Low-Dose Estramustine Phosphate and Concomitant Low-Dose Acetylsalicylic Acid in Heavily Pretreated Patients With Advanced Castration-Resistant Prostate Cancer.
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.


CONCLUSIONS
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.
Medical Oncology Unit, Santa Maria alle Scotte Hospital, University of Siena, Italy. Electronic address: r.petrioli@ao-siena.toscana.it.
Roberto
R
Petrioli
Medical Oncology Unit, Santa Maria alle Scotte Hospital, University of Siena, Italy.
Giandomenico
G
Roviello
Pharmacology Unit, Santa Maria alle Scotte Hospital, University of Siena, Italy.
Anna I
AI
Fiaschi
Medical Oncology Unit, Santa Maria alle Scotte Hospital, University of Siena, Italy.
Letizia
L
Laera
Medical Oncology Unit, Policlinico Umberto I Hospital, University of Rome, Rome, Italy.
Vincenzo
V
Bianco
Urological and Andrological Unit, Santa Maria alle Scotte Hospital, University of Siena, Italy.
Roberto
R
Ponchietti
Department of Urology, Santa Maria alle Scotte Hospital, University of Siena, Italy.
Gabriele
G
Barbanti
Medical Oncology Unit, Policlinico Umberto I Hospital, University of Rome, Rome, Italy.
Edoardo
E
Francini
D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D001241:Aspirin / Q000008:administration & dosage* / Q000627:therapeutic use; D004334:Drug Administration Schedule; D004961:Estramustine / Q000008:administration & dosage* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D017430:Prostate-Specific Antigen / Q000378:metabolism; D064129:Prostatic Neoplasms, Castration-Resistant / Q000188:drug therapy* / Q000378:metabolism; D016019:Survival Analysis; D016896:Treatment Outcome
D004961:Estramustine; D017430:Prostate-Specific Antigen; D001241:Aspirin
Abiraterone; Cabazitaxel; Castration-resistant prostate cancer; Estramustine; Thromboembolism