Roberto Petrioli1, Giandomenico Roviello2, Anna I Fiaschi3, Letizia Laera2, Vincenzo Bianco4, Roberto Ponchietti5, Gabriele Barbanti6, Edoardo Francini4. 1. Medical Oncology Unit, Santa Maria alle Scotte Hospital, University of Siena, Italy. Electronic address: r.petrioli@ao-siena.toscana.it. 2. Medical Oncology Unit, Santa Maria alle Scotte Hospital, University of Siena, Italy. 3. Pharmacology Unit, Santa Maria alle Scotte Hospital, University of Siena, Italy. 4. Medical Oncology Unit, Policlinico Umberto I Hospital, University of Rome, Rome, Italy. 5. Urological and Andrological Unit, Santa Maria alle Scotte Hospital, University of Siena, Italy. 6. Department of Urology, Santa Maria alle Scotte Hospital, University of Siena, Italy.
Abstract
BACKGROUND: The aim of this phase 2 study was to evaluate the activity and tolerability of low-dose estramustine phosphate (EMP) with concomitant low-dose acetylsalicylic acid (ASA) as a thromboprophylactic agent in heavily pretreated patients with advanced castration-resistant prostate cancer. METHODS: Patients received 420 mg of oral EMP twice daily and oral ASA 100 mg once daily. The primary endpoint was prostate-specific antigen response. All of the patients had been previously treated with docetaxel and abiraterone acetate, and 12 had also received cabazitaxel. RESULTS: Thirty-one patients were enrolled. Prostate-specific antigen response was observed in 9 patients (29.0%; 95% confidence interval [CI], 14-48). Median progression-free survival was 3.6 months (95% CI, 2.2-5.6), and median overall survival was 7.6 months (95% CI, 6.9-9.7). Treatment was generally well tolerated, and no grade 3/4 toxicity was observed. Ten patients (32.2%) had grade 2 nausea and vomiting. No cardiovascular event and no major bleeding occurred. No venous thromboembolism event was observed. CONCLUSION: Low-dose EMP with concomitant low-dose ASA seems to be a safe treatment option with some activity for patients with advanced castration-resistant prostate cancer who have been heavily pretreated.
BACKGROUND: The aim of this phase 2 study was to evaluate the activity and tolerability of low-dose estramustine phosphate (EMP) with concomitant low-dose acetylsalicylic acid (ASA) as a thromboprophylactic agent in heavily pretreated patients with advanced castration-resistant prostate cancer. METHODS:Patients received 420 mg of oral EMP twice daily and oral ASA 100 mg once daily. The primary endpoint was prostate-specific antigen response. All of the patients had been previously treated with docetaxel and abiraterone acetate, and 12 had also received cabazitaxel. RESULTS: Thirty-one patients were enrolled. Prostate-specific antigen response was observed in 9 patients (29.0%; 95% confidence interval [CI], 14-48). Median progression-free survival was 3.6 months (95% CI, 2.2-5.6), and median overall survival was 7.6 months (95% CI, 6.9-9.7). Treatment was generally well tolerated, and no grade 3/4 toxicity was observed. Ten patients (32.2%) had grade 2 nausea and vomiting. No cardiovascular event and no major bleeding occurred. No venous thromboembolism event was observed. CONCLUSION: Low-dose EMP with concomitant low-dose ASA seems to be a safe treatment option with some activity for patients with advanced castration-resistant prostate cancer who have been heavily pretreated.
Authors: Yu-Ning Wong; Judith Manola; Gary R Hudes; Bruce J Roth; Judd W Moul; Andrea M Barsevick; Richard M Scher; Michael J Volk; David J Vaughn; Stephen D Williams; Michael J Fisch; David Cella; Michael A Carducci; George Wilding Journal: Clin Genitourin Cancer Date: 2017-10-16 Impact factor: 2.872