PSA provocation by bipolar androgen therapy may predict duration of response to first-line androgen deprivation: Updated results from the BATMAN study.

BACKGROUND: Previously, we reported results from the Phase II BATMAN study (Bipolar Androgen Therapy for Men with Androgen-ablation Naïve prostate cancer). This study (NCT01750398) was designed to evaluate the safety and efficacy of a treatment regimen consisting of a 6-month lead in-phase of androgen deprivation therapy (ADT) followed by alternating 3-month intervals of bipolar androgen therapy (BAT) and ADT alone. Here we report > 5-year follow-up related to the duration of subsequent ADT, response to first-line androgen receptor inhibitors, safety, and survival in men with castration-sensitive prostate cancer treated on the BATMAN study. METHODS: Univariate Cox regression was utilized to compare overall survival between Responders who achieved a prostate-specific antigen (PSA) level of <4 ng/ml and Non-Responders who achieved a PSA level of ≥4 ng/ml after BAT/ADT. Kaplan-Meier method and Cox regression were used to assess progression-free (PFS) and overall survival (OS) on BAT and on subsequent abiraterone or enzalutamide and on the association between PSA peak during BAT and each time to event outcome. RESULTS: Over median follow-up of 95 months, the median PFS on ADT for the entire cohort was 47.8. Median OS has not been reached (NR). Median OS for Non-Responders is 43 months versus NR (not reached) for responders (hazard ratio [HR]: 0.176, p = 0.002). Post-BAT, the PSA50 and PSA90 responses to abiraterone or enzalutamide were 94.4% and 66.7%, respectively and median PFS was 20.6 months. Patients with peak PSA level of ≥9 ng/ml after BAT had median PFS of 20.6 months versus NR for those having PSA < 9 ng/ml (HR: 0.122, p < 0.001). Median OS was 79.6 months for patients with PSA peak of ≥9 ng/ml versus NR for those having PSA peak of <9 ng/ml (HR: 0.409, p = 0.131). CONCLUSION: The use of BAT as part of first-line hormonal therapy strategy does not induce adversely affect long-term survival or induce any significant long-term adverse sequelae in patients with prostate cancer. Cycling BAT may extend the duration of ADT response and enhance response to subsequent androgen ablative therapies. The magnitude of BAT-provoked increase in PSA may predict duration of ADT response and warrants further study.

Subretinal tenecteplase injection in a submacular hemorrhage from polypoidal choroidal vasculopathy: a case report.

PURPOSE: The purpose of this report was to describe a case with a thick submacular hemorrhage (SMH) resulting from polypoidal choroidal vasculopathy that was successfully treated with a subretinal tenecteplase injection. METHODS: A retrospective case report. RESULTS: A 63-year-old man with acute SMH secondary to polypoidal choroidal vasculopathy underwent a partial posterior vitrectomy, a subretinal tenecteplase (100 µg/0.1 mL) injection with air/fluid exchange, and an intravitreal injection of bevacizumab (2.5 mg/0.1 mL). His preoperative corrected visual acuity was 20/30, but the SMH threatened the fovea. The SMH was displaced inferiorly and absorbed completely at 1 month postoperative. His visual acuity decreased to 20/40 1 week postoperative but recovered to 20/20 2 months after surgery. The electroretinogram showed no distinct elongation of implicit time and slightly decreased amplitude of a-wave and b-wave at 3 months postoperative; optical coherence tomography presented disruption of the inner segment/outer segment line at the onset of SMH but recovered completely at 3 months postoperative. CONCLUSION: Subretinal tenecteplase was found to have sufficient hemolytic function and no retinal toxicity and could represent a feasible treatment option for the management of SMH.