Comparison of Cabozantinib and Axitinib as Second-line Therapy After Nivolumab Plus Ipilimumab in Patients With Metastatic Clear Cell Renal Cell Carcinoma: A Comparative Analysis of Retrospective Real-world Data.

To date, no studies have compared the treatment outcomes of second-line therapies in patients with metastatic clear cell renal cell carcinoma (ccRCC). This study retrospectively evaluated the efficacy of cabozantinib and axitinib as second-line treatments in patients with metastatic ccRCC who previously received immune-oncology combination therapy.

Patients with metastatic ccRCC treated with cabozantinib and axitinib as second-line therapy after nivolumab-ipilimumab treatment were identified among 243 patients with RCC treated between August 1, 2018 and January 31, 2022 at 34 institutions belonging to the Japanese Urological Oncology Group. Patients were assessed for treatment outcomes, including progression-free survival (PFS), overall survival, objective response rate (ORR), and incidence rate of treatment-related adverse events (AEs).

Forty-eight patients treated with cabozantinib and 60 treated with axitinib as second-line therapy after nivolumab-ipilimumab treatment for metastatic ccRCC were identified. The median PFS (95% confidence interval) was 11.0 months (9.0-16.0) with cabozantinib and 9.5 months (6.0-13.0) with axitinib. The ORRs were 37.5% (cabozantinib) and 38.3% (axitinib). The rates of any-grade AEs and grade ≥3 AEs were 79.2% (cabozantinib) versus 63.3% (axitinib; P = .091) and 35.4% (cabozantinib) versus 23.3% (axitinib; P = .202), respectively. In the poor-risk group, PFS was longer in the cabozantinib group than in the axitinib group (P = .033).

The efficacy and safety of cabozantinib and axitinib were comparable. In the poor-risk group, cabozantinib was more effective than axitinib. These findings provide valuable insights into the selection of second-line treatment options after nivolumab-ipilimumab treatment in patients with metastatic ccRCC.

Clinical genitourinary cancer. 2024 Apr 15 [Epub ahead of print]

Ryotaro Tomida, Masayuki Takahashi, Yuto Matsushita, Takahiro Kojima, Kazutoshi Yamana, Shuya Kandori, Yukari Bando, Naotaka Nishiyama, Shimpei Yamashita, Hisanori Taniguchi, Keisuke Monji, Ryo Ishiyama, Shuichi Tatarano, Kimihiko Masui, Ayumu Matsuda, Tomoyuki Kaneko, Takanobu Motoshima, Yusuke Shiraishi, Satoru Kira, Takaya Murashima, Hiroaki Hara, Masafumi Matsumura, Hiroshi Kitamura, Hideaki Miyake, Junya Furukawa, Japanese Urological Oncology Group

Department of Urology, Tokushima University Graduate School of Biomedical Sciences, 3-18-15 Kuramoto-cho, Tokushima 770-8503, Japan. Electronic address: ., Department of Urology, Tokushima University Graduate School of Biomedical Sciences, 3-18-15 Kuramoto-cho, Tokushima 770-8503, Japan., Department of Urology, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka 431-3192, Japan., Department of Urology, Aichi Cancer Center, 1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan., Department of Urology and Molecular Oncology, Niigata University Graduate school of medical and dental sciences, 1-757 Asahimachi-Dori, Chuo-Ku, Niigata 951-8510, Japan., Department of Urology, Institute of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan., Division of Urology, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Kobe, Hyogo 650-0017, Japan., Department of Urology, Faculty of Medicine, University of Toyama, 2630 Sugitani, Toyama 930-0194, Japan., Department of Urology, Wakayama Medical University, 811-1 Kimiidera, Wakayama 641-0012, Japan., Department of Urology and Andrology, Kansai Medical University, 2-5-1 Shin-machi, Hirakata, Osaka 573-1010, Japan., Department of Urology, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-Ku, Fukuoka 812-8582, Japan., Department of Urology, Tokyo Women's Medical University, 8-1 Kawada-Cho, Shinjuku-Ku, Tokyo 162-8666, Japan., Department of Urology, Graduate School of Medical and Dental Sciences, Kagoshima University, 8-35-1 Sakuragaoka, Kagoshima 890-8520, Japan., Department of Urology, Kyoto University Graduate School of Medicine, 54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan., Department of Urology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan., Department of Urology, Teikyo University School of Medicine, 2-11-1 Kaga, Itabashi-Ku, Tokyo 173-8606, Japan., Department of Urology, Graduate School of Medical Sciences, Kumamoto University, 1-1-1 Honjo, Kumamoto 860-8556, Japan., Department of Urology, Shizuoka General Hospital, 4-27-1 Kita Ando, Aoi-ku, Shizuoka 420-8527, Japan., Department of Urology, University of Yamanashi Graduate School of Medical Sciences, 1110 Shimokato, Chuo City, Yamanashi 409-3898, Japan., Department of Urology, Faculty of Medicine, Miyazaki University Hospital, 5200 Kihara, Kiyotake, Miyazaki 889-1692, Japan., Department of Urology, Shinshu University School of Medicine, 3-1-1 Asahi, Matsumoto, Nagano 390-8621, Japan., Department of Urology, National Hospital Organization Shikoku Cancer Center, 160 Minamiumemoto, Matsuyama, Ehime 791-0280, Japan.