PSA nadirs before surgery.
Treatment between the two groups was well tolerated, with treatment-related adverse events being similar. The potential association of ERG and PTEN alterations with worse outcomes warrants additional investigation. A phase III trial of intense androgen-deprivation therapy and radical prostatectomy for men with locally advanced prostate cancer is planned.
“We demonstrated that neoadjuvant therapy with potent AR-directed therapies is feasible, safe, and results in favorable pathologic responses in a subset of patients with high-risk disease, although differences between arms were not statistically significant,” the authors commented.
Disclosure: The study authors’ disclosure information may be found at ascopubs.org.
