250 results on '"C. Morizane"'
Search Results
2. 126P Comprehensive efforts to address multifaceted issues of rare cancers and sarcomas in Japan
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A. Kawai, S. Iwata, T. Shimoi, E. Kobayashi, K. Ogura, A. Yoshida, H.S. Okuma, Y. Goto, C. Morizane, Y. Yoshida, Y. Katoh, Y. Yatabe, K. Yonemori, K. Nakamura, T. Nishida, and T. Higashi
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Cancer Research ,Oncology - Published
- 2023
3. 64P Phase I/II study of nivolumab plus lenvatinib for advanced biliary tract cancer (JCOG1808/NCCH1817, SNIPE)
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M. Ueno, C. Morizane, M. Ikeda, M. Ozaka, F. Nagashima, T. Kataoka, J. Mizusawa, A. Ohba, S. Kobayashi, H. Imaoka, A. Kasuga, N. Okano, Y. Nagasaka, null K. Kurishita, S. Tomatsuri, M. Sasaki, T. Shibata, K. Nakamura, J. Furuse, and T. Okusaka
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Oncology ,Hematology - Published
- 2022
4. O-1 Outcomes by primary tumour location in patients with advanced biliary tract cancer treated with durvalumab or placebo plus gemcitabine and cisplatin in the phase 3 TOPAZ-1 study
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A. He, J. Valle, C. Lee, M. Ikeda, P. Potemski, C. Morizane, J. Cundom, D. Tougeron, F. Dayyani, N. Rokutanda, J. Xiong, G. Cohen, and D. Oh
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Oncology ,Hematology - Published
- 2022
5. A phase I, open-label, multi-center, dose-escalation study of codrituzumab, an anti-glypican-3 monoclonal antibody, in combination with atezolizumab in patients with locally advanced or metastatic hepatocellular carcinoma
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Yusuke Hashimoto, C.-J. Yen, Masataka Ikeda, Takuji Okusaka, Kazuomi Ueshima, C. Morizane, A-L Cheng, Tomohiro Tanaka, S.-Y. Wu, Masatoshi Kudo, Toshihiko Ohtomo, and C.-H. Hsu
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business.industry ,medicine.drug_class ,Locally advanced ,Hematology ,030204 cardiovascular system & hematology ,Monoclonal antibody ,Glypican 3 ,03 medical and health sciences ,0302 clinical medicine ,Oncology ,Atezolizumab ,030220 oncology & carcinogenesis ,Cancer research ,Dose escalation ,Medicine ,In patient ,Open label ,business ,Metastatic hepatocellular carcinoma - Published
- 2018
6. The nationwide cancer genome screening project in Japan, SCRUM-Japan GI-SCREEN: Efficient identification of cancer genome alterations in advanced pancreatic cancer
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N. Izawa, C. Morizane, H. Takahashi, M. Ueno, Y. Kawamoto, N. Okano, S. Shimizu, K. Sudo, S. Itoh, A. Asagi, Y. Kagawa, K. Kamata, T. Kudo, S. Nomura, T. Kuwata, S. Fujii, W. Okamoto, K. Shitara, A. Ohtsu, and T. Yoshino
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Oncology ,Hematology - Published
- 2018
7. The nationwide cancer genome screening project in Japan, SCRUM Japan GISCREEN: Efficient identification of cancer genome alterations in advanced biliary tract cancer
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C. Morizane, Y. Komatsu, H. Takahashi, M. Ueno, J. Furuse, T. Kudo, S. Itoh, S. Shimizu, K. Nakamura, K. Kamata, K. Ohtsubo, T. Mizukami, Y. Kagawa, S. Nomura, T. Kuwata, S. Fujii, W. Okamoto, K. Shitara, A. Ohtsu, and T. Yoshino
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Oncology ,Hematology - Published
- 2018
8. The nationwide cancer genome screening project in Japan, SCRUM-Japan GI-screen: Efficient identification of cancer genome alterations in advanced biliary tract cancer
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M. Ueno, C. Morizane, Y. Kawamoto, H. Takahashi, D. Naruge, S. Shimizu, K. Nakamura, T.E. Nakajima, T. Kato, T. Kudo, N. Mizuno, K. Ohtsubo, S. Itoh, H. Ishii, T. Sudo, S. Nomura, S. Fujii, K. Shitara, A. Ohtsu, and T. Yoshino
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Oncology ,Hematology - Published
- 2017
9. P-120 Gemcitabine + nab-paclitaxel as first-line chemotherapy for Japanese patients with advanced pancreatic cancer in real-world clinical practice: a retrospective study
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Toshifumi Yamaguchi, Mitsuhito Sasaki, Yasuhiro Sakamoto, Shunsuke Kondo, C. Morizane, T. Okusaka, and H. Ueno
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Oncology ,medicine.medical_specialty ,business.industry ,Retrospective cohort study ,Hematology ,medicine.disease ,Chemotherapy regimen ,Gemcitabine ,Clinical Practice ,Abstracts ,Paclitaxel protein-bound ,Pancreatic cancer ,Internal medicine ,medicine ,First line chemotherapy ,business ,medicine.drug ,Nab-paclitaxel - Published
- 2016
10. Enzymatic Hydrolyses of the σ-Symmetric Dicarboxylic Diesters Bearing a Sulfinyl Group as the Prochiral Center
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Hisashi Shimizu, K. Miyagi, C. Morizane, Motoo Shiro, Satoru Miyauchi, Shigeki Sano, S. Tamai, Yoshimitsu Nagao, and Masaharu Kume
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inorganic chemicals ,chemistry.chemical_classification ,biology ,Chemistry ,Stereochemistry ,organic chemicals ,General Chemistry ,Center (group theory) ,Phenacyl ,Esterase ,chemistry.chemical_compound ,Enzyme ,Group (periodic table) ,Porcine liver ,health occupations ,polycyclic compounds ,biology.protein ,Pancreatic lipase ,heterocyclic compounds - Abstract
Enzymatic hydrolyses of the σ-symmetric dicarboxylic diesters bearing a sulfinyl group as the prochiral center were examined by employing porcine liver esterase and procine pancreatic lipase. Eventually, their chiral half esters were elaborately obtained as the corresponding chiral phenacyl esters. The stereochemistry of the chiral half esters was determined by the X-ray analysis and their chemical correlations.
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- 1994
11. ChemInform Abstract: Enzymatic Hydrolyses of the σ-Symmetric Dicarboxylic Diesters Bearing a Sulfinyl Group as the Prochiral Center
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K. Miyagi, Satoru Miyauchi, Shigeki Sano, Yoshimitsu Nagao, Hisashi Shimizu, S. Tamai, Masaharu Kume, C. Morizane, and Motoo Shiro
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inorganic chemicals ,chemistry.chemical_classification ,biology ,Stereochemistry ,organic chemicals ,General Medicine ,Center (group theory) ,Phenacyl ,Esterase ,chemistry.chemical_compound ,Enzyme ,chemistry ,Group (periodic table) ,Porcine liver ,health occupations ,polycyclic compounds ,biology.protein ,Pancreatic lipase ,heterocyclic compounds - Abstract
Enzymatic hydrolyses of the σ-symmetric dicarboxylic diesters bearing a sulfinyl group as the prochiral center were examined by employing porcine liver esterase and procine pancreatic lipase. Eventually, their chiral half esters were elaborately obtained as the corresponding chiral phenacyl esters. The stereochemistry of the chiral half esters was determined by the X-ray analysis and their chemical correlations.
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- 2010
12. ChemInform Abstract: Structures of Three New Diterpenoids, Fritillebic Acid and Fritillebins A and B, from Bulbs of Fritillaria ebeiensis G. D. Yu et G. Q. Ji
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M. Zhang, Akira Iida, M. Xu, Z.‐L. Zhou, T. Fujita, R.‐M. Li, C. Morizane, J.‐Z. Wu, and Satoshi Ueda
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Terpene ,biology ,Chemistry ,Stereochemistry ,Fritillaria ,General Medicine ,biology.organism_classification - Published
- 2010
13. A phase I and pharmacokinetic study of NK105, a paclitaxel-incorporating micellar nanoparticle formulation
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Kiyoko Kato, Kuniaki Shirao, Hikaru Ueno, Yasuhide Yamada, Kei Muro, C Morizane, Takuji Okusaka, Hisateru Yasui, Masataka Ikeda, Yoshihisa Shimada, Yasuhiro Matsumura, Tetsuya Hamaguchi, and H. Nakahama
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Adult ,Male ,Cancer Research ,medicine.medical_specialty ,Maximum Tolerated Dose ,Paclitaxel ,Cmax ,Phases of clinical research ,Neutropenia ,Digestive System Neoplasms ,Gastroenterology ,DDS ,chemistry.chemical_compound ,Pharmacokinetics ,Pancreatic cancer ,Internal medicine ,Clinical Studies ,medicine ,Humans ,Micelles ,Aged ,Bile duct ,business.industry ,Middle Aged ,medicine.disease ,NK105 ,Antineoplastic Agents, Phytogenic ,polymer micelles ,Surgery ,phase I study ,medicine.anatomical_structure ,Oncology ,chemistry ,Nanoparticles ,Premedication ,Female ,business ,Tomography, X-Ray Computed - Abstract
This phase I study was designed to examine the maximum tolerated dose (MTD), the dose-limiting toxicities (DLTs), the recommended dose (RD) for phase II, and the pharmacokinetics of NK105, a new polymeric micelle carrier system for paclitaxel (PTX). NK105 was administered as a 1-h intravenous infusion every 3 weeks, without antiallergic premedication. The starting dose was 10 mg m(-2), and the dose was escalated according to the accelerated titration method. Nineteen patients were recruited. The tumour types treated included pancreatic (n=11), bile duct (n=5), gastric (n=2), and colonic (n=1) cancers. Neutropenia was the most common haematological toxicity. A grade 3 fever developed in one patient given 180 mg m(-2). No other grades 3 or 4 nonhaematological toxicities, including neuropathy, was observed during the entire study period. DLTs occurred in two patients given 180 mg m(-2) (grade 4 neutropenia lasting for more than 5 days). Thus, this dose was designated as the MTD. Grade 2 hypersensitivity reactions developed in only one patient given 180 mg m(-2). A partial response was observed in one patient with pancreatic cancer. The maximum concentration (C(max)) and area under the concentration (AUC) of NK105 were dose dependent. The plasma AUC of NK105 at 150 mg m(-2) was approximately 15-fold higher than that of the conventional PTX formulation. NK105 was well tolerated, and the RD for the phase II study was determined to be 150 mg m(-2) every 3 weeks. The results of this phase I study warrant further clinical evaluation.
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- 2007
14. Extension of Surgical Indication for Gastric Cancer with Peritoneal Metastasis by Intraperitoneal Chemotherapy
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F. Imamura, Daisuke Makiura, Y. Goda, Y. Hashiguchi, M. Mizuta, N. Sugimoto, S. Fujita, Shinya Ueda, S. Ozaki, M. Kawayama, M. Niimi, Kojiro Futagami, N. Matsubara, T. Tamaki, M. Fukushima, K. Hirokaga, Won Seog Kim, A. Koyama, K. Matsumoto, H. Kusumoto, Y. Yoshida, T. Sasatomi, H. Akamatsu, A. Ohtsu, I. Sasaki, X. Liu, T. Ura, Chandra P. Belani, H. Yamamoto, K. Watanabe, N. Hokamura, H. Fukushima, H. Nishizaki, K. Yonesaka, Noriaki Ohuchi, S. Takao, H.-J. Tsai, Dimitri Pchejetski, K. Sunami, H. Fujimoto, J. Zhang, H. Samura, Tomoko Oku, M. Mori, Eiji Oki, T. Yano, N. Yamamoto, J. Tsukada, Yasutaka Sukawa, Kazuyoshi Yanagihara, A. Goy, J. Inoue, Kazuto Nishio, Y-C Chang, L. Wang, N. Kotani, M. Inomata, T. Nishimura, C.-C. Lin, N. Aisu, R. Saura, M. Makino, Hideki Shimodaira, Y. Fujishima, Satoshi Watanabe, H. Tanaka, Akiko Hisamoto, Koichi Akashi, J. E. Jang, T. Nobuoka, Chihiro Makimura, Taichi Isobe, T. Takahashi, C. Morizane, S.-M. Chang, N. Takigawa, F. Lv, N. Katagami, A. Kumagai, Takahide Komori, Koichi Hirata, N. Okamoto, A. Makiyama, Y. Takahashi, Hideyuki Hayashi, S. Iwasa, J.-C. Lin, J. S. Kim, K. Eguchi, A. Yokoyama, H. Kunimoto, M. Inoue, L. Sauer, H. Ueno, M. Nakano, A.-H. Kwon, Kiyoshi Ando, H. Nishimura, M. Kaibori, S. Arita, K. Tauchi, Erina Hatashita, H. Yoshioka, Ikuo Sekine, S. Iida, S.-F. Lin, J. Cao, H. Horinouchi, S. Atagi, H. Harashima, Hironori Ishigami, H. Isobe, Yoshimitsu Kobayashi, Shinichi Nishina, M. Motonaga, Tokuzo Arao, M. Edagawa, Kazuo Shirouzu, Kei Kawana, A. Kitamura, Emiko Sakaida, T. Ozaki, H. Fukada, Hiromichi Ishiyama, A. Tsuya, Manabu Muto, K. Takizawa, Satoru Kitazono, H. Uemura, T. Nakagawa, S. Kondo, Naoto Takahashi, Hisato Kawakami, M. D. Galsky, Shigeki Ito, Yoshihiko Maehara, S. Negoro, H. Matsushita, M. Kashiwa-Motoyama, Yoshinori Imamura, Kunio Okamoto, T. Ecke, Miyako Takahashi, T. Matsuno, K. Itoh, K. Tanaka, Kazuo Tamura, Y. Suzuki, A. Iwashima, K. Katayama, Tsuyoshi Shirakawa, M. Ohtsu, Ryohei Sasaki, M. Hayashi, M. Egyed, M. Tateyama, M. Munakata, T. Nomizu, T. Muta, T. Terauchi, Shin Takahashi, Y. Kohjimoto, I. Kawase, L. Qiu, Nozomi Niitsu, Y. Nishida, Hironori Yamaguchi, T. Sawai, T. Nakajima, Takanori Ishida, Tatsuo Oyake, M. Nagase, T. Yoshinami, Y. Sakata, Chiaki Imai, M. Kitazono, W. K. Oh, H. Kataoka, Y. Kakechi, Y. Terasaki, T. Miyagishima, Akira Yamada, A. Ono, R. Konno, M. Higashiguchi, Y. Namba, Hiroshi Kagamu, Eiki Ichihara, H. Nakasa, T. Yagi, Y. Tamaki, T. Onoe, N. Sonoda, Kazuhiko Nakagawa, H. Yamana, M. Sasaki, Yoji Ishida, K. Kaira, S. Yokoyama, W. Li, M. Tanioka, Eishi Baba, Hitoshi Kusaba, H. Suzuki, Sung Yong Oh, N. M. Hahn, Tomoko Kataoka, M. Mikami, Chikatoshi Katada, Y. Narita, J. Leach, T. Uehara, K. Miura, S. Yamamoto, O. Kobayashi, Kentaro Yamanaka, Katsuyuki Kiura, S. Hua, H. Miyao, Y. Kodama, Isamu Okamoto, K. Mikami, T. Hirashima, E. Konno, Naoko Chayahara, Junta Tanaka, Chang Fang Chiu, Hironobu Minami, Tadashi Hasegawa, Atsuo Okamura, T. Okusaka, K.-I. Nishiyama, M. Satouchi, Y. Maekawa, T. Kato, Rei Ono, F. Hongo, Mamoru Watanabe, T. Miki, M. Ogura, Masato Komoda, S. Natsugoe, Yuichi Takiguchi, I. Iwanaga, Hiroshi Soeda, Y. Fujiwara, M. Endo, H. Yasui, S. Katano, Satoshi Yuki, K. Nagai, H. Tsukuda, Jun Koshio, I. Hara, J. Tomomatsu, M. Kudo, Kenichi Yoshimura, T. Esaki, Satoshi Morita, R. Udagawa, M. Nakamura, S. Miura, K. Iwata, W. Su, N. Nonomura, S. J. Kim, Y. Omori, T. Shukuya, S. Y. Hyun, H. Hara, Yasunori Emi, M. Nezu, S. Tanimura, Koji Wada, Y. H. Min, D. Y. Hwang, Yoshito Komatsu, S. Takaishi, Kazuhiko Kobayashi, Mayumi Ono, K. Sato, Yuka Kato, T. Mine, S. Egawa, J. Li, N. Matsumura, Y. Tsuji, Hiroyuki Hata, Hirohisa Yoshizawa, S. Sogabe, Y. Guo, D. Kuroda, Chih-Cheng Chen, T. Takano, X. Hong, Y. D. Kim, K. Oda, Shoji Tokunaga, Masahiro Nozawa, Takeshi Sugawara, T. Fukui, Y. Saito, T. Fukuda, Yasuhisa Shinomura, Y. Yamashita, T. Minami, H. Mukai, Y. Ito, Ayumu Hosokawa, Hiroshi Nakatsumi, Y. Ohoka, S. Matsuyama, H. Takase, T. Akimoto, M. Ishizaki, T. Nakamura, Masahiro Tabata, T. Shimada, K. Shitara, Kimiharu Uozumi, T. Shiroyama, A. Umeta, N. Akakura, T.-Y. Chen, Kiyoko Kuwata, S. Emoto, Y. Naito, O. Muto, Cheolwon Suh, H. Oda, S. Fujii, Kenichiro Kudo, H. Hino, N. Morishita, Hiromichi Matsuoka, Y. Adachi, K. Minato, W.-Y. Kao, K. Hatake, Kosuke Ichikawa, Wataru Okamoto, S. H. Yoon, N. Wada, K. Uchida, U. Fujii, Ih-Jen Su, E. Vandendries, H. Ootsuka, Mitsuaki Tatsumi, K. Hatanaka, K. Matsui, M. Saijo, Fumihiko Fujita, W.-L. Hwang, Y. Negoro, M. Asanabe, Aya Kita, Hideo Baba, H. C. Chung, H. Igaki, J. Hashimoto, Yohei Funakoshi, Ukihide Tateishi, Masanori Toyoda, T. Feldman, Y. Kimura, T. Kondo, Yoshito Akagi, T. Kojima, A. Bamias, D. Takahari, Katsuyuki Hotta, K. Tobinai, K. Yamazaki, A. Volkert, T. Miyake, Hiroharu Yamashita, H. Iishi, Kazunori Murai, Y. Hata, M. Ri, H. Tomioka, S. Kato, M. Fukuoka, Y. Nakamura, Naomi Kiyota, Yee Soo Chae, T. Kimura, N. Gondo, Hiroshi Saeki, G. Sonpavde, H. S. Eom, K. Tane, Yasuo Ohashi, Yasuyuki Kawamoto, T. Beppu, T. Naito, M. Iwasaku, T. Ueda, R. Nakatake, Y. Umeyama, Takayasu Kurata, H. Kenmotsu, Hironori Ashinuma, Y. Miura, Ken-ichi Nibu, Y. Ogata, Toshihiro Miyamoto, N. Uike, K. Muro, S. Goya, Yasushi Takamatsu, Ichiei Narita, Chikashi Ishioka, T. Sueta, Satoshi Takeuchi, M.-C. Chang, Y. Iwanami, Yasuo Hamamoto, H. Kashihara, Yoshikazu Kotani, H. Daiko, Y. Kakugawa, J.-W. Cheong, T. Oochi, Joji Kitayama, K. Matsuo, M. Tamiya, Tzeon Jye Chiou, T. Sugiura, K. Kato, S. Krege, Masatomo Otsuka, A. Kitao, Y. Tanaka, Toru Mukohara, Masataka Taguri, Y. Hattori, T. Harada, Y. Hasegawa, S. Hoshino, K. Yoneyama, M. Ikeda, Shingo Tamura, H. Murakami, M. Kitada, K. Yanase, K. Nosho, and C. S. Chim
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medicine.medical_specialty ,Chemotherapy ,medicine.diagnostic_test ,Colorectal cancer ,business.industry ,medicine.medical_treatment ,Cancer ,Hematology ,medicine.disease ,Gastroenterology ,Chemotherapy regimen ,Surgery ,Metastasis ,Oncology ,Pancreatic fistula ,Internal medicine ,medicine ,Gastrectomy ,business ,Laparoscopy - Abstract
Background The prognosis of gastric cancer with peritoneal metastasis is extremely poor. Neither systemic chemotherapy nor surgery alone prolongs survival of patients significantly. Methods Patients diagnosed with advanced gastric cancer underwent staging laparoscopy and received chemotherapy when peritoneal dissemination and/or cancer cells on peritoneal cytology were confirmed. The chemotherapy regimen consisted of S-1, weekly intravenous and intraperitoneal paclitaxel, which was verified in our phase II trial (Ann Oncol 2009). S-1 was administered at 80 mg/m2/day for 14 consecutive days, followed by 7 days rest. Paclitaxel was administered intravenously at 50 mg/m2 and intraperitoneally at 20 mg/m2 on days 1 and 8. Clinical response of chemotherapy was assessed by computed tomography, gastroendoscopy, peritoneal cytology and second-look laparoscopy. Radical gastrectomy was carried out when macroscopic curative resection was made achievable by chemotherapy. Chemotherapy was restarted after operation as soon as possible. Overall survival, relapse free survival, morbidity and mortality of gastrectomy were evaluated. Results Out of 100 patients with peritoneal metastasis who received chemotherapy, 60 patients underwent gastrectomy after response to chemotherapy, including 54 with macroscopic metastasis and 6 with positive peritoneal cytology only. A median of three courses were administered preoperatively (range 1–16). Total or distal gastrectomy with lymphnode dissection was carried out in 54 or 6 patients, respectively. The median survival time was 34.5 months. The median relapse-free survival was 16.7 months. The first site of relapse was the peritoneum in 24 patients and the other organ site in 17 patients. Postoperative complications included anastomotic leakage and pancreatic fistula in two patients each, which were healed conservatively. There were no treatment-related deaths. Conclusions Gastrectomy combined with S-1, intravenous and intraperitoneal paclitaxel is safe and active for gastric cancer patients with peritoneal metastasis.
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- 2012
15. SRPX2 is a Novel Chondroitin Sulfate Proteoglycan that is Overexpressed in Gastrointestinal Cancer
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T. Hirashima, Y. Omuro, C. Kondo, T. Kanematsu, K. Muraki, Po-Chuan Wang, K. Ishiguro, Young-Ae Park, C.-Y. Lu, C.-C. Liao, H. Tei, H. Takeyama, M. Toishi, A. D. Abdullah, M. Terada, K. Yamamoto, N. Yamamoto, K. Fujii, M. Sugimoto, H. Kakizaki, K. Shinozaki, Y. Okada, Yoko Inaguma, S. Shimizu, Shigeki Ito, H. Y. Lim, N. Nogami, N. Awata, M. Nishioka, H. Ueoka, Tomoya Ishii, Y. Ahn, Kazumichi Kawakubo, Y. Aoyagi, C. Nishijima, R. Kameda, A. Okamoto, Y. Yamashita-Kashima, H. Suzuki, K. Yamao, A. Yonemori, H. Fukuda, H. Katayama, K. Honoki, T. Nomura, Y. Tono, T. Shimoyama, J. Nagano, H. Miyamoto, Y. Takeda, M. Fukutake, N. Katsumata, S. Fujita, K. Fujimoto-Ouchi, D. Tamura, H. Obaishi, S. Mitsunaga, J.-H. Baek, Yuichiro Tada, K. Uno, S. Oura, M. Nakamura, Y. Imanura, Atsushi Kumanogoh, M. Manabe, Kaoru Tanaka, T. Yokota, K. Saito, K. Tamura, Yukihiko Fujii, T. Lim, Toshihiko Tomita, C. Seki, Masafumi Taniwaki, Tomohide Sugiyama, N. Kunami, T. Yoshino, Y. Takeoka, T. Yoshikawa, Won-Suk Lee, M. Hattori, H. Yasui, T. Motoya, T. Nishizaki, N. Kouge, E. Sato, S.H. Park, J.H. Hong, N. Mori, M. Tajika, K. Yasuda, Mika Nakamae, Kazuya Fukuoka, T. Shimomura, A. Suzuki, M. Arima, Hideo Koh, S. Tokunaga, N. Miyamoto, Masao Nakata, T. Ueda, Hideharu Kimura, H. Nakano, Kimikazu Yakushijin, M. Hayashi, K. Ishitani, K. Yoshida, T. Takeuchi, Shohei Yokota, K. Hirano, N. Horikawa, S. Bandoh, G. Naka, Y. Seki, M. A. De Velasco, F. Tanikawa, S. Hirano, S. Ohkawa, S. Kadowaki, M. Sakurai, R. Kaji, J.-I. Lee, K. Kitahara, K. Nihei, T. Sumi, Meiki Fukuda, S. Park, K. Nosaka, T. Maeda, O. Morimura, G. Sano, H.-L. Wu, Haruhiko Hirata, Mizuki Aimoto, Y. Igeta, K. Itoh, Y. Ikari, Kentaro Iwanaga, K. Itatsu, Akira Ueda, C. Oabata, H. Fujiwara, T. W. Kim, K. Misu, H. Mikayama, K. Morise, K. Nagata, M. Sato, Takashi Kijima, Kazuo Kasahara, Takahiro Mori, N. Mizuno, Y. Fujitani, Abdul Aziz Baba, K. Takashima, Kazuhide Higuchi, J.-C. Jo, G. Tamaki, S. Magoshi, R. Watanabe, A. Abe, M. Iino, H. Goto, Junji Tsurutani, Y. Katashiba, K. Kato, K. Hosono, L. Y. Kwan, Y. Okabe, N. Takeuchi, Chih-Hsin Tang, I. Kawase, Takayuki Kii, D. Kishino, K. Matsuura, K. Isobe, K. Monden, H. Udagawa, K. Kim, M. Tada, Kazuyoshi Yanagihara, Cheryn Song, T. Terui, Yasuhito Fujisaka, I. Yamaguchi, Hirokazu Fukui, K. Naito, T. Suzumura, H. A. Jung, N. Ureshino, Wataru Okamoto, H. Miyawaki, N. Nakamura, T. Tsukazaki, K. Furuta, K. Matsuda, S. J. Lee, Y. Ishiura, J.-L. Lee, Y. Kato, Shinichiro Hayashi, Y. Horita, J. H. Kim, Y. Tsutsumi, M. Inaoki, K.-P. Kim, Y. Ishigatsubo, T. Mikawa, M. Yamane, A. Husin, Yasufumi Takeshita, S. Kobayashi, N. Kubo, N. Hosono, Yeong-Shiau Pu, M. Ando, Keita Kudo, Hitoshi Nishitani, M. Mori, H. Daga, T. Fukuda, A. Nakaya, N. Fuse, I. Miki, W. Yamamoto, M. Fukushima, T. Ikezoe, H. Ueno, J.-H. Ahn, T. Matsumoto, A. Kuwahara, T. Ogura, N. Hirai, S. Mizuta, A. Ochiai, N. Masumori, S. Kim, Y. Ohki, Yoshinori Imamura, T. Tamaki, K. Nishino, Y. Aoyama, T. Ogawa, T. Koyama, M. Morise, K. Kawada, T. Masaki, Keishi Yamashita, S. Yamamoto, K. Tanimoto, M. Hori, Atsuo Okamura, Masataka Ikeda, K. Oishi, H. Hashimoto, Y. Ohe, M. Yasui, Y. Akatsuka, F. Imamura, Y. Hirayama, Ho Young Kim, S. Kishi, M. Jung, Y. Inukai, K. Miwa, S.-H. Nam, T. Hishima, T. Okusaka, Y. Horiuchi, A. Ioka, W. Fukushima, M. Yamauchi, N. Hokamura, K. Hirata, Y. Katou, K. Tada, K. Suzuki, K. Teramoto, Syusai Yamada, M. Iikura, Takeo Shimasaki, Y. Inoue, K. Kawahara, T. Kitani, H. Sawai, T. Terashima, K. Honda, Hitomi Umeguchi, Masataka Okamoto, M. Kita, Y. Yatabe, Y.-M. Cho, Sojiro Kusumoto, K. Hokkoku, Takaaki Sasaki, Masayuki Hino, M. Omi, H. Tanaka, S. Kawazoe, M. Sakai, H. Tsuchihashi, Kazushi Endo, R. Mauchi, K. Ohashi, H. Takasaki, N. Naganobu, K. Aoe, S.Y. Oh, C. Honma, Takahiro Miyamoto, K. Yamazaki, M. Fujii, T. Fujisawa, S. Morikawa, T. Yamauchi, Masayoshi Kobune, K. Kuwano, T. Onikubo, M. Kuyama, M. Asayama, T. Kozuki, M. Kanie, Masahiko Shibuya, Y. Yamamoto, N. Morishita, Y. Yoshii, Toru Mukohara, K. Izumi, Y.S. Park, N.-R. Lee, Y. Horio, K. Nakamura, M. Matsuda, K. Sugino, S.H. Lee, S. Ueno, Tsutomu Sato, Y. Hasumi, H. Yamamoto, T. Karasuno, Yong Chan Ahn, M. Kitamura, Y. Namba, K. Karasawa, S. Hayasi, K. Hashimoto, Y. Ozaki, Takayuki Takahama, A. Todaka, M. Inoue, S. Boku, A. Ohtsu, Tadashi Matsunaga, K. Togitani, H.-H. Wu, Hirofumi Kogure, H. Kitamura, T. Matsuzaki, M. Gouchi, Hyun-Jin Kim, T. Shiroyama, K. Okada, Y. Terasaki, K. Park, H. Katou, N. Kobayashi, D. Mohri, Y. Hasegawa, T. Yoshimasu, Masahiro Tabata, S. Hijioka, Y.-Y. Chen, Shinji Nakao, M. Kodaira, Akihiko Gemma, T. Yoshida, Hiroya Takiuchi, Masaki Fujimura, A. Shimoda, Hiroyuki Isayama, K. Ohta, T.-L. Chen, T. Maruyama, K. Maruyama, K.-W. Lee, Takashi Hirose, Y. Fujita, H. Kato, Maya Watanabe, S. Iwasa, H. Okuyama, Cherry Wu, A. Hata, K. Myo, M. Takase, Y. Urasaki, K. Shingu, Shingo Nishikawa, M. Tsuzuki, I. Hoshi, T. Maruo, Hiroki Yoshita, Hirohisa Nakamae, Shigeru Hatabe, Hideko Ikeda, Hayato Koba, Y. Hata, S. Matsushima, M. Yunokawa, S. Tamaru, J. S. Ahn, T. Funakoshi, S.-J. Jang, S. Kageyama, K. Nakagawa, H. Nishimori, Eizaburo Sueoka, K. Hashidume, S. H. Hong, Atsushi Kawaguchi, Tomomi Nakamura, H. Kaneko, A. Seki, K.-L. Tan, T. Ichimura, Y. Matsuda, M. Nezu, M. Kudo, H. Fujii, K. Shibata, S. J. Sym, K. Takeuchi, Chiharu Tabata, M. Takeshita, Y. Ueda, A. Nakayama, N. Nishiyama, Sang We Kim, Y. S. Kim, H. Suzushima, S. Soma, K. Miura, H. Gonda, D. Gomi, A. Mogi, K. Ishizuka, T. Mizutani, Y. Yamada, A. Sato, G. Kaneko, T. Samejima, R. Shimabukuro, Masahide Fujita, K. Horie, R. Ohhashi, T. Wakasa, H. Nomura, K. Sato, T. Hamaguchi, S. Horiguchi, M. Ootsuka, S. Kawabata, Y. Okamoto, A. Yoshida, H. Takeda, M. Sugiyama, Y. S. Hong, Y. Yanagita, Yasushi Ichikawa, K. Tomii, T. Enokida, Tzyh-Chyuan Hour, Y. Takeyama, Y. Matsuura, Y. Kakehi, S. Kanazawa, S. Kimura, T. Yamada-Murano, D. Abe, Nagio Takigawa, T. Yana, A. Ogino, R. Sakai, S. Watanabe, K. A. Kwon, Y. Nakai, O. Watanabe, Naokatsu Nakada, Masanori Toyoda, H. Inomata, R. Sekine, J. S. Lee, T. Shukuya, O. Ishiko, Y. Ikeda, K. Nakase, S. Kuzu, H. Mukai, K. Ozaki, R. Koyama, Takashi Nakano, K. Hashizume, E. Noguchi, N. Hida, Y. Takamatsu, Tomoko Yamagishi, H. Agatsuma, S. Miyamoto, D.H. Lee, H. Kunimoto, H. Ogino, T. Miya, Naoki Sasahira, A. Yamane, T. Takami, N. Imai, Y. Fukui, Tae Min Kim, T. Kita, Jiro Watari, H. Kawabata, N. Motohashi, K. Aomatsu, T. Obayashi, H. Hayashi, S.-H. Li, S. Sakata, H. Okada, K. Masa, T. Iwata, H. Yoshida, Tokuzo Arao, R. Hassan, H. Imaoka, M. Kobayashi, H. Iwasaki, K. Nomura, H. Harada, T. Watanabe, K. Kaneko, H. Nakagawa, K. Sakamoto, A. Hiasa, Katsuyuki Hotta, Nobuhiko Emi, S. Maruyama, M. Yonemura, H. Tsurumi, Takuhiro Yamaguchi, M. Nagata, T. Nakai, Motoki Yoshida, S. Motomura, A. Sakai, H. Inoue, Toshimitsu Yamaoka, T. Morikita, S. Hirokawa, Hideaki Ijichi, Namiki Masayuki, Meiko Nishimura, Y. Ishii, A. Shimatani, Jong-Hyeok Kim, M. Ujihara, Yuko Kanbayashi, Y. Nakashima, T. Hosoda, K. Sanada, S. Kondo, Y. Honma, S. Sakamoto, H. Kubo, M. Kondo, F. Nomura, M. Hashizume, T. Shiraishi, B.-S. Kim, T. Kouno, T. Maki, H. Akaike, Z. Saito, Junya Fukuoka, T. Ohnishi, C. H. Maeng, M. Wada, Jong-Mu Sun, C. Morizane, Y. Matsumoto, K. Migita, Y. Okamura, Sun Young Rha, Hiroyoshi Ichihara, J. Kato, N. Yoshimura, W.-J. Wu, N. Wada, M. Yoshihara, K. Hamai, Kazuhiko Koike, Woo Kyun Bae, Y. Maeda, S. Mimura, Y. Sakai, H. Wakasugi, H. Nishimoto, M. Nagano, K. Taira, I. Park, T. Inokuma, Katsuhiko Shimizu, Y. Nakahara, S. Okamura, K. Ogawa, F. Saito, Y. Miura, Hyo Jin Lee, K. Fujita, K. Takagi, T. Shiina, Charny Park, Shin Kuwakado, N. Moto, Y.-C. Chiu, S. Saji, T. Araya, J. Takeshita, H. Iwase, Naoe Goto, H. Murakami, T. Hayashi, K. Otsuka, Rishu Takimoto, H. Nakahama, C.-C. Shih, Naoko Aragane, S. Hamauchi, H. K. Ahn, N. Tomita, N. Chyayahara, T. Hida, K. Watanabe, Y. Kokubo, N. Katusmata, L. K. Chi, M. Okumura, T. Kusakabe, S. Homma, H. Nakagomi, Hiroo Katsuya, D. B. Shin, Naoko Chayahara, F. Fukuta, Kazutoshi Shibuya, Ayumu Hosokawa, F. Ota, R. Yoshino, M. Goto, Y. Shibata, J. E. Kim, H. Watanabe, K. Mandai, T. Shimamura, S. Inoue, M. Fujimoto, S. Mitsuoka, Kunio Okamoto, M.-J. Kim, E. Chung, H. Moriwaki, Y. Misumi, S. Ogawa, K. C. Lee, J.-O. Lee, H. Hirosawa, Yoshiki Terada, A. Kinoshita, J. Hong, Y. J. Kim, A. Kido, M. Kijima, Y. Shiota, H. Hayase, A. Sekikawa, M. Ahn, K. Komuta, M. Sasaki, T. Murakami, M. Okuda, N. Matsubara, R. Saitou, R. Nakamura, K. Masuo, Kazuko Matsumoto, K. Mouri, Y. Ookuma, Kazutoshi Komiya, K. Sakai, N. Yogo, Takahiko Nakane, M. Mukai, Isao Tachibana, Shiro Kimbara, Kentaro Okuda, T. Fujisaki, S.-J. Chuang, Y. Niwa, H. Oda, Y. Nishida, T. Ando, Yuichi Ando, J. Tong, C. Shimizu, J. Choi, Satoshi Iyama, H. Imai, K. H. Park, T. Misao, Yohei Funakoshi, Chang-Sik Yu, Tadashi Kimura, J. Hori, M. Itoh, S. Ebihara, S.-H. Gan, T. Yano, H. Okamoto, E. Fukutani, U. Tateishi, T. Ishihara, Takuro Yoshimura, T. Shinkai, A. Yokoyama, T. Kikuchi, Y. Yamashita, K. Hagiwara, Y. Noda, Y. Oyama, K. Okuno, Naomi Kiyota, K. Yonemori, K. Kuramoto, T. Shimoi, H. Hong, Ryuya Yamanaka, E. Matsuki, O. Kondo, H. Gondou, Yusuke Nakamura, M.-J. Ahn, Yoshiki Hayashi, Shiro Koh, S. Kosaka, Masahiro Gotoh, S. Mizuno, H. Nakamura, S. Okazaki, E. Ichiki, M. Ishizu, K. Ishikawa, Hiroyasu Kaneda, R. Yamamura, Tomonobu Koizumi, R. Ankathil, T. Takahashi, S. Nakatsuka, A. Kamuro, M. Ueno, T. Eguchi, S. Hirai, G. Saito, S. Kudoh, Masanao Nakashima, N. Okamoto, K. Akiyoshi, Hironobu Minami, K. Kubota, K. Okafuji, M. Aoe, T. Ito, K. Nishimura, S. Ota, C. Wong, A. Ooki, Takao Shirai, Wen-Yi Chou, M. Tamiya, H. Tabuse, Y. Kaneko, Y. Shimizu, Y. Murata, A. Okada, S. Sasada, Y. Takagi, A. Naitou, N. Katayama, Kaori Ito, T. Araki, Y. Fujiwara, H. Yokota, Shinya Kajiura, M. Imano, T. Iwai, T. Kobayashi, T. Kubota, N. Kanaji, M. Ohdate, T. Tsukamoto, S. Zenda, A. Fukutomi, T. Kumura, R. Ogawa, K. Shintaku, Kazuto Nishio, T. Morimoto, W. Shioyama, E. K. Cho, H.-I. Lu, Y. Suginoshita, K. Yamaguchi, Y. Shindo, N. Hirokami, J. Shimizu, Chihiro Makimura, K. Araki, T. Taniyama, T. Tanaka, Y. Tanbo, Hiroto Miwa, Y. Hirai, J. Park, Asao Hirose, M. Doi, A. Goto, S. Nomura, S. Ikegaya, A. Yoshii, M. Akahane, T. Kakuma, K. Miyabayashi, S. Y. Kim, H. Kitade, B. Han, K. Yamada, Tadayuki Oshima, J. Ishizawa, M. Miyata, E. Sasak, R. Aibara, N. Takahara, S. Kanno, T. Kojima, I. Ohno, E. Sasaki, E. Tone, A. Morita, R. Suzuki, Yukio Hosomi, Hiroo Ishida, T. Akimoto, N. Hashimoto, T. Takakuwa, K. Umekawa, A. Toyoshima, K. Hara, J. Kitagawa, H. Taniguchi, T. Kamiya, M. Takai, Y. Watanabe, Yasuhito Tanaka, A. Sawada, T. Yasui, Y. Onozawa, Akihiro Hirakawa, S. Okamoto, K. K. Kim, Y.-M. Wang, Y. Takai, T. Tsumura, H. Hirama, Shigeo Horiike, K. Kawasumi, N. Shimeno, Junya Kuroda, C.-Y. Huang, Y.-H. Chen, H. Ogata, S. Matsumoto, I. Takahashi, Hideo Tomioka, I. Okamoto, Itaru Endo, T. M. S. Kam, K. Sekihara, C.-T. Liu, K. Chikamori, N. Hirota, K. Hiramatsu, D. Hamaguchi, T. Nishii, N. Ohmiya, T. Shimizu, T. Sakaizawa, Hiromichi Matsuoka, K. Kawa, J. H. Ji, S. Izumi, T. Hara, Y. Tsuyumu, T. Oguri, T. Akiyama, Y. Ichida, A. Simoyama, T. Hirakata, Y. Yoshimitsu, Y. Sasaki, T. Yamazaki, T. Tsushima, R. Okamoto, Y. Tsukioka, Nobuhiko Seki, S.-M. Bang, Y. Kubota, N. Harada, C.-H. Huang, J. Y. Hong, T. Andou, T. Shimada, T. Doi, Yoshihiro Ono, S. Nanjo, H. Hara, Y. Kikukawa, M. K. Choi, K.-M. Rau, Y. Tomizawa, O. Maeda, K. Ishida, Y. Naito, N. Machida, T. Otsuka, T. Hase, H. Morishita, K. Fukuhara, M. Yoshino, M. Takahashi, H. Takahashi, Heui June Ahn, M. Nisimoto, Y. Sunakawa, Y. Miyakawa, Choung Soo Kim, S.-W. Wang, Takashi Sone, M. Iguchi, T. Shimokawa, Tomoyuki Nagai, K. Morioka, A. Numata, R. Toyozawa, R. Miyahara, Y. M. Ahn, Hyo Song Kim, D. W. Hwang, H. Takamori, Shin-Hee Lee, Narikazu Boku, T. Mizuno, N. Katakami, J. H. Lee, Y. Okuma, Koji Kurokawa, K. Takeda, N. Sakiyama, R. Tachikawa, Satoshi Morita, T. K. Fai, K. H. Seong, K. Yorozu, T. Okamura, Ryo Takahashi, T. Kotake, Y. Arai, T. Kawamura, K. Yakushijinn, Y. Shimada, H. Sugiyama, S. Kamachi, A. Mugitani, T. Yasue, Y. Sugihara, S. Shu, Y. Osaki, Kazuhisa Takahashi, Y. Hashiguchi, K. Funasaka, Y. S. Koo, Tohru Ohmori, S. J. Koh, N. Kanemura, H. Kotani, M. Hsin, T. Kagoo, and A. Inoue
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biology ,Molecular mass ,business.industry ,Angiogenesis ,Hematology ,Cell biology ,chemistry.chemical_compound ,Oncology ,chemistry ,Proteoglycan ,Chondroitin sulfate proteoglycan ,Cancer cell ,medicine ,biology.protein ,Hepatocyte growth factor ,Antibody ,Cell adhesion ,business ,medicine.drug - Abstract
SRPX2 (Sushi repeat-containing protein, X-linked 2) has recently emerged as a multifunctional protein that is involved in seizure disorders, angiogenesis and cellular adhesion. Here, we analyzed this protein biochemically. SRPX2 protein was secreted with a highly post-translational modification. Chondroitinase ABC treatment completely decreased the molecular mass of purified SRPX2 protein to its predicted size, whereas heparitinase, keratanase and hyaluroinidase did not. Secreted SRPX2 protein was also detected using an anti-chondroitin sulfate antibody. These results indicate that SRPX2 is a novel chondroitin sulfate proteoglycan (CSPG). Furthermore, a binding assay revealed that hepatocyte growth factor dose-dependently binds to SRPX2 protein, and a ligand–glycosaminoglycans interaction was speculated to be likely in proteoglycans. Regarding its molecular architecture, SRPX2 has sushi repeat modules similar to four other CSPGs/lecticans; however, the molecular architecture of SRPX2 seems to be quite different from that of the lecticans. Taken together, we found that SRPX2 is a novel CSPG that is overexpressed in gastrointestinal cancer cells. Our findings provide key glycobiological insight into SRPX2 in cancer cells and demonstrate that SRPX2 is a new member of the cancer-related proteoglycan family.
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- 2012
16. Factors Influencing Selection of Place of Death and End-of-Life Care in Comprehensive Cancer Center
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T. Okusaka, H. Ueno, Shunsuke Kondo, and C. Morizane
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medicine.medical_specialty ,Oncology ,Place of death ,business.industry ,Family medicine ,medicine ,Cancer ,Center (algebra and category theory) ,Hematology ,medicine.disease ,business ,End-of-life care ,Selection (genetic algorithm) - Published
- 2012
17. 6595 POSTER Phase I Study of Gemcitabine as a Fixed Dose Rate Infusion and S-1 Combination Therapy (FGS) in Gemcitabine-refractory Biliary Tract Cancer (BTC) Patients
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Masafumi Ikeda, Takuji Okusaka, S. Kondo, Izumi Ohno, Satoshi Shimizu, C. Morizane, Kohei Nakachi, Yasushi Kojima, Hideki Ueno, and Shuichi Mitsunaga
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Cancer Research ,medicine.medical_specialty ,Biliary tract cancer ,Combination therapy ,business.industry ,Urology ,Fixed dose rate ,Gemcitabine ,Surgery ,Phase i study ,Oncology ,Refractory ,Medicine ,business ,medicine.drug - Published
- 2011
18. 6574 POSTER Thirty-four Cases of Advanced Ampullary Carcinoma Receiving Non-surgical Treatment – Experience at a Single Center
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S. Kondo, H. Shoji, Takuhiro Yamaguchi, T. Taniyama, Takuji Okusaka, C. Morizane, and Hideki Ueno
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Cancer Research ,medicine.medical_specialty ,Ampullary carcinoma ,Oncology ,business.industry ,medicine ,Non surgical treatment ,Single Center ,business ,Surgery - Published
- 2011
19. 6594 Phase II study of gemcitabine as a fixed dose rate infusion and S-1 combination therapy (FGS) in gemcitabine-refractory pancreatic cancer patients
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C. Morizane, T. Okusaka, M. Ikeda, J. Furuse, S. Ohkawa, K. Nakachi, E. Suzuki, and M. Ueno
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Cancer Research ,Oncology - Published
- 2009
20. 196 The efficacy, toxicity and pharmacokinetic findings of S-1 in patients (pts) with advanced biliary tract cancer (BTC): a phase II trial
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C. Morizane, Hikaru Ueno, Y. Takezako, M. Ikeda, and T. Okusaka
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Cancer Research ,medicine.medical_specialty ,Biliary tract cancer ,Oncology ,Pharmacokinetics ,business.industry ,Internal medicine ,Toxicity ,medicine ,In patient ,business ,Gastroenterology ,Surgery - Published
- 2003
21. Trastuzumab Deruxtecan in Human Epidermal Growth Factor Receptor 2-Expressing Biliary Tract Cancer (HERB; NCCH1805): A Multicenter, Single-Arm, Phase II Trial.
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Ohba A, Morizane C, Kawamoto Y, Komatsu Y, Ueno M, Kobayashi S, Ikeda M, Sasaki M, Furuse J, Okano N, Hiraoka N, Yoshida H, Kuchiba A, Sadachi R, Nakamura K, Matsui N, Nakamura Y, Okamoto W, Yoshino T, and Okusaka T
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- Humans, Female, Male, Aged, Middle Aged, Camptothecin analogs & derivatives, Camptothecin therapeutic use, Adult, Antineoplastic Agents, Immunological therapeutic use, Antineoplastic Agents, Immunological adverse effects, Aged, 80 and over, Immunoconjugates, Trastuzumab therapeutic use, Trastuzumab adverse effects, Receptor, ErbB-2 metabolism, Biliary Tract Neoplasms drug therapy, Biliary Tract Neoplasms metabolism, Biliary Tract Neoplasms pathology
- Abstract
Purpose: Treatment options for patients with unresectable or recurrent biliary tract cancer (BTC) who progress on a gemcitabine-containing regimen are limited. In addition, the significance of anti-human epidermal growth factor receptor 2 (HER2) therapy in HER2-expressing BTC has not been sufficiently investigated., Methods: In this phase II trial, participants from five institutions in Japan were enrolled. Eligible patients had pathologically confirmed unresectable or recurrent BTC with centrally confirmed HER2-positive (immunohistochemistry [IHC]3+ or IHC2+ and in situ hybridization [ISH]+) or HER2-low (IHC2+ and ISH-, IHC1+, and IHC0 and ISH+) and were refractory or intolerant to a gemcitabine-containing regimen. The patients received 5.4 mg/kg trastuzumab deruxtecan (T-DXd) once every 3 weeks until disease progression or unacceptable toxicity. The primary end point was the confirmed objective response rate (ORR) in HER2-positive BTC by an independent central review (threshold ORR, 15%; expected ORR, 40%)., Results: A total of 32 patients were enrolled and treated. Among these patients, 22 with HER2-positive disease comprised the primary efficacy population and had a confirmed ORR of 36.4% (90% CI, 19.6 to 56.1; P = .01), meeting the primary end point. Eight with HER2-low disease comprised the exploratory population and had a confirmed ORR of 12.5%. The most common ≥grade 3 treatment-related adverse events were anemia (53.1%) and neutropenia (31.3%). Eight patients (25.0%) had interstitial lung disease (ILD), including two grade 5 events., Conclusion: T-DXd showed promising activity in patients with HER2-positive BTC and a signal of efficacy in patients with HER2-low BTC. Although the safety profile was generally manageable, ILD requires careful monitoring and early intervention.
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- 2024
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22. A Phase II Placebo-Controlled Study of the Effect and Safety of Nanvuranlat in Patients with Advanced Biliary Tract Cancers Previously Treated by Systemic Chemotherapy.
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Furuse J, Ikeda M, Ueno M, Furukawa M, Morizane C, Takehara T, Nishina T, Todaka A, Okano N, Hara K, Nakai Y, Ohkawa K, Sasaki T, Sugimori K, Yokoyama N, and Yamamoto K
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- Humans, Female, Male, Middle Aged, Aged, Adult, Double-Blind Method, Aged, 80 and over, Treatment Outcome, Progression-Free Survival, Biliary Tract Neoplasms drug therapy, Biliary Tract Neoplasms pathology, Biliary Tract Neoplasms mortality
- Abstract
Purpose: To evaluate the efficacy and safety of nanvuranlat [an L-type amino acid transporter 1 inhibitor] monotherapy as a later-line treatment in advanced, metastatic, and refractory biliary tract cancers., Patients and Methods: A multicenter, randomized, double-blind, placebo-controlled phase II study was conducted across fourteen leading Japanese cancer centers and hospitals. Nanvuranlat 25 mg/m2/day or placebo was given intravenously in cycles of 5 consecutive days, followed by 9 days off. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival and disease control rate. Subgroup analysis was performed in patients with high L-type amino acid transporter 1 expression and biliary tract cancer subtypes., Results: A total of 211 patients were screened, of which 105 eligible patients were randomized. Among these, 70 received nanvuranlat and 35 received placebo. Nanvuranlat demonstrated an improvement in PFS when compared with placebo (HR, 0.56; 95% confidence interval, 0.34-0.90; P = 0.02). Grade 3 or higher adverse events were reported in 30.0% and 22.9% of those in the nanvuranlat and placebo groups, respectively. The overall survival was not statistically different between nanvuranlat- and placebo-treated patients. An exploratory analysis indicated that nanvuranlat is warranted to evaluate its long-term clinical benefit in patients with intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer., Conclusions: Compared with placebo, nanvuranlat improved PFS in patients with advanced and refractory biliary tract cancer with an acceptable safety profile. Further studies of this promising compound are warranted in the population of patients who are exhausted from treatment options., (©2024 American Association for Cancer Research.)
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- 2024
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23. Statistics of Visceral Sarcoma in Japan: Report From the Population-Based National Cancer Registry (NCR) in Japan.
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Muramatsu S, Ogura K, Morizane C, Satake T, Toda Y, Iwata S, Kobayashi E, Higashi T, Ikeuchi M, and Kawai A
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Background and Objectives: Sarcomas developing in the visceral organs are extremely rare, with no previous reports to describe their national epidemiology. We analyzed Japanese domestic statistics for visceral sarcoma, using the National Cancer Registry (NCR) in Japan, a population-based database launched in 2016., Methods: We identified 3245 cases of visceral sarcomas in the NCR dated 2016-2019 to analyze demographic and disease information, initial diagnostic process, volume and type of the hospitals, treatment, and prognosis., Results: Visceral sarcoma shows a higher prevalence in the older generation (60+ years), with a significant male predominance (p = 0.006). Leiomyosarcomas occurred frequently in the gastrointestinal tract (N = 240; 39.5%), and angiosarcomas in the liver, gall bladder, pancreas, and spleen (N = 244; 43.9%). Visceral sarcomas were often treated in facilities of lower volume without specific adjuvant treatments (p < 0.001). The cumulative 3-year overall survival was 44.8%, and several factors such as surgery or absence of chemotherapy positively affected survival., Conclusions: This is the first nationwide study in Japan to analyze the inclusive epidemiology of visceral sarcomas. Visceral sarcomas are characterized by senior and male predominance with relatively poor prognosis, often managed in nonspecialized facilities and rarely with adjuvant therapies. Several histologic subtypes had the propensity to develop in specific organs., (© 2024 Wiley Periodicals LLC.)
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- 2024
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24. Sedative effects of propofol and risk factors for excessive sedation in the endoscopic treatment of biliary and pancreatic diseases.
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Maruki Y, Hijioka S, Yagi S, Takasaki T, Chatto M, Fukuda S, Yamashige D, Okamoto K, Agarie D, Hara H, Hagiwara Y, Nagashio Y, Morizane C, Sone M, Okusaka T, and Saito Y
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Objectives: The safety and effectiveness of propofol in more complex endoscopic procedures, such as endoscopic retrograde cholangiopancreatography, remain unknown. Thus, we aimed to evaluate propofol sedation during endoscopic cholangiopancreatography, ultrasound-guided intervention, and gastroduodenal stenting and examine risk factors for excessive sedation., Methods: We retrospectively analyzed data from 870 patients who underwent endoscopic treatment with propofol sedation for biliary and pancreatic disease between October 2020 and September 2021. Sedation included propofol and fentanyl, with continuous monitoring of vital signs and the bispectral index. The assessed risk factors included age, complications, body mass index, treatment duration, and specialty., Results: Distal bile duct treatment ( n = 367), hilar bile duct treatment ( n = 197), post-small-intestinal reconstruction treatment ( n = 75), endoscopic ultrasound-guided intervention ( n = 140), and gastrointestinal obstruction treatment ( n = 91) were performed. The rates of excessive sedation, hypoxemia, and hypotension were 7.8%, 6.0%, and 1.8%, respectively. Post-small-intestinal reconstruction treatment had the highest incidence rate of excessive sedation (16%), whereas endoscopic ultrasound-guided intervention had the lowest incidence rate (4.3%). Multivariate analysis revealed significant associations between excessive sedation and comorbid sleep apnea, obesity, and prolonged procedural time., Conclusions: Obesity, sleep apnea syndrome, and prolonged procedure time are risk factors for excessive sedation related to propofol use. Thus, sedation techniques should be tailored for these patients., Competing Interests: None., (© 2024 The Author(s). DEN Open published by John Wiley & Sons Australia, Ltd on behalf of Japan Gastroenterological Endoscopy Society.)
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- 2024
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25. Early tumor shrinkage as a prognostic predictor in chemotherapy-naïve patients with locally advanced pancreatic cancer treated with modified FOLFIRINOX or gemcitabine plus nab-paclitaxel combination therapy: An exploratory analysis of JCOG1407.
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Tezuka S, Ozaka M, Furuse J, Yokoyama M, Uemura K, Sano Y, Nakachi K, Imaoka H, Unno M, Shirakawa H, Shimizu S, Kato N, Kojima Y, Sano K, Kobayashi S, Terashima T, Morizane C, Ikeda M, and Ueno M
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- Humans, Male, Female, Middle Aged, Aged, Prognosis, Adult, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Pancreatic Neoplasms drug therapy, Pancreatic Neoplasms pathology, Paclitaxel administration & dosage, Paclitaxel therapeutic use, Deoxycytidine analogs & derivatives, Deoxycytidine administration & dosage, Deoxycytidine therapeutic use, Fluorouracil therapeutic use, Fluorouracil administration & dosage, Gemcitabine, Oxaliplatin therapeutic use, Oxaliplatin administration & dosage, Irinotecan therapeutic use, Irinotecan administration & dosage, Leucovorin therapeutic use, Leucovorin administration & dosage, Albumins administration & dosage, Albumins therapeutic use
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Background: Early tumor shrinkage (ETS) is a prognostic predictor for patients treated with chemotherapy in colorectal cancer, although scarce studies evaluated its potential in locally advanced pancreatic cancer (LAPC). In this exploratory analysis of JCOG1407, a randomized phase II study comparing modified 5-fluorouracil, levofolinate, irinotecan, and oxaliplatin (mFOLFIRINOX) and gemcitabine plus nab-paclitaxel (GnP), we evaluated whether ETS can predict prognosis of patients with LAPC., Methods: Of the 126 patients enrolled in JCOG1407, 112 with measurable lesions were included in this study. ETS was defined as a ≥20 % reduction in tumor diameter compared with baseline at the initial imaging assessment 6-10 weeks after initiating chemotherapy. Patients were divided into the ETS (achieved ETS) and non-ETS (failed to achieve ETS) groups based on their ETS status. The impact of ETS on overall survival (OS) was compared using multivariable Cox regression analysis., Results: Fourteen of 55 (25.5 %) and 24 of 57 (42.1 %) patients in the mFOLFIRINOX and GnP arms, respectively, achieved ETS. In the overall population, mFOLFIRINOX arm, and GnP arm, the median OS in the ETS and non-ETS groups was 27.1 and 20.4, 29.8 and 20.6, and 24.1 and 20.4, months, respectively. The adjusted hazard ratios of OS for the ETS group in the overall population, mFOLFIRINOX arm, and GnP arm were 0.451 (95 % confidence interval [CI]: 0.270-0.754), 0.371 (95 % CI: 0.149-0.926), and 0.508 (95 % CI: 0.255-1.004), respectively., Conclusions: ETS may be a prognostic predictor in chemotherapy-naïve patients with LAPC treated with mFOLFIRINOX or GnP., Competing Interests: Declaration of competing interest JF reports grants from the Japan Agency for Medical Research and Development (AMED) and the National Cancer Center Research and Development Fund, during the study, as well as grants from Ono Pharmaceutical, MSD, J-Ph arma, Taiho Pharmaceutical, Takeda Pharmaceutical, Chugai Pharmaceutical, AstraZeneca, Eisai, Daiichi Sankyo, Sanofi, Sumitomo Dainippon, Astellas, Delta-Fly-Pharma, and Incyte Biosciences Japan and personal fees from Fujifilm, Delta-Fly-Pharma, Onco Therapy Science, Merck Biopharma, Ono Pharmaceutical, MSD, Taiho Pharmaceutical, Chugai Pharmaceutical, Astellas, AstraZeneca, Incyte Biosciences Japan, J-Pharma, Eisai, Daiichi Sankyo, Eli Lilly Japan, Yakult Honsha, Nihon Servier, Novartis Pharma, Takeda Pharmaceutical, Bayer, Teijin Pharma, Terumo, and Incyte Biosciences Japan outside the submitted work. KN reports personal fees from Ono Pharmaceutical, Yakult Honsha, Chugai Pharmaceutical, AstraZeneca, and Taiho Pharmaceutical outside the submitted work. HI reports grants from Ono Pharmaceutical and Nihon Servier and personal fees from Nihon Servier, Yakult Honsha, Boston Scientific, Kaneka Medix, Medico's Hirata, and SB KAWASUMI LABORATORIES outside the submitted work. SS reports grants from AstraZeneca, Incyte Corporation, and Delta-Fly-Pharma outside the submitted work. SK reports personal fees from Yakult Honsha outside the submitted work. CM reports grants from Eisai, Yakult Honsha, Ono Pharmaceutical, Taiho Pharmaceutical, J-Pharma, AstraZeneca, Merck Biopharma, Daiichi Sankyo, HITACHI, and Boehringer Ingelheim and personal fees from Yakult Honsha, MSD, Nihon Servier, Boehringer Ingelheim, Taiho Pharmaceutical, Novartis Pharma, Teijin Pharma, Eisai, and AstraZeneca outside the submitted work. MU reports grants from Japan AMED and the National Cancer Center Research and Development Fund, during the study, as well as grants from Ono Pharmaceutical, Taiho Pharmaceutical, J-Pharma, AstraZeneca, Merck Biopharma, MSD, Astellas, Eisai, Boehringer Ingelheim, Delta-Fly-Pharma, Incyte Biosciences Japan, Chugai Pharmaceutical, and Novartis Pharma and personal fees from Yakult Honsha, MSD, Nihon Servier, Ono Pharmaceutical, Chugai Pharmaceutical, Boehringer Ingelheim, Taiho Pharmaceutical, Novartis Pharma, J-Pharma, Incyte Biosciences Japan, Daiichi Sankyo, and AstraZeneca outside the submitted work. All other authors declare no competing interests., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)
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- 2024
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26. Statistics of bone sarcoma in Japan: report from the population-based cancer registry in Japan.
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Ogura K, Morizane C, Satake T, Iwata S, Toda Y, Muramatsu S, Kobayashi E, Arakawa A, Ogawa C, Kato Y, Higashi T, and Kawai A
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- Humans, Japan epidemiology, Male, Female, Middle Aged, Aged, Child, Adult, Adolescent, Aged, 80 and over, Child, Preschool, Young Adult, Infant, Sarcoma epidemiology, Sarcoma pathology, Prognosis, Osteosarcoma epidemiology, Osteosarcoma pathology, Infant, Newborn, Registries, Bone Neoplasms epidemiology, Bone Neoplasms pathology
- Abstract
Background: No previous reports have characterized national bone sarcoma profiles overall. We examined the nationwide statistics for bone sarcoma in Japan using data from the National Cancer Registry (NCR), a population-based cancer registry., Methods: We identified 3,755 patients with bone sarcomas entered in the NCR during 2016-2019 using International Classification of Diseases-Oncology, Third Edition codes for cancer topography and morphology. We extracted data on patient demographics, tumor details (reason for diagnosis, tumor location, histology, extent of disease), hospital volume/type, treatment, and prognosis for each patient., Results: Bone sarcoma showed a slight male preponderance. The age distribution peaked at ages 10-20 and 60-80; approximately 44% of patients were aged over 60 years. Chordoma, chondrosarcoma, and malignant fibrous histiocytoma of bone peaked in the elderly, and Ewing's sarcoma peaked in children. Osteosarcoma had two peaks in Japan as well as in Western countries. The most frequent tumor locations were the limb (45%) and the pelvis (21%). Extent of disease was categorized as: "localized" (39%), "regional" (27%), and "distant" (11%). We found significant associations between overall survival and age, tumor location, facility type, hospital volume, histologic subtype, reason for diagnosis, and extent of disease. The latter had the poorest survival., Conclusions: This is the first study to outline the epidemiology, clinical features, treatment, prognosis, and significant factors affecting prognosis of bone sarcoma in Japan using the NCR. Documenting our data regarding elderly patients' outcomes is essential so other countries showing similar population-aging trends can learn from our experiences., Level of Evidence: Prognostic studies, Level III., (© 2024. The Author(s) under exclusive licence to Japan Society of Clinical Oncology.)
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- 2024
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27. Clinical utility of BRCA and ATM mutation status in circulating tumour DNA for treatment selection in advanced pancreatic cancer.
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Sudo K, Nakamura Y, Ueno M, Furukawa M, Mizuno N, Kawamoto Y, Okano N, Umemoto K, Asagi A, Ozaka M, Ohtsubo K, Shimizu S, Matsuhashi N, Itoh S, Matsumoto T, Satoh T, Okuyama H, Goto M, Hasegawa H, Yamamoto Y, Odegaard JI, Bando H, Yoshino T, Ikeda M, and Morizane C
- Abstract
Background: Identification of homologous recombination deficiency (HRD) remains a challenge in advanced pancreatic cancer (APC). We investigated the utility of circulating tumour DNA (ctDNA) profiling in the assessment of BRCA1/2 and ATM mutation status and treatment selection in APC., Methods: We analysed clinical and ctDNA data of 702 patients with APC enroled in GOZILA, a ctDNA profiling study using Guardant360., Results: Inactivating BRCA1/2 and ATM mutations were detected in 4.8% (putative germline, 3.7%) and 4.4% (putative germline, 0.9%) of patients, respectively. Objective response (63.2% vs. 16.2%) and PFS (HR 0.55, 95% CI 0.32-0.93) on platinum-containing chemotherapy were significantly better in patients with putative germline BRCA1/2 (gBRCA) mutation than those without. In contrast, putative gBRCA mutation had no impact on the efficacy of gemcitabine plus nab-paclitaxel. In 2 patients treated with platinum-containing therapy, putative BRCA2 reversion mutations were detected. Three of seven patients with somatic BRCA mutations responded to platinum-containing therapy, while only one of four with putative germline ATM mutations did. One-third of somatic ATM mutations were in genomic loci associated with clonal haematopoiesis., Conclusion: Comprehensive ctDNA profiling provides clinically relevant information regarding HRD status. It can be a practical, convenient option for HRD screening in APC., (© 2024. The Author(s), under exclusive licence to Springer Nature Limited.)
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- 2024
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28. Clear cell sarcoma in Japan: an analysis of the population-based cancer registry in Japan.
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Takemori T, Ogura K, Morizane C, Satake T, Iwata S, Toda Y, Muramatsu S, Kondo H, Kobayashi E, Higashi T, and Kawai A
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Background: Clear cell sarcoma is rare, so no reports have previously characterized its national profiles. We examined the nationwide epidemiology and clinical outcomes of patients with clear cell sarcoma based on the National Cancer Registry in Japan., Methods: Overall, 23 522 patients with soft tissue sarcoma-entered in the National Cancer Registry in 2016-2019 using the International Classification of Diseases for Oncology, Third Edition cancer topography and morphology codes-were enrolled in either the clear cell or the non-clear cell sarcoma group. Data extracted included: demographics (sex and age), tumor details (reason for diagnosis, tumor location, histology and stage), hospital volume and facility type, treatment and prognosis for each patient., Results: Of 23 522 soft tissue sarcoma patients, 122 were enrolled in the clear cell sarcoma group and 23 400 in the non-clear cell sarcoma group. The incidence of clear cell sarcoma was 0.52% of all soft tissue sarcoma, with an age-adjusted incidence of 0.024/100 000/year. The age at diagnosis was significantly younger, and more tumors were at the localized stage in the clear cell than the non-clear cell sarcoma group. In addition, the overall survival in the clear cell group was worse than in the non-clear cell group (P < 0.001). Of 122 patients with clear cell sarcoma, the localized stage, surgical treatment and treatment without chemotherapy were associated with better overall survival in the univariate analyses., Conclusions: The present study is the first to have clarified the epidemiology, clinical features, treatment, prognosis and significant factors affecting the prognosis of patients with clear cell sarcoma in Japan., (© The Author(s) 2024. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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- 2024
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29. Immune-related adverse event-associated sclerosing cholangitis due to immune checkpoint inhibitors: imaging findings and treatments.
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Okamoto K, Hijioka S, Nagashio Y, Okada M, Ohba A, Maruki Y, Kondo S, Morizane C, Ueno H, and Okusaka T
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- Humans, Male, Female, Retrospective Studies, Middle Aged, Aged, Tomography, X-Ray Computed, Adult, Aged, 80 and over, Cholangitis, Sclerosing chemically induced, Cholangitis, Sclerosing diagnostic imaging, Cholangitis, Sclerosing pathology, Cholangitis, Sclerosing immunology, Cholangitis, Sclerosing drug therapy, Immune Checkpoint Inhibitors adverse effects
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Objectives: Immune-related adverse event-sclerosing cholangitis caused by treatment with immune checkpoint inhibitors is rare, and the diagnostic criteria and treatment strategy remain unclear. In this study, we confirmed the clinicopathological features of immune-related adverse event-sclerosing cholangitis and clarified its diagnosis and appropriate management., Methods: We retrospectively evaluated 10 patients diagnosed with immune-related adverse event-sclerosing cholangitis and identified by electronic database searches., Results: Blood tests revealed liver dysfunction with a predominance of biliary tract enzymes in all patients; however, jaundice was present in only one patient. Contrast-enhanced computed tomography revealed diffuse hypertrophy of the extrahepatic bile duct wall as the most frequent finding; however, endoscopic retrograde cholangiopancreatography showed various imaging features, such as the pruned-tree appearance of intrahepatic bile ducts, in all patients. Transpapillary bile duct biopsy showed inflammatory cell infiltration using immunostaining, with a predominance of cluster of differentiation 8-positive T cells in 63% of the cases. Initial steroid therapy was effective in two cases. Mycophenolate mofetil and tacrolimus were used in steroid-refractory cases. Although six patients showed improvements, all of the remaining patients died owing to immune-related adverse event-sclerosing cholangitis., Conclusions: Various bile duct imaging findings of immune-related adverse event-sclerosing cholangitis were revealed; transpapillary bile duct biopsy may be useful in the diagnosis of immune-related adverse event-sclerosing cholangitis. Despite the combination of multiple immunosuppressive agents, prognosis of immune-related adverse event-sclerosing cholangitis remains poor. Longer follow-up and larger clinical studies are necessary to establish its treatment strategy., (© The Author(s) 2024. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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- 2024
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30. Study Protocol for a Prospective Self-Controlled Trial on Success in Meeting Comprehensive Genomic Profiling Analysis Criteria for Specimens Obtained by Endoscopic Ultrasound-Guided Tissue Acquisition Using a 19G Needle from Primary and Metastatic Lesions in Pancreatic Cancer with Metastatic Lesions: The PRIMATE Study.
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Takeshita K, Hijioka S, Nagashio Y, Hara H, Agarie D, Kawasaki Y, Takasaki T, Yagi S, Hagiwara Y, Okamoto K, Yamashige D, Fukuda S, Kuwada M, Komori Y, Okada M, Maruki Y, Morizane C, Ueno H, Yatabe Y, and Okusaka T
- Abstract
EUS-TA in unresectable pancreatic cancer requires not only a tissue diagnosis but also tissue collection in anticipation of comprehensive genomic profiling. However, the optimal puncture target remains controversial. Therefore, the Primary and Metastatic Lesions in Pancreatic Cancer (PRIMATE) study was designed to clarify the optimal target by comparing the success rates for meeting OncoGuide NCC Oncopanel (NOP) analysis criteria on pre-check primary and metastatic lesion specimens obtained during the same EUS-TA session in patients with invasive pancreatic ductal adenocarcinoma. In this ongoing prospective study, two specimens, each from primary and metastatic lesions, are obtained by EUS-TA (typically using a 19G fine-needle biopsy needle) in patients with invasive pancreatic ductal adenocarcinoma. The primary endpoint is the proportion of EUS-TA specimens that meet NOP analysis criteria during pre-check (i.e., tumor cellularity of ≥20% and a tissue area of ≥4 mm
2 ), which are then compared between primary and metastatic lesions. This study has been approved by the National Cancer Center Institutional Review Board (Research No. 2022-168). The results of this study will be reported at an international conference and published in an international peer-reviewed journal. The trial registration number is UMIN 000048966.- Published
- 2024
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31. Utility of Transpapillary Biopsy and Endoscopic Ultrasound-Guided Tissue Acquisition for Comprehensive Genome Profiling of Unresectable Biliary Tract Cancer.
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Fukuda S, Hijioka S, Nagashio Y, Yamashige D, Agarie D, Hagiwara Y, Okamoto K, Yagi S, Komori Y, Kuwada M, Maruki Y, Morizane C, Ueno H, Hiraoka N, Tsuchiya K, and Okusaka T
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Tissue sampling in biliary tract cancer (BTC) is generally performed through transpapillary biopsy (TPB) or endoscopic ultrasound-guided tissue acquisition (EUS-TA). For the first time, we compared the suitability of specimens obtained using TPB and EUS-TA to determine the optimal tissue-sampling method for comprehensive genome profiling (CGP) analysis in patients with unresectable BTC (UR-BTC). Pathology precheck criteria for CGP analysis comprised the OncoGuide NCC Oncopanel System (NCCOP) and FoundationOne CDx (F1CDx). Seventy-eight patients with UR-BTC (35 TPB and 43 EUS-TA) were included. The NCCOP analysis suitability achievement rate was higher in EUS-TA specimens than in TPB specimens (34.9% vs. 8.6%, p = 0.007), whereas that of F1CDx was 0% in both groups. EUS-TA was identified as an independent factor that contributed to the suitability of the NCCOP analysis. The suitability of the NCCOP analysis of EUS-TA specimens showed a tendency to be higher for mass lesions (43.8% vs. 9.1%, p = 0.065), especially for target size ≥ 18.5 mm, and lower for perihilar cholangiocarcinoma (0% vs. 41.7%, p = 0.077). In TPB, papillary-type lesions (66.7% vs. 3.2%, p = 0.016) and peroral cholangioscopy-assisted biopsies (50.0% vs. 3.3%, p = 0.029) showed better potential for successful NCCOP analysis. EUS-TA is suitable for NCCOP analysis in UR-BTC and may be partially complemented by TPB.
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- 2024
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32. Durvalumab or placebo plus gemcitabine and cisplatin in participants with advanced biliary tract cancer (TOPAZ-1): updated overall survival from a randomised phase 3 study.
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Oh DY, He AR, Bouattour M, Okusaka T, Qin S, Chen LT, Kitano M, Lee CK, Kim JW, Chen MH, Suksombooncharoen T, Ikeda M, Lee MA, Chen JS, Potemski P, Burris HA 3rd, Ostwal V, Tanasanvimon S, Morizane C, Zaucha RE, McNamara MG, Avallone A, Cundom JE, Breder V, Tan B, Shimizu S, Tougeron D, Evesque L, Petrova M, Zhen DB, Gillmore R, Gupta VG, Dayyani F, Park JO, Buchschacher GL Jr, Rey F, Kim H, Wang J, Morgan C, Rokutanda N, Żotkiewicz M, Vogel A, and Valle JW
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- Humans, Male, Female, Middle Aged, Double-Blind Method, Aged, Adult, Survival Rate, Cisplatin administration & dosage, Cisplatin therapeutic use, Gemcitabine, Deoxycytidine analogs & derivatives, Deoxycytidine administration & dosage, Deoxycytidine therapeutic use, Biliary Tract Neoplasms drug therapy, Biliary Tract Neoplasms mortality, Biliary Tract Neoplasms pathology, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Antineoplastic Combined Chemotherapy Protocols adverse effects, Antibodies, Monoclonal administration & dosage, Antibodies, Monoclonal therapeutic use, Antibodies, Monoclonal adverse effects
- Abstract
Background: In the preplanned interim analysis of the TOPAZ-1 study, durvalumab plus gemcitabine-cisplatin significantly improved overall survival versus placebo plus gemcitabine-cisplatin in participants with advanced biliary tract cancer. We aimed to report updated overall survival and safety data from TOPAZ-1 with additional follow-up and data maturity beyond the interim analysis., Methods: TOPAZ-1 was a phase 3, randomised, double-masked, placebo-controlled, global study done at 105 sites in 17 countries. Participants aged 18 years or older with unresectable, locally advanced, or metastatic biliary tract cancer were randomly assigned (1:1) to durvalumab plus gemcitabine-cisplatin or placebo plus gemcitabine-cisplatin using a computer-generated randomisation scheme, stratified by disease status and primary tumour location. Participants received durvalumab (1500 mg) or placebo on day 1 of each cycle every 3 weeks for up to eight cycles, plus gemcitabine (1000 mg/m
2 ) and cisplatin (25 mg/m2 ) intravenously on days 1 and 8 of each cycle every 3 weeks for up to eight cycles, followed by durvalumab (1500 mg) or placebo monotherapy every 4 weeks until disease progression or other discontinuation criteria were met. Investigators and participants were masked to study treatment. The primary endpoint was overall survival. TOPAZ-1 met its primary endpoint at the preplanned interim analysis, and the study is active but no longer recruiting participants. Updated overall survival and safety data from TOPAZ-1, with additional follow-up (data cutoff Feb 25, 2022) and data maturity beyond the interim analysis, are reported here. Efficacy was assessed in the full analysis set (all randomly assigned participants). Safety was assessed in the safety analysis set (all participants who received at least one dose of study treatment). The TOPAZ-1 study is registered with ClinicalTrials.gov, NCT03875235., Findings: From April 16, 2019, to Dec 11, 2020, 914 participants were enrolled, 685 of whom were randomly assigned (341 to the durvalumab plus gemcitabine-cisplatin group and 344 to the placebo plus gemcitabine-cisplatin group). 345 (50%) participants were male and 340 (50%) were female. Median follow-up at the updated data cutoff was 23·4 months (95% CI 20·6-25·2) in the durvalumab plus gemcitabine-cisplatin group and 22·4 months (21·4-23·8) in the placebo plus gemcitabine-cisplatin group. At the updated data cutoff, 248 (73%) participants in the durvalumab plus gemcitabine-cisplatin group and 279 (81%) participants in the placebo plus gemcitabine-cisplatin group had died (median overall survival 12·9 months [95% CI 11·6-14·1] vs 11·3 months [10·1-12·5]; hazard ratio 0·76 [95% CI 0·64-0·91]). Kaplan-Meier-estimated 24-month overall survival rates were 23·6% (95% CI 18·7-28·9) in the durvalumab plus gemcitabine-cisplatin group and 11·5% (7·6-16·2) in the placebo plus gemcitabine-cisplatin group. Maximum grade 3 or 4 adverse events occurred in 250 (74%) of 338 participants in the durvalumab plus gemcitabine-cisplatin group and 257 (75%) of 342 in the placebo plus gemcitabine-cisplatin group. The most common maximum grade 3 or 4 treatment-related adverse events were decreased neutrophil count (70 [21%] vs 86 [25%]), anaemia (64 [19%] vs 64 [19%]), and neutropenia (63 [19%] vs 68 [20%])., Interpretation: Durvalumab plus gemcitabine-cisplatin showed robust and sustained overall survival benefit with no new safety signals. Findings continue to support the regimen as a standard of care for people with untreated, advanced biliary tract cancer., Funding: AstraZeneca., Competing Interests: Declaration of interests D-YO reports advisory fees from Arcus Biosciences, Aslan Pharmaceuticals, AstraZeneca, Basilea, Bayer, BeiGene, Bristol Myers Squibb/Celgene, Genentech/Roche, Halozyme, IQVIA, Merck Serono, Novartis, Taiho Pharmaceutical, Turning Point Therapeutics, Yuhan, and Zymeworks; and institutional research funding from Array BioPharma, AstraZeneca, BeiGene, Eli Lilly, Handok, MSD, Novartis, and Servier. ARH reports consulting fees from AstraZeneca, Bristol Myers Squibb, and Genentech/Roche; research funding from Genentech and Merck; and speakers bureau fees from Eisai and Bristol Myers Squibb. MB reports consulting fees from AstraZeneca, Bayer, Bristol Myers Squibb, Eisai, Ipsen, MSD, Roche, and Sirtex Medical; speakers bureau fees from Bayer, Eisai, and Roche; and support for travel and attending meetings from AstraZeneca, Bayer, and Sirtex Medical. TO reports advisory fees from AstraZeneca, Daiichi Sankyo, Dainippon Sumitomo Pharma, Eisai, Eli Lilly, Incyte, Meiji Seika Pharma, Mundipharma, Nihon Servier, Nippon Shinyaku, Pfizer, Taiho Pharmaceutical, and Takara Bio; and speaker fees from AstraZeneca, Baxter, Bayer, Bristol Myers Squibb, Chugai Pharma, Dainippon Sumitomo Pharma, Eisai, Eli Lilly, MSD, Nihon Servier, Novartis, Ono Pharmaceutical, Taiho Pharmaceutical, Teijin Pharma, and Yakult Honsha. L-TC reports personal speaker fees from Bristol Myers Squibb, CStone, Eli Lilly, Ipsen, Ono Pharmaceutical, Novartis, PharmaEngine, and TTY; fees for medical monitoring for clinical trials for Taivex; fees received as a data and safety monitoring committee member for clinical trials for OBI Pharma; advisory fees from AstraZeneca, MSD, and SynCoreBio; speaker fees from AstraZeneca, HuniLife Biotechnology, Ono Pharmaceutical, ScinoPharm Taiwan, SynCoreBio, and TTY; and research funding from Celgene. MK reports research funding from AbbVie and Takeda; and honoraria from EA Pharma and AstraZeneca. JWK reports research funding from inno.N and Jeil Pharmaceutical; and consulting fees from AstraZeneca, BeiGene, BeyondBio, Bristol Myers Squibb/Celgene, Eisai, GC Cell, MSD Ono, Sanofi-Aventis, Servier, and TCUBEit. TS reports speaker fees from Amgen, AstraZeneca, Bayer, Bristol Myers Squibb, Baxter, Eli Lilly, Mundipharma (Thailand), Janssen, MSD, Novartis, Roche, and Takeda; and advisory fees from Novartis and Roche. MI reports grant or research support from Aslan Pharmaceuticals, AstraZeneca, Bayer, Bristol Myers Squibb, Chiome Bioscience, Chugai Pharma, Delta-Fly Pharma, EA Pharma, Eisai, Eli Lilly Japan, J-Pharma, Merck, Merus NV, Nihon Servier, Novartis, Ono Pharmaceutical, Pfizer, Takeda, and Yakult; fees or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Astellas Pharma, Bayer, Bristol Myers Squibb, Chugai Pharma, Eisai, Eli Lilly Japan, MSD, Nihon Servier, Novartis, Otsuka, Dainippon Sumitomo Pharma, Taiho Pharmaceutical, Takeda, Teijin Pharma, and Yakult; and fees for participation on a data safety monitoring board or advisory board from Aslan Pharmaceuticals, Bayer, Bristol Myers Squibb, Chugai Pharma, Eisai, Eli Lilly Japan, GlaxoSmithKline, Nihon Servier, Novartis, and Takeda. J-SC reports grant or research support from Astellas Pharma, AstraZeneca, Bristol Myers Squibb, Janssen, Eli Lilly, Merck KGaA, MSD, MSD Oncology, Oncologie, Ono Pharmaceutical, Roche, Senhwa Biosciences, SynCore, and TTY; and consulting fees from Ono Pharmaceutical. PP reports personal fees for an advisory board from AstraZeneca, Sanofi-Aventis, Bristol Myers Squibb, Janssen Oncology, MSD, Pierre Fabre, Roche, and Servier; personal fees as an invited speaker from AstraZeneca, Ipsen, Pierre Fabre, and Merck; and being a principal investigator for AstraZeneca and Roche. HAB reports research funding from AbbVie, Agios, Arch Pharmalabs, ARMO BioSciences, Array BioPharma, Arvinas, AstraZeneca, Bayer, BIND Therapeutics, BioAtla, BioMed Valley Discoveries, Biotheryx, Boehringer Ingelheim, Bristol Myers Squibb, CALGB, CicloMed, Coordination Pharmaceuticals, CytomX, eFFECTOR Therapeutics, Eli Lilly, EMD Serono, Foundation Medicine, Gossamer Bio, Gilead Sciences, GlaxoSmithKline, Harpoon Therapeutics, Incyte, Infinity Pharmaceuticals, Janssen, Jiangsu Hengrui Pharmaceuticals, Jounce Therapeutics, Kymab, MacroGenics, MedImmune, Merck, Millennium/Takeda, miRNA Therapeutics, Moderna, NGM Bio, Novartis, Pfizer, Revolution Medicine, Roche/Genentech, Ryvu Therapeutics, Seattle Genetics, Tesaro, TG Therapeutics, Verastem Oncology, Vertex Pharmaceuticals, XBiotech, and Zymeworks; and consulting fees from AstraZeneca, Bayer, Boehringer Ingelheim, Daiichi Sankyo, Forma Therapeutics, Grail, Incyte, Novartis, Pfizer, and Vincerx Pharma. VO reports grant or research support from Dr Reddy's Laboratories and Zydus Cadila; institutional fees for advisory board participation from AstraZeneca, Panacea Biotec, Dr Reddy's Laboratories, and Zydus Cadila; travel reimbursement as an invited speaker from AstraZeneca; other institutional financial interests with Alkem Laboratories, Eisai, Intas Pharmaceuticals, and Micro Labs; and non-financial interests with the Indian Association of Supportive Care in Cancer. ST reports honoraria from AstraZeneca, Bayer, Bristol Myers Squibb, Eisai, MSD, Novartis, and Roche; speaker fees from Bristol Myers Squibb, Ipsen, and Novartis; and non-financial interests with AstraZeneca, Bristol Myers Squibb, Ipsen, Janssen, and Roche. CM reports institutional grant or research support from AstraZeneca, Daiichi Sankyo, Eisai, J-Pharma, Hitachi, Merck BioReliance, MSD, Kyowa Kirin, Ono Pharmaceutical, Taiho Pharmaceutical, and Yakult Honsha; personal fees for advisory board participation from AstraZeneca, Boehringer Ingelheim, Merck BioReliance, MSD, Servier, Taiho Pharmaceutical, and Yakult; and personal fees received as an invited speaker from AstraZeneca, Eisai, Kyowa Kirin, MSD, Novartis, Servier, Taiho Pharmaceutical, Teijin Pharma, and Yakult Honsha. REZ reports speaker fees from Bristol Myers Squibb, Ipsen, and Novartis; and travel grants from Pierre Fabre. MGM reports grant or research support from Ipsen, NuCana, and Servier; consulting fees from AstraZeneca and Incyte; and honoraria from Advanced Accelerator Applications and AstraZeneca. AA reports research funding from Amgen, Bayer, and Bristol Myers Squibb; and advisory fees from AstraZeneca, Amgen, Eisai, and MSD. JEC reports advisory fees from MSD; and fees as an invited speaker for AstraZeneca, Boehringer Ingelheim, Takeda, and Roche. VB reports consulting fees from Bayer, Bristol Myers Squibb Russia, Eisai, MSD, Novartis, Pfizer, Roche Russia, and Takeda; and travel expenses from Bayer, Bristol Myers Squibb Russia, MSD, and Roche Russia. BT reports research funding from Adaptimmune, AstraZeneca, Bristol Myers Squibb, and Exelixis. SS reports grant or research support from Delta-Fly Pharma and Incyte. DT reports personal fees for advisory board participation from Amgen, AstraZeneca, MSD, Pierre Fabre, Roche, Sanofi, and Servier. LE reports personal fees for advisory board participation from Amgen, Merk, MSD, and Servier. MP reports personal fees for advisory board participation from Roche and Servier; personal fees as an invited speaker from AstraZeneca, Ewopharma, and Takeda; and non-financial interests with AstraZeneca and Sanofi. DBZ reports advisory fees from Cornerstone Pharmaceuticals, Ipsen, Jazz Pharmaceuticals/Zymeworks, and QED Therapeutics; and research funding from AstraZeneca, Bayer, Bristol Meyers Squibb, Cornerstone Pharmaceuticals, Daiichi Sankyo, Eli Lily, Ipsen, Roche/Genentech, Legend Biotech, Merck, and Seagen. VGG holds stock in RPG Life Sciences and Zydus Lifesciences. FD reports grant or research support from Amgen, AstraZeneca, Bristol Myers Squibb, Exelixis, Genentech, Ipsen, Signatera, and Taiho Pharmaceutical; consulting fees from AstraZeneca, Eisai, Exelixis, Genentech, and Ipsen; and payment or honoraria from Astellas, Eisai, Exelixis, Ipsen, Servier, and Sirtex Medical. JOP reports advisory board fees from Adicet Bio, AstraZeneca, Bristol Myers Squibb (Celgene), MediRama, MedPacto, Merck Serono, and Servier; support for travel to meetings from Minneamrita Therapeutics; and grant or research support from ABL Bio, Bristol Myers Squibb (Celgene), Eutilex, MedPacto, and Servier. HK, CM, and MŻ are employees of AstraZeneca. JW and NR are employees of and hold stock in AstraZeneca. AV reports speaker fees from BeiGene, Bristol Myers Squibb, Eisai, Imaging Equipment, Incyte, Ipsen, Jiangsu Hengrui Pharmaceuticals, Eli Lilly, MSD, Novartis, Pierre Fabre, and Roche; and advisory fees from AstraZeneca, Bayer, Bristol Myers Squibb, Boston Scientific, Daiichi Sankyo, Eisai, Ipsen, Incyte, Lilly, MSD, Pierre Fabre, Roche, and Sirtex Medical. JWV reports advisory fees from Agios, AstraZeneca, Autem Therapeutics, Baxter, Hutchison MediPharma, Image Equipment, NuCana, QED Therapeutics, Sirtex Medical, Servier, and Zymeworks; speaker fees from Incyte, Ipsen, and Mylan; and research funding from AstraZeneca and Redx. All other authors declare no competing interests., (2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.)- Published
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33. Familial and hereditary pancreatic cancer in Japan.
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Matsubayashi H and Morizane C
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- Humans, Japan, Germ-Line Mutation, Genetic Testing, Carcinoma, Pancreatic Neoplasms genetics, Genetic Predisposition to Disease
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As in Western countries, familial pancreatic cancer accounts for 5-7% of pancreatic cancer (PC) in Japan. Opportunities for diagnosing hereditary pancreatic cancer (HPC) are increasing owing to the coverage of companion diagnostics and cancer genomic profiling by national health insurance in patients with unresectable or recurrent PC refractory to standard chemotherapies. HPC is recognized in 7% of PCs and 15% of familial pancreatic cancer, including germline variants of BRCA1/2, ATM, PALB2, APC, and mismatch repair genes. Individuals with 5-fold or greater inherited risks of PC are recommended to undergo pancreatic surveillance according to Japanese guidelines. The imaging modalities for this surveillance include endoscopic ultrasound, magnetic resonance cholangiopancreatography, abdominal ultrasound, and enhanced computed tomography. Currently, a nationwide prospective surveillance study is ongoing in Japan. Platinum-based chemotherapy is an effective pancreatic cancer treatment in patients with variants of homologous recombination repair genes (BRCA1/2 and PALB2); however, the use of platinum regimens solely based on familial/personal cancer history remains controversial. The efficacy of olaparib maintenance therapy, as confirmed by the POLO study, has significantly impacted the clinical treatment of advanced PC patients in Japan. Since the initiation of precision cancer medicine in 2019, genetic medicine for PC patients has expanded in Japan., (© 2024. The Author(s), under exclusive licence to Springer Nature B.V.)
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34. The SCRUM-MONSTAR Cancer-Omics Ecosystem: Striving for a Quantum Leap in Precision Medicine.
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Hashimoto T, Nakamura Y, Fujisawa T, Imai M, Shibuki T, Iida N, Ozaki H, Nonomura N, Morizane C, Iwata H, Okano S, Yamagami W, Yamazaki N, Kadowaki S, Taniguchi H, Ueno M, Boku S, Oki E, Komatsu Y, Yuki S, Makiyama A, Otsuka T, Hara H, Okano N, Nishina T, Sakamoto Y, Miki I, Kobayashi S, Yuda J, Kageyama SI, Nagamine M, Sakashita S, Sakamoto N, Yamashita R, Koga Y, Bando H, Ishii G, Kuwata T, Park WY, Ohtsu A, and Yoshino T
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The SCRUM-Japan MONSTAR-SCREEN consortium is a nationwide molecular profiling project employing artificial intelligence-driven multi-omics analyses for patients with advanced malignancies, aiming to develop novel therapeutics and diagnostics and deliver effective drugs to patients. Concurrently, studies assessing molecular residual disease-based precision medicine for resectable solid tumors, including CIRCULATE-Japan, are ongoing. The substantial data generated by these platforms are stored within a state-of-the-art supercomputing infrastructure, VAPOR CONE. Since 2015, our project has registered over 24,000 patients as of December 2023. Among 16,144 patients with advanced solid tumors enrolled in MONSTAR-SCREEN projects, 5.0% participated in matched clinical trials, demonstrating a 29.2% objective response rate and 14.8-month median survival (95% confidence interval, 13.4-16.3), for patients treated in the matched clinical trials. Notably, patients who received matched therapy demonstrated significantly prolonged overall survival compared with those who did not (hazard ratio 0.77; 95% confidence interval, 0.71-0.83).
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35. Comparison of stent patency between EUS-guided hepaticogastrostomy with bridging and endoscopic transpapillary biliary drainage for hilar obstruction.
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Takeshita K, Hijioka S, Nagashio Y, Maruki Y, Ohba A, Kawasaki Y, Takasaki T, Yagi S, Agarie D, Hara H, Hagiwara Y, Yamashige D, Okamoto K, Fukuda S, Kuwada M, Chatto M, Kondo S, Morizane C, Ueno H, Saito Y, and Okusaka T
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Background and study aims Endoscopic ultrasound-guided hepaticogastrostomy with bridging between the left and right bile ducts is an alternative to endoscopic transpapillary drainage for malignant hilar biliary obstruction. We aimed to analyze the long-term stent patency of endoscopic ultrasound-guided hepaticogastrostomy with bridging. Patients and methods Patients who underwent endoscopic ultrasound-guided hepaticogastrostomy with bridging between April 2018 and July 2023 were retrospectively analyzed. We retrospectively compared the stent patency of these patients with that of the individuals who underwent endoscopic transpapillary drainage-multi-stenting using unmatched (entire) and propensity score-matched cohorts. Results Endoscopic ultrasound-guided hepaticogastrostomy with bridging had a technical success rate of 90% (18/20). Adverse events were minimal. The number of clinical success cases was 17 and 82 for endoscopic ultrasound-guided hepaticogastrostomy with bridging using metallic stent and endoscopic transpapillary drainage-multi-stenting, respectively. The recurrent biliary obstruction rate was 17.6% and 58.5% for endoscopic ultrasound-guided hepaticogastrostomy with bridging and endoscopic transpapillary drainage-multi-stenting, respectively; the median time to recurrent biliary obstruction (days) was significantly longer for endoscopic ultrasound-guided hepaticogastrostomy with bridging in the entire (not reached vs. 104, P =0.03) and propensity score-matched (183 vs. 79, P =0.05) cohorts. The non-recurrent biliary obstruction rate for endoscopic ultrasound-guided hepaticogastrostomy with bridging was 91.6% at 3 and 6 months and 57% at 12 months. Multivariate analyses revealed that endoscopic ultrasound-guided hepaticogastrostomy with bridging contributed to a lower recurrent biliary obstruction incidence (hazard ratio, 0.31, P =0.05) without significant difference. Conclusions Stent patency was significantly better for endoscopic ultrasound-guided hepaticogastrostomy with bridging. However, future prospective studies are needed., Competing Interests: Conflict of Interest The authors declare that they have no conflict of interest., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)
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- 2024
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36. Soft-tissue sarcoma in Japan: National Cancer Registry-based analysis from 2016 to 2019.
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Ogura K, Morizane C, Satake T, Iwata S, Toda Y, Muramatsu S, Takemori T, Kondo H, Kobayashi E, Katoh Y, Higashi T, and Kawai A
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Background: No previous reports have characterized national profiles of soft-tissue sarcoma overall. We examined the nationwide statistics for soft-tissue sarcoma in Japan using data from the population-based National Cancer Registry., Methods: We identified 23 522 soft-tissue-sarcoma patients who were entered in the National Cancer Registry during 2016-19 using International Classification of Diseases-Oncology, Third Edition codes for cancer topography and morphology. We extracted data on patient demographics, tumor details (reason for diagnosis, tumor location, histology, extent of disease), hospital volume/type, treatment, and prognosis for each patient., Results: Soft-tissue sarcoma showed a slight male preponderance. Approximately 5500-6000 new cases were diagnosed as soft-tissue sarcoma per year, with the age-adjusted incidence of soft-tissue sarcoma being 3.22/100000/year. The age distribution showed a single peak in the 70-79 age range, and sex-stratified data showed it was higher in men. The most common histologic subtype was liposarcoma. The most frequent tumor locations were the soft tissue and skin, followed by the retroperitoneum. Extent of disease was categorized as: "localized" (31.3%), "regional" (38.9%), or "distant" (10.5%). We found significant associations between overall survival and sex, age, tumor location, facility type, hospital volume, reason for diagnosis, extent of disease, and surgical treatment., Conclusions: This is the first study to outline the epidemiology, clinical features, treatment, prognosis, and significant factors affecting prognosis of soft-tissue sarcoma in Japan using the National Cancer Registry. Documenting our data regarding elderly patients' outcomes is essential so other countries showing similar population-aging trends can learn from our experiences., Level of Evidence: Prognostic studies, Level III., (© The Author(s) 2024. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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- 2024
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37. Protocol digest of a randomized phase III trial comparing S-1-based chemoradiotherapy with/without nivolumab for unresectable locally advanced or borderline resectable pancreatic cancer: JCOG1908E (PENETRATE).
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Sano Y, Kanai M, Morizane C, Sasaki K, Yoshimura M, Ito Y, Furuse J, Ozaka M, Fukuda H, and Ueno M
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Pancreatic cancer remains a highly lethal disease with a 5-year survival proportion of <10%. Chemoradiotherapy is a treatment option for unresectable locally advanced (UR-LA) or borderline resectable (BR) pancreatic cancer, but its efficacy is not sufficient. Induction of the synergistic effect of irradiation and immune checkpoint inhibitors can be an attractive strategy. An open-label randomized phase III trial has been conducted since October 2020 to confirm the superiority of nivolumab plus S-1-based chemoradiotherapy over S-1-based chemoradiotherapy alone in patients with UR-LA or BR pancreatic cancer. A total of 216 patients will be enrolled in 14 institutions within 3.5 years. The primary endpoint of the safety run-in part is dose-limiting toxicity, and that of the phase III part is overall survival. This trial was registered at the Japan Registry of Clinical Trials as jRCT2080225361 (https://jrct.niph.go.jp/latest-detail/jRCT2080225361)., (© The Author(s) 2024. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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- 2024
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38. Plain language summary of the FOENIX-CCA2 study: futibatinib for people with advanced bile duct cancer.
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Goyal L, Meric-Bernstam F, Hollebecque A, Valle JW, Morizane C, Karasic TB, Abrams TA, Furuse J, Kelley RK, Cassier PA, Klümpen HJ, Chang HM, Chen LT, Tabernero J, Oh DY, Mahipal A, Moehler M, Komatsu Y, Ahn DH, Epstein RS, Halim AB, Wacheck V, He Y, Liu M, Benhadji KA, and Bridgewater JA
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What Is This Summary About?: This summary describes the results from a phase 2 study called FOENIXCCA2. The study evaluated treatment with futibatinib in people with a rare form of advanced bile duct cancer called intrahepatic cholangiocarcinoma (or iCCA), where the tumors have changes in the structure of a gene called FGFR2. These changes include FGFR2 gene fusions. Bile duct cancer often returns after surgery or cannot be treated by surgery because the tumor has spread, so it requires treatment with chemotherapy. People live for a median of 1 year after their first chemotherapy treatment and 6 months after their second treatment. This study included people whose cancer had grown/spread after one or more chemotherapy treatments. The aims of the study were to see if futibatinib could shrink the size of tumors and stop the cancer from growing/spreading and to see how long people lived when treated with futibatinib. Clinicians also looked at side effects from taking futibatinib and at how it affected people's quality of life., What Were the Results?: Futibatinib treatment shrank tumors in over 80% of people who received treatment. Tumors shrank by at least 30% in 42% of people. Futibatinib stopped tumors from growing/spreading for a median of 9.7 months. People who took the medicine lived for a median of 21.7 months, and 72% of people were still alive after 1 year. Side effects from taking futibatinib were like those reported for similar medicines, and clinicians considered the side effects to be manageable by adjusting the dose of futibatinib or treating the side effects. Most people reported that their quality of life stayed the same or improved during the first 9 months of taking futibatinib., What Do the Results Mean?: The results support the use of futibatinib for treating people with advanced bile duct cancer. Based on the results of this study, futibatinib is now approved in the US, Europe, and Japan. Futibatinib is approved for treating adults with advanced bile duct cancer who have received previous treatment for their cancer, and whose tumors have a gene fusion or other change in the FGFR2 gene. Clinical Trial Registration: NCT02052778 (FOENIX-CCA2).
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- 2024
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39. Efficacy of hemostasis by gastroduodenal covered metal stent placement for hemorrhagic duodenal stenosis due to pancreatobiliary cancer invasion: a retrospective study.
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Sakamoto Y, Sakamoto T, Ohba A, Sasaki M, Kondo S, Morizane C, Ueno H, Saito Y, Arai Y, and Okusaka T
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Background/aims: Advanced pancreatic and biliary tract cancers can invade the duodenum and cause duodenal hemorrhagic stenosis. This study aimed to evaluate the efficacy of covered self-expandable metal stents in the treatment of cancer-related duodenal hemorrhage with stenosis., Methods: Between January 2014 and December 2016, metal stents were placed in 51 patients with duodenal stenosis. Among these patients, a self-expandable covered metal stent was endoscopically placed in 10 patients with hemorrhagic duodenal stenosis caused by pancreatobiliary cancer progression. We retrospectively analyzed the therapeutic efficacy of the stents by evaluating the technical and clinical success rates based on successful stent placement, degree of oral intake, hemostasis, stent patency, and overall survival., Results: The technical and clinical success rates were 100%. All 10 patients achieved a Gastric Outlet Obstruction Scoring System score of three within two weeks after the procedure and had no recurrence of melena. The median stent patency duration and overall survival after stent placement were 52 days (range, 20-220 days) and 66.5 days (range, 31-220 days), respectively., Conclusions: Endoscopic placement of a covered metal stent for hemorrhagic duodenal stenosis associated with pancreatic or biliary tract cancer resulted in duodenal hemostasis, recanalization, and improved quality of life.
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- 2024
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40. Efficacy of endoscopic ultrasound-guided gastroenterostomy using self-expandable metallic stent for afferent loop syndrome: A single-center retrospective study.
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Hagiwara Y, Hijioka S, Nagashio Y, Maruki Y, Ohba A, Kawasaki Y, Takeshita K, Takasaki T, Agarie D, Hara H, Yagi S, Fukuda S, Kuwada M, Yamashige D, Okamoto K, Chatto M, Kondo S, Morizane C, Ueno H, Endo M, Sugawara S, Sone M, Saito Y, Tsuchiya K, and Okusaka T
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Background and Aim: Endoscopic ultrasound-guided gastroenterostomy is a procedure used to connect the stomach and dilated afferent loop using a stent under endoscopic ultrasound for afferent loop syndrome. However, the actual efficacy and safety of this procedure remain unclear. Therefore, this retrospective study aimed to evaluate the efficacy and safety of endoscopic ultrasound-guided gastroenterostomy using a laser-cut-type fully covered self-expandable metallic stent and an anchoring plastic stent for afferent loop syndrome., Methods: Technical and clinical success rates, adverse events, recurrent intestinal obstruction rates, time to recurrent intestinal obstruction, and technical and clinical success rates of re-intervention were evaluated in intended patients who underwent endoscopic ultrasound-guided gastroenterostomy for afferent loop syndrome from October 2018 to August 2022., Results: In 25 intended patients with afferent loop syndrome who intended endoscopic ultrasound-guided gastroenterostomy, the technical success rate was 100% (25/25), whereas the clinical success rate was 96% (24/25). Two patients experienced grade ≥ 3 early adverse events, including one with intra-abdominal abscess and one with hypotension. Both events were attributed to intestinal fluid leakage. No late adverse events were observed. The recurrent intestinal obstruction rate was 32% (8/25), and the median time to recurrent intestinal obstruction was 6.5 months (95% confidence interval: 2.8-not available). The technical and clinical success rates of re-intervention were both 100% (8/8)., Conclusions: Endoscopic ultrasound-guided gastroenterostomy using a fully covered self-expandable metallic stent and an anchoring plastic stent is effective and safe as a treatment procedure for afferent loop syndrome., (© 2024 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.)
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- 2024
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41. Feasibility and safety of a novel plastic stent designed specifically for endoscopic ultrasound-guided pancreatic duct drainage.
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Fukuda S, Hijioka S, Nagashio Y, Maruki Y, Ohba A, Agarie D, Hagiwara Y, Hara H, Okamoto K, Yamashige D, Yagi S, Kuwada M, Chatto M, Kondo S, Morizane C, Ueno H, Saito Y, and Okusaka T
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Background and study aims Endoscopic ultrasound-guided pancreatic duct drainage (EUS-PD) is emerging as an effective alternative treatment for obstructive pancreatitis after unsuccessful endoscopic retrograde pancreatography (ERP). However, the high incidence of adverse events associated with EUS-PD (approximately 20%) remains an issue. Recently, we developed a novel plastic stent for EUS-PD, with a radiopaque marker positioned at approximately one-third of the length from the distal end of the stent and side holes positioned exclusively distal to the marker. This study aimed to evaluate the feasibility and safety of using this stent in EUS-PD. Patients and methods We retrospectively reviewed data from 10 patients who underwent EUS-PD with the novel plastic stent at the National Cancer Center Hospital between March 2021 and October 2023. Technical and clinical success, procedure times, adverse events (AEs), recurrent pancreatic duct obstruction (RPO), and time to RPO were assessed. Results Of the 10 patients, five had postoperative benign pancreaticojejunal anastomotic strictures and five had malignant pancreatic duct obstruction. The technical and clinical success rates were both 100% (10/10). An AE (self-limited abdominal pain) occurred in one patient (10.0%). Two patients (20.0%) died of their primary disease during the follow-up period (median, 44 days; range, 25-272 days). The incidence of RPO was 10.0% (1/10), and the 3-month non-RPO rate was 83.3%. Conclusions The novel plastic stent shows potential as a useful and safe tool in EUS-PD., Competing Interests: Conflict of Interest The authors declare that they have no conflict of interest., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)
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42. Current status of head and neck sarcomas in Japan in 2016-2019: an analysis using the national cancer registry.
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Rikitake R, Mizushima Y, Yoshimoto S, Higashi T, Satake T, Morizane C, and Kawai A
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- Humans, Male, Female, Japan epidemiology, Middle Aged, Aged, Adult, Adolescent, Young Adult, Child, Incidence, Child, Preschool, Survival Rate, Aged, 80 and over, Infant, Prognosis, Registries, Head and Neck Neoplasms therapy, Head and Neck Neoplasms epidemiology, Head and Neck Neoplasms pathology, Head and Neck Neoplasms mortality, Sarcoma therapy, Sarcoma epidemiology, Sarcoma pathology
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Background: Head and neck sarcomas are especially rare in Asia, leading to limited clinical evidence. This study aimed to investigate the incidence, clinical features, treatment status, and outcome of these sarcomas using data from the National Cancer Registry in Japan., Methods: All head and neck sarcomas diagnosed between 2016 and 2019 and recorded in the National Cancer Registry were analyzed. Data on sex, age, primary site, histological type, stage, treatment modality, and prognostic information were collected. Age-adjusted incidence and 3-year survival rates of patients with head and neck sarcomas were calculated., Results: Overall, 635 head and neck sarcoma patients were identified. Head and neck sarcoma occurred more frequently in men and patients in their 70 s. The age-adjusted annual incidence rate was 0.125 per 100,000 patients in the 2015 Japanese model or 0.089 per 100,000 patients in the world population model. The nasal cavity and paranasal sinuses were the most frequent primary sites, with rhabdomyosarcoma as the most common histologic type. Treatment typically involved chemotherapy and/or radiation therapy for rhabdomyosarcoma and Ewing's sarcoma, whereas surgical approaches for other types. Three-year survival rate of head and neck sarcoma patients was 64.8%., Conclusions: Head and neck sarcomas occurred rarely, but most frequently in the nasal cavity and paranasal sinuses in Japan. Poor outcomes were observed for sarcoma patients than for non-sarcoma head and neck cancer patients., (© 2024. The Author(s).)
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- 2024
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43. Two Cases of Disseminated Alveolar Echinococcosis: The Diagnosis, Management, and Differential Considerations for Liver Lesions.
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Hirano K, Maruki Y, Yamashige D, Kobayashi O, Shiotsuka M, Morizane C, Imamura T, Hiraoka N, and Okusaka T
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- Adult, Animals, Female, Humans, Male, Middle Aged, Diagnosis, Differential, Liver pathology, Liver diagnostic imaging, Liver parasitology, Tomography, X-Ray Computed, Echinococcosis diagnosis, Echinococcosis diagnostic imaging, Echinococcosis, Hepatic diagnostic imaging, Echinococcosis, Hepatic diagnosis, Echinococcus multilocularis
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Alveolar echinococcosis (AE), caused by Echinococcus multilocularis, is an aggressive and potentially critical infestation that primarily affects the liver and can metastasize to any part of the body. We herein report two cases of echinococcosis, which could be differentiated from malignancy on imaging studies, with infections of the liver and mediastinal lymph nodes, and also associated with systemic disseminated lesions. AE is a very invasive infectious disease, and in order to detect such lesions at an early stage when they are still resectable, it is necessary to understand the characteristic imaging findings and determine the patient's current medical history.
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- 2024
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44. Phase II trial of niraparib for BRCA -mutated biliary tract, pancreatic and other gastrointestinal cancers: NIR-B.
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Kawamoto Y, Morizane C, Komatsu Y, Kondo S, Ueno M, Kobayashi S, Furukawa M, Lee L, Satoh T, Sakai D, Ikeda M, Imaoka H, Miura A, Hatanaka Y, Yokota I, Nakamura Y, and Yoshino T
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Due to the widespread use of cancer genetic testing in gastrointestinal cancer, the BRCA1/2 genetic mutation has been identified in biliary tract cancer as well as pancreatic cancer. Niraparib is a poly(ADP-ribose) polymerase (PARP) inhibitor, and PARP inhibitors exert their cytotoxicity against cancer cells in the context of homologous recombination deficiency, such as BRCA mutations, via the mechanism of synthetic lethality. The aim of this phase II NIR-B trial is to evaluate the efficacy and safety of niraparib for patients with unresectable advanced or recurrent biliary tract cancer, pancreatic cancer or other gastrointestinal cancers with germline or somatic BRCA1/2 mutations revealed by genetic testing. The primary end point is an investigator-assessed objective response rate in each cohort. Clinical Trial Registration: jRCT2011200023 (ClinicalTrials.gov).
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- 2024
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45. The impact of rare cancer and early-line treatments on the benefit of comprehensive genome profiling-based precision oncology.
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Kubo T, Sunami K, Koyama T, Kitami M, Fujiwara Y, Kondo S, Yonemori K, Noguchi E, Morizane C, Goto Y, Maejima A, Iwasa S, Hamaguchi T, Kawai A, Namikawa K, Arakawa A, Sugiyama M, Ohno M, Yoshida T, Hiraoka N, Yoshida A, Yoshida M, Nishino T, Furukawa E, Narushima D, Nagai M, Kato M, Ichikawa H, Fujiwara Y, Kohno T, and Yamamoto N
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- Humans, Female, Male, Middle Aged, Prospective Studies, Aged, Adult, Aged, 80 and over, Progression-Free Survival, Young Adult, Rare Diseases genetics, Rare Diseases drug therapy, Genomics methods, Neoplasms genetics, Neoplasms drug therapy, Precision Medicine methods
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Background: Comprehensive genome profiling (CGP) serves as a guide for suitable genomically matched therapies for patients with cancer. However, little is known about the impact of the timing and types of cancer on the therapeutic benefit of CGP., Materials and Methods: A single hospital-based pan-cancer prospective study (TOP-GEAR; UMIN000011141) was conducted to examine the benefit of CGP with respect to the timing and types of cancer. Patients with advanced solid tumors (>30 types) who either progressed with or without standard treatments were genotyped using a single CGP test. The subjects were followed up for a median duration of 590 days to examine therapeutic response, using progression-free survival (PFS), PFS ratio, and factors associated with therapeutic response., Results: Among the 507 patients, 62 (12.2%) received matched therapies with an overall response rate (ORR) of 32.3%. The PFS ratios (≥1.3) were observed in 46.3% (19/41) of the evaluated patients. The proportion of subjects receiving such therapies in the rare cancer cohort was lower than that in the non-rare cancer cohort (9.6% and 17.4%, respectively; P = 0.010). However, ORR of the rare cancer patients was higher than that in the non-rare cancer cohort (43.8% and 20.0%, respectively; P = 0.046). Moreover, ORR of matched therapies in the first or second line after receiving the CGP test was higher than that in the third or later lines (62.5% and 21.7%, respectively; P = 0.003). Rare cancer and early-line treatment were significantly and independently associated with ORR of matched therapies in multivariable analysis (P = 0.017 and 0.004, respectively)., Conclusion: Patients with rare cancer preferentially benefited from tumor mutation profiling by increasing the chances of therapeutic response to matched therapies. Early-line treatments after profiling increase the therapeutic benefit, irrespective of tumor types., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)
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- 2024
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46. Clinicopathological Findings and Treatment Outcomes of Patients with Primary Hepatobiliary Neuroendocrine Neoplasms: A Retrospective Single-institution Analysis.
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Komiyama S, Okusaka T, Maruki Y, Ohba A, Nagashio Y, Kondo S, Hijioka S, Morizane C, Ueno H, Sukeda A, Mizui T, Takamoto T, Nara S, Ban D, Esaki M, Hiraoka N, and Shimada K
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- Humans, Retrospective Studies, Prognosis, Treatment Outcome, Gastrointestinal Neoplasms, Neuroendocrine Tumors diagnosis, Neuroendocrine Tumors surgery, Carcinoma, Neuroendocrine diagnosis, Carcinoma, Neuroendocrine therapy, Carcinoma, Neuroendocrine pathology, Pancreatic Neoplasms pathology
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Objective Primary hepatobiliary neuroendocrine neoplasms (NENs) are rare tumors exhibiting several morphological and behavioral characteristics. Considering the lack of relevant data on this topic, we evaluated the clinicopathological features and treatment outcomes of patients with primary hepatobiliary NENs. Methods/Patients We examined 43 consecutive patients treated at the National Cancer Center Hospital with pathological diagnoses of primary hepatobiliary NEN between 1980 and 2016. Results Nine patients were diagnosed with neuroendocrine tumor (NET) G1, 9 with NET G2, and 25 with neuroendocrine carcinoma (NEC) based on the World Health Organization 2019 classification. Patients with NEC had primary sites across the hepatobiliary organs, although sites in patients with NET G1 and NET G2 only included the liver and ampulla of Vater. Patients with primary extrahepatic bile duct or ampulla of Vater NENs tended to be diagnosed earlier than patients with primary gallbladder NENs. The median survival times in the NET G1, NET G2, and NEC groups were 167.9, 97.4, and 11.1 months, respectively. A good performance status, absence of distant metastases, and low tumor grade were identified as independent predictors of a favorable prognosis. Conclusion The NET-to-NEC ratio and tumor stage distribution at the diagnosis differed depending on the primary site. Patients with G1 and G2 NETs who underwent surgical resection had good prognoses, whereas those with NEC exhibited more advanced disease and poorer prognoses. The performance status, staging classification, and tumor grade are important factors to consider when devising an appropriate treatment strategy and predicting the prognoses of patients with primary hepatobiliary NEN.
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- 2024
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47. Incidence and factors associated with stent dysfunction and pancreatitis after gastroduodenal stenting for malignant gastric outlet obstruction.
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Yamashige D, Hijioka S, Nagashio Y, Maruki Y, Fukuda S, Yagi S, Okamoto K, Hara H, Hagiwara Y, Agarie D, Takasaki T, Chatto M, Ohba A, Kondo S, Morizane C, Ueno H, Sone M, Saito Y, and Okusaka T
- Abstract
Background and study aims Endoscopic gastroduodenal stent (GDS) deployment is currently a standard treatment for malignant gastric outlet obstruction (mGOO) in patients with limited life expectancy; however, stent dysfunction (SD) and complicated pancreatitis often occur after GDS deployment. We investigated incidence and contributing factors of SD and complicated pancreatitis. Patients and methods We retrospectively reviewed 203 patients who underwent initial GDS deployment for palliation of mGOO symptoms between October 2017 and July 2022, including 109 who underwent GDS deployment across the duodenal papilla (sub-cohort). Results SDs, including tumor ingrowth (n = 26), kinking (n = 14), and migration (n = 13), occurred in 68 patients (33.5%). Cumulative SD incidence was 41.1% (95% confidence interval, 32.6-49.4%). SD incidence increased to 0.4%, 0.16%, and 0.06% per day at < 8, 8-16, and>16 weeks, respectively. On multivariate analysis, Niti-S pyloric/duodenal stent deployment (sub-distribution hazard ratio [sHR] 0.26, P = 0.01) and survival length ≥ 90 days (sHR 2.5, P = 0.01) were respectively identified as favorable and risk factors significantly associated with SD. Pancreatitis developed in 14 patients (12.8%) in the sub-cohort, which had significantly higher parenchymal diameter ( P < 0.01) and lower main pancreatic duct (MPD) caliber ( P < 0.01) than the non-pancreatitis cohort. On multivariate analysis, MPD caliber < 3 mm independently predicted pancreatitis (odds ratio 6.8, P = 0.03). Conclusions Deployment of the Niti-S pyloric/duodenal stent, with conformability even for angulated strictures, significantly reduced the incidence of SD. Stent selection, life expectancy, and MPD caliber should be taken into consideration during decision-making for GDS deployment for mGOO., Competing Interests: Conflict of Interest The authors declare that they have no conflict of interest., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)
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- 2024
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48. Clinical development of a blood biomarker using apolipoprotein-A2 isoforms for early detection of pancreatic cancer.
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Kashiro A, Kobayashi M, Oh T, Miyamoto M, Atsumi J, Nagashima K, Takeuchi K, Nara S, Hijioka S, Morizane C, Kikuchi S, Kato S, Kato K, Ochiai H, Obata D, Shizume Y, Konishi H, Nomura Y, Matsuyama K, Xie C, Wong C, Huang Y, Jung G, Srivastava S, Kutsumi H, and Honda K
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- Humans, Biomarkers, Tumor, Apolipoprotein A-II, Reproducibility of Results, Early Detection of Cancer, Protein Isoforms, CA-19-9 Antigen, Pancreatic Neoplasms diagnosis
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Background: We have previously reported apolipoprotein A2-isoforms (apoA2-is) as candidate plasma biomarkers for early-stage pancreatic cancer. The aim of this study was the clinical development of apoA2-is., Methods: We established a new enzyme-linked immunosorbent sandwich assay for apoA2-is under the Japanese medical device Quality Management System requirements and performed in vitro diagnostic tests with prespecified end points using 2732 plasma samples. The clinical equivalence and significance of apoA2-is were compared with CA19-9., Results: The point estimate of the area under the curve to distinguish between pancreatic cancer (n = 106) and healthy controls (n = 106) was higher for apoA2-ATQ/AT [0.879, 95% confidence interval (CI): 0.832-0.925] than for CA19-9 (0.849, 95% CI 0.793-0.905) and achieved the primary end point. The cutoff apoA2-ATQ/AT of 59.5 μg/mL was defined based on a specificity of 95% in 2000 healthy samples, and the reliability of specificities was confirmed in two independent healthy cohorts as 95.3% (n = 106, 95% CI 89.4-98.0%) and 95.8% (n = 400, 95% CI 93.3-97.3%). The sensitivities of apoA2-ATQ/AT for detecting both stage I (47.4%) and I/II (50%) pancreatic cancers were higher than those of CA19-9 (36.8% and 46.7%, respectively). The combination of apoA2-ATQ/AT (cutoff, 59.5 μg/mL) and CA19-9 (37 U/mL) increased the sensitivity for pancreatic cancer to 87.7% compared with 69.8% for CA19-9 alone. The clinical performance of apoA2-is was blindly confirmed by the National Cancer Institute Early Detection Research Network., Conclusions: The clinical performance of ApoA2-ATQ/AT as a blood biomarker is equivalent to or better than that of CA19-9., (© 2024. The Author(s).)
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- 2024
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49. Diagnostic performance of EUS-guided tissue acquisition for solid pancreatic lesions ≤10 mm.
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Kawasaki Y, Hijioka S, Nagashio Y, Ohba A, Maruki Y, Takeshita K, Takasaki T, Agarie D, Hagiwara Y, Hara H, Okamoto K, Yamashige D, Kondo S, Morizane C, Ueno H, Mizui T, Takamoto T, Nara S, Ban D, Esaki M, Saito Y, Hiraoka N, and Okusaka T
- Abstract
Background and Objectives: EUS tissue acquisition (EUS-TA) is the standard diagnostic method for solid pancreatic lesions (SPLs); however, there are few reports on EUS-TA results for SPLs ≤10 mm. Furthermore, given the recent advent of fine-needle biopsy, the current diagnostic accuracy of EUS-TA for SPLs ≤10 mm is unknown. This study aimed to evaluate the diagnostic accuracy and efficacy of EUS-TA for SPLs ≤10 mm., Methods: We retrospectively analyzed the data of 109 patients with SPLs ≤10 mm who underwent EUS-TA. All patients underwent rapid on-site specimen evaluation., Results: The median tumor diameter was 8 mm (range, 2.5-10 mm), and the technical success rate was 99.1% (108/109). Adverse events were observed in 3 patients (2.8%). The diagnostic performance was as follows: sensitivity, 90.1% (64/71); specificity, 97.3% (36/37); accuracy, 92.6% (100/108); positive predictive value, 98.5% (64/65); and negative predictive value, 83.7% (36/43). Multivariate analysis revealed that the number of punctures (odds ratio, 7.03; 95% confidence interval, 1.32-37.5; P = 0.023) and tumor type (odds ratio, 11.90; 95% confidence interval, 1.38-102.0; P = 0.024) were independent risk factors for inaccurate EUS-TA results. The diagnostic accuracy of EUS-TA for pancreatic ductal adenocarcinoma was 87.5% (14/16). No EUS-TA-related needle-tract seeding was observed in patients with pancreatic ductal adenocarcinoma during the observation period., Conclusions: EUS-TA for SPLs ≤10 mm showed adequate diagnostic accuracy and was safe for use with rapid on-site specimen evaluation in all cases., Competing Interests: The authors declare that they have no financial conflict of interest with regard to the content of this report., (Copyright © 2024 The Author(s). Published by Wolters Kluwers Health, Inc on behalf of Scholar Media Publishing.)
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- 2024
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50. Identification of activity-based biomarkers for early-stage pancreatic tumors in blood using single-molecule enzyme activity screening.
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Sakamoto S, Hiraide H, Minoda M, Iwakura N, Suzuki M, Ando J, Takahashi C, Takahashi I, Murai K, Kagami Y, Mizuno T, Koike T, Nara S, Morizane C, Hijioka S, Kashiro A, Honda K, Watanabe R, Urano Y, and Komatsu T
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- Humans, Proteins, Biomarkers, Pancreatic Hormones, Peptide Hydrolases metabolism, Pancreatic Neoplasms, Phosphorous Acids
- Abstract
Single-molecule enzyme activity-based enzyme profiling (SEAP) is a methodology to globally analyze protein functions in living samples at the single-molecule level. It has been previously applied to detect functional alterations in phosphatases and glycosidases. Here, we expand the potential for activity-based biomarker discovery by developing a semi-automated synthesis platform for fluorogenic probes that can detect various peptidases and protease activities at the single-molecule level. The peptidase/protease probes were prepared on the basis of a 7-amino-4-methylcoumarin fluorophore. The introduction of a phosphonic acid to the core scaffold made the probe suitable for use in a microdevice-based assay, while phosphonic acid served as the handle for the affinity separation of the probe using Phos-tag. Using this semi-automated scheme, 48 fluorogenic probes for the single-molecule peptidase/protease activity analysis were prepared. Activity-based screening using blood samples revealed altered single-molecule activity profiles of CD13 and DPP4 in blood samples of patients with early-stage pancreatic tumors. The study shows the power of single-molecule enzyme activity screening to discover biomarkers on the basis of the functional alterations of proteins., Competing Interests: Declaration of interests S.S. and Y.K. are cofounders, employees, and shareholders of Cosomil, Inc. H.H., N.I., and M.S. are employees of Cosomil, Inc. T.M. and K.H., are advisors and shareholders of Cosomil, Inc. R.W. and T. Komatsu are cofounders, advisors, and shareholders of Cosomil, Inc. S.S., Y.K., R.W., Y.U., and T. Komatsu are inventors of a patent describing the SAS-based probe synthesis., (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)
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- 2024
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