Safety and efficacy of sorafenib in patients with castrate resistant prostate cancer: a Phase II study.
OBJECTIVE
We determined the safety and efficacy of sorafenib in patients with castrate resistant prostate cancer (CRPC).


METHODS
Sixty-four chemotherapy and radiotherapy naïve patients with CRPC received 400 mg sorafenib orally twice daily in 6-week cycles. All patients had bone metastasis, while 16 had lymph node-, 9 had liver-, and 10 had lung metastases. Treatment was continued until disease progression or excessive toxicity.


RESULTS
All patients were assessable for response. A median of 6.4 consecutive cycles was administered per patient. Median overall survival for all patients was 14.6 months (confidence interval [CI], 8.2-22.2). No complete response (CR) occurred. Of the 35 patients with measurable extraosseous disease, 7 (20%) had a partial response. Overall, 13 patients (20.3%; 95% CI, 4%-32%) achieved a 50% or greater reduction (partial response [PR]) in prostate-specific antigen (PSA) level after two cycles. The median response duration was 2.5 months (95% CI, 1.4 to 4.8), and the median time to progression was 5.9 months (95% CI 3.6 to 7.6). There was no treatment-related death. Toxicities were well tolerated.


CONCLUSIONS
Sorafenib demonstrated some antitumor activity. Further studies are necessary to determine a subgroup of patients who would likely respond better to sorafenib.
Safarinejad
Mohammad Reza
MR
Urology and Nephrology Research Center, Shahid Beheshti University (MS), Teheran, Iran. safarinejad@urologist.md
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000601:surgery; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001557:Benzenesulfonates / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009536:Niacinamide / Q000031:analogs & derivatives; D009919:Orchiectomy; D010671:Phenylurea Compounds; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000601:surgery; D011725:Pyridines / Q000009:adverse effects / Q000627:therapeutic use*; D000077157:Sorafenib; D017211:Treatment Failure; D055815:Young Adult
D000970:Antineoplastic Agents; D001557:Benzenesulfonates; D010671:Phenylurea Compounds; D011725:Pyridines; D009536:Niacinamide; D000077157:Sorafenib