Limited information is currently available on the efficacy and safety of axitinib for metastatic renal cell carcinoma (mRCC) patients with renal impairment. Therefore, the present study investigated the efficacy and toxicity of axitinib in patients with chronic kidney disease.
Post-hoc analyses were performed on a Japanese multicenter cohort study of 477 mRCC patients who received axitinib followed by 1 or 2 regimens of systemic antiangiogenic therapy between January 2012 and December 2016. Differences in clinical characteristics and the efficacy and safety of axitinib were assessed based on pretreatment renal function.
Patients were categorized into the following 5 renal function groups according to baseline renal function: estimated glomerular filtration rate (eGFR) ≥60 ml/min (n = 133), 45 ml/min ≤eGFR <60 ml/min (n = 153), 30 ml/min ≤eGFR< 45 ml/min (n = 130), eGFR <30 ml/min (n = 45), and dialysis (n = 16). Median progression-free survival (PFS) (95% confidence interval [CI]) in the 5 groups was 11 (8-16), 14 (11-19), 14 (10-19), 12 (8-24), and 6 (3-NR) months, respectively (p = 0.781). After adjustments for treatment-related confounders, the renal function group was not a significant prognostic factor for PFS. Objective response rates in the 5 groups were 22%, 23%, 23%, 18%, 20%, and 38%, respectively (p = 0.468). Regarding adverse events of all grades, hypertension (p = 0.0006) and renal and urinary disorders (p < 0.0001) were more frequently observed in the eGFR <30 ml/min group than in the other groups.
Since renal function at the initiation of treatment with axitinib does not adversely affect the efficacy of VEGF-TKI therapy, clinicians do not need to avoid its administration to mRCC patients with impaired renal function in consideration of the risk of progression to end-stage renal disease.
Urologic oncology. 2023 Oct 03 [Epub ahead of print]
Keita Minami, Takahiro Osawa, Takahiro Kojima, Tomohiko Hara, Masatoshi Eto, Ario Takeuchi, Yasutomo Nakai, Kosuke Ueda, Michinobu Ozawa, Motohide Uemura, Kojiro Ohba, Keita Tamura, Tetsuya Shindo, Hiroshi Nakagomi, Atsushi Takahashi, Satoshi Anai, Akira Yokomizo, Shuichi Morizane, Takahiro Kimura, Toru Shimazui, Yasuyuki Miyauchi, Koji Mitsuzuka, Hiroaki Hara, Koji Yoshimura, Hiroaki Shiina, Youichi M Ito, Sachiyo Murai, Hiroyuki Nishiyama, Nobuo Shinohara, Hiroshi Kitamura, Japanese Urological Oncology Group
Department of Urology, Sapporo City General Hospital, Sapporo, Japan., Department of Urology, Hokkaido University Hospital, Sapporo, Japan. Electronic address: ., Department of Urology, Aichi Cancer Center, Aichi, Japan., Office of Pharmacovigilance II, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan., Department of Urology, Kyushu University, Fukuoka, Japan., Department of Urology, Osaka International Cancer Institute, Osaka, Japan., Department of Urology, Kurume University Hospital, Kurume, Japan., Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan., Department of Urology, Osaka University Hospital, Suita, Japan., Department of Urology, Nagasaki University Hospital, Nagasaki, Japan., Department of Urology, Hamamatsu University School of Medicine, Hamamatsu, Japan., Department of Urology, Sapporo Medical University, Sapporo, Japan., Department of Urology, University of Yamanashi Hospital, Chuo, Japan., Department of Urology, Hakodate Goryoukaku Hospital, Hakodate, Japan., Department of Urology, Nara Medical University, Kashihara, Japan., Department of Urology, Harasanshin Hospital, Fukuoka, Japan., Department of Urology, Tottori University, Yonago, Japan., Department of Urology, The Jikei University, School of Medicine, Tokyo, Japan., Department of Urology, Ibaraki Prefectural Central Hospital, Ibaraki Cancer Center, Kasama, Japan., Department of Urology, Kagawa University, Takamatsu, Japan., Department of Urology, Tohoku University, Sendai, Japan., Department of Urology, Shinshu University Hospital, Matsumoto, Japan., Department of Urology, Shizuoka General Hospital, Shizuoka, Japan., Department of Urology, Shimane University, Izumo, Japan., Data Science Center, Promotion Unit, Institute of Health Science Innovation for Medical Care, Hokkaido University Hospital, Sapporo, Japan., Department of Urology, Hokkaido University Hospital, Sapporo, Japan., Department of Urology, University of Tsukuba Hospital, Tsukuba, Japan., Department of Urology, Toyama University Hospital, Toyama, Japan.