Kusakabe Naohisa, Osawa Takahiro, Miyata Haruka, Kikuchi Hiroshi, Matsumoto Ryuji, Maruyama Satoru, Abe Takashige, Shinohara Nobuo
The Department of Renal and Genitourinary Surgery, Hokkaido University Graduate School of Medicine.
Hinyokika Kiyo. 2018 Sep;64(9):353-358. doi: 10.14989/ActaUrolJap_64_9_353.
Axitinib was approved for use in Japan as a salvage therapy for patients with metastatic renal cell carcinoma (RCC) in 2012. We retrospectively evaluated the cases of 32 RCC patients that were treated with Axitinib as a 2nd- or further-line therapy between November 2012 and March 2017. Overall survival (OS), progression-free survival (PFS), and adverse events were assessed. The median OS and PFS from the initiation of Axitinib were 29 and 11 months, respectively. Nineteen patients received Axitinib as a 2nd-line treatment, in whom the median OS and median PFS were 22 and 10 months, respectively, while the median OS and PFS were 29 and 15.5 months, respectively, amongthe 13 patients who received Axitinib as a 3rd- or further-line treatment, which suggested that Axitinib is effective in the 3rd-line and further-line settings. A Cox multivariate model revealed that bone metastasis was a significant adverse factor for OS. Common grade 3 or higher adverse events included hypertension (28%), diarrhea (7%), and proteinuria (7%). Although the present study demonstrated the efficacy and safety of salvage Axitinib treatment in patients who had recurrent disease after the initial systemic therapy, further large-scale studies should be warranted to make clear its clinical effectiveness in these patients.
阿昔替尼于2012年在日本被批准作为转移性肾细胞癌(RCC)患者的挽救疗法。我们回顾性评估了2012年11月至2017年3月期间接受阿昔替尼作为二线或更后线治疗的32例RCC患者的病例。评估了总生存期(OS)、无进展生存期(PFS)和不良事件。从开始使用阿昔替尼起,中位OS和PFS分别为29个月和11个月。19例患者接受阿昔替尼作为二线治疗,其中位OS和中位PFS分别为22个月和10个月,而在13例接受阿昔替尼作为三线或更后线治疗的患者中,中位OS和PFS分别为29个月和15.5个月,这表明阿昔替尼在三线及更后线治疗中有效。Cox多变量模型显示骨转移是OS的一个显著不良因素。常见的3级或更高等级不良事件包括高血压(28%)、腹泻(7%)和蛋白尿(7%)。尽管本研究证明了挽救性阿昔替尼治疗对初始全身治疗后复发疾病患者的疗效和安全性,但仍需要进一步的大规模研究来明确其在这些患者中的临床有效性。