To evaluate the efficacy and safety of cabozantinib, through a bridging study to METEOR, in Japanese patients with advanced renal cell carcinoma who had progressed after prior tyrosine kinase inhibitor therapy.
This phase II, open-label, single-arm study (ClinicalTrials.gov registration number: NCT03339219) included adult Japanese patients with advanced renal cell carcinoma and measurable disease who had received one or more tyrosine kinase inhibitors. Patients received cabozantinib 60 mg orally once daily while there was clinical benefit, or until unacceptable toxicity or disease progression. The primary end-point was objective response rate per Response Evaluation Criteria in Solid Tumors Version 1.1. Secondary end-points included clinical benefit rate (complete or partial response, or ≥8-week stable disease), progression-free survival, overall survival and safety.
Of the 35 patients enrolled, 68.6%, 22.9% and 8.6% had previously received one, two and three prior tyrosine kinase inhibitors, respectively. The median duration of cabozantinib exposure was 27.0 weeks (range 5.1-43.0 weeks). The objective response rate was 20.0% (90% confidence interval 9.8-34.3%), and the clinical benefit rate was 85.7% (95% confidence interval 69.7-95.2%). The 6-month estimated progression-free survival was 72.3% (95% confidence interval 53.3-84.6%); the median progression-free survival and overall survival were not reached. All patients reported adverse events, which were manageable by supportive treatment or dose modification; two patients (5.7%) discontinued therapy due to adverse events.
The results showed that findings from METEOR can be extrapolated, and that cabozantinib 60 mg/day is a viable treatment option in Japanese patients with advanced renal cell carcinoma who had progressed after prior tyrosine kinase inhibitor therapy.
International journal of urology : official journal of the Japanese Urological Association. 2020 Aug 12 [Epub ahead of print]
Yoshihiko Tomita, Katsunori Tatsugami, Noboru Nakaigawa, Takahiro Osawa, Mototsugu Oya, Hiroomi Kanayama, Chihiro Nakayama Kondoh, Naoto Sassa, Kazuo Nishimura, Masahiro Nozawa, Naoya Masumori, Yasuhide Miyoshi, Shingo Kuroda, Shingo Tanaka, Akiko Kimura, Satoshi Tamada
Department of Urology, Molecular Oncology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan., Department of Urology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan., Department of Urology, Yokohama City University Graduate School of Medicine, Yokohama, Japan., Department of Renal and Genitourinary Surgery, Hokkaido University, Sapporo, Japan., Department of Urology, Keio University School of Medicine, Tokyo, Japan., Department of Urology, Graduate School of Biomedical Sciences, Tokushima University, Tokushima, Japan., Department of Medical Oncology, Toranomon Hospital, Tokyo, Japan., Department of Urology, Nagoya University Graduate School of Medicine, Nagoya, Japan., Department of Urology, Osaka International Cancer Institute, Osaka, Japan., Department of Urology, Kindai University Faculty of Medicine, Osaka-sayama, Japan., Department of Urology, Sapporo Medical University School of Medicine, Sapporo, Japan., Department of Urology and Renal Transplantation, Yokohama City University Medical Center, Yokohama, Japan., Biostatistics, Japan Development Center, Takeda Pharmaceutical Company Limited, Osaka, Japan., PRA Health Sciences Company Limited, Osaka, Japan., Oncology Clinical Science, Oncology Therapeutic Area Unit for Japan and Asia, Takeda Pharmaceutical Company Limited, Tokyo, Japan., Department of Urology, Osaka City University Graduate School of Medicine, Osaka, Japan.