Fixed higher dose schedule of suramin plus hydrocortisone in patients with hormone refractory prostate carcinoma a multicenter Phase II study.
BACKGROUND
Using a fixed higher-dose schedule, the efficacy and toxicity of suramin plus hydrocortisone were assessed in patients with metastatic hormone-refractory prostate carcinoma (HRPC).


METHODS
Fifty consecutive patients with HRPC (including those in whom hormonotherapy was withdrawn) and an Eastern Cooperative Oncology Group performance status of 0-2 were recruited. Treatment was comprised of a bolus intravenous infusion of 200 mg of suramin followed by suramin (500 mg/m(2) intravenously [i.v.] over 24 hours) given daily over 5 days as a loading course, followed by suramin (350 mg/m(2) i.v. over 2 hours) administered weekly for 12 weeks. This 12-week course was repeated at 6-month intervals. All patients received concomitant hydrocortisone.


RESULTS
Five hundred fifty weekly doses of therapy were delivered over the course of the entire study. A partial response, based on a > 50% decrease in the prostate specific antigen (PSA) level, was achieved in 27 patients (54%; 95% confidence interval [95% CI], 44.7-65.0%), 16 of whom (32%; 95%CI, 23.9-43.2%) had a > 75% decrease in their PSA levels. The measurable disease objective response rate was 18% (95% CI, 2.3-51.8%). Of the 37 patients with bone pain requiring analgesia, 27 patients (73%; 95% CI, 55.9-86.2%) reduced their medication consumption to a lower level on the World Health Organization analgesic ladder. The median duration of response was 15.5 weeks (range, 6-70 weeks), the median time to disease progression was 13 weeks, and the median overall survival time was 11 months. Treatment generally was well tolerated. Fatigue and severe lymphopenia were the most commonly reported significant toxicities. In addition, there was 1 septic toxic death reported, and 10% of the patients were found to have NCI Grade 3-4 neurotoxicity.


CONCLUSIONS
The results of the current study demonstrated that the fixed-dose suramin regimen administered herein showed high, although short-lived, activity and a good tolerance profile in HRPC patients.
Calvo
E
E
Department of Oncology, Clínica Universitaria de Navarra, Pamplona, Spain. calvo@hsanjaime.com
Cortés
J
J
Rodríguez
J
J
Sureda
M
M
Beltrán
C
C
Rebollo
J
J
Martínez-Monge
R
R
Berián
J M
JM
de Irala
J
J
Brugarolas
A
A
D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002277:Carcinoma / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D004334:Drug Administration Schedule; D019008:Drug Resistance, Neoplasm; D006801:Humans; D006854:Hydrocortisone / Q000008:administration & dosage; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000139:chemically induced; D017430:Prostate-Specific Antigen / Q000032:analysis; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D013498:Suramin / Q000008:administration & dosage; D016019:Survival Analysis; D016896:Treatment Outcome
D013498:Suramin; D017430:Prostate-Specific Antigen; D006854:Hydrocortisone