The optimal treatment strategy for patients with metastatic non-clear cell type renal cell carcinoma (nccRCC) remains unclear. Although several inhibitors of vascular endothelial growth factor have recently shown efficacy against nccRCC, the clinical benefit of pazopanib in nccRCC has not been analyzed. We therefore designed a single-arm, open-label, phase II study to determine the efficacy and safety of pazopanib in patients with nccRCC.
Patients with locally advanced or metastatic nccRCC, except for collecting duct or sarcomatoid type, received 800mg/day of pazopanib daily until progression of disease or intolerable toxicity. One cycle was defined as 4 weeks and tumor response was evaluated every two cycles. The primary objective was overall response rate (ORR).
A total of 29 eligible patients were enrolled at nine centers in Korea from December 2012 and September 2014. The median age of the patients was 58 years (range, 27-76 years) and 21 patients (72%) were male. Regarding histology type, 19 patients had papillary, three had chromophobe, two had unclassified and five had unknown non-clear cell type. Of 28 evaluable patients, eight achieved a confirmed partial response with ORR of 28%. The median progression-free survival was 16.5 months (95% CI, 10.9-22.1 months) and median overall survival was not reached. Sixteen patients (55%) experienced treatment-related toxicity of grade 3 or more, but most adverse events were overcome through dose reduction and delay.
In this prospective phase II study, pazopanib demonstrated promising activity and tolerable safety profile in patients with metastatic nccRCC.
Cancer research and treatment : official journal of Korean Cancer Association. 2017 May 22 [Epub ahead of print]
Ki Sun Jung, Su Jin Lee, Se Hoon Park, Jae-Lyun Lee, Se-Hoon Lee, Jae Yun Lim, Jung Hun Kang, Suee Lee, Sun Young Rha, Kyung Hee Lee, Ho Young Kim, Ho Yeong Lim
Division of Hematology and Oncology, 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., Department of Oncology, Seoul National University Hospital, Seoul, Korea., Department of Oncology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea., Division of Hematology and Oncology, Department of Internal Medicine, Gyeongsang National University Hospital, Gyeongsang National University School of Medicine, Jinju, Korea., Division of Hematology and Oncology, Department of Internal Medicine, Dong-A University Medical Center, Busan, Korea., Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea., Division of Oncology-Hematology, Department of Medicine, Yeungnam University College of Medicine, Daegu, Korea., Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Anyang, Korea.