Urology and Nephrology Research Center, Shahid Beheshti University (MS), Teheran, Iran.
Urol Oncol. 2010 Jan-Feb;28(1):21-7. doi: 10.1016/j.urolonc.2008.06.003. Epub 2008 Sep 12.
We determined the safety and efficacy of sorafenib in patients with castrate resistant prostate cancer (CRPC).
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.
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.
Sorafenib demonstrated some antitumor activity. Further studies are necessary to determine a subgroup of patients who would likely respond better to sorafenib.
我们评估了索拉非尼在去势抵抗性前列腺癌（CRPC）患者中的安全性和疗效。
64 例化疗和放疗初治的 CRPC 患者接受 400mg 索拉非尼口服，每日 2 次，6 周为 1 个周期。所有患者均有骨转移，16 例有淋巴结转移，9 例有肝转移，10 例有肺转移。治疗持续至疾病进展或出现无法耐受的毒性。
所有患者均进行了疗效评估。中位每位患者接受了 6.4 个连续周期的治疗。所有患者的中位总生存期为 14.6 个月（置信区间[CI]，8.2-22.2）。无完全缓解（CR）。在 35 例可测量的骨外疾病患者中，7 例（20%）有部分缓解。总体而言，13 例患者（20.3%；95%CI，4%-32%）在 2 个周期后前列腺特异性抗原（PSA）水平下降 50%或更多（部分缓解[PR]）。中位缓解持续时间为 2.5 个月（95%CI，1.4 至 4.8），中位无进展时间为 5.9 个月（95%CI，3.6 至 7.6）。无治疗相关死亡。毒性反应可耐受。
索拉非尼显示出一定的抗肿瘤活性。需要进一步的研究来确定哪些患者可能对索拉非尼有更好的反应。
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