Oral estramustine plus oral etoposide in the treatment of hormone refractory prostate cancer patients: a phase II study with a 5-year follow-up.
BACKGROUND
Chemotherapy regimens that target microtubular trafficking were repeatedly found to be active in the treatment of hormone refractory prostate cancer patients, but disease responses were reportedly short-lived on average.


METHODS
From 1994 to 1997, 46 consecutive patients with hormone refractory prostate cancer were enrolled in a multicenter Phase II trial of oral etoposide 100 mg/day and estramustine 560 mg/day for 21 days, followed by a 7-day rest period. Final evaluation of this trial was performed after a follow-up of 5 years.


RESULTS
Fifty-four percent of patients attained a PSA response and 46% attained a response on measurable lesions. Median time to progression (TTP) and overall survival were 7.4 and 18.4 months, respectively. Fourteen patients (30.4%) had a TTP greater than 12 months and 9 (19.5%) a TTP greater than 18 months. Sixteen patients (34.8.%) survived more than 2 years and 2 (4.3%) survived more than 5 years. One patient was still alive and free from progression more than 7 years after starting treatment.


CONCLUSIONS
This Phase II trial with a long-term follow-up revealed that some patients with hormone refractory prostate cancer could obtain durable disease response and long survival with an oral etoposide and estramustine combination regimen.
Berruti
Alfredo
A
Oncologia Medica, Dipartimento di Scienze, Cliniche e Biologiche, Università di Torino, Azienda Ospedaliera San Luigi, Orbassano, Italy.
Fara
Enrica
E
Tucci
Marcello
M
Tarabuzzi
Roberto
R
Mosca
Alessandra
A
Terrone
Carlo
C
Gorzegno
Gabriella
G
Fasolis
Giuseppe
G
Tampellini
Marco
M
Porpiglia
Francesco
F
De Stefanis
Marinella
M
Fontana
Dario
D
Bertetto
Oscar
O
Dogliotti
Luigi
L
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D004961:Estramustine / Q000008:administration & dosage; D005047:Etoposide / Q000008:administration & dosage; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009376:Neoplasms, Hormone-Dependent / Q000188:drug therapy* / Q000473:pathology; D017430:Prostate-Specific Antigen / Q000378:metabolism; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D015996:Survival Rate; D016896:Treatment Outcome
D004961:Estramustine; D005047:Etoposide; D017430:Prostate-Specific Antigen