Low-Dose Oral Ethinylestradiol With Concomitant Low-Dose Acetylsalicylic Acid for Advanced Castrate-Resistant Prostate Cancer.
The aim of the present study was to evaluate the activity and tolerability of low-dose oral ethinylestradiol (EE) and luteinizing hormone-releasing hormone analogue with concomitant low-dose acetylsalicylic acid (ASA) as a thromboprophylactic agent for advanced castrate-resistant prostate cancer (CRPC).



The patients received an EE dose of 150 μg daily (50 μg 3 times daily) and an ASA dose of 100 mg once daily. The primary endpoint was the prostate-specific antigen response.



A total of 32 patients were enrolled. A PSA response was observed in 19 patients (59.3%; 95% confidence interval [CI], 41%-76%). The median progression-free survival was 9.4 months (95% CI, 6.5-14.1 months). The treatment was generally well tolerated and no grade 3-4 toxicity was observed. Only 1 patient interrupted EE because of a cardiac event and 1 patient experienced grade 2 nausea and vomiting. No major bleeding occurred.



Low-dose EE with concomitant low-dose ASA is safe, showing potential activity in patients with advanced CRPC, and should be investigated further.
Department of Molecular and Translational Medicine, University of Brescia, Brescia, Italy; Molecular Therapy and Pharmacogenomic Unit, ASST di Cremona, Cremona, Italy. Electronic address: giandomenicoroviello@gmail.com.
Giandomenico
G
Roviello
Molecular Therapy and Pharmacogenomic Unit, ASST di Cremona, Cremona, Italy.
Laura
L
Zanotti
Molecular Therapy and Pharmacogenomic Unit, ASST di Cremona, Cremona, Italy.
Angela
A
Gobbi
Molecular Therapy and Pharmacogenomic Unit, ASST di Cremona, Cremona, Italy.
Martina
M
Dester
Molecular Therapy and Pharmacogenomic Unit, ASST di Cremona, Cremona, Italy; Department of Medical, Surgery and Health Sciences, University of Trieste, Trieste, Italy.
Daniele
D
Generali
Department of Medical, Surgical and Neurological Sciences, University Hospital of Siena, Siena, Italy.
Chiara
C
Pacifico
Molecular Therapy and Pharmacogenomic Unit, ASST di Cremona, Cremona, Italy.
Maria Rosa
MR
Cappelletti
Department of Radiotherapy, ASST Cremona, Cremona, Italy.
Alberto
A
Bonetta
D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D001241:Aspirin / Q000008:administration & dosage* / Q000009:adverse effects; D054796:Drug Dosage Calculations; D004997:Ethinyl Estradiol / Q000008:administration & dosage* / Q000009:adverse effects; 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
D004997:Ethinyl Estradiol; D017430:Prostate-Specific Antigen; D001241:Aspirin
Castration-resistant prostate cancer; Estrogens; Hormonal therapy