35 results on '"Uemura, Hiroji"'
Search Results
2. Health-related Quality of Life in Patients with Previously Treated Advanced Urothelial Carcinoma from EV-301: A Phase 3 Trial of Enfortumab Vedotin Versus Chemotherapy
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Rosenberg, Jonathan E., Mamtani, Ronac, Sonpavde, Guru P., Loriot, Yohann, Duran, Ignacio, Lee, Jae-Lyun, Matsubara, Nobuaki, Vulsteke, Christof, Castellano, Daniel, Sridhar, Srikala S., Pappot, Helle, Gurney, Howard, Bedke, Jens, van der Heijden, Michiel S., Galli, Luca, Keam, Bhumsuk, Masumori, Naoya, Meran, Johannes, O'Donnell, Peter H., Park, Se Hoon, Grande, Enrique, Sengeløv, Lisa, Uemura, Hiroji, Skaltsa, Konstantina, Campbell, Mary, Matsangou, Maria, Wu, Chunzhang, Hepp, Zsolt, McKay, Caroline, Powles, Thomas, and Petrylak, Daniel P.
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- 2024
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3. Comparison of Urinary Liver Fatty Acid Binding Protein Level and Pathologic Biopsy Findings 1 Year After Kidney Transplantation
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Teranishi, Jun-Ichi, Takamoto, Daiji, Ishida, Hiroaki, Kawahara, Takashi, Uemura, Hiroji, and Makiyama, Kazuhide
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- 2024
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4. MP05-07 GDF15 PROPEPTIDE IS A NOVEL BLOOD BIOMARKER FOR CASTRATION-RESISTANT PROSTATE CANCER WITH BONE METASTASIS VIA PROMOTING THE VICIOUS CYCLE
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Yamamichi, Gaku, primary, Kato, Taigo, additional, Arakawa, Noriaki, additional, Motoyama, Yuichi, additional, Outani, Hidetatsu, additional, Myoba, Shohei, additional, Ishizuya, Yu, additional, Yamamoto, Yoshiyuki, additional, Hatano, Koji, additional, Kawashima, Atsunari, additional, Uemura, Hiroji, additional, Uemura, Motohide, additional, and Nonomura, Norio, additional
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- 2024
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5. Current issues and management consensus of advanced prostate cancer: Report of the Advanced Prostate Cancer Consensus Conference—JAPAN 2023.
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Hashimoto, Kohei, Kosaka, Takeo, Terada, Naoki, Kimura, Takahiro, Nonomura, Norio, Suzuki, Hiroyoshi, and Uemura, Hiroji
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UROLOGISTS ,PHYSICIANS ,PROSTATE cancer ,VOTING ,MEDICAL care - Abstract
Objective: To evaluate and compare the voting results of Japanese urologists with the global panel at the Advanced Prostate Cancer Consensus Conference (APCCC) 2022. Methods: Among the 198 questions discussed at the APCCC 2022, the APCCC‐JAPAN 2023 focused on 14 key questions related to the management of advanced prostate cancer with insufficient high‐level evidence based on their relevance to the Japanese cohort. A panel of six prostate cancer experts addressed these 14 questions and presented the latest evidence to Japanese urologists who voted on‐site using a web‐based system. The results were compared with those of APCCC 2022. Results: This study found significant differences in the voting results between Japanese urologists and the global panel regarding several crucial issues related to advanced prostate cancer management. These differences were those observed in treatment preferences, monitoring strategies, and treatment choices in specific clinical scenarios. These findings highlight the need for a nuanced approach tailored to the unique challenges with considerations of the Japanese healthcare environment. Conclusions: APCCC‐JAPAN 2023 provides valuable insights into the current clinical issues surrounding the management of advanced prostate cancer in Japan. The partial divergence in the consensus between Japanese urologists and the global panel underscores the importance of a context‐specific approach. The results of this study provide practical guidance for physicians facing complex challenges and should be used to inform decision‐making in the management of advanced prostate cancer. [ABSTRACT FROM AUTHOR]
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- 2024
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6. Prostate ductal adenocarcinoma exhibiting a late recurrence in the anterior urethra 13 years post-total prostatectomy: a case report.
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Honda, Seiichiro, Kawahara, Takashi, Tanaka, Reiko, Yuguchi, Shu, Yamanaka, Shoji, Fujii, Satoshi, Hasizume, Akihito, Osaka, Kimito, Mimura, Noboru, Karibe, Jurii, Noguchi, Takeaki, Shimokihara, Kota, Takamoto, Daiji, Takeshima, Teppei, Teranishi, Jun-ichi, Makiyama, Kazuhide, and Uemura, Hiroji
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URETHRAL cancer ,PROSTATE-specific antigen ,LYMPHATIC metastasis ,RADICAL prostatectomy ,GLEASON grading system ,PROSTATE cancer - Abstract
Background: Prostate ductal adenocarcinoma, a rare histology observed in 0.4–0.8% of all prostate cancers, is treated similarly to acinar adenocarcinoma but tends to have a higher likelihood of metastasis, recurrence, and poorer prognosis. Case presentation: A 73-year-old Asian-Japanese male presented with gross hematuria, with investigations revealing a prostate ductal adenocarcinoma. Subsequent radical prostatectomy indicated a Gleason score of 8 with no lymph node metastasis. Despite initial prostate-specific antigen level reductions post-prostatectomy and salvage radiation therapy due to recurring elevated prostate-specific antigen levels, no recurrence was evident until 13 years later. A tumor in the anterior urethra was identified as metastasis of his prostate ductal adenocarcinoma. Conclusion: This report presents an uncommon case of prostate ductal adenocarcinoma exhibiting a late recurrence in the anterior urethra 13 years post-radical prostatectomy. [ABSTRACT FROM AUTHOR]
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- 2024
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7. Laparoscopic removal of retroperitoneal schwannoma in renal hilum: a case report.
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Yamamoto, Shotaro, Kawahara, Takashi, Saito, Tomoki, Hanai, Takahiro, Takeshima, Teppei, Maeda, Koki, Makiyama, Kazuhide, and Uemura, Hiroji
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KIDNEY tumors ,RENAL veins ,KIDNEY physiology ,PORTAL vein ,TUMORS - Abstract
Background: Schwannomas in the renal hilum are rare among retroperitoneal tumors. However, the possibility of malignant findings cannot be ruled out, and surgery is often indicated. This case was expected to be difficult to remove laparoscopically because the tumor was sandwiched between the arteriovenous veins of the renal portal. Sometimes, the tumor should be resected with a conservative approach to the kidney to preserve the renal function. Case presentation: Our patient was a 51-year-old Asian-Japanese man who was referred to our department for a retroperitoneal tumor in the renal hilum. Since malignancy could not be ruled out due to its size (45 × 48 × 55 mm) on imaging, the tumor was excised laparoscopically. Histopathology revealed schwannoma. Conclusions: We herein report a case in which a renal hilar tumor between renal arteriovenous vessels was successfully resected laparoscopically. [ABSTRACT FROM AUTHOR]
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- 2024
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8. Supplementary Methods S1 from A Phase I Study of Acapatamab, a Half-life Extended, PSMA-Targeting Bispecific T-cell Engager for Metastatic Castration-Resistant Prostate Cancer
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Dorff, Tanya, primary, Horvath, Lisa G., primary, Autio, Karen, primary, Bernard-Tessier, Alice, primary, Rettig, Matthew B., primary, Machiels, Jean-Pascal, primary, Bilen, Mehmet A., primary, Lolkema, Martijn P., primary, Adra, Nabil, primary, Rottey, Sylvie, primary, Greil, Richard, primary, Matsubara, Nobuaki, primary, Tan, Daniel S.W., primary, Wong, Alvin, primary, Uemura, Hiroji, primary, Lemech, Charlotte, primary, Meran, Johannes, primary, Yu, Youfei, primary, Minocha, Mukul, primary, McComb, Mason, primary, Penny, Hweixian Leong, primary, Gupta, Vinita, primary, Hu, Xuguang, primary, Jurida, Gabor, primary, Kouros-Mehr, Hosein, primary, Janát-Amsbury, Margit M., primary, Eggert, Tobias, primary, and Tran, Ben, primary
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- 2024
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9. Supplementary Table S3 from A Phase I Study of Acapatamab, a Half-life Extended, PSMA-Targeting Bispecific T-cell Engager for Metastatic Castration-Resistant Prostate Cancer
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Dorff, Tanya, primary, Horvath, Lisa G., primary, Autio, Karen, primary, Bernard-Tessier, Alice, primary, Rettig, Matthew B., primary, Machiels, Jean-Pascal, primary, Bilen, Mehmet A., primary, Lolkema, Martijn P., primary, Adra, Nabil, primary, Rottey, Sylvie, primary, Greil, Richard, primary, Matsubara, Nobuaki, primary, Tan, Daniel S.W., primary, Wong, Alvin, primary, Uemura, Hiroji, primary, Lemech, Charlotte, primary, Meran, Johannes, primary, Yu, Youfei, primary, Minocha, Mukul, primary, McComb, Mason, primary, Penny, Hweixian Leong, primary, Gupta, Vinita, primary, Hu, Xuguang, primary, Jurida, Gabor, primary, Kouros-Mehr, Hosein, primary, Janát-Amsbury, Margit M., primary, Eggert, Tobias, primary, and Tran, Ben, primary
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- 2024
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10. Supplementary Figure S2 from A Phase I Study of Acapatamab, a Half-life Extended, PSMA-Targeting Bispecific T-cell Engager for Metastatic Castration-Resistant Prostate Cancer
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Dorff, Tanya, primary, Horvath, Lisa G., primary, Autio, Karen, primary, Bernard-Tessier, Alice, primary, Rettig, Matthew B., primary, Machiels, Jean-Pascal, primary, Bilen, Mehmet A., primary, Lolkema, Martijn P., primary, Adra, Nabil, primary, Rottey, Sylvie, primary, Greil, Richard, primary, Matsubara, Nobuaki, primary, Tan, Daniel S.W., primary, Wong, Alvin, primary, Uemura, Hiroji, primary, Lemech, Charlotte, primary, Meran, Johannes, primary, Yu, Youfei, primary, Minocha, Mukul, primary, McComb, Mason, primary, Penny, Hweixian Leong, primary, Gupta, Vinita, primary, Hu, Xuguang, primary, Jurida, Gabor, primary, Kouros-Mehr, Hosein, primary, Janát-Amsbury, Margit M., primary, Eggert, Tobias, primary, and Tran, Ben, primary
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- 2024
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11. Data from A Phase I Study of Acapatamab, a Half-life Extended, PSMA-Targeting Bispecific T-cell Engager for Metastatic Castration-Resistant Prostate Cancer
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Dorff, Tanya, primary, Horvath, Lisa G., primary, Autio, Karen, primary, Bernard-Tessier, Alice, primary, Rettig, Matthew B., primary, Machiels, Jean-Pascal, primary, Bilen, Mehmet A., primary, Lolkema, Martijn P., primary, Adra, Nabil, primary, Rottey, Sylvie, primary, Greil, Richard, primary, Matsubara, Nobuaki, primary, Tan, Daniel S.W., primary, Wong, Alvin, primary, Uemura, Hiroji, primary, Lemech, Charlotte, primary, Meran, Johannes, primary, Yu, Youfei, primary, Minocha, Mukul, primary, McComb, Mason, primary, Penny, Hweixian Leong, primary, Gupta, Vinita, primary, Hu, Xuguang, primary, Jurida, Gabor, primary, Kouros-Mehr, Hosein, primary, Janát-Amsbury, Margit M., primary, Eggert, Tobias, primary, and Tran, Ben, primary
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- 2024
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12. Supplementary Tables S1-S5 from TAS0313 plus Pembrolizumab for Post-Chemotherapy Immune Checkpoint Inhibitor—Naïve Locally Advanced or Metastatic Urothelial Carcinoma
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Nishiyama, Hiroyuki, primary, Yonese, Junji, primary, Kawahara, Takashi, primary, Matsumoto, Ryuji, primary, Miyake, Hideaki, primary, Matsubara, Nobuaki, primary, Uemura, Hiroji, primary, Eto, Masatoshi, primary, Azuma, Haruhito, primary, Obara, Wataru, primary, Terai, Akito, primary, Fukasawa, Satoshi, primary, and Suekane, Shigetaka, primary
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- 2024
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13. Data from TAS0313 plus Pembrolizumab for Post-Chemotherapy Immune Checkpoint Inhibitor—Naïve Locally Advanced or Metastatic Urothelial Carcinoma
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Nishiyama, Hiroyuki, primary, Yonese, Junji, primary, Kawahara, Takashi, primary, Matsumoto, Ryuji, primary, Miyake, Hideaki, primary, Matsubara, Nobuaki, primary, Uemura, Hiroji, primary, Eto, Masatoshi, primary, Azuma, Haruhito, primary, Obara, Wataru, primary, Terai, Akito, primary, Fukasawa, Satoshi, primary, and Suekane, Shigetaka, primary
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- 2024
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14. Supplementary Legends from TAS0313 plus Pembrolizumab for Post-Chemotherapy Immune Checkpoint Inhibitor—Naïve Locally Advanced or Metastatic Urothelial Carcinoma
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Nishiyama, Hiroyuki, primary, Yonese, Junji, primary, Kawahara, Takashi, primary, Matsumoto, Ryuji, primary, Miyake, Hideaki, primary, Matsubara, Nobuaki, primary, Uemura, Hiroji, primary, Eto, Masatoshi, primary, Azuma, Haruhito, primary, Obara, Wataru, primary, Terai, Akito, primary, Fukasawa, Satoshi, primary, and Suekane, Shigetaka, primary
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- 2024
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15. Supplementary Figure S1 from TAS0313 plus Pembrolizumab for Post-Chemotherapy Immune Checkpoint Inhibitor—Naïve Locally Advanced or Metastatic Urothelial Carcinoma
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Nishiyama, Hiroyuki, primary, Yonese, Junji, primary, Kawahara, Takashi, primary, Matsumoto, Ryuji, primary, Miyake, Hideaki, primary, Matsubara, Nobuaki, primary, Uemura, Hiroji, primary, Eto, Masatoshi, primary, Azuma, Haruhito, primary, Obara, Wataru, primary, Terai, Akito, primary, Fukasawa, Satoshi, primary, and Suekane, Shigetaka, primary
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- 2024
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16. SETD2 regulates SLC family transporter-mediated sodium and glucose reabsorptions in renal tubule
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Mitome, Taku, primary, Wakui, Hiromichi, additional, Azushima, Kengo, additional, Uehara, Tatsuki, additional, Jikuya, Ryosuke, additional, Ohtake, Shinji, additional, Noguchi, Go, additional, Kawaura, Sachi, additional, Iribe, Yasuhiro, additional, Aomori, Kota, additional, Tatenuma, Tomoyuki, additional, Ito, Hiroki, additional, Kawahara, Takashi, additional, Komeya, Mitsuru, additional, Ito, Yusuke, additional, Muraoka, Kentaro, additional, Furuya, Mitsuko, additional, Kato, Ikuma, additional, Fujii, Satoshi, additional, Nagahama, Kiyotaka, additional, Nishiyama, Akira, additional, Tamura, Tomohiko, additional, Kimura, Yayoi, additional, Kawagoe, Tatsukata, additional, Mizuki, Nobuhisa, additional, Huang, Gang, additional, Uemura, Hiroji, additional, Yao, Masahiro, additional, Makiyama, Kazuhide, additional, Tamura, Kouichi, additional, and Hasumi, Hisashi, additional
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- 2024
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17. Cardiovascular disease risk assessment and multidisciplinary care in prostate cancer treatment with ADT: recommendations from the APMA PCCV expert network
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Merseburger, Axel S., primary, Bakshi, Ganesh, additional, Chen, Dong-Yi, additional, Chiong, Edmund, additional, Jabbour, Michel, additional, Joung, Jae Young, additional, Lai, Allen Yu-Hung, additional, Lawrentschuk, Nathan, additional, Le, Tuan-Anh, additional, Ng, Chi Fai, additional, Ng, Choon Ta, additional, Ong, Teng Aik, additional, Pang, Jacob See-Tong, additional, Rabah, Danny M., additional, Ragavan, Narasimhan, additional, Sase, Kazuhiro, additional, Suzuki, Hiroyoshi, additional, Teo, Michelle Mui Hian, additional, Uemura, Hiroji, additional, and Woo, Henry H., additional
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- 2024
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18. Cold saline irrigation, a novel approach, reduces the risk of postoperative urinary tract infection in retrograde intrarenal surgery
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Kasahara, Ryo, primary, Kawahara, Takashi, additional, Ueki, Teiichiro, additional, Uemura, Hiroji, additional, and Makiyama, Kazuhide, additional
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- 2024
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19. A diagnostically challenging case of inflammatory myofibroblastic tumor primary to the peritoneum
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Karibe, Jurii, primary, Teranishi, Jun‐ichi, additional, Kawahara, Takashi, additional, Noguchi, Takeaki, additional, Takeshima, Teppei, additional, Osaka, Kimito, additional, Kumagai, Eita, additional, Sawazumi, Tomoe, additional, Fujii, Satoshi, additional, and Uemura, Hiroji, additional
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- 2024
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20. A phase 1 study of acapatamab, a half-life extended, PSMA-targeting bispecific T-cell engager for metastatic castration-resistant prostate cancer
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Dorff, Tanya, primary, Horvath, Lisa G., additional, Autio, Karen, additional, Bernard-Tessier, Alice, additional, Rettig, Matthew B., additional, Machiels, Jean-Pascal, additional, Bilen, Mehmet A., additional, Lolkema, Martijn P., additional, Adra, Nabil, additional, Rottey, Sylvie, additional, Greil, Richard, additional, Matsubara, Nobuaki, additional, Tan, Daniel S.W., additional, Wong, Alvin, additional, Uemura, Hiroji, additional, Lemech, Charlotte, additional, Meran, Johannes, additional, Yu, Youfei, additional, Minocha, Mukul, additional, McComb, Mason, additional, Penny, Hweixian Leong., additional, Gupta, Vinita, additional, Hu, Xuguang, additional, Jurida, Gabor, additional, Kouros-Mehr, Hosein, additional, Janát-Amsbury, Margit M., additional, Eggert, Tobias, additional, and Tran, Ben, additional
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- 2024
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21. Japanese clinical practice guidelines for prostate cancer 2023.
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Kohjimoto, Yasuo, Uemura, Hiroji, Yoshida, Masahiro, Hinotsu, Shiro, Takahashi, Satoru, Takeuchi, Tsutomu, Suzuki, Kazuhiro, Shinmoto, Hiroshi, Tamada, Tsutomu, Inoue, Takahiro, Sugimoto, Mikio, Takenaka, Atsushi, Habuchi, Tomonori, Ishikawa, Hitoshi, Mizowaki, Takashi, Saito, Shiro, Miyake, Hideaki, Matsubara, Nobuaki, Nonomura, Norio, and Sakai, Hideki
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PROSTATE cancer , *MEDICAL quality control , *PROSTATE cancer patients - Abstract
This fourth edition of the Japanese Clinical Practice Guidelines for Prostate Cancer 2023 is compiled. It was revised under the leadership of the Japanese Urological Association, with members selected from multiple academic societies and related organizations (Japan Radiological Society, Japanese Society for Radiation Oncology, the Department of EBM and guidelines, Japan Council for Quality Health Care (Minds), Japanese Society of Pathology, and the patient group (NPO Prostate Cancer Patients Association)), in accordance with the Minds Manual for Guideline Development (2020 ver. 3.0). The most important feature of this revision is the adoption of systematic reviews (SRs) in determining recommendations for 14 clinical questions (CQs). Qualitative SRs for these questions were conducted, and the final recommendations were made based on the results through the votes of 24 members of the guideline development group. Five algorithms based on these results were also created. Contents not covered by the SRs, which are considered textbook material, have been described in the general statement. In the general statement, a literature search for 14 areas was conducted; then, based on the general statement and CQs of the Japanese Clinical Practice Guidelines for Prostate Cancer 2016, the findings revealed after the 2016 guidelines were mainly described. This article provides an overview of these guidelines. [ABSTRACT FROM AUTHOR]
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- 2024
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22. Enzalutamide Prolonged the Duration of Drug Use in Comparison to Abiraterone Acetate and Cabazitaxel after Upfront Docetaxel: A Large Japanese Database Study.
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Yamaguchi, Katsuya, Kawahara, Takashi, Hashizume, Akihito, Ousaka, Kimito, Uemura, Koichi, Ito, Yusuke, Ito, Hiroki, Makiyama, Kazuhide, and Uemura, Hiroji
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CASTRATION-resistant prostate cancer ,DOCETAXEL ,BONE metastasis ,MEDICAL coding ,CANCER patients ,ABIRATERONE acetate - Abstract
Introduction: In the United States, a total of 268,490 men were found to have prostate cancer in 2022, thus making it the most common cancer in men, accounting for 27% of all cancers in the male population. Among all cancers in men, it was the fifth leading cause of death, with 34,500 deaths and a mortality rate of 11%. In 2019, the total number of cases was 94,748, making it the leading cancer in males, accounting for 11% of all male cancers. In terms of mortality, it ranked seventh, with 13,217 deaths and a mortality rate of 1.6%. However, new treatment options for metastatic castration-sensitive prostate cancer (mCSPC) have emerged. Docetaxel has been shown to be effective for both mCSPC and castration-resistant prostate cancer (CRPC). Upfront docetaxel has not been approved in Japan, nor has it been validated in large-scale studies. Furthermore, several agents can be used after docetaxel treatment, but it is unclear which is the most effective. We used a large Japanese health insurance database to determine which agent would be the most effective as a next-line therapy in patients who had received docetaxel. Materials and Methods: We used data from medical institutions using the Diagnosis Procedure Combination (DPC), which provides a comprehensive evaluation of medical classifications. The Medical Data Vision database covers approximately 23% of DPC hospitals in Japan. This study analyzed 2938 patients with mCSPC who received docetaxel, followed by CRPC, between April 2008 and December 2021. The study focused on three agents: enzalutamide, abiraterone acetate, and cabazitaxel. Other agents were excluded due to the small number of patients. The following data were analyzed: age, date of CRPC diagnosis, presence of bone metastasis, drug type, and prognosis. Results: This study included 1997 patients with CRPC after upfront docetaxel therapy for mCSPC (enzalutamide [ENZ] group, n = 998; abiraterone acetate [ABI] group, n = 617; and cabazitaxel [CBZ] group, n = 382). The overall survival (OS) time from drug initiation was 456 days in the enzalutamide group, which was significantly longer than that in the cabazitaxel group (p = 0.017, HR 0.94) (ENZ: ABI p = 0.54, HR 0.94; ABI: CBZ p = 0.14, HR 0.75). OS was also compared for the third-line drug in the group that received enzalutamide as the second-line drug, the group that used abiraterone acetate as the third-line drug (ENZ-ABI group), and the group that used abiraterone acetate as the second-line drug. OS from the start of the third-line drug was compared between the ENZ–ABI group and the ABI–ENZ group, which received enzalutamide as the third-line drug, but showed no significant difference (269 vs. 281 days, p = 0.85; HR 1.03). Conclusion: ENZ was shown to prolong OS relative to cabazitaxel after the cessation of docetaxel. ENZ was associated with a longer duration of drug use than ABI and CBZ. [ABSTRACT FROM AUTHOR]
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- 2024
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23. Enfortumab vedotin prolongs overall survival in metastatic urothelial carcinoma following pembrolizumab therapy in real‐world data.
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Uemura, Koichi, Ito, Hiroki, Jikuya, Ryosuke, Kondo, Takuya, Tatenuma, Tomoyuki, Kawahara, Takashi, Ito, Yusuke, Komeya, Mitsuru, Muraoka, Kentaro, Hasumi, Hisashi, Uemura, Hiroji, and Makiyama, Kazuhide
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TRANSITIONAL cell carcinoma ,OVERALL survival ,PEMBROLIZUMAB ,ANTIBODY-drug conjugates ,ELECTRIC vehicles - Abstract
Objective: In December 2021, enfortumab vedotin (EV), an antibody‐drug conjugate directed against nectin‐4, was approved in Japan as a new treatment after platinum‐containing chemotherapy and PD‐1/PD‐L1 inhibitors. This study evaluated, using real‐world data, the efficacy and safety of EV therapy in patients with metastatic urothelial carcinoma (mUC). Materials and methods: Fifty‐five patients with mUC who discontinued pembrolizumab therapy due to disease progression between June 2018 and April 2023 at Yokohama City University Hospital were evaluated retrospectively. Of the 55 patients, 25 received EV therapy (EV group) and 30 did not (non‐EV group). All patients who underwent EV therapy were diagnosed with disease progression after the approval of EV in Japan. Results: The median (range) follow‐up period after pembrolizumab discontinuation was 6.3 (0.7–31.1) months. There were eight (32.0%) deaths due to cancer in the EV group and 27 (90.0%) in the non‐EV group. The overall survival (OS) after pembrolizumab discontinuation was not reached in the EV group versus 2.6 months in the non‐EV group (p < 0.001). A multivariate analysis revealed that EV therapy (EV vs. non‐EV group; hazard ratio 0.26; 95% confidence interval 0.16–0.41; p < 0.001) was an independent prognostic factor for OS. Conclusion: EV prolonged OS in mUC following pembrolizumab therapy in real‐world data. [ABSTRACT FROM AUTHOR]
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- 2024
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24. Metastatic castration resistant prostate cancer patients' experience with Radium-223 treatment in Japan.
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Akakura, Koichiro, Uemura, Hiroji, Kawakami, Satoru, Yokomizo, Akira, Nakamura, Motonobu, Nishimura, Kazuo, Komori, Tetsushi, and Ledesma, Dianne Athene
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Aim: We aimed to determine Japanese metastatic castration resistant prostate cancer (CRPC) patients' Ra-223 treatment experience. Patients & methods: Patients answered the Cancer Therapy Satisfaction Questionnaire (CTSQ domains: Satisfaction with Therapy [SWT], Expectations of Therapy [ET], Feelings about Side Effects [FSE]), the Memorial Anxiety Scale for Prostate Cancer (MAX-PC) and the FACT-Bone Pain (FACT-BP) Questionnaire at baseline, during (vists 3 and 5) and after treatment (end of observation; EOO). Results: Data from 72 patients were included. Baseline median CTSQ scores SWT: 66.1 (IQR19.7), ET: 75.0 (IQR45), and FSE 68.8 (IQR 34.4) were unchanged during vists 3 and 5, but the SWT (-3.57 [IQR17.9]) and ET (-5.0 [IQR30]) decreased while FSE was unchanged (0.0 [IQR31.25]) at EOO. The median MAX-PC (18.0 [IQR 49]) score was unchanged (0.0, IQR 6) while the median FACT BP (54.0 [IQR13]) score decreased by -1.0 (IQR 8) at EOO. Conclusion: Japanese metastatic castration resistant prostate cancer patients' experience is stable during Ra-223 treatment. We wanted to know the treatment experience with Radium-223 (Ra-223) among Japanese prostate cancer patients. Ra-223 is a radioactive molecule used for the treatment of metastatic castration resistant prostate cancer. We asked patients to answer different questionnaires on treatment satisfaction, anxiety and quality of life before, during, and after treatment with Ra-223. Based on the patients' answers to our questionnaires, treatment satisfaction, anxiety and quality of life remain stable while the patients undergo treatment with Ra-223, but in some aspects may decline after treatment. The results mean that patients' experience during Ra-223 treatment is stable but patients should share any concerns they have about their treatment with their doctors. A study on Japanese metastatic castration resistant prostate cancer patients who receive Radium-223 therapy showed that treatment satisfaction, anxiety and health-related quality of life remain stable among patients while undergoing Ra-223 treatment. [ABSTRACT FROM AUTHOR]
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- 2024
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25. Clinical management of nonobstructive azoospermia: An update.
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Takeshima, Teppei, Karibe, Jurii, Saito, Tomoki, Kuroda, Shinnosuke, Komeya, Mitsuru, Uemura, Hiroji, and Yumura, Yasushi
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AZOOSPERMIA ,MALE infertility ,SPERM donation ,ARTIFICIAL insemination ,ORGAN culture ,KALLMANN syndrome ,FREEDOM of information - Abstract
Approximately 1% of the general male population has azoospermia, and nonobstructive azoospermia accounts for the majority of cases. The causes vary widely, including chromosomal and genetic abnormalities, varicocele, drug‐induced causes, and gonadotropin deficiency; however, the cause is often unknown. In azoospermia caused by hypogonadotropic hypogonadism, gonadotropin replacement therapy can be expected to produce sperm in the ejaculate. In some cases, upfront varicocelectomy for nonobstructive azoospermia with varicocele may result in the appearance of ejaculated spermatozoa; however, the appropriate indication should be selected. Each guideline recommends microdissection testicular sperm extraction for nonobstructive azoospermia in terms of successful sperm retrieval and avoidance of complications. Sperm retrieval rates generally ranged from 20% to 70% but vary depending on the causative disease. Various attempts have been made to predict sperm retrieval and improve sperm retrieval rates; however, the evidence is insufficient. Further evidence accumulation is needed for salvage treatment in cases of failed sperm retrieval. In Japan, there is inadequate provision on the right to know the origin of children born from artificial insemination of donated sperm and the rights of sperm donors, as well as information on unrelated family members, and the development of these systems is challenging. In the future, it is hoped that the pathogenesis of nonobstructive azoospermia with an unknown cause will be elucidated and that technology for omics technologies, human spermatogenesis using pluripotent cells, and organ culture methods will be developed. [ABSTRACT FROM AUTHOR]
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- 2024
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26. Pembrolizumab plus enzalutamide for metastatic castration-resistant prostate cancer progressing on enzalutamide: cohorts 4 and 5 of the phase 2 KEYNOTE-199 study
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Graff, Julie N., Hoimes, Christopher J., Gerritsen, Winald R., Vaishampayan, Ulka N., Elliott, Tony, Hwang, Clara, ten Tije, Albert J., Omlin, Aurelius, McDermott, Raymond S., Fradet, Yves, Tagawa, Scott T., Kilari, Deepak, Ferrario, Cristiano, Uemura, Hiroji, Jones, Robert J., Fukasawa, Satoshi, Peer, Avivit, Niu, Cuizhen, Poehlein, Christian H., Qiu, Ping, Suttner, Leah, de Wit, Ronald, Schloss, Charles, de Bono, Johann S., and Antonarakis, Emmanuel S.
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Background: KEYNOTE-199 (NCT02787005) is a multicohort phase 2 study evaluating pembrolizumab in patients with metastatic castration-resistant prostate cancer (mCRPC). Results from cohorts 4 (C4) and 5 (C5) are presented. Methods: Eligible patients had not received chemotherapy for mCRPC and had responded to enzalutamide prior to developing resistance as defined by Prostate Cancer Clinical Trials Working Group 3 guidelines. Patients with RECIST-measurable disease were enrolled in C4, and patients with bone-only or bone-predominant disease were enrolled in C5. All patients received pembrolizumab 200 mg every 3 weeks for ≤35 cycles with ongoing enzalutamide until progression, unacceptable toxicity, or withdrawal. The primary end point was objective response rate (ORR) per RECIST v1.1 by blinded independent central review in C4. Secondary end points included disease control rate (DCR), overall survival, and safety in each cohort and both cohorts combined. Results: A total of 126 patients were treated (C4, n= 81; C5, n= 45). Median age was 72 years (range 43–92), and 87.3% had received ≥6 months of enzalutamide prior to study entry. Confirmed ORR was 12.3% (95% CI 6.1–21.5%) for C4. Median duration of response in C4 was 8.1 months (range, 2.5+ to 15.2), and 5 of these patients experienced an objective response lasting ≥6 months. DCR was 53.1% (95% CI 41.7–64.3%) in C4 and 51.1% (95% CI 35.8–66.3%) in C5. Median overall survival was 17.6 months (95% CI 14.0–22.6) in C4 and 20.8 months (95% CI 14.1–28.9) in C5. Grade ≥3 treatment-related adverse events occurred in 35 patients (27.8%); 2 patients in C4 died from immune-related adverse events (myasthenic syndrome and Guillain-Barré syndrome). Conclusions: The addition of pembrolizumab to ongoing enzalutamide treatment in patients with mCRPC that progressed on enzalutamide after initial response demonstrated modest antitumor activity with a manageable safety profile. Clinical trial registry and ID: ClinicalTrials.gov, NCT02787005.
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- 2024
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27. Tolerability of Olaparib Combined with Abiraterone in Patients with Metastatic Castration-resistant Prostate Cancer: Further Results from the Phase 3 PROpel Trial
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Saad, Fred, Armstrong, Andrew J., Oya, Mototsugu, Vianna, Karina, Özgüroğlu, Mustafa, Gedye, Craig, Buchschacher, Gary L., Youl Lee, Ji, Emmenegger, Urban, Navratil, Jiri, Antonio Virizuela, Juan, Salazar, Anibal, Maillet, Denis, Uemura, Hiroji, Kim, Jeri, Oscroft, Emma, Barker, Laura, Degboe, Arnold, and Clarke, Noel W.
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Olaparib plus abiraterone has a manageable and predictable safety profile, allowingthe majority of patients to remain on treatment while continuing to receive clinical benefit. Anaemia was the most common adverse event, managed primarily by supportive measures and olaparib dose modification.
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- 2024
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28. Clinical case of 45,X/46,XY mosaic male with ejaculatory disorder associated with seminal vesicle dysplasia: a case report.
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Karibe J, Takeshima T, Takamoto D, Kawahara T, Osaka K, Teranishi JI, Makiyama K, Uemura H, and Yumura Y
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Introduction: 45,X/46,XY mosaicism is a rare anomaly in sexual differentiation, presenting with diverse phenotypes and often leading to infertility due to abnormal gonadal development., Aims: This report aims to present a case study of a 45,X/46,XY mosaic male patient with an ejaculatory disorder attributed to seminal vesicle dysplasia., Methods: In this case study, diagnostic procedures encompassed blood tests, semen analysis, chromosomal examination, and imaging studies to assess gonadal morphology. Treatment strategies included attempted varicocelectomy, pharmacological intervention with amoxapine, and surgical testicular sperm extraction. Additionally, the patient underwent assisted reproductive techniques, specifically intracytoplasmic sperm injection (ICSI), to facilitate pregnancy for his wife., Results: A 32-year-old man could not ejaculate, with post-orgasmic urinalysis revealing minimal sperm presence. Chromosomal analysis confirmed 45,X/46,XY mosaicism. Despite undergoing microsurgical varicocelectomy for clinical varicocele and receiving tricyclic antidepressants, no improvement in semen volume occurred. Imaging studies indicated ejaculatory disorder due to prostate and seminal vesicle aplasia. Consequently, surgical retrieval of testicular sperm was performed, leading to successful pregnancy via ICSI for his wife., Conclusion: Our approach has effectively addressed ejaculatory disorder in 45,X/46,XY mosaic men, resulting in successful pregnancy., Competing Interests: The authors declare no conflict of interest., (© The Author(s) 2024. Published by Oxford University Press on behalf of The International Society for Sexual Medicine.)
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- 2024
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29. SETD2 regulates SLC family transporter-mediated sodium and glucose reabsorptions in renal tubule.
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Mitome T, Wakui H, Azushima K, Uehara T, Jikuya R, Ohtake S, Noguchi G, Kawaura S, Iribe Y, Aomori K, Tatenuma T, Ito H, Kawahara T, Komeya M, Ito Y, Muraoka K, Furuya M, Kato I, Fujii S, Nagahama K, Nishiyama A, Tamura T, Kimura Y, Kawagoe T, Mizuki N, Huang G, Uemura H, Yao M, Makiyama K, Tamura K, and Hasumi H
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A regulatory mechanism for SLC family transporters, critical transporters for sodium and glucose reabsorptions in renal tubule, is incompletely understood. Here, we report an important regulation of SLC family transporter by SETD2, a chromatin remodeling gene whose alterations have been found in a subset of kidney cancers. Kidney-specific inactivation of Setd2 resulted in hypovolemia with excessive urine excretion in mouse and interestingly, RNA-sequencing analysis of Setd2-deficient murine kidney exhibited decreased expressions of SLC family transporters, critical transporters for sodium and glucose reabsorptions in renal tubule. Importantly, inactivation of Setd2 in murine kidney displayed attenuated dapagliflozin-induced diuresis and glucose excretion, further supporting that SETD2 might regulate SLCfamily transporter-mediated sodium and glucose reabsorptions in renal tubule. These data uncover an important regulation of SLC family transporter by SETD2, which may illuminate a crosstalk between metabolism and epigenome in renal tubule., Competing Interests: Declaration of competing interest The authors declare neither competing interests nor conflict of financial interest., (Copyright © 2024 Elsevier Inc. All rights reserved.)
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- 2024
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30. Testicular sperm extraction for fertility preservation in young patients with cancer.
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Karibe J, Takeshima T, Kuroda S, Takamoto D, Kawahara T, Osaka K, Teranishi JI, Murase M, Makiyama K, Uemura H, and Yumura Y
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Background: Cancer survivors in the adolescent and young adult generation often experience marriage, pregnancy, and childbirth after treatment; thus, fertility preservation is very important. In male patients, testicular sperm extraction (TESE) is sometimes performed due to azoospermia. Such a procedure is called oncological TESE (onco-TESE). In the present study, we aimed to define onco-TESE as TESE for fertility preservation in cancer patients, including those receiving gonadotoxic treatment., Methods: Seventeen male patients with cancer who had undergone onco-TESE for fertility preservation at Yokohama City University Medical Center between April 2014 and March 2023 were included in the study., Results: Motile testicular sperm were acquired by TESE in 9 out of 17 cases. Among patients who had initiated chemotherapy before surgery, Motile sperm could be acquired by onco-TESE in 3 out of 9 cases. In chemotherapy-naive patients, Motile sperm were acquired by onco-TESE in 6 out of 8 cases. In the end, sperm cryopreservation was performed in 10 patients. Cryopreserved sperm were used in 2 of the 10 cases, and live birth was achieved after intracytoplasmic sperm injection in both cases., Conclusions: Before starting gonadotoxic treatment, it is important to confirm whether the patient desires to bear children. If having a baby is desired, a referral to a reproductive medicine doctor is recommended. Fertility preservation before starting gonadotoxic treatment is preferable, but fertility preservation could be considered even after such a treatment., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://tau.amegroups.com/article/view/10.21037/tau-24-21/coif). The authors have no conflicts of interest to declare., (2024 Translational Andrology and Urology. All rights reserved.)
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- 2024
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31. Complete Response to Pembrolizumab in a Patient with Castration-Resistant Prostate Cancer with Both BRCA Positivity and a High Frequency of Microsatellite Instability: A Case Report.
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Hirano T, Yonezawa K, Kawahara T, Mizuno N, Hayashi H, Karibe Y, Asano J, Fusayasu S, Makiyama K, Uemura H, Ohta J, and Moriyama M
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Introduction: There have been few reports of patients for whom a cancer gene panel test for solid tumors revealed the simultaneous presence of BRCA mutation and microsatellite instability (MSI)-high status. BRCA mutations have been reported in 13% of castration-resistant prostate cancer (CRPC) patients, and 3.1% of prostate cancer cases are MSI-high/mismatch repair deficient., Case Presentation: A 71-year-old man with a history of urinary retention was referred to our department for clinically suspected prostate cancer and a high prostate-specific antigen (PSA) level (141 ng/mL). MRI revealed features of prostate cancer invading the bladder, seminal vesicles, and rectum. A histopathological examination of a transperineal needle biopsy specimen obtained from the prostate revealed adenocarcinoma. Bone scintigraphy revealed multiple metastases. The patient was treated with abiraterone acetate combined with androgen deprivation therapy followed by local radiation. Rectal wall thickening and lymph node metastasis were also observed, and docetaxel was administered. A cancer gene panel test was positive results for BRCA2 mutation with a MSI-high. After six courses of docetaxel, lymph node enlargement was observed and olaparib was initiated. Two months later, the metastatic lesions showed enlargement and the PSA level increased. Subsequently, pembrolizumab was administered. At 2 to the patient months after the initiation of pembrolizumab administration, PSA levels decreased to <0.025 ng/mL and the rectal lesions and lymph node metastases disappeared. The patient was continuing to receive pembrolizumab without any apparent adverse events or exacerbations, 9 months after initiation., Conclusion: We herein report a case in which pembrolizumab treatment resulted in a complete response in a CRPC patient with both a BRCA2 mutation and an MSI-high status., Competing Interests: The authors declare no conflicts of interest in association with the present study., (© 2024 The Author(s). Published by S. Karger AG, Basel.)
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- 2024
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32. An Age-Specific Crisis Awareness Survey of COVID-19 Vaccines and Treatments Among Healthy Japanese Adults.
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Kawahara T, Takeshima T, Makiyama K, and Uemura H
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Introduction and objectives The spread of coronavirus disease 2019 (COVID-19) has been a worldwide phenomenon. This study conducted a chronological survey of crisis awareness regarding COVID-19 within different age groups. Methods An internet-based survey was performed on healthy Japanese adults to investigate the value of a hypothetical prophylactic vaccine and therapeutic drug for COVID-19 in each age group. In total, 12 groups comprising males and females in six different age groups, leading to a total of 1,200 individuals, were surveyed on a weekly basis. The survey was conducted on Friday of each week commencing from February 14, 2020, to April 10, 2020. At certain times or events such as when the government released major announcements or when there was a rapid increase in the number of infected individuals, a similar survey was conducted on an additional 1,200 individuals per week. Results A total of 12 surveys, including weekly surveys spanning over nine weeks, were conducted; a total of 19,113 samples from 12,254 individuals were obtained. The mean price for a hypothetical prophylactic vaccine was 2876.3 JPY (26.9 USD) at the first survey and was significantly increased to 3357.4 JPY (31.4 USD) for the most recent survey (p<0.0001). The percentage of healthy individuals who were unwilling to pay for a hypothetical therapeutic drug at the onset of COVID-19 symptoms was higher in the young age group than in the elderly groups at all phases, indicating a low level of crisis awareness among some young individuals. On the other hand, the percentage of those willing to pay for more than the standard prophylaxis influenza vaccine remained almost the same in all age groups, and it also increased when COVID-19 infection was widespread. In the sub-analysis, females who have children and married individuals tended to answer higher costs for prevention. Conclusions Changes in crisis awareness in all age groups were found to be associated with an increasing familiarity along with an increase in the number of locally infected individuals. Though the percentage of those who will not pay was higher in the young age group than in the elderly age group, the percentage of those who will pay more than the standard costs of influenza vaccine or treatment drugs was the same between each aging group., Competing Interests: Human subjects: Consent was obtained or waived by all participants in this study. Institutional Review Board of Yokohama City University Medical Center issued approval #B200300041. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work., (Copyright © 2024, Kawahara et al.)
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- 2024
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33. Identification of Factors Contributing to Testosterone Recovery After Hormone Therapy Combined With External Radiation Therapy.
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Yokomizo Y, Ito Y, Kawahara T, Hayashi N, Miyoshi Y, Makiyama K, Hata M, and Uemura H
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- Humans, Male, Aged, Middle Aged, Aged, 80 and over, Gonadotropin-Releasing Hormone agonists, Combined Modality Therapy, Treatment Outcome, Antineoplastic Agents, Hormonal therapeutic use, Testosterone blood, Prostatic Neoplasms radiotherapy, Prostatic Neoplasms drug therapy, Prostatic Neoplasms blood, Prostatic Neoplasms therapy
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Background/aim: When hormone therapy (HT) is combined with radiotherapy, understanding the recovery of testosterone levels after the end of HT becomes crucial for considering subsequent therapy. The aim of this study was to determine the factors influencing the time to recovery of testosterone levels after discontinuation of HT and the likelihood of recovery., Patients and Methods: The study included a total of 108 patients with prostate cancer who were treated with GnRH agonist in combination with radiotherapy and followed up for at least 12 months after discontinuation of the GnRH agonist. The presence of recovery of testosterone levels and the time to recovery were investigated. Univariate and multivariate analyses were performed on several factors contributing to testosterone recovery, including age at initiation of HT, and the duration of HT., Results: Testosterone levels recovered in 61 cases (56.5%). The median time to recovery was 14.8 months. There was a significant difference in the recovery of testosterone levels between patients aged ≥71 years and those aged <71 years at the start of HT (p=0.002), and between those who had been on HT for ≥34 months and those for <34 months (p=0.031). In both univariate and multivariate analyses, age at initiation of HT and duration of HT contributed to the recovery of testosterone levels., Conclusion: The rate of recovery of testosterone levels after long-term (median 34.3 months) HT was lower in patients who were older than 71 years at the start of HT., (Copyright © 2024, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)
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- 2024
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34. A Phase I Study of Acapatamab, a Half-life Extended, PSMA-Targeting Bispecific T-cell Engager for Metastatic Castration-Resistant Prostate Cancer.
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Dorff T, Horvath LG, Autio K, Bernard-Tessier A, Rettig MB, Machiels JP, Bilen MA, Lolkema MP, Adra N, Rottey S, Greil R, Matsubara N, Tan DSW, Wong A, Uemura H, Lemech C, Meran J, Yu Y, Minocha M, McComb M, Penny HL, Gupta V, Hu X, Jurida G, Kouros-Mehr H, Janát-Amsbury MM, Eggert T, and Tran B
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- Male, Humans, Prostate-Specific Antigen, Half-Life, Treatment Outcome, Androgen Receptor Antagonists therapeutic use, T-Lymphocytes metabolism, Prostatic Neoplasms, Castration-Resistant pathology, Antineoplastic Agents therapeutic use
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Purpose: Safety and efficacy of acapatamab, a prostate-specific membrane antigen (PSMA) x CD3 bispecific T-cell engager were evaluated in a first-in-human study in metastatic castration-resistant prostate cancer (mCRPC)., Patients and Methods: Patients with mCRPC refractory to androgen receptor pathway inhibitor therapy and taxane-based chemotherapy received target acapatamab doses ranging from 0.003 to 0.9 mg in dose exploration (seven dose levels) and 0.3 mg (recommended phase II dose) in dose expansion intravenously every 2 weeks. Safety (primary objective), pharmacokinetics, and antitumor activity (secondary objectives) were assessed., Results: In all, 133 patients (dose exploration, n = 77; dose expansion, n = 56) received acapatamab. Cytokine release syndrome (CRS) was the most common treatment-emergent adverse event seen in 97.4% and 98.2% of patients in dose exploration and dose expansion, respectively; grade ≥ 3 was seen in 23.4% and 16.1%, respectively. Most CRS events were seen in treatment cycle 1; incidence and severity decreased at/beyond cycle 2. In dose expansion, confirmed prostate-specific antigen (PSA) responses (PSA50) were seen in 30.4% of patients and radiographic partial responses in 7.4% (Response Evaluation Criteria in Solid Tumors 1.1). Median PSA progression-free survival (PFS) was 3.3 months [95% confidence interval (CI): 3.0-4.9], radiographic PFS per Prostate Cancer Clinical Trials Working Group 3 was 3.7 months (95% CI: 2.0-5.4). Acapatamab induced T-cell activation and increased cytokine production several-fold within 24 hours of initiation. Treatment-emergent antidrug antibodies were detected in 55% and impacted serum exposures in 36% of patients in dose expansion., Conclusions: Acapatamab was safe and tolerated and had a manageable CRS profile. Preliminary signs of efficacy with limited durable antitumor activity were observed. Acapatamab demonstrated pharmacokinetic and pharmacodynamic activity., (©2024 American Association for Cancer Research.)
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- 2024
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35. TAS0313 plus Pembrolizumab for Post-Chemotherapy Immune Checkpoint Inhibitor-Naïve Locally Advanced or Metastatic Urothelial Carcinoma.
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Nishiyama H, Yonese J, Kawahara T, Matsumoto R, Miyake H, Matsubara N, Uemura H, Eto M, Azuma H, Obara W, Terai A, Fukasawa S, and Suekane S
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- Humans, Immune Checkpoint Inhibitors therapeutic use, B7-H1 Antigen metabolism, Antineoplastic Combined Chemotherapy Protocols adverse effects, Carcinoma, Transitional Cell drug therapy, Antineoplastic Agents, Immunological adverse effects, Urinary Bladder Neoplasms drug therapy, Urinary Bladder Neoplasms etiology, Antibodies, Monoclonal, Humanized
- Abstract
We evaluated the efficacy and safety of TAS0313, a multi-epitope long peptide vaccine, plus pembrolizumab in post-chemotherapy immune checkpoint inhibitor-naïve patients with locally advanced/metastatic urothelial carcinoma (la/mUC). TAS0313 9 mg was administered subcutaneously followed by pembrolizumab 200 mg on Day 1, and as monotherapy on Day 8 and 15 of Cycles 1 and 2, and Day 1 of subsequent cycles in 21-day cycles. The primary endpoint was the objective response rate (ORR). Secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety. Biomarkers of response were assessed. In 36 patients enrolled, the ORR was 33.3% (complete response: 7 patients; partial response: 5 patients). Median PFS was 5.0 months; 6- and 12-month progression-free rates were 46.4% and 36.5%, respectively. Median OS was not reached; 6-, 12-, and 24-month OS rates were 83.3%, 72.2%, and 55.1%, respectively. In post hoc analysis, patients with a tumor infiltrating CD8+ lymphocyte (CD8+ TIL) count ≥99 and/or programmed cell death ligand 1 (PD-L1) combined positive score (CPS) ≥50 and lymphocyte count >1,380 cells/μL had higher ORRs and prolonged PFS versus patients with a CD8+ TIL count <99, PD-L1 CPS <50, and lymphocyte count ≤1,380 cells/μL. Thirty-four (94.4%) patients receiving combination therapy experienced treatment-related adverse events (AE), with pyrexia (n = 15, 41.7%), injection-site reactions (n = 15, 41.7%), injection-site induration (n = 6, 16.7%), and malaise (n = 6, 16.7%) the most common. No grade ≥3 treatment-related AEs occurred in ≥10% of patients. TAS0313 plus pembrolizumab combination therapy showed promising efficacy and manageable safety in la/mUC. Clinical Trial Registration: JapicCTI-183824., (©2023 The Authors; Published by the American Association for Cancer Research.)
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- 2024
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