Kidney Cancer Research Bureau, Mayakovskogo pereulok, 2, 109147, Moscow, Russia.
City Clinical Oncology Center, St. Petersburg, Russia.
Target Oncol. 2019 Feb;14(1):33-38. doi: 10.1007/s11523-018-0613-y.
Targeted therapy with axitinib resulted in a greater objective response rate and prolonged progression-free survival (PFS) compared to sorafenib in patients with previously treated metastatic renal cell carcinoma (mRCC) in the phase 3 AXIS study, where 75% of patients had intermediate and poor International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk.
In this phase 2 study (FavorAx), we assessed the activity of axitinib in mRCC patients with a favorable risk and history of prior vascular endothelial growth factor receptor (VEGFR)-directed therapy.
Patients were required to have clear-cell mRCC, favorable risk according to IMDC criteria, and to have received first-line treatment with sunitinib or pazopanib. Prior treatment with other agents was not permitted. The primary endpoint of the study was 5 months PFS. Additional endpoints included response rate, safety, PFS, and overall survival (OS).
A total of 21 patients were enrolled, 62% of whom were male. The mean age was 60 years. Eleven (52%) patients had two or more metastatic sites. 67% and 33% of patients received first-line sunitinib or pazopanib, respectively, with a median PFS of 17 months [95% confidence interval (CI), 14-20]. After a median follow-up of 25 months, the median PFS was 19 months (95% CI, 15-23). The current study did achieve its primary endpoint based on the 5-month PFS of 100%. The median OS was not yet reached. The 18 months OS rate was 85.7%. The objective response rate was 33% and one patient achieved a complete response. Seven patients had dose escalation of axitinib and four patients had dose reduction. Grade 3 adverse events were observed in 19% of cases. There was no discontinuation of therapy due to toxicity.
The encouraging PFS and favorable safety profile observed in the FavorAx study support the administration of axitinib in mRCC patients with favorable IMDC risk and a history of prior sunitinib or pazopanib.
在 AXIS 研究中，与索拉非尼相比，阿昔替尼靶向治疗可使既往治疗的转移性肾细胞癌（mRCC）患者的客观缓解率更高，无进展生存期（PFS）更长，其中 75%的患者具有中等和较差的国际转移性肾细胞癌数据库联盟（IMDC）风险。
在这项 2 期研究（FavorAx）中，我们评估了阿昔替尼在具有有利风险和既往血管内皮生长因子受体（VEGFR）靶向治疗史的 mRCC 患者中的活性。
患者必须患有透明细胞肾细胞癌，根据 IMDC 标准为低危风险，并且接受过舒尼替尼或帕唑帕尼的一线治疗。不允许其他药物治疗。该研究的主要终点是 5 个月 PFS。其他终点包括缓解率、安全性、PFS 和总生存期（OS）。
共入组 21 例患者，其中 62%为男性。平均年龄为 60 岁。11 例（52%）患者有两个或更多转移部位。分别有 67%和 33%的患者接受了一线舒尼替尼或帕唑帕尼治疗，中位 PFS 分别为 17 个月[95%置信区间（CI），14-20]。在中位随访 25 个月后，中位 PFS 为 19 个月[95%CI，15-23]。目前的研究确实达到了其主要终点，5 个月 PFS 为 100%。中位 OS 尚未达到。18 个月 OS 率为 85.7%。客观缓解率为 33%，1 例患者达到完全缓解。7 例患者增加了阿昔替尼的剂量，4 例患者减少了剂量。观察到 19%的病例出现 3 级不良事件。没有因毒性而停止治疗。
在 FavorAx 研究中观察到令人鼓舞的 PFS 和有利的安全性特征，支持在具有有利的 IMDC 风险和既往接受舒尼替尼或帕唑帕尼治疗的 mRCC 患者中使用阿昔替尼。
