Minoru Kato1, Takashi Kobayashi2, Yoshiyuki Matsui3, Katsuhiro Ito4, Kensuke Hikami5, Takeshi Yamada6, Kosuke Ogawa7, Kenji Nakamura8, Naoto Sassa9, Akira Yokomizo10, Takashige Abe11, Kazunari Tsuchihashi12, Shuichi Tatarano13, Junichi Inokuchi14, Ryotaro Tomida15, Maki Fujiwara16, Atsushi Takahashi17, Kazumasa Matsumoto18, Kosuke Shimizu19, Hiromasa Araki20, Ryoma Kurahashi21, Yu Ozaki22, Yu Tashiro23, Masayuki Uegaki24, Takahiro Kojima25, Junji Uchida1, Osamu Ogawa2, Hiroyuki Nishiyama25, Hiroshi Kitamura26. 1. Department of Urology, Osaka City University, Osaka, Japan. 2. Department of Urology, Kyoto University Graduate School of Medicine, Kyoto, Japan. 3. Department of Urology, National Cancer Center Hospital, Tokyo, Japan. 4. Department of Urology, Ijinkai Takeda General Hospital, Kyoto, Japan. 5. Department of Urology, Japanese Red Cross Wakayama Medical Center, Wakayama, Japan. 6. Department of Urology, Kyoto Prefectural University of Medicine, Kyoto, Japan. 7. Department of Urology, Kobe City Nishi-Kobe Medical Center, Kobe, Japan. 8. Department of Urology, Japanese Red Cross Osaka Hospital, Osaka, Japan. 9. Department of Urology, Aichi Medical University Hospital, Nagakute, Japan. 10. Department of Urology, Harasanshin Hospital, Fukuoka, Japan. 11. Department of Urology, Hokkaido University, Sapporo, Japan. 12. Department of Urology, Japanese Red Cross Otsu Hospital, Otsu, Japan. 13. Department of Urology, Kagoshima University, Kagoshima, Japan. 14. Department of Urology, Kyushu University, Fukuoka, Japan. 15. Department of Urology, Shikoku Cancer Center, Matsuyama, Japan. 16. Department of Urology, Tenri Hospital, Tenri, Japan. 17. Department of Urology, Hakodate Goryoukaku Hospital, Hakodate, Japan. 18. Department of Urology, Kitasato University, Sagamihara, Japan. 19. Department of Urology, Kyoto Katsura Hospital, Kyoto, Japan. 20. Department of Urology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan. 21. Department of Urology, Kumamoto University, Kumamoto, Japan. 22. Department of Urology, National Hospital Organization Himeji Medical Center, Himeji, Japan. 23. Department of Urology, Tazuke Kofukai Medical Research Institute Kitano Hospital, Osaka, Japan. 24. Department of Urology, Toyooka Hospital, Toyooka, Japan. 25. Department of Urology, University of Tsukuba, Tsukuba, Japan. 26. Department of Urology, University of Toyama, Toyama, Japan.
Abstract
OBJECTIVES: To investigate the impact of the number of cycles and objective response to chemotherapy on overall survival in patients with metastatic urothelial carcinoma treated with pembrolizumab. METHODS: This multicenter, retrospective study included 755 patients from 59 institutions with advanced, chemoresistant urothelial carcinoma who received pembrolizumab. The associations of the overall survival with the number of cycles and best objective response were investigated using Cox multiple regression analysis. RESULTS: Overall, 391 patients received standard first-line chemotherapy and pembrolizumab as a second-line treatment, and were included in the final analysis. Of the 391 patients, 185 received less than four cycles, 134 received four to six cycles and 72 received more than six cycles of first-line chemotherapy. An objective response (complete or partial response) to chemotherapy was observed in 145 patients (37.1%). Univariate analysis showed that the overall survival of patients who received more than six cycles or responded to chemotherapy (complete or partial response) was significantly longer than that of patients who received less than four cycles or did not respond to chemotherapy (stable or progressive disease). At multivariate levels, no correlations were observed between overall survival and the number of cycles of or the response to chemotherapy. CONCLUSIONS: Therapeutic benefit of pembrolizumab can be expected irrespective of the objective response to and number of cycles of platinum-based first-line chemotherapy.
OBJECTIVES: To investigate the impact of the number of cycles and objective response to chemotherapy on overall survival in patients with metastatic urothelial carcinoma treated with pembrolizumab. METHODS: This multicenter, retrospective study included 755 patients from 59 institutions with advanced, chemoresistant urothelial carcinoma who received pembrolizumab. The associations of the overall survival with the number of cycles and best objective response were investigated using Cox multiple regression analysis. RESULTS: Overall, 391 patients received standard first-line chemotherapy and pembrolizumab as a second-line treatment, and were included in the final analysis. Of the 391 patients, 185 received less than four cycles, 134 received four to six cycles and 72 received more than six cycles of first-line chemotherapy. An objective response (complete or partial response) to chemotherapy was observed in 145 patients (37.1%). Univariate analysis showed that the overall survival of patients who received more than six cycles or responded to chemotherapy (complete or partial response) was significantly longer than that of patients who received less than four cycles or did not respond to chemotherapy (stable or progressive disease). At multivariate levels, no correlations were observed between overall survival and the number of cycles of or the response to chemotherapy. CONCLUSIONS: Therapeutic benefit of pembrolizumab can be expected irrespective of the objective response to and number of cycles of platinum-based first-line chemotherapy.