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4. Treatment patterns and prognosis in patients with Bacillus Calmette–Guérin-exposed high-risk non-muscle invasive bladder cancer: a real-world data analysis

Author

Nishimura, Nobutaka, Miyake, Makito, Iida, Kota, Miyamoto, Tatsuki, Tomida, Ryotaro, Numakura, Kazuyuki, Inokuchi, Junichi, Yoneyama, Takahiro, Okajima, Eijiro, Yajima, Shugo, Masuda, Hitoshi, Terada, Naoki, Taoka, Rikiya, Kobayashi, Takashi, Kojima, Takahiro, Matsui, Yoshiyuki, Nishiyama, Naotaka, Kitamura, Hiroshi, Nishiyama, Hiroyuki, and Fujimoto, Kiyohide

Published
2024
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7. Clinical questions and good practice statements of clinical practice guidelines for management of kidney injury during anticancer drug therapy 2022

Author

Yanagita, Motoko, Muto, Satoru, Nishiyama, Hiroyuki, Ando, Yuichi, Hirata, Sumio, Doi, Kent, Fujiwara, Yutaka, Hanafusa, Norio, Hatta, Takahiro, Hoshino, Junichi, Ichioka, Satoko, Inoue, Takamitsu, Ishikura, Kenji, Kato, Taigo, Kitamura, Hiroshi, Kobayashi, Yusuke, Koizumi, Yuichi, Kondoh, Chihiro, Matsubara, Takeshi, Matsubara, Kazuo, Matsumoto, Koji, Okuda, Yusuke, Okumura, Yuta, Sakaida, Emiko, Shibagaki, Yugo, Shimodaira, Hideki, Takano, Nao, Uchida, Akiko, Yakushijin, Kimikazu, Yamamoto, Takehito, Yamamoto, Kazuhiro, Yasuda, Yoshinari, Oya, Mototsugu, Okada, Hirokazu, Nangaku, Masaomi, and Kashihara, Naoki

Published
2024
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8. Epacadostat plus pembrolizumab versus placebo plus pembrolizumab for advanced urothelial carcinoma: results from the randomized phase III ECHO-303/KEYNOTE-698 study

Author

Cicin, Irfan, Plimack, Elizabeth R., Gurney, Howard, Leibowitz, Raya, Alekseev, Boris Y., Parnis, Francis X., Peer, Avivit, Necchi, Andrea, Bellmunt, Joaquim, Nishiyama, Hiroyuki, Clark, Jason, Munteanu, Mihaela, Kataria, Ritesh, Jia, Calvin, Powles, Thomas, and Sternberg, Cora N.

Published
2024
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9. Comparison of perioperative outcomes and complications between intracorporeal, extracorporeal, and hybrid ileal conduit urinary diversion during robot-assisted radical cystectomy: a comparative propensity score-matched analysis from nationwide multi-institutional study in Japan

Author

Morizane, Shuichi, Nakane, Keita, Tanaka, Toshiaki, Zennami, Kenji, Muraoka, Kentaro, Ebara, Shin, Miura, Noriyoshi, Uemura, Koichi, Sobu, Ryuta, Hoshi, Akio, Taoka, Rikiya, Sugimoto, Mikio, Noma, Hisashi, Sunada, Hiroshi, Nishiyama, Hiroyuki, Habuchi, Tomonori, Ikeda, Ichiro, Saika, Takashi, Makiyama, Kazuhide, Shiroki, Ryoichi, Masumori, Naoya, Koie, Takuya, and Takenaka, Atsushi

Published
2024
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13. Japanese Society of Medical Oncology/Japan Society of Clinical Oncology/Japanese Society of Pediatric Hematology/Oncology-led clinical recommendations on the diagnosis and use of immunotherapy in patients with DNA mismatch repair deficient (dMMR) tumors, third edition

Author

Mishima, Saori, Naito, Yoichi, Akagi, Kiwamu, Hayashi, Naomi, Hirasawa, Akira, Hishiki, Tomoro, Igarashi, Ataru, Ikeda, Masafumi, Kadowaki, Shigenori, Kajiyama, Hiroaki, Kato, Motohiro, Kenmotsu, Hirotsugu, Kodera, Yasuhiro, Komine, Keigo, Koyama, Takafumi, Maeda, Osamu, Miyachi, Mitsuru, Nishihara, Hiroshi, Nishiyama, Hiroyuki, Ohga, Shouichi, Okamoto, Wataru, Oki, Eiji, Ono, Shigeru, Sanada, Masashi, Sekine, Ikuo, Takano, Tadao, Tao, Kayoko, Terashima, Keita, Tsuchihara, Katsuya, Yatabe, Yasushi, Yoshino, Takayuki, and Baba, Eishi

Published
2023
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14. Chapter 3: Management of kidney injury caused by cancer drug therapy, from clinical practice guidelines for the management of kidney injury during anticancer drug therapy 2022

Author

Ando, Yuichi, Nishiyama, Hiroyuki, Shimodaira, Hideki, Takano, Nao, Sakaida, Emiko, Matsumoto, Koji, Nakanishi, Koki, Sakai, Hideki, Tsukamoto, Shokichi, Komine, Keigo, Yasuda, Yoshinari, Kato, Taigo, Fujiwara, Yutaka, Koyama, Takafumi, Kitamura, Hiroshi, Kuwabara, Takashige, Yonezawa, Atsushi, Okumura, Yuta, Yakushijin, Kimikazu, Nozawa, Kazuki, Goto, Hideaki, Matsubara, Takeshi, Hoshino, Junichi, and Yanagita, Motoko

Published
2023
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15. Japanese Society of Medical Oncology/Japan Society of Clinical Oncology/Japanese Society of Pediatric Hematology/Oncology-led clinical recommendations on the diagnosis and use of immunotherapy in patients with high tumor mutational burden tumors

Author

Mishima, Saori, Naito, Yoichi, Akagi, Kiwamu, Hayashi, Naomi, Hirasawa, Akira, Hishiki, Tomoro, Igarashi, Ataru, Ikeda, Masafumi, Kadowaki, Shigenori, Kajiyama, Hiroaki, Kato, Motohiro, Kenmotsu, Hirotsugu, Kodera, Yasuhiro, Komine, Keigo, Koyama, Takafumi, Maeda, Osamu, Miyachi, Mitsuru, Nishihara, Hiroshi, Nishiyama, Hiroyuki, Ohga, Shouichi, Okamoto, Wataru, Oki, Eiji, Ono, Shigeru, Sanada, Masashi, Sekine, Ikuo, Takano, Tadao, Tao, Kayoko, Terashima, Keita, Tsuchihara, Katsuya, Yatabe, Yasushi, Yoshino, Takayuki, and Baba, Eishi

Published
2023
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18. Correction to: Clinical questions and good practice statements of clinical practice guidelines for management of kidney injury during anticancer drug therapy 2022

Author

Yanagita, Motoko, Muto, Satoru, Nishiyama, Hiroyuki, Ando, Yuichi, Hirata, Sumio, Doi, Kent, Fujiwara, Yutaka, Hanafusa, Norio, Hatta, Takahiro, Hoshino, Junichi, Ichioka, Satoko, Inoue, Takamitsu, Ishikura, Kenji, Kato, Taigo, Kitamura, Hiroshi, Kobayashi, Yusuke, Koizumi, Yuichi, Kondoh, Chihiro, Matsubara, Takeshi, Matsubara, Kazuo, Matsumoto, Koji, Okuda, Yusuke, Okumura, Yuta, Sakaida, Emiko, Shibagaki, Yugo, Shimodaira, Hideki, Takano, Nao, Uchida, Akiko, Yakushijin, Kimikazu, Yamamoto, Takehito, Yamamoto, Kazuhiro, Yasuda, Yoshinari, Oya, Mototsugu, Okada, Hirokazu, Nangaku, Masaomi, and Kashihara, Naoki

Published
2024
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19. Pembrolizumab monotherapy for high-risk non-muscle-invasive bladder cancer without carcinoma in situ and unresponsive to BCG (KEYNOTE-057): a single-arm, multicentre, phase 2 trial

Author

Necchi, Andrea, Roumiguié, Mathieu, Kamat, Ashish M, Shore, Neal D, Boormans, Joost L, Esen, Ahmet Adil, Lebret, Thierry, Kandori, Shuya, Bajorin, Dean F, Krieger, Laurence E M, Niglio, Scot A, Uchio, Edward M, Seo, Ho Kyung, de Wit, Ronald, Singer, Eric A, Grivas, Petros, Nishiyama, Hiroyuki, Li, Haojie, Baranwal, Pranshu, Van den Sigtenhorst-Fijlstra, Margot, Kapadia, Ekta, and Kulkarni, Girish S

Published
2024
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22. Japanese Society of Medical Oncology/Japan Society of Clinical Oncology/Japanese Society of Pediatric Hematology/Oncology-led clinical recommendations on the diagnosis and use of tropomyosin receptor kinase inhibitors in adult and pediatric patients with neurotrophic receptor tyrosine kinase fusion-positive advanced solid tumors

Author

Naito, Yoichi, Mishima, Saori, Akagi, Kiwamu, Hayashi, Naomi, Hirasawa, Akira, Hishiki, Tomoro, Igarashi, Ataru, Ikeda, Masafumi, Kadowaki, Shigenori, Kajiyama, Hiroaki, Kato, Motohiro, Kenmotsu, Hirotsugu, Kodera, Yasuhiro, Komine, Keigo, Koyama, Takafumi, Maeda, Osamu, Miyachi, Mitsuru, Nishihara, Hiroshi, Nishiyama, Hiroyuki, Ohga, Shouichi, Okamoto, Wataru, Oki, Eiji, Ono, Shigeru, Sanada, Masashi, Sekine, Ikuo, Takano, Tadao, Tao, Kayoko, Terashima, Keita, Tsuchihara, Katsuya, Yatabe, Yasushi, Yoshino, Takayuki, and Baba, Eishi

Published
2023
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25. Updated Overall Survival by Circulating Tumor DNA Status from the Phase 3 IMvigor010 Trial: Adjuvant Atezolizumab Versus Observation in Muscle-invasive Urothelial Carcinoma

Author

Powles, Thomas, Assaf, Zoe June, Degaonkar, Viraj, Grivas, Petros, Hussain, Maha, Oudard, Stephane, Gschwend, Jürgen E., Albers, Peter, Castellano, Daniel, Nishiyama, Hiroyuki, Daneshmand, Siamak, Sharma, Shruti, Sethi, Himanshu, Aleshin, Alexey, Shi, Yi, Davarpanah, Nicole, Carter, Corey, Bellmunt, Joaquim, and Mariathasan, Sanjeev

Published
2024
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26. Predictive biomarkers for survival benefit with ramucirumab in urothelial cancer in the RANGE trial

Author

van der Heijden, Michiel S, Powles, Thomas, Petrylak, Daniel, de Wit, Ronald, Necchi, Andrea, Sternberg, Cora N, Matsubara, Nobuaki, Nishiyama, Hiroyuki, Castellano, Daniel, Hussain, Syed A, Bamias, Aristotelis, Gakis, Georgios, Lee, Jae-Lyun, Tagawa, Scott T, Vaishampayan, Ulka, Aragon-Ching, Jeanny B, Eigl, Bernie J, Hozak, Rebecca R, Rasmussen, Erik R, Xia, Meng Summer, Rhodes, Ryan, Wijayawardana, Sameera, Bell-McGuinn, Katherine M, Aggarwal, Amit, and Drakaki, Alexandra

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Immunology, Clinical Research, Genetic Testing, Cancer, Genetics, Good Health and Well Being, Antibodies, Monoclonal, Humanized, B7-H1 Antigen, Biomarkers, Biomarkers, Tumor, Carcinoma, Transitional Cell, Humans, Urinary Bladder Neoplasms
Abstract

The RANGE study (NCT02426125) evaluated ramucirumab (an anti-VEGFR2 monoclonal antibody) in patients with platinum-refractory advanced urothelial carcinoma (UC). Here, we use programmed cell death-ligand 1 (PD-L1) immunohistochemistry (IHC) and transcriptome analysis to evaluate the association of immune and angiogenesis pathways, and molecular subtypes, with overall survival (OS) in UC. Higher PD-L1 IHC and immune pathway scores, but not angiogenesis scores, are associated with greater ramucirumab OS benefit. Additionally, Basal subtypes, which have higher PD-L1 IHC and immune/angiogenesis pathway scores, show greater ramucirumab OS benefit compared to Luminal subtypes, which have relatively lower scores. Multivariable analysis suggests patients from East Asia as having lower immune/angiogenesis signature scores, which correlates with decreased ramucirumab OS benefit. Our data highlight the utility of multiple biomarkers including PD-L1, molecular subtype, and immune phenotype in identifying patients with UC who might derive the greatest benefit from treatment with ramucirumab.

Published
2022

29. Efficacy and Safety of Bladder Preservation Therapy in Combination with Atezolizumab and Radiation Therapy (BPT-ART) for Invasive Bladder Cancer: Interim Analysis from a Multicenter, Open-label, Prospective Phase 2 Trial

Author

Kimura, Tomokazu, Ishikawa, Hitoshi, Nagumo, Yoshiyuki, Sekino, Yuta, Kageyama, Yukio, Ushijima, Hiroki, Kawai, Taketo, Yamashita, Hideomi, Azuma, Haruhito, Nihei, Keiji, Takemura, Masae, Hashimoto, Koichi, Maruo, Kazushi, Tsuzuki, Toyonori, and Nishiyama, Hiroyuki

Published
2023
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30. The third nationwide surveillance of antimicrobial susceptibility against Neisseria gonorrhoeae from male urethritis in Japan, 2016–2017

Author

Yasuda, Mitsuru, Takahashi, Satoshi, Miyazaki, Jun, Wada, Koichiro, Kobayashi, Kanao, Matsumoto, Masahiro, Hayami, Hiroshi, Yamamoto, Shingo, Kiyota, Hiroshi, Sato, Junko, Matsumoto, Tetsuya, Yotsuyanagi, Hiroshi, Hanaki, Hideaki, Masumori, Naoya, Hiyama, Yoshiki, Nishiyama, Hiroyuki, Kimura, Takahiro, Yamada, Hiroki, Matsumoto, Kazumasa, Ishikawa, Kiyohito, Togo, Yoshikazu, Tanaka, Kazushi, Sadahira, Takuya, Inokuchi, Junichi, Hamasuna, Ryoichi, Ito, Kenji, Hirayama, Hideo, Hayashi, Kenji, Kurimura, Yuichiro, Kadena, Hitoshi, Ito, Shin, Shiono, Yutaka, Maruyama, Takahiro, Ito, Masayasu, Hatano, Koichi, Chokyu, Hirofumi, Ihara, Hideari, Uno, Satoshi, Monden, Koichi, Yokoyama, Teruhiko, Kano, Motonori, Kaji, Shinichi, Kawahara, Motoshi, Sumii, Toru, Tojo, Takanori, Hosobe, Takahide, Naito, Kazuhiko, Kawai, Shuichi, Nishimura, Hirofumi, Izumitani, Masanobu, Yoh, Mutsumasa, Matsumura, Masaru, Fujita, Ryuji, Takayama, Kazuo, Hara, Makoto, and Nishi, Shohei

Published
2023
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31. Adjuvant atezolizumab versus observation in muscle-invasive urothelial carcinoma (IMvigor010): a multicentre, open-label, randomised, phase 3 trial.

Author

Bellmunt, Joaquim, Hussain, Maha, Gschwend, Jürgen, Albers, Peter, Oudard, Stephane, Castellano, Daniel, Daneshmand, Siamak, Nishiyama, Hiroyuki, Majchrowicz, Martin, Degaonkar, Viraj, Shi, Yi, Mariathasan, Sanjeev, Grivas, Petros, Drakaki, Alexandra, ODonnell, Peter, Rosenberg, Jonathan, Geynisman, Daniel, Petrylak, Daniel, Hoffman-Censits, Jean, Bedke, Jens, Kalebasty, Arash, Zakharia, Yousef, van der Heijden, Michiel, Sternberg, Cora, Davarpanah, Nicole, and Powles, Thomas

Subjects
Adolescent, Adult, Aged, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Antineoplastic Agents, Antineoplastic Combined Chemotherapy Protocols, B7-H1 Antigen, Carcinoma, Transitional Cell, Cisplatin, Disease-Free Survival, Female, Humans, Male, Middle Aged, Muscles, Neoplasm Invasiveness, Progression-Free Survival, Urothelium
Abstract

BACKGROUND: Despite standard curative-intent treatment with neoadjuvant cisplatin-based chemotherapy, followed by radical surgery in eligible patients, muscle-invasive urothelial carcinoma has a high recurrence rate and no level 1 evidence for adjuvant therapy. We aimed to evaluate atezolizumab as adjuvant therapy in patients with high-risk muscle-invasive urothelial carcinoma. METHOD: In the IMvigor010 study, a multicentre, open-label, randomised, phase 3 trial done in 192 hospitals, academic centres, and community oncology practices across 24 countries or regions, patients aged 18 years and older with histologically confirmed muscle-invasive urothelial carcinoma and an Eastern Cooperative Oncology Group performance status of 0, 1, or 2 were enrolled within 14 weeks after radical cystectomy or nephroureterectomy with lymph node dissection. Patients had ypT2-4a or ypN+ tumours following neoadjuvant chemotherapy or pT3-4a or pN+ tumours if no neoadjuvant chemotherapy was received. Patients not treated with neoadjuvant chemotherapy must have been ineligible for or declined cisplatin-based adjuvant chemotherapy. No post-surgical radiotherapy or previous adjuvant chemotherapy was allowed. Patients were randomly assigned (1:1) using a permuted block (block size of four) method and interactive voice-web response system to receive 1200 mg atezolizumab given intravenously every 3 weeks for 16 cycles or up to 1 year, whichever occurred first, or to observation. Randomisation was stratified by previous neoadjuvant chemotherapy use, number of lymph nodes resected, pathological nodal status, tumour stage, and PD-L1 expression on tumour-infiltrating immune cells. The primary endpoint was disease-free survival in the intention-to-treat population. Safety was assessed in patients who either received at least one dose of atezolizumab or had at least one post-baseline safety assessment. This trial is registered with ClinicalTrials.gov, NCT02450331, and is ongoing but not recruiting patients. FINDINGS: Between Oct 5, 2015, and July 30, 2018, we enrolled 809 patients, of whom 406 were assigned to the atezolizumab group and 403 were assigned to the observation group. Median follow-up was 21·9 months (IQR 13·2-29·8). Median disease-free survival was 19·4 months (95% CI 15·9-24·8) with atezolizumab and 16·6 months (11·2-24·8) with observation (stratified hazard ratio 0·89 [95% CI 0·74-1·08]; p=0·24). The most common grade 3 or 4 adverse events were urinary tract infection (31 [8%] of 390 patients in the atezolizumab group vs 20 [5%] of 397 patients in the observation group), pyelonephritis (12 [3%]) vs 14 [4%]), and anaemia (eight [2%] vs seven [2%]). Serious adverse events occurred in 122 (31%) patients who received atezolizumab and 71 (18%) who underwent observation. 63 (16%) patients who received atezolizumab had a treatment-related grade 3 or 4 adverse event. One treatment-related death, due to acute respiratory distress syndrome, occurred in the atezolizumab group. INTERPRETATION: To our knowledge, IMvigor010 is the largest, first-completed phase 3 adjuvant study to evaluate the role of a checkpoint inhibitor in muscle-invasive urothelial carcinoma. The trial did not meet its primary endpoint of improved disease-free survival in the atezolizumab group over observation. Atezolizumab was generally tolerable, with no new safety signals; however, higher frequencies of adverse events leading to discontinuation were reported than in metastatic urothelial carcinoma studies. These data do not support the use of adjuvant checkpoint inhibitor therapy in the setting evaluated in IMvigor010 at this time. FUNDING: F Hoffmann-La Roche/Genentech.

Published
2021

32. Health-related quality of life in the randomized phase 3 study of ramucirumab plus docetaxel versus placebo plus docetaxel in platinum-refractory advanced urothelial carcinoma (RANGE).

Author

Necchi, Andrea, Nishiyama, Hiroyuki, Matsubara, Nobuaki, Lee, Jae-Lyun, Petrylak, Daniel, de Wit, Ronald, Drakaki, Alexandra, Liepa, Astra, Mao, Huzhang, Bell-McGuinn, Katherine, and Powles, Thomas

Subjects
Antiangiogenesis, Bladder cancer, Neoplasm metastatsis, Patient-reported outcomes, Quality of life, Ramucirumab, Urinary bladder neoplasm, Urothelial carcinoma, Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Humanized, Antineoplastic Agents, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Transitional Cell, Docetaxel, Double-Blind Method, Female, Humans, Male, Middle Aged, Neoplasm Staging, Quality of Life, Urologic Neoplasms, Ramucirumab
Abstract

BACKGROUND: To evaluate patient-reported outcomes with ramucirumab plus docetaxel, a regimen which improved progression-free survival in platinum-refractory advanced urothelial carcinoma (aUC). METHODS: RANGE-a randomized, double-blinded, phase 3 trial in patients with platinum-refractory aUC. Ramucirumab (10 mg/kg) plus docetaxel (75 mg/m2) or placebo plus docetaxel were administered every 21 days until disease progression or unacceptable toxicity. Patients received maximum 10 cycles of docetaxel. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) and EuroQoL five-dimensions (EQ-5D-5L) were administered at baseline, start of each cycle, and 30-day follow-up visit. A ≥ 10-point change in QLQ-C30 scores was considered meaningful. Rates of improved/stable scores were compared between treatment arms using Fishers exact test. Time to deterioration (TtD) was estimated and compared using Kaplan-Meier estimation and log-rank test. RESULTS: Of the 530 patients, ~ 97% patients in each arm provided baseline QLQ-C30 data. On-treatment compliance was ≥ 88% for first 8 cycles. Mean baseline QLQ-C30 scores were similar between arms, with global quality of life (QoL), fatigue, pain, and insomnia having greatest impairment. Postbaseline rates of improved/stable QLQ-C30 scores were similar between treatment arms except for greater improvement in pain score with ramucirumab. TtD of QLQ-C30 scales favored ramucirumab arm. Baseline EQ-5D-5L index and visual analogue scale scores were similar between arms, followed by relatively stable on-treatment scores. EQ-5D-5L scores worsened at post-discontinuation follow-up visit. CONCLUSIONS: Ramucirumab plus docetaxel did not negatively impact QoL compared with docetaxel alone in platinum-refractory aUC. Improved TtD and tumor associated rates of pain favored ramucirumab treatment. CLINICAL TRAIL REGISTRATION: NCT02426125. https://clinicaltrials.gov/ct2/show/NCT02426125 . Date of registration: April 24th 2015.

Published
2020

34. Ramucirumab plus docetaxel versus placebo plus docetaxel in patients with locally advanced or metastatic urothelial carcinoma after platinum-based therapy (RANGE): overall survival and updated results of a randomised, double-blind, phase 3 trial.

Author

Petrylak, Daniel, de Wit, Ronald, Chi, Kim, Drakaki, Alexandra, Sternberg, Cora, Nishiyama, Hiroyuki, Castellano, Daniel, Hussain, Syed, Fléchon, Aude, Bamias, Aristotelis, Yu, Evan, van der Heijden, Michiel, Matsubara, Nobuaki, Alekseev, Boris, Necchi, Andrea, Géczi, Lajos, Ou, Yen-Chuan, Coskun, Hasan, Su, Wen-Pin, Bedke, Jens, Gakis, Georgios, Percent, Ivor, Lee, Jae-Lyun, Tucci, Marcello, Semenov, Andrey, Laestadius, Fredrik, Peer, Avivit, Tortora, Giampaolo, Safina, Sufia, Garcia Del Muro, Xavier, Rodriguez-Vida, Alejo, Cicin, Irfan, Harputluoglu, Hakan, Tagawa, Scott, Vaishampayan, Ulka, Aragon-Ching, Jeanny, Hamid, Oday, Liepa, Astra, Wijayawardana, Sameera, Russo, Francesca, Walgren, Richard, Zimmermann, Annamaria, Hozak, Rebecca, Bell-McGuinn, Katherine, and Powles, Thomas

Subjects
Aged, Antibodies, Monoclonal, Humanized, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Transitional Cell, Docetaxel, Double-Blind Method, Female, Follow-Up Studies, Humans, Male, Middle Aged, Neoplasm Invasiveness, Neoplasm Metastasis, Platinum, Prognosis, Salvage Therapy, Survival Rate, Urologic Neoplasms, Ramucirumab
Abstract

BACKGROUND: Ramucirumab-an IgG1 vascular endothelial growth factor receptor 2 antagonist-plus docetaxel was previously reported to improve progression-free survival in platinum-refractory, advanced urothelial carcinoma. Here, we report the secondary endpoint of overall survival results for the RANGE trial. METHODS: We did a randomised, double-blind, phase 3 trial in patients with advanced or metastatic urothelial carcinoma who progressed during or after platinum-based chemotherapy. Patients were enrolled from 124 investigative sites (hospitals, clinics, and academic centres) in 23 countries. Previous treatment with one immune checkpoint inhibitor was permitted. Patients were randomly assigned (1:1) using an interactive web response system to receive intravenous ramucirumab 10 mg/kg or placebo 10 mg/kg volume equivalent followed by intravenous docetaxel 75 mg/m2 (60 mg/m2 in Korea, Taiwan, and Japan) on day 1 of a 21-day cycle. Treatment continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met. Randomisation was stratified by geographical region, Eastern Cooperative Oncology Group performance status at baseline, and visceral metastasis. Progression-free survival (the primary endpoint) and overall survival (a key secondary endpoint) were assessed in the intention-to-treat population. The study is registered with ClinicalTrials.gov, NCT02426125; patient enrolment is complete and the last patient on treatment is being followed up for safety issues. FINDINGS: Between July 20, 2015, and April 4, 2017, 530 patients were randomly allocated to ramucirumab plus docetaxel (n=263) or placebo plus docetaxel (n=267) and comprised the intention-to-treat population. At database lock (March 21, 2018) for the final overall survival analysis, median follow-up was 7·4 months (IQR 3·5-13·9). In our sensitivity analysis of investigator-assessed progression-free survival at the overall survival database lock, median progression-free survival remained significantly improved with ramucirumab compared with placebo (4·1 months [95% CI 3·3-4·8] vs 2·8 months [2·6-2·9]; HR 0·696 [95% CI 0·573-0·845]; p=0·0002). Median overall survival was 9·4 months (95% CI 7·9-11·4) in the ramucirumab group versus 7·9 months (7·0-9·3) in the placebo group (stratified HR 0·887 [95% CI 0·724-1·086]; p=0·25). Grade 3 or worse treatment-related treatment-emergent adverse events in 5% or more of patients and with an incidence more than 2% higher with ramucirumab than with placebo were febrile neutropenia (24 [9%] of 258 patients in the ramucirumab group vs 16 [6%] of 265 patients in the placebo group) and neutropenia (17 [7%] of 258 vs six [2%] of 265). Serious adverse events were similar between groups (112 [43%] of 258 patients in the ramucirumab group vs 107 [40%] of 265 patients in the placebo group). Adverse events related to study treatment and leading to death occurred in eight (3%) patients in the ramucirumab group versus five (2%) patients in the placebo group. INTERPRETATION: Additional follow-up supports that ramucirumab plus docetaxel significantly improves progression-free survival, without a significant improvement in overall survival, for patients with platinum-refractory advanced urothelial carcinoma. Clinically meaningful benefit might be restricted in an unselected population. FUNDING: Eli Lilly and Company.

Published
2020

38. Moderately hypofractionated proton beam therapy for localized prostate cancer: 5-year outcomes of a phase II trial

Author

Murakami, Motohiro, primary, Ishikawa, Hitoshi, additional, Sekino, Yuta, additional, Nishiyama, Hiroyuki, additional, Suzuki, Hiroyoshi, additional, Sugahara, Shinji, additional, Iizumi, Takashi, additional, Mizumoto, Masashi, additional, Okumura, Toshiyuki, additional, Keino, Naoto, additional, Iizumi, Yuichi, additional, Hashimoto, Koichi, additional, Gosho, Masahiko, additional, and Sakurai, Hideyuki, additional

Published
2024
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39. MP01-03 CURRENT TREATMENT PATTERNS AND OUTCOMES OF 109 PATIENTS WITH SEX CORD STROMAL TUMORS IN JAPAN: A MULTI-INSTITUTIONAL STUDY

Author

Abe, Takashige, primary, Miyai, Kosuke, additional, Tsuzuki, Toyonori, additional, Hashine, Katsuyoshi, additional, Yamashita, Shinichi, additional, Kawahara, Takashi, additional, Nishiya, Naotaka, additional, Kitamura, Hiroshi, additional, Nishiyama, Hiroyuki, additional, Miyata, Haruka, additional, Matusmoto, Ryuji, additional, Osawa, Takahiro, additional, Murai, Sachiyo, additional, and Shinohara, Nobuo, additional

Published
2024
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42. Impact of carcinoma in situ on the outcome of intravesical Bacillus Calmette-Guérin therapy for non-muscle-invasive bladder cancer: a comparative analysis of large real-world data

Author

Tomida, Ryotaro, Miyake, Makito, Minato, Ryoei, Sawada, Yuichiro, Matsumura, Masafumi, Iida, Kota, Hori, Shunta, Fukui, Shinji, Ohyama, Chikara, Miyake, Hideaki, Hongo, Fumiya, Taoka, Rikiya, Kobayashi, Takashi, Kojima, Takahiro, Matsui, Yoshiyuki, Nishiyama, Naotaka, Kitamura, Hiroshi, Nishiyama, Hiroyuki, Fujimoto, Kiyohide, and Hashine, Katsuyoshi

Published
2022
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43. Guidance on the need for contraception related to use of pharmaceuticals: the Japan Agency for Medical Research and Development Study Group for providing information on the proper use of pharmaceuticals in patients with reproductive potential

Author

Suzuki, Nao, Takai, Yasushi, Yonemura, Masahito, Negoro, Hiromitsu, Motonaga, Shinya, Fujishiro, Noriko, Nakamura, Eishin, Takae, Seido, Yoshida, Saori, Uesugi, Koji, Ohira, Takashi, Katsura, Aiko, Fujiwara, Michio, Horiguchi, Itsuko, Kosaki, Kenjiro, Onodera, Hiroshi, and Nishiyama, Hiroyuki

Published
2022
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45. Correction to: Significance of upfront cytoreductive nephrectomy stratified by IMDC risk for metastatic renal cell carcinoma in targeted therapy era – a multi‑institutional retrospective study

Author

Kato, Renpei, Naito, Sei, Numakura, Kazuyuki, Hatakeyama, Shingo, Koguchi, Tomoyuki, Kojima, Takahiro, Kawasaki, Yoshihide, Kandori, Shuya, Kawamura, Sadafumi, Arai, Yoichi, Ito, Akihiro, Nishiyama, Hiroyuki, Kojima, Yoshiyuki, Ohyama, Chikara, Habuchi, Tomonori, Tsuchiya, Norihiko, and Obara, Wataru

Published
2023
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46. Significance of upfront cytoreductive nephrectomy stratified by IMDC risk for metastatic renal cell carcinoma in targeted therapy era – a multi-institutional retrospective study

Author

Kato, Renpei, Naito, Sei, Numakura, Kazuyuki, Hatakeyama, Shingo, Koguchi, Tomoyuki, Kojima, Takahiro, Kawasaki, Yoshihide, Kandori, Shuya, Kawamura, Sadafumi, Arai, Yoichi, Ito, Akihiro, Nishiyama, Hiroyuki, Kojima, Yoshiyuki, Ohyama, Chikara, Habuchi, Tomonori, Tsuchiya, Norihiko, and Obara, Wataru

Published
2022
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47. Japan Society of Clinical Oncology Clinical Practice Guidelines 2017 for fertility preservation in childhood, adolescent, and young adult cancer patients: part 2

Author

Tozawa, Akiko, Kimura, Fuminori, Takai, Yasushi, Nakajima, Takeshi, Ushijima, Kimio, Kobayashi, Hiroaki, Satoh, Toyomi, Harada, Miyuki, Sugimoto, Kohei, Saji, Shigehira, Shimizu, Chikako, Akiyama, Kyoko, Bando, Hiroko, Kuwahara, Akira, Furui, Tatsuro, Okada, Hiroshi, Kawai, Koji, Shinohara, Nobuo, Nagao, Koichi, Kitajima, Michio, Suenobu, Souichi, Soejima, Toshinori, Miyachi, Mitsuru, Miyoshi, Yoko, Yoneda, Akihiro, Horie, Akihito, Ishida, Yasushi, Usui, Noriko, Kanda, Yoshinobu, Fujii, Nobuharu, Endo, Makoto, Nakayama, Robert, Hoshi, Manabu, Yonemoto, Tsukasa, Kiyotani, Chikako, Okita, Natsuko, Baba, Eishi, Muto, Manabu, Kikuchi, Iwaho, Morishige, Ken-ichirou, Tsugawa, Koichiro, Nishiyama, Hiroyuki, Hosoi, Hajime, Tanimoto, Mitsune, Kawai, Akira, Sugiyama, Kazuhiko, Boku, Narikazu, Yonemura, Masato, Hayashi, Naoko, Aoki, Daisuke, Suzuki, Nao, and Osuga, Yutaka

Published
2022
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48. Japan Society of Clinical Oncology Clinical Practice Guidelines 2017 for fertility preservation in childhood, adolescent, and young adult cancer patients: part 1

Author

Harada, Miyuki, Kimura, Fuminori, Takai, Yasushi, Nakajima, Takeshi, Ushijima, Kimio, Kobayashi, Hiroaki, Satoh, Toyomi, Tozawa, Akiko, Sugimoto, Kohei, Saji, Shigehira, Shimizu, Chikako, Akiyama, Kyoko, Bando, Hiroko, Kuwahara, Akira, Furui, Tatsuro, Okada, Hiroshi, Kawai, Koji, Shinohara, Nobuo, Nagao, Koichi, Kitajima, Michio, Suenobu, Souichi, Soejima, Toshinori, Miyachi, Mitsuru, Miyoshi, Yoko, Yoneda, Akihiro, Horie, Akihito, Ishida, Yasushi, Usui, Noriko, Kanda, Yoshinobu, Fujii, Nobuharu, Endo, Makoto, Nakayama, Robert, Hoshi, Manabu, Yonemoto, Tsukasa, Kiyotani, Chikako, Okita, Natsuko, Baba, Eishi, Muto, Manabu, Kikuchi, Iwaho, Morishige, Ken-ichirou, Tsugawa, Koichiro, Nishiyama, Hiroyuki, Hosoi, Hajime, Tanimoto, Mitsune, Kawai, Akira, Sugiyama, Kazuhiko, Boku, Narikazu, Yonemura, Masato, Hayashi, Naoko, Aoki, Daisuke, Osuga, Yutaka, and Suzuki, Nao

Published
2022
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49. Indications for fertility preservation not included in the 2017 Japan Society of Clinical Oncology Guideline for Fertility Preservation in Pediatric, Adolescent, and Young Adult Patients treated with gonadal toxicity, including benign diseases

Author

Ono, Masanori, Matsumoto, Kimikazu, Boku, Narikazu, Fujii, Nobuharu, Tsuchida, Yumi, Furui, Tatsuro, Harada, Miyuki, Kanda, Yoshinobu, Kawai, Akira, Miyachi, Mitsuru, Murashima, Atsuko, Nakayama, Robert, Nishiyama, Hiroyuki, Shimizu, Chikako, Sugiyama, Kazuhiko, Takai, Yasushi, Fujio, Keishi, Morishige, Ken-Ichirou, Osuga, Yutaka, and Suzuki, Nao

Published
2022
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50. Pre-pembrolizumab neutrophil-to-lymphocyte ratio (NLR) predicts the efficacy of second-line pembrolizumab treatment in urothelial cancer regardless of the pre-chemo NLR

Author

Kobayashi, Takashi, Ito, Katsuhiro, Kojima, Takahiro, Maruyama, Satoru, Mukai, Shoichiro, Tsutsumi, Masakazu, Miki, Jun, Okuno, Tomoya, Yoshio, Yuko, Matsumoto, Hiroaki, Shimazui, Toru, Segawa, Takehiko, Karashima, Takashi, Masui, Kimihiko, Fukuta, Fumimasa, Tashiro, Kojiro, Imai, Kazuto, Suekane, Shigetaka, Nagasawa, Seiji, Higashi, Shin, Fukui, Tomohiro, Ogawa, Osamu, Kitamura, Hiroshi, and Nishiyama, Hiroyuki

Published
2022
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