Phase II trial of estramustine phosphate and oral etoposide in patients with hormone-refractory prostate cancer.
BACKGROUND
There is a need for active agents with a better safety profile than docetaxel, yet good activity, for patients with hormone-refractory prostate cancer (HRPC). We carried out a phase II trial to determine the activity and safety of estramustine plus oral etoposide in HRPC.


METHODS
Patients were given estramustine (280 mg twice daily) and etoposide (100 mg/day, days 1-21) in 28-day cycles until disease progression or unacceptable toxicity. Primary end points were overall response rate and safety, as determined by prostate-specific antigen (PSA) levels and lesion assessment.


RESULTS
From November 2001 to February 2007, 75 patients were enrolled. All patients were assessable for safety; 17 (22.6%) had grade 3/4 toxicity. PSA response was assessable in 69, 14 of whom had a >50% reduction in PSA. Of 10 patients with one or more measurable lesions, two (20%) had partial response and two (20%) disease stabilization. Overall, median time to progression was 4.4 months (range 1 week-43 months); median survival was 23 months (range 3 weeks-64+ months).


CONCLUSIONS
Estramustine plus etoposide is active and has a manageable safety profile in patients with HRPC. In asymptomatic patients with nonaggressive disease this combination could be useful to delay the start of more demanding treatments.
Spitaleri
G
G
Division of Medical Oncology, European Institute of Oncology, Milan, Italy. gianluca.spitaleri@ieo.it
Matei
D V
DV
Curigliano
G
G
Detti
S
S
Verweij
F
F
Zambito
S
S
Scardino
E
E
Rocco
B
B
Nolè
F
F
Ariu
L
L
De Pas
T
T
de Braud
F
F
De Cobelli
O
O
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004961:Estramustine / Q000008:administration & dosage; D005047:Etoposide / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008875:Middle Aged; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000188:drug therapy*; D016896:Treatment Outcome
D004961:Estramustine; D005047:Etoposide; D017430:Prostate-Specific Antigen