多中心 II 期研究舒尼替尼在非透明细胞肾细胞癌患者中的应用。
Multicenter phase II study of sunitinib in patients with non-clear cell renal cell carcinoma.
机构信息
Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul.
Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul.
出版信息
Ann Oncol. 2012 Aug;23(8):2108-2114. doi: 10.1093/annonc/mdr586. Epub 2012 Jan 6.
BACKGROUND
Retrospective and molecular biologic data suggest that sunitinib may be effective in patients with non-clear cell renal cell carcinoma (nccRCC).
PATIENTS AND METHODS
Eligibility criteria included advanced nccRCC except for collecting duct carcinoma and sarcomatoid carcinoma without identifiable renal cell carcinoma subtypes. Patients were treated with 50 mg/day oral sunitinib for 4 weeks, followed by 2 weeks of rest. The primary end point was overall response rate (RR).
RESULTS
Thirty-one eligible patients were enrolled. Twenty-four patients (77%) had prior nephrectomy. By Memorial Sloan-Kettering Cancer Center criteria, 8 patients (26%) had poor risk and 14 (45%) had intermediate risk. Twenty-two patients had papillary renal cell carcinoma (RCC), and three had chromophobe RCC. Eleven patients had partial response with a RR of 36% (95% confidence interval (CI) 19% to 52%) and an additional 17 patients (55%) had stable disease. Median duration of response was 12.7 months (95% CI 6.3-19.1 months), and median progression-free survival was 6.4 months (95% CI 4.2-8.6 months). At a median follow-up duration of 18.7 months (95% CI 13.7-23.7 months), 13 patients (42%) had died, resulting in an estimated median survival of 25.6 months (95% CI 8.4-42.9 months). Toxicity profiles were commensurate with prior reports.
CONCLUSIONS
Sunitinib has promising activity in patients with nccRCC (NCT01219751).
背景
回顾性和分子生物学数据表明，舒尼替尼可能对非透明细胞肾细胞癌（nccRCC）患者有效。
患者和方法
入选标准包括除集合管癌和无法识别肾细胞癌亚型的肉瘤样癌以外的晚期 nccRCC。患者接受 50mg/天的口服舒尼替尼治疗 4 周，随后休息 2 周。主要终点是总缓解率（RR）。
结果
共纳入 31 名符合条件的患者。24 名患者（77%）曾行肾切除术。根据 Memorial Sloan-Kettering 癌症中心标准，8 名患者（26%）为高危，14 名患者（45%）为中危。22 名患者患有乳头状肾细胞癌（RCC），3 名患者患有嫌色细胞 RCC。11 名患者有部分缓解，RR 为 36%（95%置信区间[CI]为 19%至 52%），另外 17 名患者（55%）病情稳定。缓解持续时间的中位数为 12.7 个月（95%CI为 6.3-19.1 个月），无进展生存期的中位数为 6.4 个月（95%CI为 4.2-8.6 个月）。在中位随访时间为 18.7 个月（95%CI为 13.7-23.7 个月）时，13 名患者（42%）死亡，估计中位生存期为 25.6 个月（95%CI为 8.4-42.9 个月）。毒性谱与先前的报告相符。
结论
舒尼替尼在 nccRCC 患者中具有良好的疗效（NCT01219751）。
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