Biweekly doxorubicin/ketoconazole as second-line treatment in docetaxel-resistant, hormone-refractory prostate cancer.
OBJECTIVE
Docetaxel is an effective first-line treatment for hormone-refractory prostate cancer. Nevertheless, the prognosis subsequent to progression after first-line therapy is poor and no second-line treatment has been established.


METHODS
A total of 34 patients with androgen-independent prostate cancer received doxorubicin, 30 mg/m(2), every 2 weeks and ketoconazole daily, 400 mg orally every 8 hours. All patients had been treated with docetaxel and had disease progression within 6 months after completion of first-line treatment.


RESULTS
Of the 32 evaluable patients, 13 (43.7%, 95% confidence interval [CI] 26.3% to 62.3%) had a prostate-specific antigen (PSA) response, and 4 (28%, 95% CI 8.4% to 58.1%) of 14 patients with measurable disease had a response to therapy. The median time to progression (TTP) was 3.9 months (95% CI 2.0 to 5.9), and the median overall survival (OS) was 13 months (95% CI 8.7 to 17.3). Toxicity was mild, with only 4 cases of nonhematologic grade 3 or 4 toxicity. The most frequent toxicity was nail changes (33 of 34 patients), which was mainly grade 1 (30 cases).


CONCLUSIONS
The combination of biweekly doxorubicin and ketoconazole is an effective, well-tolerated, second-line therapy for hormone-refractory prostate cancer.
Lainakis
George
G
Department of Clinical Therapeutics, University of Athens Medical School, Athens, Greece.
Nikos
Antoniou
A
Gerassimos
Alivizatos
A
Michael
Chrisofos
C
Iraklis
Mitsoyiannis
M
Konstantinos
Livadas
L
Ioannis
Varkarakis
V
Harilaos
Katsifotis
K
Dimopoulos
Meletios A
MA
Bamias
Aristotelis
A
D000368:Aged; D000369:Aged, 80 and over; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage*; D000935:Antifungal Agents / Q000008:administration & dosage*; D000970:Antineoplastic Agents / Q000627:therapeutic use; D000077143:Docetaxel; D004317:Doxorubicin / Q000008:administration & dosage*; D004334:Drug Administration Schedule; D019008:Drug Resistance, Neoplasm; D004359:Drug Therapy, Combination; D005500:Follow-Up Studies; D006801:Humans; D007654:Ketoconazole / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011471:Prostatic Neoplasms / Q000188:drug therapy*; D043823:Taxoids / Q000627:therapeutic use
D000903:Antibiotics, Antineoplastic; D000935:Antifungal Agents; D000970:Antineoplastic Agents; D043823:Taxoids; D000077143:Docetaxel; D004317:Doxorubicin; D007654:Ketoconazole