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Neoadjuvant androgen deprivation therapy with enzalutamide active in high-risk localized prostate cancer
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CHICAGO — Six months of neoadjuvant androgen deprivation therapy with enzalutamide demonstrated activity among men with high-risk localized prostate cancer, according to study results presented at ASCO Annual Meeting.
A small number of patients achieved exceptional responses, according to researchers.
Up to 10% of patients with localized disease who undergo neoadjuvant androgen deprivation therapy with abiraterone acetate (Zytiga, Janssen) and prednisone achieve pathological complete response.
David James VanderWeele, MD, PhD, assistant clinical investigator in Laboratory of Genitourinary Cancer Pathogenesis at NIH, and colleagues conducted a single-institution trial to evaluate the efficacy of neoadjuvant androgen deprivation therapy with goserelin plus 160 mg daily enzalutamide (Xtandi; Astellas, Pfizer) for patients with high-risk localized disease.
All patients underwent MRI/transrectal ultrasound-guided fusion biopsy at screening, as well as repeat multiparametric MRI followed by radical prostatectomy after 6 months of therapy.
Investigators also assessed the ability of posttreatment multiparametric MRI to measure response.
At the time of analysis, 22 women had completed therapy and undergone radical prostatectomy.
Baseline characteristics appeared typical of those with high-risk disease, according to researchers. Median PSA was 10.3 ng/mL (range, 2.1-985.9) and clinical stage by multiparametric MRI was cT2 to cT4.
After 6 months of therapy but prior to radical prostatectomy, median PSA was 0.02 ng/mL (range, < .02-0.35).
On final pathology, no patients were upstaged and five patients (23%) were unchanged.
Fifteen patients (77%) were downstaged, including four (18%) who achieved partial complete response or near-partial complete response (residual cancer burden < 0.001 cc). Of the four who achieved partial complete response or near-partial complete response, one was cT0 on posttreatment multiparametric MRI, one was cT2, and two were cT3. Another patient who achieved radiographic complete response was pT3a on pathological review.
Five of nine patients who had bulky nodes at baseline were downstaged to pN0. Six of the nine patients who had p%3 disease at time of prostatectomy were cT3 on posttreatment multiparametric MRI.
“Standard analysis of multiparametric MRI identifies most patients with persistent T3 disease but does not reliably identify exceptional responses,” VanderWeele and colleagues wrote. “Evaluation of molecular characteristics that predict exceptional response or intrinsic resistance is ongoing.” – by Mark Leiser
For more information:
VanderWeele DJ, et al. Abstract 5082. Presented at: ASCO Annual Meeting; June 1-5, 2018; Chicago.
Disclosures: VanderWeele reports no relevant financial disclosures. Please see the abstract for all other authors’ relevant financial disclosures.
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Donald L. “Skip” Trump, MD, FACP
This study included 22 men with high-risk prostate cancer for whom radical prostatectomy was planned and who received goserelin plus enzalutamide (Xtandi; Astellas, Pfizer) for 6 months prior to prostatectomy. The question posed was: What effect does this potent approach to androgen deprivation have in the prostate?
The changes were striking and very encouraging with regard to use of this more potent approach to androgen deprivation. Among 22 patients with high-risk disease, no patient had any sign of progression on repeat MRI or PSA measurement. Almost 80% showed reduction in tumor and 20% were unchanged. In four of the 22 patients, little or no cancer was found when the prostate was removed at the time of surgery.
This indicates that — in as many as 20% of men with poor-prognosis, clinically localized prostate cancer — remarkable tumor reduction can be obtained with potent neoadjuvant androgen deprivation. This is another indication for how we might consider using these powerful approaches to androgen deprivation in early-stage disease.
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