Genitourinary Oncology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY 10065, USA.
Clin Genitourin Cancer. 2013 Sep;11(3):297-302. doi: 10.1016/j.clgc.2013.04.001. Epub 2013 May 24.
Sunitinib achieves objective response and prolongs progression-free survival (PFS) in patients with metastatic renal cell carcinoma (RCC). A subset of patients achieves long-term responses. The characteristics of patients who achieved long-term response (defined as patients achieving ongoing complete response [CR] or remaining progression free for > 18 months while receiving sunitinib) are reported.
A database of 186 patients treated with sunitinib alone (n = 89) or in combination (n = 97) in 9 clinical trials was reviewed; all had 1 year or more follow-up from sunitinib start to data cutoff for analysis. Median PFS was 10.8 months (95% CI, 8.3-13.3); median overall survival (OS) was 30.4 months (95% CI, 21.5-36.8 months) for the 186 patients. Thirty-four patients were identified as long-term responders because they either had durable CR or remained progression free while receiving sunitinib for > 18 months.
Best response for 34 long-term responders was CR in 3 patients, partial response (PR) in 24 patients, and stable disease in 7 patients. The median duration of sunitinib therapy was 24.9 months (range, 18.1-73.9 months). The median PFS among the long-term responders was 17.4 months (95% CI, 7-29.9 months) at a landmark PFS analysis performed after 18 months from treatment start. Univariate analysis from the 186 patients identified bone metastasis, lung metastasis, and intermediate/poor risk groups as adverse prognostic factors for long-term response.
Sunitinib achieves long-term response in a subset of patients with metastatic RCC. Lack of bone metastasis or lung metastasis and good MSKCC risk status may predict long-term response.
舒尼替尼可使转移性肾细胞癌（RCC）患者获得客观缓解并延长无进展生存期（PFS）。有一部分患者可获得长期缓解。本研究报告了获得长期缓解（定义为接受舒尼替尼治疗时持续完全缓解[CR]或无进展超过 18 个月）的患者特征。
回顾了 9 项临床试验中单独（n = 89）或联合（n = 97）应用舒尼替尼治疗的 186 例患者的数据库；所有患者从舒尼替尼开始治疗到分析数据截止时间的随访时间均为 1 年或更长。中位 PFS 为 10.8 个月（95%CI，8.3-13.3）；186 例患者的中位总生存期（OS）为 30.4 个月（95%CI，21.5-36.8 个月）。34 例患者被确定为长期缓解者，因为他们接受舒尼替尼治疗 18 个月以上时，要么持续 CR，要么保持无进展。
34 例长期缓解者的最佳缓解情况为 3 例患者完全缓解（CR），24 例患者部分缓解（PR），7 例患者疾病稳定。舒尼替尼治疗的中位持续时间为 24.9 个月（范围，18.1-73.9 个月）。在治疗开始后 18 个月进行的里程碑式 PFS 分析中，长期缓解者的中位 PFS 为 17.4 个月（95%CI，7-29.9 个月）。对 186 例患者的单因素分析发现，骨转移、肺转移和中高危组是长期缓解的不良预后因素。
舒尼替尼可使转移性 RCC 的一部分患者获得长期缓解。无骨转移或肺转移和良好的 MSKCC 风险状态可能预测长期缓解。
