Oral chemotherapy in hormone-refractory prostate carcinoma patients unwilling to be admitted to hospital.
OBJECTIVE
To investigate the safety and efficacy in terms of PSA response of a low-dose oral combination of estramustine phosphate (EMP) and etoposide (VP16) in hormone- refractory prostate cancer (HRPC) patients. Well-tolerated outpatient chemotherapy regimens for patients unfit and/or unwilling to be admitted to hospital are needed.


METHODS
Fifty-six HRPC patients with metastatic disease (median age 75 years) were randomized between arm A (daily oral EMP 10 mg/kg, in 3 doses) and arm B (28-day cycle with low-dose EMP 3 mg/kg once daily plus VP16 25 mg/m(2) once daily on days 1 through 14). Baseline characteristics between the two groups were similar. LHRH therapy was maintained. Anti- androgen was stopped 1 month before entry.


RESULTS
The low-dose combination was better tolerated, with a significant advantage in terms of time to treatment interruption for any reason (p = 0.01) or toxicity (6 vs. 12 months, p = 0.02). A trend in favour of arm B was evident in terms of PSA reduction (41.4 vs. 15%), performance status and pain improvement. Hospital admission due to toxicity was never required for arm B patients and there were no treatment-related deaths.


CONCLUSIONS
Low-dose oral combination of EMP and VP16 might represent a treatment option for patients unfit for i.v. chemotherapy. This regimen requires minimal toxicity monitoring when administered at home for prolonged periods.
Serretta
Vincenzo
V
Department of Urology, University of Palermo, Palermo, Italy. vserretta@libero.it
Altieri
Vincenzo
V
Morgia
Giuseppe
G
Siragusa
Alfredo
A
De Grande
Gaetano
G
Napoli
Matteo
M
Falsaperla
Mario
M
Melloni
Darvinio
D
Allegro
Rosalinda
R
D000230:Adenocarcinoma / Q000188:drug therapy*; D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D004961:Estramustine / Q000008:administration & dosage*; D005047:Etoposide / Q000008:administration & dosage*; D006760:Hospitalization; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D011471:Prostatic Neoplasms / Q000188:drug therapy*
D000970:Antineoplastic Agents; D004961:Estramustine; D005047:Etoposide