A Multicenter Phase II Trial of Axitinib in Patients With Recurrent or Metastatic Non-clear-cell Renal Cell Carcinoma Who Had Failed Prior Treatment With Temsirolimus

The optimal treatment option for non-clear-cell renal cell carcinoma (nccRCC) is not established. We conducted a multicenter phase II trial of axitinib for patients with advanced nccRCC who had failed prior treatment with temsirolimus.

Patients with histologically confirmed metastatic or recurrent nccRCC received 5 mg axitinib twice daily. Prior use of vascular endothelial growth factor pathway inhibitors was not allowed. The primary endpoint was progression-free survival (PFS), and the secondary endpoints were objective response rate (ORR), disease control rate, overall survival, and safety.

Forty patients were included between January 2013 and December 2016. The median age was 59 years (range, 22-84 years). Eastern Cooperative Oncology Group performance status were 0 (7.5%) and 1 (92.5%), and 82.5% of patients had undergone prior nephrectomy. Papillary type 2 (60.0%) was the most common histology, and patients belonged to favorable (12.5%), intermediate (72.5%), and poor (15.0%) risk groups according to the International Metastatic Renal Cell Carcinoma Database Consortium risk stratification. With a median follow-up duration of 14.7 months (95% confidence interval, [CI], 10.8-18.6 months), the median PFS was 7.4 months (95% CI, 5.2-9.5 months). The ORR was 37.5%, and the disease control rate was 67.5%. The median overall survival was 12.1 months (95% CI, 6.4-17.7 months). Most adverse events were manageable, and no unexpected toxicities were found.

Axitinib showed promising efficacy in terms of ORR and PFS in recurrent or metastatic nccRCC when used after failure with temsirolimus.

Clinical genitourinary cancer. 2018 May 23 [Epub ahead of print]

Inkeun Park, Se Hoon Lee, Jae Lyun Lee

Division of Medical Oncology, Department of Internal Medicine, Gil Medical Center, Gachon University College of Medicine, Incheon, Korea., Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea., Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. Electronic address: .