US Oncology Research, Inc., Houston, TX; Texas Oncology PA, Webster, TX.
US Oncology Research, Inc., Houston, TX; Texas Oncology PA, Amarillo, TX.
Ann Oncol. 2010 Feb;21(2):319-324. doi: 10.1093/annonc/mdp323. Epub 2009 Jul 24.
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 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.
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 > or =50% prostate-specific antigen (PSA) decline and seven (21.2%) had a > or =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 > or =2 points occurred in 13.6% of 22 assessable patients. Drug discontinuation due to toxic effects occurred in 52.8% of patients.
Sunitinib malate demonstrated promising activity in metastatic CRPC progressing after prior docetaxel.
对于接受多西紫杉醇（泰索帝）治疗后进展的转移性去势抵抗性前列腺癌（CRPC）患者，其全身治疗选择有限。这项 II 期试验评估了舒尼替尼马来酸盐在先前接受多西紫杉醇治疗后进展的转移性 CRPC 患者中的应用。
纳入了接受一种或两种化疗方案（包括多西紫杉醇）治疗后进展的转移性 CRPC 患者。主要终点是根据影像学和临床评估的无进展生存期（PFS）。舒尼替尼口服剂量为 50mg/天，每 4 周为一个周期，持续用药 2 周，最多 8 个周期，或直至出现临床进展或无法耐受的毒性。
共纳入 36 例中位年龄为 69.5 岁的患者。中位 PFS 为 19.4 周，12 周 PFS 为 75.8%。4 例患者（12.1%）的前列腺特异性抗原（PSA）下降幅度>或=50%，7 例患者（21.2%）的 PSA 下降幅度>或=30%。18 例可测量疾病患者中有 2 例（11.1%）的 RECIST 评估下降幅度>或=30%，8 例（44.4%）显示出一定程度的缩小。22 例可评估患者中有 13.6%的疼痛评分下降>或=2 分。由于毒性作用，52.8%的患者停止用药。
舒尼替尼马来酸盐在先前接受多西紫杉醇治疗后进展的转移性 CRPC 中显示出有前景的活性。
