Centro Médico Nacional Siglo XXI, Av. Cuauhtémoc 330, Doctores, Cuauhtémoc, 06720 Ciudad de México, CDMX, Mexico City, Mexico.
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Vasco de Quiroga 15, Belisario Dominguez Sección XVI, 14080, Mexico City, PC, Mexico.
BMC Cancer. 2021 Jan 5;21(1):16. doi: 10.1186/s12885-020-07720-5.
Sequential inhibition of the vascular endothelial growth factor (VEGF) pathway with sorafenib could be useful for patients with metastatic renal cell carcinoma (RCC). Our aim was to determine the activity and tolerability of sorafenib as a second-line therapy in advanced RCC initially treated with a different VEGF-tyrosine kinase inhibitor (TKI).
A prospective observational cohort in Mexico (2012-2019). We included 132 subjects with metastatic RCC and who had progression despite treatment with sunitinib. The primary end-point was time to disease progression as evaluated every 12-16 weeks.
The mean age of the cohort was 59 years (interquartile range [IQR] 50-72), 96 (73%) were men, and 48 (36%) had a favorable prognosis according to the IMDC (International Metastatic RCC Database Consortium) prognostic model. The median progression-free survival (PFS) and overall-survival after the introduction of sorafenib treatment was 8.6 months (95% confidence interval [CI]: 6.7-10.5) and 40 months (95% CI: 34.5-45.4) respectively. The median overall survival from RCC diagnosis to death was 71 months (95% CI: 58.2-83.8). On multivariable analyses, age > 65 years was associated with a longer PFS (HR 0.51; 95% CI: 0.31-0.86; p = 0.018). The median PFS in subjects aged > 65 years was longer compared to subjects ≤65 years (14.0 [95% CI: 9.2-18.8] vs. 7.2 months [95% CI: 5.3-9.1]; p = 0.012). Adverse events grade ≥ 3 associated with sorafenib occurred in 38 (29%) patients.
Sequential inhibition of VEGF with sorafenib as a second-line treatment may benefit patients with metastatic RCC, especially in subjects > 65 years old.
索拉非尼序贯抑制血管内皮生长因子（VEGF）通路可能对转移性肾细胞癌（RCC）患者有用。我们的目的是确定索拉非尼作为二线治疗在转移性 RCC 患者中的活性和耐受性，这些患者最初接受了不同的 VEGF-酪氨酸激酶抑制剂（TKI）治疗。
墨西哥的一项前瞻性观察队列研究（2012-2019 年）。我们纳入了 132 例转移性 RCC 患者，这些患者在接受舒尼替尼治疗后仍有进展。主要终点是每 12-16 周评估的疾病进展时间。
队列的平均年龄为 59 岁（四分位距 [IQR] 50-72），96 名（73%）为男性，根据 IMDC（国际转移性 RCC 数据库联盟）预后模型，48 名（36%）预后良好。引入索拉非尼治疗后，中位无进展生存期（PFS）和总生存期分别为 8.6 个月（95%CI：6.7-10.5）和 40 个月（95%CI：34.5-45.4）。从 RCC 诊断到死亡的中位总生存期为 71 个月（95%CI：58.2-83.8）。多变量分析显示，年龄>65 岁与较长的 PFS 相关（HR 0.51；95%CI：0.31-0.86；p=0.018）。年龄>65 岁的患者的中位 PFS 长于年龄≤65 岁的患者（14.0 [95%CI：9.2-18.8] vs. 7.2 个月 [95%CI：5.3-9.1]；p=0.012）。与索拉非尼相关的 3 级及以上不良事件发生在 38 名（29%）患者中。
索拉非尼作为二线治疗药物序贯抑制 VEGF 可能对转移性 RCC 患者有益，尤其是年龄>65 岁的患者。
