Naotaka Nishiyama1, Takashi Kobayashi2, Shintaro Narita3, Yu Hidaka4, Katsuhiro Ito5, Satoru Maruyama6, Shoichiro Mukai7, Masakazu Tsutsumi8, Jun Miki9, Tomoya Okuno10, Yuko Yoshio11, Hiroaki Matsumoto12, Toru Shimazui13, Takehiko Segawa14, Takashi Karashima15, Kimihiko Masui16, Fumimasa Fukuta17, Kojiro Tashiro18, Kazuto Imai19, Shigetaka Suekane20, Seiji Nagasawa21, Shin Higashi22, Tomohiro Fukui23, Takahiro Kojima24, Satoshi Morita4, Osamu Ogawa25, Hiroyuki Nishiyama24, Hiroshi Kitamura1. 1. Department of Urology, Faculty of Medicine, University of Toyama, Toyama, Japan. 2. Department of Urology, Kyoto University Graduate School of Medicine, Kyoto, Japan. Electronic address: selecao@kuhp.kyoto-u.ac.jp. 3. Department of Urology, Akita University School of Medicine, Akita, Japan. 4. Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan. 5. Department of Urology, Ijinkai Takeda General Hospital, Kyoto, Japan. 6. Department of Urology, Hokkaido Cancer Center, Sapporo, Japan. 7. Department of Urology, Miyazaki University, Miyazaki, Japan. 8. Department of Urology, Hitachi General Hospital, Hitachi, Japan. 9. Department of Urology, Jikei University Kashiwa Hospital, Kashiwa, Japan. 10. Department of Urology, Shimada Municipal Hospital, Shimada, Japan. 11. Department of Urology, Mie University, Tsu, Japan. 12. Department of Urology, Yamaguchi University, Ube, Japan. 13. Department of Urology, Ibaraki Prefectural Central Hospital, Kasama, Japan. 14. Department of Urology, Kyoto City Hospital, Kyoto, Japan. 15. Department of Urology, Kochi University, Kochi, Japan. 16. Department of Urology, Otsu City Hospital, Otsu, Japan. 17. Department of Urology, Sapporo Medical University, Sapporo, Japan. 18. Department of Urology, Jikei University School of Medicine, Tokyo, Japan. 19. Department of Urology, Kansai Electric Power Hospital, Osaka, Japan. 20. Department of Urology, Kurume University School of Medicine, Kurume, Japan. 21. Department of Urology, Hyogo College of Medicine, Nishinomiya, Japan. 22. Department of Urology, Hirakata Kohsai Hospital, Hirakata, Japan. 23. Department of Urology, Rakuwakai Otowa Hospital, Kyoto, Japan. 24. Department of Urology, University of Tsukuba, Tsukuba, Japan. 25. Department of Urology, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Abstract
BACKGROUND: We used real-world and large-scale data to assess the clinical efficacy and safety of pembrolizumab in older patients with advanced urothelial carcinoma (UC). METHODS: A total of 608 patients who received pembrolizumab for the treatment of chemoresistant UC were retrospectively analyzed. All patients were histologically diagnosed with pure UC. Using propensity score matching (PSM) (ECOG performance status, site of metastasis, hemoglobin level and neutrophil-to-lymphocyte ratio, 1:1 matching), the overall survival (OS) and adverse events (AEs) of patients <75 and ≥75 years old were compared. RESULTS: The median follow-up (IQR) period was 16.1 (9.9-20.5) months. After PSM, there were 215 patients each in the aged <75 years and aged ≥75-year-old groups. The median OS of all patients was estimated to be 10.4 months (95% confidence interval [CI] = 8.8-12.1). After PSM, the median OS was 7.8 months (95% CI = 5.2-10.4) in the <75-year-old group and 10.4 months (95% CI = 7.3-13.5) in the ≥75-year-old group (P = 0.186). Any-grade AEs were more frequently reported in the ≥75-year-old group in comparison to the age <75-year-old group (55.3% vs. 41.9%, P = 0.007), whereas there was no significant difference between the two groups in the incidence of grade ≥3 AEs (10.2% vs. 12.6%, P = 0.544). The objective response rate, defined as complete remission or a partial response, was 22.8% in the <75-year-old group and 25.1% in the ≥75-year-old group (P = 0.651). CONCLUSIONS: The present study demonstrates that age does not affect the efficacy and safety of pembrolizumab treatment for advanced chemoresistant UC. Pembrolizumab treatment should not be avoided based on chronological age; however, close monitoring for the development of treatment-related AE should be considered for older patients.
BACKGROUND: We used real-world and large-scale data to assess the clinical efficacy and safety of pembrolizumab in older patients with advanced urothelial carcinoma (UC). METHODS: A total of 608 patients who received pembrolizumab for the treatment of chemoresistant UC were retrospectively analyzed. All patients were histologically diagnosed with pure UC. Using propensity score matching (PSM) (ECOG performance status, site of metastasis, hemoglobin level and neutrophil-to-lymphocyte ratio, 1:1 matching), the overall survival (OS) and adverse events (AEs) of patients <75 and ≥75 years old were compared. RESULTS: The median follow-up (IQR) period was 16.1 (9.9-20.5) months. After PSM, there were 215 patients each in the aged <75 years and aged ≥75-year-old groups. The median OS of all patients was estimated to be 10.4 months (95% confidence interval [CI] = 8.8-12.1). After PSM, the median OS was 7.8 months (95% CI = 5.2-10.4) in the <75-year-old group and 10.4 months (95% CI = 7.3-13.5) in the ≥75-year-old group (P = 0.186). Any-grade AEs were more frequently reported in the ≥75-year-old group in comparison to the age <75-year-old group (55.3% vs. 41.9%, P = 0.007), whereas there was no significant difference between the two groups in the incidence of grade ≥3 AEs (10.2% vs. 12.6%, P = 0.544). The objective response rate, defined as complete remission or a partial response, was 22.8% in the <75-year-old group and 25.1% in the ≥75-year-old group (P = 0.651). CONCLUSIONS: The present study demonstrates that age does not affect the efficacy and safety of pembrolizumab treatment for advanced chemoresistant UC. Pembrolizumab treatment should not be avoided based on chronological age; however, close monitoring for the development of treatment-related AE should be considered for older patients.