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2. Efficacy and safety of Vibegron for the treatment of residual overactive bladder symptoms after laser vaporization of the prostate: A single‐center prospective randomized controlled trial (VAPOR TRIAL).

Author

Seki, Narihito, Masaoka, Hiroyuki, Song, Yoohyun, Dejima, Takashi, Sato, Yoshiaki, and Maeda, Shotaro

Subjects
*OVERACTIVE bladder, *RANDOMIZED controlled trials, *VAPORIZATION, *PROSTATE, *BENIGN prostatic hyperplasia, *TRANSURETHRAL prostatectomy, *LASERS
Abstract

Objectives: This study aimed to evaluate the efficacy and safety of Vibegron for the treatment of residual overactive bladder (OAB) symptoms after laser vaporization of the prostate (photo‐selective vaporization of the prostate, contact laser vaporization of the prostate, and thulium laser vaporization). Methods: This randomized, open‐label, parallel‐group, single‐center superiority trial with a 12‐week observation (jRCTs071190040) enrolled male patients with OAB aged 40 years or older who had undergone laser vaporization of the prostate for not less than 12 weeks and not more than 1 year earlier. Patients were allocated to receive Vibegron 50 mg once daily or follow‐up without treatment for 12 weeks. Results: Forty‐seven patients were enrolled between January 2020 and March 2023. The median age (interquartile range) was 75.5 (72.5–78.5) years for the Vibegron group and 76.5 (71.0–81.0) years for the control group. The intergroup difference in the mean change (95% confidence interval) in the 24‐hour urinary frequency at 12 weeks after randomization was −3.66 (−4.99, −2.33), with a significant decrease for the Vibegron group. The Overactive Bladder Symptom Score, International Prostate Symptom Score, IPSS storage score, and Overactive Bladder Questionnaire score significantly improved for the Vibegron group. Voided volume per micturition also increased for the Vibegron group. Conclusions: The administration of 50 mg of Vibegron once daily for 12 weeks showed significant improvement compared with follow‐up without treatment in bladder storage (OAB) symptoms after laser vaporization of the prostate for symptomatic benign prostatic hyperplasia. [ABSTRACT FROM AUTHOR]

Published
2024
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3. Prognostic Impact of Histologic Subtype and Divergent Differentiation in Patients with Metastatic Urothelial Carcinoma Treated with Enfortumab Vedotin: A Multicenter Retrospective Study

Author

Minato, Akinori, primary, Furubayashi, Nobuki, additional, Nagata, Yujiro, additional, Tomoda, Toshihisa, additional, Masaoka, Hiroyuki, additional, Song, Yoohyun, additional, Hori, Yoshifumi, additional, Kiyoshima, Keijiro, additional, Negishi, Takahito, additional, Kuroiwa, Kentaro, additional, Seki, Narihito, additional, Tomisaki, Ikko, additional, Harada, Kenichi, additional, Nakamura, Motonobu, additional, and Fujimoto, Naohiro, additional

Published
2024
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6. Early Phase Persistent Changes in the White Blood Cell Fraction in Patients With Advanced Urothelial Carcinoma Treated With Pembrolizumab: A Multicenter Retrospective Study

Author

FURUBAYASHI, NOBUKI, primary, MINATO, AKINORI, additional, NEGISHI, TAKAHITO, additional, SAKAMOTO, NAOTAKA, additional, SONG, YOOHYUN, additional, HORI, YOSHIFUMI, additional, TOMODA, TOSHIHISA, additional, MASAOKA, HIROYUKI, additional, HARADA, MIRII, additional, TAMURA, SHINGO, additional, KOBAYASHI, HIROKI, additional, MORIHARA, KAEDE, additional, KUROIWA, KENTARO, additional, SEKI, NARIHITO, additional, FUJIMOTO, NAOHIRO, additional, and NAKAMURA, MOTONOBU, additional

Published
2023
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8. Bone‐modifying agents are protective for symptomatic skeletal events in Radium‐223 treatment.

Author

Blas, Leandro, Shiota, Masaki, Matsumoto, Takashi, Hori, Yoshifumi, Nakamura, Motonobu, Seki, Narihito, Kuroiwa, Kentaro, Yokomizo, Akira, Morokuma, Futoshi, Kiyoshima, Keijiro, and Eto, Masatoshi

Subjects
CASTRATION-resistant prostate cancer, PROSTATE cancer patients, BONE metastasis, SPONTANEOUS fractures, LOG-rank test
Abstract

Introduction: Radium‐223 (Ra‐223) dichloride therapy increases overall survival and delays time to the first symptomatic skeletal event (SSE) in patients with castration‐resistant prostate cancer (CRPC) and bone metastases. Bone‐modifying agents (BMA) reduce SSE in patients with bone metastasis, but there is little information on their use with Ra‐223. This study aimed to investigate the effect of BMA on SSE in patients with bone metastatic CRPC treated with Ra‐223 in real‐world practice. Methods: We included 73 patients treated with Ra‐223 from 10 institutions in Japan. Time to the first SSE was estimated using the Kaplan–Meier method and compared between groups using the log‐rank test. We used univariate analysis to ascertain the association between variables and SSE. Results: During a median follow‐up of 12.7 months (interquartile range, 7–21.7), 12 (16.4%) patients presented SSE. Age and BMA use were different between men with and without SSE. The 1‐year SSE‐free survival rate from Ra‐223 treatment initiation was 82.4% (95% CI, 69.4%–90.2%). BMA use was associated with favorable SSE‐free survival (hazard risk, 0.23; 95% confidence interval, 0.061–0.85; p = 0.027). Two (4.7%) and seven (23.3%) patients presented symptomatic pathological bone fracture in groups with and without BMA use, respectively (p = 0.017). Conclusion: This study stresses the importance of BMA use in patients with CRPC and bone metastases in Ra‐223 treatment. [ABSTRACT FROM AUTHOR]

Published
2023
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11. The Eosinophil Changes, Efficacy and Safety of Pembrolizumab in Advanced Urothelial Carcinoma Patients with an Older Age and a Poor Performance Status

Author

Furubayashi, Nobuki, primary, Minato, Akinori, additional, Negishi, Takahito, additional, Sakamoto, Naotaka, additional, Song, Yoohyun, additional, Hori, Yoshifumi, additional, Tomoda, Toshihisa, additional, Harada, Mirii, additional, Tamura, Shingo, additional, Kobayashi, Hiroki, additional, Wada, Yamato, additional, Kuroiwa, Kentaro, additional, Seki, Narihito, additional, Fujimoto, Naohiro, additional, and Nakamura, Motonobu, additional

Published
2022
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12. Effectiveness and safety of radium‐223 dichloride in patients with castration‐resistant prostate cancer and bone metastases in real‐world practice: A multi‐institutional study

Author

Matsumoto, Takashi, primary, Hori, Yoshifumi, additional, Shiota, Masaki, additional, Blas, Leandro, additional, Nakamura, Motonobu, additional, Seki, Narihito, additional, Kuroiwa, Kentaro, additional, Yokomizo, Akira, additional, Morokuma, Futoshi, additional, Kiyoshima, Keijiro, additional, and Eto, Masatoshi, additional

Published
2022
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13. Dissociated response among multiple metastatic lesions in the patients with metastatic renal cell carcinoma treated with immune checkpoint inhibitors

Author

Negishi, Takahito, primary, Nakagawa, Tohru, additional, Nishiyama, Naotaka, additional, Kitamura, Hiroshi, additional, Okajima, Eijiro, additional, Furubayashi, Nobuki, additional, Hori, Yoshifumi, additional, Kuroiwa, Kentarou, additional, Son, Yuhyon, additional, Seki, Narihito, additional, Tomoda, Toshihisa, additional, and Nakamura, Motonobu, additional

Published
2022
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14. Testicle Carcinoma Surveillance Counterpoint: Japan

Author

Seki, Narihito, Johnson, Frank E., editor, Maehara, Yoshihiko, editor, Browman, George P., editor, Margenthaler, Julie A., editor, Audisio, Riccardo A., editor, Thompson, John F., editor, Johnson, David Y., editor, Earle, Craig C., editor, and Virgo, Katherine S., editor

Published
2013
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15. A prospective, single‐center, randomized clinical trial to evaluate the efficacy of three types of laser vaporization surgeries using a 180‐W GreenLight XPS laser, a 300‐W diode laser, and a 200‐W thulium laser for the treatment of benign prostatic hyperplasia

Author

Okada, Tatsunori, primary, Koura, Mikifumi, additional, Sumikawa, Ryota, additional, Masaoka, Hiroyuki, additional, Song, Yoohyun, additional, Dejima, Takashi, additional, and Seki, Narihito, additional

Published
2022
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16. Association Between Immune-Related Adverse Events and Efficacy and Changes in the Relative Eosinophil Count Among Patients with Advanced Urothelial Carcinoma Treated by Pembrolizumab

Author

Furubayashi, Nobuki, primary, Minato, Akinori, additional, Negishi, Takahito, additional, Sakamoto, Naotaka, additional, Song, Yoohyun, additional, Hori, Yoshifumi, additional, Tomoda, Toshihisa, additional, Harada, Mirii, additional, Tamura, Shingo, additional, Miura, Akihiro, additional, Komori, Hiroki, additional, Kuroiwa, Kentaro, additional, Seki, Narihito, additional, Fujimoto, Naohiro, additional, and Nakamura, Motonobu, additional

Published
2022
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18. Effectiveness and safety of radium‐223 dichloride in patients with castration‐resistant prostate cancer and bone metastases in real‐world practice: A multi‐institutional study.

Author

Matsumoto, Takashi, Hori, Yoshifumi, Shiota, Masaki, Blas, Leandro, Nakamura, Motonobu, Seki, Narihito, Kuroiwa, Kentaro, Yokomizo, Akira, Morokuma, Futoshi, Kiyoshima, Keijiro, and Eto, Masatoshi

Subjects
CASTRATION-resistant prostate cancer, PROSTATE cancer patients, BONE cancer, BONE metastasis, METASTASIS
Abstract

Objective: Radium‐223 (Ra‐223) dichloride is the bone‐targeted radioligand therapy that prolongs overall survival (OS) in patients with bone‐metastatic castration‐resistant prostate cancer (CRPC). We aimed to evaluate the safety and effectiveness of this treatment in real‐world practice. Methods: We included Japanese men treated with Ra‐223 for bone‐metastatic CRPC from 10 institutions, retrospectively. Primary endpoint was OS. Secondary endpoint was maximum decline of alkaline phosphatase (ALP), lactate dehydrogenase, and prostate‐specific antigen values, the rate of adverse events, and time to pathological fracture after Ra‐223 treatment. Exploratory endpoint was the associations between clinical parameters and OS. Results: In total, 73 men with bone metastatic CRPC treated with Ra‐223 were enrolled. The median OS was 20.9 months. ALP levels decreased significantly from pre‐treatment (p = 0.03). Anemia occurred in three (4.1%) patients. Grade ≥ 3 non‐pathological fractures occurred in four (5.5%) men. Nine (12.3%) patients presented pathological fracture; 7/30 (23.3%) were in men without concomitant use of a bone‐modifying agent (BMA) while 2/43 (4.7%) were in patients with concomitant BMA (p = 0.03). The median OS in patients with ≥3 cycles treatment (27.2 months, p < 0.001) or hemoglobin ≥12 g/dl (27.2 months, p = 0.001) or absence of bone pain (36.3 months, p = 0.004) was significantly longer compared to those who with ≤2 cycles or hemoglobin<12 g/dl or presence of bone paint, respectively. Conclusions: This study has shown the outcomes of Ra‐223 treatment in real‐world practice, where the number of treatment cycles, baseline anemia and bone pain may be useful to predict OS in Ra‐223 treatment. [ABSTRACT FROM AUTHOR]

Published
2023
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22. The Association of Clinical Outcomes with Posttreatment Changes in the Relative Eosinophil Counts and Neutrophil-to-Eosinophil Ratio in Patients with Advanced Urothelial Carcinoma Treated with Pembrolizumab

Author

Furubayashi, Nobuki, primary, Minato, Akinori, additional, Negishi, Takahito, additional, Sakamoto, Naotaka, additional, Song, Yoohyun, additional, Hori, Yoshifumi, additional, Tomoda, Toshihisa, additional, Tamura, Shingo, additional, Kuroiwa, Kentaro, additional, Seki, Narihito, additional, Fujimoto, Naohiro, additional, and Nakamura, Motonobu, additional

Published
2021
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25. Non-inferiority of silodosin 4 mg once daily to twice daily for storage symptoms score evaluated by the International Prostate Symptom Score in Japanese patients with benign prostatic hyperplasia: A multicenter, randomized, parallel-group study

Author

Seki, Narihito, Takahashi, Ryosuke, Yamaguchi, Akito, Ito, Kenji, Takayama, Kazuo, Nanri, Kazushige, Kamiryo, Yoriaki, Yamashita, Hiroshi, Komine, Shinichiro, Miyazaki, Yoshiharu, Uozumi, Jiro, and Naito, Seiji

Published
2015
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27. Site-specific Response to Nivolumab in Renal Cell Carcinoma

Author

NEGISHI, TAKAHITO, primary, FURUBAYASHI, NOBUKI, additional, NAKAGAWA, TOHRU, additional, NISHIYAMA, NAOTAKA, additional, KITAMURA, HIROSHI, additional, HORI, YOSHIFUMI, additional, KUROIWA, KENTAROU, additional, SON, YUHYON, additional, SEKI, NARIHITO, additional, TOMODA, TOSHIHISA, additional, OKAJIMA, EIJIRO, additional, and NAKAMURA, MOTONOBU, additional

Published
2021
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28. Organ-Specific Tumor Response to Pembrolizumab in Advanced Urothelial Carcinoma After Platinum-Based Chemotherapy

Author

Furubayashi, Nobuki, primary, Negishi, Takahito, additional, Sakamoto, Naotaka, additional, Shimokawa, Hozumi, additional, Morokuma, Futoshi, additional, Song, Yoohyun, additional, Hori, Yoshifumi, additional, Tomoda, Toshihisa, additional, Tokuda, Noriaki, additional, Seki, Narihito, additional, Kuroiwa, Kentaro, additional, and Nakamura, Motonobu, additional

Published
2021
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30. Clinical Outcomes of Mixed Response to Pembrolizumab in Advanced Urothelial Carcinoma After Platinum-based Chemotherapy

Author

FURUBAYASHI, NOBUKI, primary, NEGISHI, TAKAHITO, additional, SAKAMOTO, NAOTAKA, additional, TAMURA, SHINGO, additional, MOROKUMA, FUTOSHI, additional, SONG, YOOHYUN, additional, HORI, YOSHIFUMI, additional, TOMODA, TOSHIHISA, additional, SEKI, NARIHITO, additional, KUROIWA, KENTARO, additional, and NAKAMURA, MOTONOBU, additional

Published
2021
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44. OnabotulinumtoxinA (botulinum toxin type A) for the treatment of Japanese patients with overactive bladder and urinary incontinence: Results of single‐dose treatment from a phase III, randomized, double‐blind, placebo‐controlled trial (interim analysis)

Author

Yokoyama, Osamu, primary, Honda, Masashi, additional, Yamanishi, Tomonori, additional, Sekiguchi, Yuki, additional, Fujii, Kenji, additional, Nakayama, Takashi, additional, Mogi, Takao, additional, Kitta, Takeya, additional, Ohyama, Chikara, additional, Kambe, Koichi, additional, Tanahashi, Yoshikatsu, additional, Sasagawa, Isoji, additional, Ootani, Mikinobu, additional, Nozawa, Eiyu, additional, Saito, Toshihiko, additional, Manabe, Fumio, additional, Suzuki, Yasutomo, additional, Tomoe, Hikaru, additional, Takahashi, Satoru, additional, Kawata, Nozomu, additional, Matsushima, Hisashi, additional, Kawai, Taketo, additional, Kinjo, Manami, additional, Fukagai, Takashi, additional, Takahashi, Atsuko, additional, Nakajima, Fumio, additional, Sasaki, Haruaki, additional, Okuno, Norihiko, additional, Itoi, Toshiyuki, additional, Ishiura, Yoshiyuki, additional, Mizokami, Atsushi, additional, Matsuta, Yosuke, additional, Sawada, Norifumi, additional, Miwa, Kosei, additional, Otsuka, Atsushi, additional, Funahashi, Yasuhito, additional, Yoshida, Masaki, additional, Tobiume, Motoi, additional, Kawauchi, Akihiro, additional, Okuno, Hiroshi, additional, Nakamura, Terukazu, additional, Ninomiya, Noriko, additional, Matsushita, Chie, additional, Takenaka, Atsushi, additional, Watanabe, Takeshi, additional, Watanabe, Toyohiko, additional, Ishito, Noritaka, additional, Yamamoto, Yasuyo, additional, Ikeda, Hiroshi, additional, Seki, Narihito, additional, Kanegae, Shigehiro, additional, Suyama, Kenichi, additional, Sagiyama, Kazuyuki, additional, Tokuda, Noriaki, additional, Sakai, Hideki, additional, Nishimura, Hiroaki, additional, and Kawahara, Motoshi, additional

Published
2020
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45. Fifth Joint Meeting of the American Urological Association and the Japanese Urological Association International Affiliate Society Meeting at the 105th Annual Meeting of the American Urological Association

Author

Myers, Robert P, Seki, Narihito, Gotoh, Momokazu, Chai, Toby C, Kaplan, Steven A, Inoue, Keiji, Trachtenberg, John, Kikuchi, Eiji, Nishiyama, Hiroyuki, Chang, Sam S, Lee, Cheryl, Muto, Satoru, Ito, Kazuto, Andriole, Gerald L, Eto, Masatoshi, Sumitomo, Makoto, Kamba, Tomomi, Wood, Chrsitopher G, Margulis, Vitaly, Naito, Seiji, and Egawa, Shin

Published
2010
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