Sunitinib malate for metastatic castration-resistant prostate cancer following docetaxel-based chemotherapy
Sunitinib malate for metastatic castration-resistant prostate cancer following docetaxel-based chemotherapy
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DOI：
10.1093/annonc/mdp323
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发表时间：
2010-02-01
影响因子：
50.5
通讯作者：
Hutson, T. E.
中科院分区：
文献类型：
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作者：
Sonpavde, G.;Periman, P. O.;Hutson, T. E.
背景：转移性去势抵抗性前列腺癌（CRPC）患者在多西紫杉醇（泰索帝）治疗后进展的全身治疗选择有限。这项II期试验评估了苹果酸舒尼替在既往多西他赛后进展性转移性CRPC患者中的疗效。患者和方法：包括多西他赛在内的一到两种化疗方案后转移性CRPC进展的患者纳入研究。主要终点是放射学和临床评估的无进展生存期（PFS）。口服舒尼替尼50mg /天，持续4周，然后每个周期休息2周，最多8个周期，或直到临床进展或无法忍受的毒性。结果：共纳入36例患者，中位年龄69.5岁。中位PFS为19.4周，12周PFS为75.8%。4例（12.1%）患者前列腺特异性抗原（PSA）下降50%，7例（21.2%）患者PSA下降30%。18例可测量疾病患者中有2例（11.1%）经RECIST检查显示下降30%，8例（44.4%）显示萎缩。在22名可评估的患者中，有13.6%的患者疼痛评分下降了2分。52.8%的患者因毒副作用而停药。结论：苹果酸舒尼替尼在既往多西他赛后转移性CRPC进展中显示出有希望的活性。
Background: Systemic therapy options are limited for metastatic castration-resistant prostate cancer (CRPC) patients who progress following docetaxel (Taxotere). This phase II trial evaluated sunitinib malate in patients with progressing metastatic CRPC following prior docetaxel.Patients and methods: Patients with metastatic CRPC progressing following one to two chemotherapy regimens including docetaxel were included. The primary end point was progression-free survival (PFS) per radiographic and clinical evaluations. Oral sunitinib was administered 50 mg/day 4-weeks on followed by 2-weeks off per cycle up to a maximum of eight cycles or until clinical progression or intolerable toxicity.Results: Thirty-six patients with a median age of 69.5 years were accrued. The median PFS was 19.4 weeks with a 12-week PFS of 75.8%. Four patients (12.1%) had a 50% prostate-specific antigen (PSA) decline and seven (21.2%) had a 30% PSA decline. Two of 18 patients (11.1%) with measurable disease demonstrated 30% declines by RECIST and eight (44.4%) displayed some shrinkage. A decline in pain score 2 points occurred in 13.6% of 22 assessable patients. Drug discontinuation due to toxic effects occurred in 52.8% of patients.Conclusion: Sunitinib malate demonstrated promising activity in metastatic CRPC progressing after prior docetaxel.