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2. Efficacy of liposomal irinotecan + 5-FU/LV vs. S-1 in gemcitabine-refractory metastatic pancreatic cancer: a real-world study using inverse probability of treatment weighting

Author

Imaoka, Hiroshi, Ikeda, Masafumi, Kobayashi, Satoshi, Ohba, Akihiro, Ueno, Masayuki, Suzuki, Yuko, Tsumura, Hidetaka, Kimura, Nana, Kawaguchi, Shinya, Kawamoto, Yasuyuki, Nakachi, Kohei, Tsuji, Kunihiro, Kobayashi, Noritoshi, Ashida, Reiko, Okano, Naohiro, Umemoto, Kumiko, Murohisa, Gou, Hosokawa, Ayumu, Asagi, Akinori, Nebiki, Hiroko, Suzuki, Rei, Terashima, Takeshi, Shibata, Ryusuke, Kawata, Kazuhito, Doi, Toshifumi, Ohyama, Hiroshi, Kitano, Yohei, Shioji, Kazuhiko, Okuyama, Hiroyuki, Naganuma, Atsushi, Negoro, Yuji, Sakamoto, Yasunari, Shimizu, Satoshi, Morizane, Chigusa, Ueno, Makoto, Furuse, Junji, and Nagano, Hiroaki

Published
2024
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4. Influence of major hepatectomy on gemcitabine-based chemotherapy for recurrent biliary tract cancer after surgery: a subgroup analysis of JCOG1113

Author

Okuno, Tatsuya, Morizane, Chigusa, Mizusawa, Junki, Yanagimoto, Hiroaki, Kobayashi, Satoshi, Imaoka, Hiroshi, Terashima, Takeshi, Kawakami, Hisato, Sano, Yusuke, Okusaka, Takuji, Ikeda, Masafumi, Ozaka, Masato, Miwa, Haruo, Todaka, Akiko, Shimizu, Satoshi, Mizuno, Nobumasa, Sekimoto, Mitsugu, Sano, Keiji, Tobimatsu, Kazutoshi, Katanuma, Akio, Gotoh, Kunihito, Yamaguchi, Hironori, Ishii, Hiroshi, Furuse, Junji, and Ueno, Makoto

Published
2024
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5. Clinical utility of BRCA and ATM mutation status in circulating tumour DNA for treatment selection in advanced pancreatic cancer

Author

Sudo, Kentaro, Nakamura, Yoshiaki, Ueno, Makoto, Furukawa, Masayuki, Mizuno, Nobumasa, Kawamoto, Yasuyuki, Okano, Naohiro, Umemoto, Kumiko, Asagi, Akinori, Ozaka, Masato, Ohtsubo, Koushiro, Shimizu, Satoshi, Matsuhashi, Nobuhisa, Itoh, Shinji, Matsumoto, Toshihiko, Satoh, Taroh, Okuyama, Hiroyuki, Goto, Masahiro, Hasegawa, Hiroko, Yamamoto, Yoshiyuki, Odegaard, Justin I., Bando, Hideaki, Yoshino, Takayuki, Ikeda, Masafumi, and Morizane, Chigusa

Published
2024
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7. A multi-institutional randomized phase III study comparing minimally invasive distal pancreatectomy versus open distal pancreatectomy for pancreatic cancer; Japan Clinical Oncology Group study JCOG2202 (LAPAN study)

Author

Ikenaga, Naoki, Hashimoto, Tadayoshi, Mizusawa, Junki, Kitabayashi, Ryo, Sano, Yusuke, Fukuda, Haruhiko, Nakata, Kohei, Shibuya, Kazuto, Kitahata, Yuji, Takada, Minoru, Kamei, Keiko, Kurahara, Hiroshi, Ban, Daisuke, Kobayashi, Shogo, Nagano, Hiroaki, Imamura, Hajime, Unno, Michiaki, Takahashi, Amane, Yagi, Shintaro, Wada, Hiroshi, Shirakawa, Hirofumi, Yamamoto, Naoto, Hirono, Seiko, Gotohda, Naoto, Hatano, Etsuro, Nakamura, Masafumi, and Ueno, Makoto

Published
2024
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15. 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

Author

Tezuka, Shun, Ozaka, Masato, Furuse, Junji, Yokoyama, Masayuki, Uemura, Kohei, Sano, Yusuke, Nakachi, Kohei, Imaoka, Hiroshi, Unno, Michiaki, Shirakawa, Hirofumi, Shimizu, Satoshi, Kato, Naoya, Kojima, Yasushi, Sano, Keiji, Kobayashi, Satoshi, Terashima, Takeshi, Morizane, Chigusa, Ikeda, Masafumi, and Ueno, Makoto

Published
2024
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17. Feasibility of S-1 adjuvant chemotherapy after major hepatectomy for biliary tract cancers: An exploratory subset analysis of JCOG1202

Author

Kobayashi, Shogo, Nakachi, Kohei, Ikeda, Masafumi, Konishi, Masaru, Ogawa, Gakuto, Sugiura, Teiichi, Yanagimoto, Hiroaki, Morinaga, Soichiro, Wada, Hiroshi, Shimada, Kazuaki, Takahashi, Yu, Nakagohri, Toshio, Kamata, Ken, Shimizu, Yasuhiro, Ajiki, Tetsuo, Hirano, Satoshi, Gotohda, Naoto, Ueno, Makoto, Okusaka, Takuji, and Furuse, Junji

Published
2024
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19. Clinical significance of circulating-tumour DNA analysis by metastatic sites in pancreatic cancer

Author

Umemoto, Kumiko, Sunakawa, Yu, Ueno, Makoto, Furukawa, Masayuki, Mizuno, Nobumasa, Sudo, Kentaro, Kawamoto, Yasuyuki, Kajiwara, Takeshi, Ohtsubo, Koushiro, Okano, Naohiro, Matsuhashi, Nobuhisa, Itoh, Shinji, Matsumoto, Toshihiko, Shimizu, Satoshi, Otsuru, Toru, Hasegawa, Hiroko, Okuyama, Hiroyuki, Ohama, Hideko, Moriwaki, Toshikazu, Ohta, Takashi, Odegaard, Justin I., Nakamura, Yoshiaki, Bando, Hideaki, Yoshino, Takayuki, Ikeda, Masafumi, and Morizane, Chigusa

Published
2023
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20. Development of a nomogram to predict survival in advanced biliary tract cancer

Author

Imaoka, Hiroshi, Ikeda, Masafumi, Nomura, Shogo, Morizane, Chigusa, Okusaka, Takuji, Ozaka, Masato, Shimizu, Satoshi, Yamazaki, Kentaro, Okano, Naohiro, Sugimori, Kazuya, Shirakawa, Hirofumi, Mizuno, Nobumasa, Satoi, Sohei, Yamaguchi, Hironori, Sugimoto, Rie, Gotoh, Kunihito, Sano, Keji, Asagi, Akinori, Nakamura, Kazuyoshi, and Ueno, Makoto

Published
2023
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26. Validity and utility of blood tumor mutational burden (bTMB) is dependent on circulating tumor DNA (ctDNA) shed: SCRUM-Japan MONSTAR-SCREEN

Author

Mishima, Saori, Nakamura, Yoshiaki, Tukachinsky, Hanna, Taniguchi, Hiroya, Kadowaki, Shigenori, Kato, Ken, Oki, Eiji, Satoh, Taroh, Aoki, Daisuke, Yamazaki, Kentaro, Esaki, Taito, Ueno, Makoto, Nishina, Tomohiro, Sunakawa, Yu, Denda, Tadamichi, Bando, Hideaki, Kuramoto, Naomi, Horasawa, Satoshi, Abutani, Hikaru, Lee, Jessica K., Madison, Russell W., Oxnard, Geoffrey R., and Yoshino, Takayuki

Published
2023
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28. Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Akce, Mehmet, Ales Diaz, Inmaculada, Alves, Gustavo, Anand, Sumitra, Arslan, Cagatay, Asselah, Jamil, Assenat, Eric, Aubin, Francine, Bai, Li-Yuan, Bai, Yuxian, Barajas, Olga, Bates, Susan, Begbie, Stephen, Ben-Aharon, Irit, Beri, Nina, Berres, Marie-Luise, Blanc, Jean-Frederic, Borbath, Ivan, Bordonaro, Robert, Bouattour, Mohamed, Brandi, Giovanni, Burgoyne, Adam, Butthongkomvong, Kritiya, Camandaroba, Marcos, Cao, Ke, Carballido, Marcela, Chan, Stephan Lam, Chen, Jen-Shi, Chen, Ming-Huang, Chen, Xiaoming, Cheng, Ashley, Chiu, Tai-Jan, Choi, Hye Jin, Chon, Hong Jae, Collignon, Joelle, Cubillo Gracian, Antonio, Davis, Sarah, de Carvalho, Ricardo Saraiva, de Groot, D.J.A., Demols, Anne, De Vos, Judith, Diab, Maria, Easaw, Jacob, Eatock, Martin, Edeline, Julien, Elias, Rawad, Eskens, Fredericus, Falcone, Alfredo, Fernandez, Plinio, Finn, Richard, Franke, Fabio, Furukawa, Masayuki, Furuse, Junji, Gbolahan, Olumide, Geboes, Karen, Geneser, Keri-Lee, Geng, Zhimin, Geva, Ravit, Gillmore, Roopinder, Goetze, Thorsten, Gou, Hongfeng, Grasselli, Julieta, Gu, Shanzhi, Gumus, Mahmut, Haj Mohammad, Nadia, Hao, Chunyi, Harputluoglu, Hakan, Hatoum, Hassan, Heinemann, Volker, Ho, Wang Kwong, Hsu, Chiun, Hubert, Ayala, Hwang, Juneul, Inanc, Mevlude, Iseas, Soledad, Jeyasingam, Vaishnavi, Jimenez Fonseca, Paula, Joubert, Warren, Juengsamarn, Jitlada, Kaen, Diego, Kanai, Masashi, Kasper-Virchow, Stefan, Kazemi, Ghazaleh, Kelleher, Fergal, Kelley, Robin, Kim, Jin Won, Kim, Jong Gwang, Kinupe Abrahao, Ana Beatriz, Klumpen, Heinz, Kochenderfer, Mark, Kose, Fatih, Lam, Ho Ching, Lee, Choong-kun, Lee, Hyun Woo, Lee, Margaret, Lee, Myung Ah, Lee, Wai Man Sarah, Le Sourd, Samuel, Li, Dongliang, Li, Wei, Liang, Houjie, Liang, Tingbo, Lim, Chun Sen, Lingerfelt, Brian, Lopez, Charles, Low, John, Macarulla Mercade, Teresa, Malka, David, Mao, Yimin, Masi, Gianluca, McCune, Steven, McDermott, Ray, McWhirter, Elaine, Mendez, Guillermo, Milella, Michele, Mizuno, Nobumasa, Mizutani, Tomonori, Moniz, Camila, Morales, Luisa, Munoz Martin, Andres Jesús, Nervi, Bruno, Ngamphaiboon, Nuttapong, Oh, Sang Cheul, Oksuzoglu, Berna, Outlaw, Darryl, Ozaka, Masato, Ozguroglu, Mustafa, Ozyilkan, Ozgur, Painemal, Claudio, Pan, Yueyin, Park, Joon Oh, Pelzer, Uwe, Peng, Chuang, Petorin, Caroline, Pezet, Denis, Power, Derek, Qin, Shukui, Ren, Zhenggang, Roohullah, Aflah, Ryu, Hyewon, Salman, Pamela, Sasaki, Mitsuhito, Sasidharan, Rita, Satoh, Taroh, Schulze, Kornelius, Scott-Brown, Martin, Segovia, Ruben, Seufferlein, Thomas, Siena, Salvatore, Sinapi, Isabelle, Smolenschi, Cristina, Song, Tianqiang, Sookprasert, Aumkhae, Soparattanapaisarn, Nopadol, Starling, Naureen, Stein, Stacey, Stemmer, Salomon, Su, Haichuan, Sugimoto, Rie, Suksombooncharoen, Thatthan, Tam, Vincent, Tan, Ai Lian, Tan, Chih Kiang, Tanasanvimon, Suebpong, Tonini, Giuseppe, Tortora, Giampaolo, Tsuji, Akihito, Ueno, Makoto, Uribe, Rodrigo, Venerito, Marino, Verdaguer Mata, Helena, Verslype, Chris, Victorino, Ana Paula, Vogel, Arndt, Wade, James, Waldschmidt, Dirk Thomas, Wang, Lu, Wan Isahk, Wan Zamaniah, Wasan, Harpeet, Weschenfelder, Rui, Wong, Chun Yin, Wong, Yoke Fui, Yalcin, Suayib, Yanez Weber, Patricio, Yang, Xuezhong, Yasui, Hisateru, Yau, Thomas, Yazici, Ozan, Yen, Chia-Jui, Ying, Jieer, Yoo, Changhoon, Yu, Wenchang, Zhao, Haitao, Kelley, Robin Kate, Finn, Richard S, Klümpen, Heinz-Josef, Chan, Stephen L, Valle, Juan W, Yu, Li, Malhotra, Usha, and Siegel, Abby B

Published
2023
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29. Napabucasin plus nab-paclitaxel with gemcitabine versus nab-paclitaxel with gemcitabine in previously untreated metastatic pancreatic adenocarcinoma: an adaptive multicentre, randomised, open-label, phase 3, superiority trial

Author

Bekaii-Saab, Tanios, Okusaka, Takuji, Goldstein, David, Oh, Do-Youn, Ueno, Makoto, Ioka, Tatsuya, Fang, Weijia, Anderson, Eric C., Noel, Marcus S., Reni, Michele, Choi, Hye Jin, Goldberg, Jonathan S., Oh, Sang Cheul, Li, Chung-Pin, Tabernero, Josep, Li, Jian, Foos, Emma, Oh, Cindy, and Van Cutsem, Eric

Published
2023
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30. A randomised phase II study of modified FOLFIRINOX versus gemcitabine plus nab-paclitaxel for locally advanced pancreatic cancer (JCOG1407)

Author

Ozaka, Masato, Nakachi, Kohei, Kobayashi, Satoshi, Ohba, Akihiro, Imaoka, Hiroshi, Terashima, Takeshi, Ishii, Hiroshi, Mizusawa, Junki, Katayama, Hiroshi, Kataoka, Tomoko, Okusaka, Takuji, Ikeda, Masafumi, Sasahira, Naoki, Miwa, Haruo, Mizukoshi, Eishiro, Okano, Naohiro, Mizuno, Nobumasa, Yamamoto, Tomohisa, Komatsu, Yoshito, Todaka, Akiko, Kamata, Ken, Furukawa, Masayuki, Fujimori, Nao, Katanuma, Akio, Takayama, Yukiko, Tsumura, Hidetaka, Fukuda, Haruhiko, Ueno, Makoto, and Furuse, Junji

Published
2023
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31. Adjuvant S-1 compared with observation in resected biliary tract cancer (JCOG1202, ASCOT): a multicentre, open-label, randomised, controlled, phase 3 trial

Author

Okamura, Keiya, Kawamoto, Yasuyuki, Katanuma, Akio, Unno, Michiaki, Shirakawa, Hirofumi, Yamaguchi, Hironori, Takahashi, Amane, Ikeda, Masafumi, Yanagibashi, Hiroo, Kato, Naoya, Okusaka, Takuji, Sakamoto, Yoshihiro, Kojima, Yasushi, Higuchi, Ryota, Sasahira, Naoki, Sano, Keiji, Nakagohri, Toshio, Sunakawa, Yu, Morinaga, Soichiro, Kumamoto, Yusuke, Sugimori, Kazuya, Nomura, Tatsuya, Shibuya, Kazuto, Makino, Isamu, Yamazaki, Kentaro, Mizuno, Nobumasa, Kamata, Ken, Wada, Hiroshi, Gotoh, Kunihito, Sekimoto, Mitsugu, Ajiki, Tetsuo, Nakamura, Ikuo, Miki, Ikuya, Nagano, Hiroaki, Ohta, Koji, Okabayashi, Takehiro, Furukawa, Masayuki, Fujimori, Nao, Nakachi, Kohei, Konishi, Masaru, Nomura, Shogo, Katayama, Hiroshi, Kataoka, Tomoko, Todaka, Akiko, Yanagimoto, Hiroaki, Kobayashi, Shogo, Shimada, Kazuaki, Takahashi, Yu, Shimizu, Yasuhiro, Ueno, Makoto, Ishii, Hiroshi, and Furuse, Junji

Published
2023
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37. Prognostic nutritional index is an independent risk factor for continuing S-1 adjuvant chemotherapy in patients with pancreatic cancer who received neoadjuvant chemotherapy and surgical resection.

Author

Kawahara, Shinnosuke, Aoyama, Toru, Murakawa, Masaaki, Kanemoto, Rei, Takahashi, Daishi, Kamioka, Yuto, Hashimoto, Itaru, Maezawa, Yukio, Kobayashi, Satoshi, Ueno, Makoto, Yamamoto, Naoto, Oshima, Takashi, Yukawa, Norio, Rino, Yasushi, Saito, Aya, and Morinaga, Soichiro

Abstract

Purpose: Reports on the association of perioperative nutritional and inflammatory status with the clinical course of adjuvant chemotherapy did not include neoadjuvant chemotherapy. We aimed to clarify the mechanism by which perioperative nutritional and inflammatory status affect the clinical course of postoperative adjuvant chemotherapy in patients with pancreatic cancer. Methods: We enrolled 123 patients with pancreatic cancer retrospectively who underwent surgical resection with neoadjuvant and S-1 adjuvant chemotherapy between January 2013 and December 2022. The duration of continuing S-1 treatment and the continuation rates at 3 and 6 months after initiating adjuvant chemotherapy were calculated using the Kaplan–Meier method. The log-rank test was used to evaluate statistical differences between the high and low prognostic nutritional index (PNI) groups. Univariable and multivariable analyses were performed to determine the risk factors for continuing S-1 adjuvant chemotherapy. Results: The optimal cut-off value for preoperative PNI was 45. Preoperative PNI was an independent risk factor for continuing S-1 adjuvant chemotherapy in patients who underwent perioperative adjuvant chemotherapy and surgical resection (hazard ratio = 2.435, 95% confidence interval = 1.229 − 4.824, p = 0.011). Low PNI was associated with lower S-1completion (p = 0.02) and higher S-1 withdrawal (p = 0.031). Additionally, the preoperative PNI status affected ≥ grade 2 adverse events caused by adjuvant chemotherapy (p < 0.001). Conclusion: Preoperative PNI affected adjuvant chemotherapy continuation and related adverse events in patients who underwent neoadjuvant chemotherapy and curative resection. Additional perioperative anti-inflammatory management and nutritional support may be required to improve the clinical course of postoperative adjuvant chemotherapy and patient survival. [ABSTRACT FROM AUTHOR]

Published
2024
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38. Outcomes of patients with initially unresectable pancreatic cancer who underwent conversion surgery after FOLFIRINOX or gemcitabine plus nab‐paclitaxel chemotherapy: A multicenter retrospective cohort study (PC‐CURE‐1).

Author

Okano, Naohiro, Kawai, Manabu, Ueno, Makoto, Yu, Xianjun, Inoue, Yosuke, Takahashi, Shinichiro, Wang, Wenquan, Takahashi, Hidenori, Okamura, Yukiyasu, Morinaga, Soichiro, Matsumoto, Ippei, Shimizu, Yasuhiro, Yoshida, Kazuhiro, Yamamoto, Tomohisa, Ohtsuka, Masayuki, Inokawa, Yoshikuni, Nara, Satoshi, Tamura, Jun, Shinoda, Satoru, and Yamamoto, Kouji

Abstract

Background: The efficacy and safety of conversion surgery (CS) after FOLFIRINOX or gemcitabine plus nab‐paclitaxel (GnP) chemotherapy in patients with initially unresectable pancreatic cancer (PC) remains unclear. Methods: This multicenter retrospective cohort study enrolled patients, between 2014 and 2018, with initially locally advanced or metastatic PC who were considered candidates for CS following FOLFIRINOX or GnP chemotherapy. They were classified into surgery (207 patients [194 resection and 13 exploratory laparotomy only]) and continued chemotherapy (10 patients, control) groups. The primary endpoint was overall survival (OS) from the day of diagnosis of potentially curative resection on imaging studies, with an expected hazard ratio (HR) of 0.7. Results: OS in the surgery group was longer than that in the control group (HR, 0.47; 95% confidence interval [CI]: 0.24–0.93). The median OS was 34.4 (95% CI: 27.9–43.4) and 19.8 (95% CI: 14.9–31.1) months in the surgery and control groups, respectively. The Clavien‐Dindo grade ≥ IIIa postoperative complication and in‐hospital mortality rates were 19.6% and 0.5%, respectively. Multivariate analysis revealed that preoperative chemotherapy duration was not associated with OS. Conclusions: CS, following a favorable response to FOLFIRINOX or GnP chemotherapy, improved initially unresectable PC prognosis (specifically, OS), regardless of the chemotherapy duration. [ABSTRACT FROM AUTHOR]

Published
2024
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39. Japanese classification of pancreatic carcinoma by the Japan Pancreas Society: Eighth edition.

Author

Ishida, Masaharu, Fujii, Tsutomu, Kishiwada, Masashi, Shibuya, Kazuto, Satoi, Sohei, Ueno, Makoto, Nakata, Kohei, Takano, Shigetsugu, Uchida, Katsunori, Ohike, Nobuyuki, Masugi, Yohei, Furukawa, Toru, Hirabayashi, Kenichi, Fukushima, Noriyoshi, Yi, Shuang‐Qin, Isayama, Hiroyuki, Itoi, Takao, Ohtsuka, Takao, Okusaka, Takuji, and Inoue, Dai

Abstract

In 2023, the Japan Pancreas Society (JPS) published the new eighth edition of the Japanese classification of pancreatic carcinoma. We present here an excerpted version in English, based on the latest edition. The major changes in this revision are as follows: In the eighth edition of the Union for International Cancer Control (UICC), the T category was changed to be based on tumor size; however, the eighth edition of the Japanese classification retains the previous T category based on local invasion factors. Lymph nodes have been renamed, and regional lymph nodes have been defined by location. Peritoneal cytology, which was not previously included in distant metastasis (M), has now been included in the M category. Moreover, significant additions have been made regarding the pathological diagnosis of endoscopic ultrasound‐guided fine‐needle aspiration biopsy (EUS‐FNAB) and criteria for histological assessment of the effects after chemotherapy and radiation therapy. Although this classification is aimed at carcinoma originating in the pancreas, not in the bile duct or duodenum, if the differentiation of the primary organ is difficult, this classification should be applied. It is also desirable to describe tumors other than carcinoma and metastatic tumors to the pancreas in accordance with this classification. [ABSTRACT FROM AUTHOR]

Published
2024
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40. 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).

Author

Sano, Yusuke, Kanai, Masashi, Morizane, Chigusa, Sasaki, Keita, Yoshimura, Michio, Ito, Yoshinori, Furuse, Junji, Ozaka, Masato, Fukuda, Haruhiko, Ueno, Makoto, and Group, on behalf of the Hepatobiliary and Pancreatic Oncology Group in Japan Clinical Oncology

Published
2024
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41. Phase II trial of niraparib for BRCA-mutated biliary tract, pancreatic and other gastrointestinal cancers: NIR-B.

Author

Kawamoto, Yasuyuki, Morizane, Chigusa, Komatsu, Yoshito, Kondo, Shunsuke, Ueno, Makoto, Kobayashi, Satoshi, Furukawa, Masayuki, Lee, Lingaku, Satoh, Taroh, Sakai, Daisuke, Ikeda, Masafumi, Imaoka, Hiroshi, Miura, Arisa, Hatanaka, Yutaka, Yokota, Isao, Nakamura, Yoshiaki, and Yoshino, Takayuki

Abstract

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) Plain Language Summary A clinical study to confirm the efficacy and safety of niraparib for people with advanced biliary tract, pancreatic and other abdominal cancers with the BRCA genetic mutation: the NIR-B trial. BRCA gene is involved in repairing DNA injury and plays an important role in cancer growth. Cells with a mutation in the BRCA gene cannot repair DNA using a method called homologous recombination repair. Niraparib is part of a class of drugs called 'PARP inhibitors' that inhibit enzymes called 'PARP' involved in repairing DNA injury, and has shown efficacy against cancers with BRCA gene mutations. BRCA gene mutations are infrequent but have been found in a variety of cancers. The NIR-B trial is a clinical trial to evaluate the efficacy and safety of niraparib for people with advanced biliary tract, pancreatic and other abdominal cancers with BRCA gene mutations. Executive summary Background Recent comprehensive genomic profiling testing has revealed therapeutic target molecules. It has been proven that the BRCA1/2 genetic mutation has been identified in biliary tract and pancreatic cancer. Niraparib is classified as a poly(ADP-ribose) polymerase (PARP) inhibitor, and PARP inhibitors exert cytotoxicity against cancer cells in the context of homologous recombination deficiency, such as BRCA mutations, by the mechanism of synthetic lethality. Niraparib has been shown to be selective for PARP1/2 as well as more cytotoxic than other PARP inhibitors owing to its PARP-trapping activity. NIR-B trial This NIR-B trial is a multicenter, open-label, single-arm, three-cohort and basket-type phase II study, with the aim to evaluate the efficacy and safety of niraparib for patients with unresectable advanced or recurrent biliary tract cancer, pancreatic cancer and other gastrointestinal cancers with germline or somatic BRCA1/2 mutations observed on genetic testing. Eligible patients will be enrolled at six trial sites in Japan. Patients with a body weight ≥77 kg and platelet count ≥150,000/mm3 will be administered 300 mg of niraparib orally once daily, while patients with a body weight <77 kg or platelet count <150,000/mm3 will be administered 200 mg of niraparib orally once daily. The primary end point is an investigator-assessed objective response rate (ORR) in each cohort with a threshold ORR of 10% and an expected ORR of 35%. The key secondary end points are progression-free survival, overall survival, disease control rate, duration of response and safety. Pretreatment tumor tissue and serial circulating tumor DNA will be collected and analyzed to investigate the resistance mechanisms and to provide a clinically meaningful biomarker that can be used to identify and implement treatment changes. The trial was initiated in January 2021, and enrollment is ongoing. [ABSTRACT FROM AUTHOR]

Published
2024
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42. Degradation of autotoxic chemicals and maintainence of electrical conductivity recover growth, yield and nutrient absorption of successive lettuce in recycled hydroponics.

Author

Razzak, Md. Abdur, Yamazaki, Chiaki, Fuse, Tetsuhito, Yakura, Yasuhiro, Matsushita, Kounosuke, Ueno, Makoto, Asaduzzaman, Md., and Asao, Toshiki

Subjects
PLANT exudates, CULTURE media (Biology), ELECTRIC conductivity, CHEMICAL decomposition, BENZOIC acid, LETTUCE
Abstract

In recycled hydroponics, successive crop cultivation by maintaining electrical conductivity (EC) suffers lower growth performance due to accumulating autotoxic root exudates. In this study, the efficiency of alternate current electro degradation (AC-ED) was evaluated for degrading allelochemicals and recovering retarded lettuce yield cultivated in EC-adjusted repeatedly used nutrient solutions. From benzoic acid (BA)-added nutrient solution, BA was completely degraded after 24 h by applying AC-ED at 551 and 940 Hz frequency with 50 and 80% electrical duty. In lettuce bioassay, fresh mass was negatively affected without the AC-ED-treated solution. Finally, lettuce seedlings were hydroponically grown in a plant factory using a half-strength Enshi nutrient solution. Culture solutions were unchanged in non-renewed solutions. Nutrient elements were supplied based on the EC (1.42 dS m−1) of culture solutions. The fresh weight of lettuce was gradually decreased in subsequent cultures. Nutrient absorption rate was reduced in non-renewed solutions though enough of all nutrient elements were available in the solution. In the final culture, the highest shoot fresh weight (SFW) was recorded in the renewed (83.0 g plant−1) solution which was similar to the AC-ED-treated solution (81.0 g plant−1) and the lowest (58.0 g plant−1) was in the non-renewed solution. By applying AC-ED, 40% lettuce yield was recovered in the EC-adjusted solution without renewing. Therefore, it is recommended that the continuous application of AC-ED with the capacity of 551 Hz and 50% duty would be applied for recovering the retarded lettuce yield cultivated with repeatedly used culture solutions in recycled hydroponics. [ABSTRACT FROM AUTHOR]

Published
2024
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44. A prospective observational cohort study of lenvatinib as initial treatment in patients with BCLC-defined stage B hepatocellular carcinoma

Author

Kobayashi, Satoshi, Fukushima, Taito, Ueno, Makoto, Moriya, Satoshi, Chuma, Makoto, Numata, Kazushi, Tsuruya, Kota, Hirose, Shunji, Kagawa, Tatehiro, Hattori, Nobuhiro, Watanabe, Tsunamasa, Matsunaga, Kotaro, Suzuki, Michihiro, Uojima, Haruki, Hidaka, Hisashi, Kusano, Chika, Suzuki, Motoko, and Morimoto, Manabu

Published
2022
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45. The clinical outcomes of combination chemotherapy in elderly patients with advanced biliary tract cancer: an exploratory analysis of JCOG1113

Author

Yamada, Ikuhiro, Morizane, Chigusa, Okusaka, Takuji, Mizusawa, Junki, Kataoka, Tomoko, Ueno, Makoto, Ikeda, Masafumi, Okano, Naohiro, Todaka, Akiko, Shimizu, Satoshi, Mizuno, Nobumasa, Sekimoto, Mitsugu, Tobimatsu, Kazutoshi, Yamaguchi, Hironori, Nishina, Tomohiro, Shirakawa, Hirofumi, Kojima, Yasushi, Oono, Takamasa, Kawamoto, Yasuyuki, Furukawa, Masayuki, Iwai, Tomohisa, Sudo, Kentaro, Okamura, Keiya, Yamashita, Tatsuya, Kato, Naoya, Shioji, Kazuhiko, Shimizu, Kyouko, Nakagohri, Toshio, Kamata, Ken, Ishii, Hiroshi, and Furuse, Junji

Published
2022
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