In a phase III clinical trial, CheckMate 025, treatment of metastatic renal cell carcinoma (mRCC) with nivolumab demonstrated superior efficacy over everolimus. However, as the clinical trial excluded patients with specific complications and poor performance status (PS), the effectiveness and safety of nivolumab in clinical practice, in which patients with various clinical complications are treated, is unclear. This study explored real-world nivolumab treatment in Japanese mRCC patients.
This is an interim analysis of a multicenter, non-interventional, medical record review study (minimum follow-up: 9 months). All eligible Japanese mRCC patients who first received nivolumab between February and October 2017 were included; data cut-off was April 2019. We analyzed nivolumab treatment patterns, efficacy (including overall survival, progression-free survival, objective response rate, and duration of response) and safety (including immune-related adverse events).
Of 208 evaluable patients, 31.7% received nivolumab as fourth- or later line of treatment. At data cut-off, 26.9% of patients were continuing nivolumab treatment. The major reason for discontinuation was disease progression (n = 100, 65.8%). Median overall survival was not reached; the 12-month survival rate was 75.6%. Median progression-free survival was 7.1 months, the objective response rate was 22.6%, and median duration of response was 13.3 months. Patients who were excluded or limited in number in CheckMate 025, such as those with non-clear cell RCC or poor PS, also received benefits from nivolumab treatment. Immune-related adverse events occurred in 27.4% of patients (grade ≥ 3, 10.1%).
Nivolumab was effective and well-tolerated in real-world Japanese mRCC patients.
UMIN000033312.
International journal of clinical oncology. 2020 Jun 09 [Epub ahead of print]
Nobuyuki Hinata, Junji Yonese, Satoru Masui, Yasutomo Nakai, Suguru Shirotake, Katsunori Tatsugami, Teruo Inamoto, Masahiro Nozawa, Kosuke Ueda, Toru Etsunaga, Takahiro Osawa, Motohide Uemura, Go Kimura, Kazuyuki Numakura, Kazutoshi Yamana, Hideaki Miyake, Satoshi Fukasawa, Kenya Ochi, Hirokazu Kaneko, Hirotsugu Uemura
Division of Urology, Department of Surgery Related, Kobe University Graduate School of Medicine, Kobe, Japan., Department of Urology, Cancer Institute Hospital of JFCR, Tokyo, Japan., Division of Reparative and Regenerative Medicine, Nephro-Urologic Surgery and Andrology, Institute of Medical Life Science, Mie University Graduate School of Medicine, Mie, Japan., Department of Urology, Osaka International Cancer Institute, Osaka, Japan., Department of Uro-Oncology, Saitama Medical University International Medical Center, Saitama, Japan., Department of Urology, Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan., Department of Urology, Osaka Medical College, Osaka, Japan., Department of Urology, Kindai University, Faculty of Medicine, 377-2, OhnoHigashi, Osakasayama-shi, Osaka, 589-8511, Japan., Department of Urology, Kurume University School of Medicine, Fukuoka, Japan., Department of Urology, Isesaki Municipal Hospital, Gunma, Japan., Department of Urology, Hokkaido University Graduate School of Medicine, Hokkaido, Japan., Department of Urology, Osaka University Graduate School of Medicine, Osaka, Japan., Department of Urology, Nippon Medical School Hospital, Tokyo, Japan., Department of Urology, Akita University Graduate School of Medicine, Akita, Japan., Department of Urology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan., Department of Urology, Hamamatsu University School of Medicine, Shizuoka, Japan., Prostate Center and Division of Urology, Chiba Cancer Center, Chiba, Japan., Ono Pharmaceutical Co., Ltd, Osaka, Japan., Bristol-Myers Squibb K.K, Tokyo, Japan., Department of Urology, Kindai University, Faculty of Medicine, 377-2, OhnoHigashi, Osakasayama-shi, Osaka, 589-8511, Japan. .