Isaacsson Velho Pedro, Nardo Mirella, Souza Manoel Carlos Leonardi de Azevedo, Bonadio Renata R C Colombo, Marta Guilherme Nader, Muniz David Q B, Bastos Diogo Assed, Dzik Carlos
Pedro Isaacsson Velho, Johns Hopkins University, Baltimore, MD, and Hospital Moinhos de Vento, Porto Alegre; and Mirella Nardo, Manoel Carlos Leonardi de Azevedo Souza, Renata R.C. Colombo Bonadio, Guilherme Nader Marta, David Q.B. Muniz, Diogo Assed Bastos, and Carlos Dzik, Instituto do Cancer do Estado de Sao Paulo, São Paulo, Brazil.
J Glob Oncol. 2018 Aug;4:1-10. doi: 10.1200/JGO.18.00073.
Purpose Sunitinib and pazopanib are multitargeted tyrosine kinase inhibitors (TKIs) that act against vascular endothelial growth factor receptors and are standard first-line treatment options for metastatic clear cell renal cell carcinoma (ccRCC). The Brazilian public health system diverges from the randomized clinical trials in the availability of first and subsequent lines of treatment and in clinical and demographic characteristics of patients. Therefore, it is essential to describe the history of advanced ccRCC during and after TKI treatment in this population. Methods We performed a retrospective analysis of patients with advanced ccRCC treated with a first-line TKI (either sunitinib or pazopanib) between February 2009 and March 2017 in a single academic Brazilian cancer center (Instituto do Câncer do Estado de São Paulo). Results Of the 222 patients, 109 were treated with sunitinib and 113 with pazopanib. The median duration of treatment and overall survival (OS) were 6.4 and 15.2 months for sunitinib and 6.7 and 14.2 months for pazopanib, respectively. Discontinuation of treatment occurred secondarily to progressive disease or death in 64.2% of patients using sunitinib and in 54.8% of patients using pazopanib. Adverse events were responsible for discontinuation of treatment in 28.4% of patients in the sunitinib group and in 22.1% in the pazopanib group. According to Memorial Sloan-Kettering Cancer Center risk categories, the OS was 32.9 months, 15.9 months, and 8.1 months for low risk, intermediate risk, and poor risk, respectively (hazard ratio, 1.72; 95% CI, 1.13 to 2.26; P < .001). Conclusion The use of TKI inhibitors as first-line treatment of metastatic RCC is effective and feasible in the Brazilian public health. However, the median OS of our population is considerably lower compared with the prospective trials that evaluated the same drugs.
目的 舒尼替尼和帕唑帕尼是多靶点酪氨酸激酶抑制剂（TKIs），作用于血管内皮生长因子受体，是转移性透明细胞肾细胞癌（ccRCC）的标准一线治疗选择。巴西公共卫生系统在一线及后续治疗的可及性以及患者的临床和人口统计学特征方面与随机临床试验有所不同。因此，描述该人群中晚期ccRCC在TKI治疗期间及之后的病程至关重要。方法 我们对2009年2月至2017年3月期间在巴西一家学术性癌症中心（圣保罗州癌症研究所）接受一线TKI（舒尼替尼或帕唑帕尼）治疗的晚期ccRCC患者进行了回顾性分析。结果 在222例患者中，109例接受舒尼替尼治疗，113例接受帕唑帕尼治疗。舒尼替尼治疗的中位持续时间和总生存期（OS）分别为6.4个月和15.2个月，帕唑帕尼治疗的分别为6.7个月和14.2个月。使用舒尼替尼的患者中有64.2%、使用帕唑帕尼的患者中有54.8%因疾病进展或死亡而停止治疗。不良事件导致舒尼替尼组28.4%的患者、帕唑帕尼组22.1%的患者停止治疗。根据纪念斯隆凯特琳癌症中心风险分类，低风险、中风险和高风险患者的OS分别为32.9个月、15.9个月和8.1个月（风险比，1.72；95%CI，1.13至2.26；P <.001）。结论 在巴西公共卫生系统中，使用TKI抑制剂作为转移性RCC的一线治疗是有效且可行的。然而，与评估相同药物的前瞻性试验相比，我们人群的中位OS显著更低。
