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624 results on '"Ogasawara, Sadahisa"'

51. Exploration of new positions for cabozantinib for advanced hepatocellular carcinoma in the latest real-world practice

Author

Kanzaki, Hiroaki, primary, Ogasawara, Sadahisa, additional, Okubo, Tomomi, additional, Itokawa, Norio, additional, Yoshino, Ryohei, additional, Fujimoto, Kentaro, additional, Kogure, Tadayoshi, additional, Yumita, Sae, additional, Ishino, Takamasa, additional, Ogawa, Keita, additional, Iwanaga, Terunao, additional, Nakagawa, Miyuki, additional, Fujiwara, Kisako, additional, Kojima, Ryuta, additional, Koroki, Keisuke, additional, Inoue, Masanori, additional, Kobayashi, Kazufumi, additional, Kanogawa, Naoya, additional, Kiyono, Soichiro, additional, Nakamura, Masato, additional, Kondo, Takayuki, additional, Nakagawa, Ryo, additional, Nakamoto, Shingo, additional, Muroyama, Ryosuke, additional, Chiba, Tetsuhiro, additional, Itobayashi, Ei, additional, Atsukawa, Masanori, additional, Kato, Jun, additional, and Kato, Naoya, additional

Published
2023
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52. Successful Identification of a Novel Therapeutic Compound for Hepatocellular Carcinoma Through Screening of ADAM9 Inhibitors

Author

OGAWA, KEITA, primary, CHIBA, TETSUHIRO, additional, NAKAMURA, MASATO, additional, ARAI, JUN, additional, ZHANG, JIAQI, additional, MA, YAOJIA, additional, QIANG, NA, additional, AO, JUNJIE, additional, YUMITA, SAE, additional, ISHINO, TAKAMASA, additional, KAN, MOTOYASU, additional, IWANAGA, TERUNAO, additional, NAKAGAWA, MIYUKI, additional, FUJIWARA, KISAKO, additional, SAKUMA, TAKAFUMI, additional, KANZAKI, HIROAKI, additional, KOROKI, KEISUKE, additional, KUSAKABE, YUKO, additional, KOBAYASHI, KAZUFUMI, additional, KANOGAWA, NAOYA, additional, KIYONO, SOICHIRO, additional, KONDO, TAKAYUKI, additional, NAKAGAWA, RYO, additional, OGASAWARA, SADAHISA, additional, MUROYAMA, RYOSUKE, additional, NAKAMOTO, SHINGO, additional, KANDA, TATSUO, additional, MARUYAMA, HITOSHI, additional, KATO, JUN, additional, MATSUMOTO, SHOJI, additional, ARAI, TAKAYOSHI, additional, MOTOHASHI, SHINICHIRO, additional, and KATO, NAOYA, additional

Published
2023
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53. Pembrolizumab as Second-Line Therapy for Advanced Hepatocellular Carcinoma: Longer-Term Follow-Up From the Phase 3 KEYNOTE-240 Trial

Author

Merle, Philippe, primary, Kudo, Masatoshi, additional, Edeline, Julien, additional, Bouattour, Mohamed, additional, Cheng, Ann-Lii, additional, Chan, Stephen Lam, additional, Yau, Thomas, additional, Garrido, Marcelo, additional, Knox, Jennifer, additional, Daniele, Bruno, additional, Breder, Valeriy, additional, Lim, Ho Yeong, additional, Ogasawara, Sadahisa, additional, Cattan, Stéphane, additional, Chao, Yee, additional, Siegel, Abby B., additional, Martinez-Forero, Iván, additional, Wei, Ziwen, additional, Liu, Chih-Chin, additional, and Finn, Richard S., additional

Published
2023
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54. A prospective study exploring the safety and efficacy of lenvatinib for patients with advanced hepatocellular carcinoma potential in current real-world practice.

Author

Kobayashi, Kazufumi, primary, Ogasawara, Sadahisa, additional, Maruta, Susumu, additional, Okubo, Tomomi, additional, Moriguchi, Michihisa, additional, Kanzaki, Hiroaki, additional, Koroki, Keisuke, additional, Kanogawa, Naoya, additional, Shiko, Yuki, additional, Inaba, Yosuke, additional, Nakamura, Kazuyoshi, additional, Azemoto, Ryosaku, additional, Ito, Kenji, additional, Okabe, Shinichiro, additional, Atsukawa, Masanori, additional, Itobayashi, Ei, additional, Ikeda, Masafumi, additional, Morimoto, Naoki, additional, Itoh, Yoshito, additional, and Kato, Naoya, additional

Published
2023
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55. Miglustat, a glucosylceramide synthase inhibitor, mitigates liver fibrosis through TGF-β/Smad pathway suppression in hepatic stellate cells

Author

Iwanaga, Terunao, primary, Chiba, Tetsuhiro, additional, Nakamura, Masato, additional, Kaneko, Tatsuya, additional, Ao, Junjie, additional, Qiang, Na, additional, Ma, Yaojia, additional, Zhang, Jiaqi, additional, Kogure, Tadayoshi, additional, Yumita, Sae, additional, Ishino, Takamasa, additional, Ogawa, Keita, additional, Kan, Motoyasu, additional, Nakagawa, Miyuki, additional, Fujiwara, Kisako, additional, Fujita, Naoto, additional, Sakuma, Takafumi, additional, Kanzaki, Hiroaki, additional, Koroki, Keisuke, additional, Kusakabe, Yuko, additional, Inoue, Masanori, additional, Kobayashi, Kazufumi, additional, Kanogawa, Naoya, additional, Kiyono, Soichiro, additional, Kondo, Takayuki, additional, Nakagawa, Ryo, additional, Ogasawara, Sadahisa, additional, Nakamoto, Shingo, additional, Muroyama, Ryosuke, additional, Kato, Jun, additional, Kanda, Tatsuo, additional, Maruyama, Hitoshi, additional, Mimura, Naoya, additional, Honda, Takuya, additional, Murayama, Toshihiko, additional, Nakamura, Hiroyuki, additional, and Kato, Naoya, additional

Published
2023
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56. Clinical Features Focusing on Extraintestinal Manifestations in Japanese Patients with Inflammatory Bowel Diseases: Far East 1000

Author

Ohta, Yuki, primary, Taida, Takashi, additional, Kato, Jun, additional, Ogasawara, Sadahisa, additional, Oyama, Yuhei, additional, Mamiya, Yukiyo, additional, Nakazawa, Hayato, additional, Horio, Ryosuke, additional, Goto, Chihiro, additional, Takahashi, Satsuki, additional, Kurosugi, Akane, additional, Sonoda, Michiko, additional, Shiratori, Wataru, additional, Kaneko, Tatsuya, additional, Yokoyama, Yuya, additional, Akizue, Naoki, additional, Ishigami, Hideaki, additional, Koseki, Hirotaka, additional, Okimoto, Kenichiro, additional, Saito, Keiko, additional, Saito, Masaya, additional, Matsumura, Tomoaki, additional, Nakagawa, Tomoo, additional, Masuya, Yoshio, additional, Fukuda, Yoshihiro, additional, Kitsukawa, Yoshio, additional, Shimura, Haruhisa, additional, Tsuyuguchi, Toshio, additional, and Kato, Naoya, additional

Published
2023
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58. Asia–Pacific clinical practice guidelines on the management of hepatocellular carcinoma: a 2017 update

Author

Omata, Masao, Cheng, Ann-Lii, Kokudo, Norihiro, Kudo, Masatoshi, Lee, Jeong Min, Jia, Jidong, Tateishi, Ryosuke, Han, Kwang-Hyub, Chawla, Yoghesh K., Shiina, Shuichiro, Jafri, Wasim, Payawal, Diana Alcantara, Ohki, Takamasa, Ogasawara, Sadahisa, Chen, Pei-Jer, Lesmana, Cosmas Rinaldi A., Lesmana, Laurentius A., Gani, Rino A., Obi, Shuntaro, Dokmeci, A. Kadir, and Sarin, Shiv Kumar

Published
2017
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59. Clinical effects and emerging issues of atezolizumab plus bevacizumab in patients with advanced hepatocellular carcinoma from Japanese real‐world practice

Author

Nakagawa, Miyuki, primary, Inoue, Masanori, additional, Ogasawara, Sadahisa, additional, Maruta, Susumu, additional, Okubo, Tomomi, additional, Itokawa, Norio, additional, Iino, Yotaro, additional, Obu, Masamichi, additional, Haga, Yuki, additional, Seki, Atsuyoshi, additional, Kikuchi, Yasuharu, additional, Kogure, Tadayoshi, additional, Yumita, Sae, additional, Ishino, Takamasa, additional, Ogawa, Keita, additional, Fujiwara, Kisako, additional, Iwanaga, Terunao, additional, Fujita, Naoto, additional, Sakuma, Takafumi, additional, Kojima, Ryuta, additional, Kanzaki, Hiroaki, additional, Koroki, Keisuke, additional, Taida, Takashi, additional, Kobayashi, Kazufumi, additional, Kiyono, Soichiro, additional, Nakamura, Masato, additional, Kanogawa, Naoya, additional, Kondo, Takayuki, additional, Nakagawa, Ryo, additional, Nakamoto, Shingo, additional, Muroyama, Ryosuke, additional, Chiba, Tetsuhiro, additional, Itobayashi, Ei, additional, Atsukawa, Masanori, additional, Koma, Yoshihiro, additional, Azemoto, Ryosaku, additional, Ito, Kenji, additional, Mizumoto, Hideaki, additional, Shinozaki, Masami, additional, Kato, Jun, additional, and Kato, Naoya, additional

Published
2022
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60. Antiviral Compounds Screening Targeting HBx Protein of the Hepatitis B Virus

Author

Ma, Yaojia, primary, Nakamoto, Shingo, additional, Ao, Junjie, additional, Qiang, Na, additional, Kogure, Tadayoshi, additional, Ogawa, Keita, additional, Nakagawa, Miyuki, additional, Fujiwara, Kisako, additional, Iwanaga, Terunao, additional, Kojima, Ryuta, additional, Kanzaki, Hiroaki, additional, Koroki, Keisuke, additional, Kobayashi, Kazufumi, additional, Kanogawa, Naoya, additional, Kiyono, Soichiro, additional, Nakamura, Masato, additional, Kondo, Takayuki, additional, Nakagawa, Ryo, additional, Ogasawara, Sadahisa, additional, Muroyama, Ryosuke, additional, Chiba, Tetsuhiro, additional, Kato, Jun, additional, and Kato, Naoya, additional

Published
2022
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64. Controlling Major Portal Vein Invasion Progression during Lenvatinib Treatment by Carbon-Ion Radiotherapy in Patients with Advanced Hepatocellular Carcinoma

Author

Yoshida, Ryoi, Koroki, Keisuke, Makishima, Hirokazu, Ogasawara, Sadahisa, Ishino, Takamasa, Ogawa, Keita, Nakagawa, Miyuki, Fujiwara, Kisako, Hidemi Unozawa, Iwanaga, Terunao, Fujita, Naoto, Sakuma, Takafumi, Kanzaki, Hiroaki, Kobayashi, Kazufumi, Kanogawa, Naoya, Kiyono, Soichiro, Nakamura, Masato, Kondo, Takayuki, Saito, Tomoko, Nakagawa, Ryo, Suzuk, Eiichiro, Ooka, Yoshihiko, Nakamoto, Shingo, Tawada, Akinobu, Chiba, Tetsuhiro, Arai, Makoto, Kaneko, Takashi, Wakatsuki, Masaru, Kato, Jun, Tsuji, Hiroshi, Kato, Naoya, Hirokazu, Makishima, Keita, Ogawa, Naoto, Fujita, Naoya, Kanogawa, Tomoko, Saitou, Takashi, Kaneko, Masaru, Wakatsuki, and Hiroshi, Tsuji

Abstract

Macrovascular invasion (MVI), including portal vein tumor thrombosis (PVTT), is strongly associated with poor prognosis in patients with hepatocellular carcinoma (HCC). While recommended standard treatment for patients with advanced HCC is systemic therapy, various treatment approaches, including resection, transarterial chemoembolization, and radiation, have been empirically suggested to improve prognosis by eliminating or controlling MVI. Herein, we report our experience of a case with advanced HCC where MVI was controlled by carbon-ion radiotherapy (CIRT) while on systemic therapy, resulting in a prolonged survival. A female patient with HCC in her early 60s had multiple intrahepatic lesions (maximum 60 mm in diameter) with PVTT. The PVTT of this patient had reached the main trunk of the portal vein despite the use of lenvatinib. The other intrahepatic lesions of the patient, except PVTT, had been controlled by lenvatinib. Therefore, hoping to control PVTT, we attempted CIRT. The patient resumed lenvatinib therapy after the irradiation. During lenvatinib re-treatment, no evident progression of PVTT was observed in the patient.

Published
2021

66. Analysis of hyperprogressive disease due to atezolizumab plus bevacizumab treatment in patients with advanced hepatocellular carcinoma

Author

Yumita, Sae, primary, Ogasawara, Sadahisa, additional, Nakagawa, Miyuki, additional, Maruta, Susumu, additional, Okubo, Tomomi, additional, Itokawa, Norio, additional, Iino, Yotaro, additional, Obu, Masamichi, additional, Haga, Yuki, additional, Seki, Atsuyoshi, additional, Kogure, Tadayoshi, additional, Ishino, Takamasa, additional, Ogawa, Keita, additional, Fujiwara, Kisako, additional, Iwanaga, Terunao, additional, Fujita, Naoto, additional, Sakuma, Takafumi, additional, Kojima, Ryuta, additional, Kanzaki, Hiroaki, additional, Koroki, Keisuke, additional, Inoue, Masanori, additional, Kobayashi, Kazufumi, additional, Kiyono, Soichiro, additional, Nakamura, Masato, additional, Kanogawa, Naoya, additional, Saito, Tomoko, additional, Kondo, Takayuki, additional, Nakagawa, Ryo, additional, Nakamoto, Shingo, additional, Muroyama, Ryosuke, additional, Chiba, Tetsuhiro, additional, Itobayashi, Ei, additional, Atsukawa, Masanori, additional, Koma, Yoshihiro, additional, Azemoto, Ryosaku, additional, Ito, Kenji, additional, Mizumoto, Hideaki, additional, Kato, Jun, additional, and Kato, Naoya, additional

Published
2022
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67. Carbon‐ion radiotherapy versus radiofrequency ablation as initial treatment for early‐stage hepatocellular carcinoma

Author

Fujita, Naoto, primary, Kanogawa, Naoya, additional, Makishima, Hirokazu, additional, Ogasawara, Sadahisa, additional, Maruta, Susumu, additional, Iino, Yotaro, additional, Shiko, Yuki, additional, Kanzaki, Hiroaki, additional, Koroki, Keisuke, additional, Kobayashi, Kazufumi, additional, Kiyono, Soichiro, additional, Nakamura, Masato, additional, Kondo, Takayuki, additional, Nakamoto, Shingo, additional, Chiba, Tetsuhiro, additional, Wakatsuki, Masaru, additional, Itobayashi, Ei, additional, Obu, Masamichi, additional, Koma, Yoshihiro, additional, Azemoto, Ryosaku, additional, Kawasaki, Yohei, additional, Kato, Jun, additional, Tsuji, Hiroshi, additional, and Kato, Naoya, additional

Published
2022
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68. Real‐world outcomes of molecular targeted agents for patients with hepatocellular carcinoma over 80 years old

Author

Sato, Rui, primary, Moriguchi, Michihisa, additional, Iwai, Kenji, additional, Tsuchiya, Satoshi, additional, Seko, Yuya, additional, Takahashi, Aya, additional, Kobayashi, Kazufumi, additional, Ogasawara, Sadahisa, additional, Watanabe, Shunji, additional, Morimoto, Naoki, additional, Kato, Naoya, additional, Itoh, Yoshito, additional, and Aramaki, Takeshi, additional

Published
2022
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69. Use of ramucirumab for various treatment lines in real-world practice of patients with advanced hepatocellular carcinoma

Author

Kanogawa, Naoya, primary, Ogasawara, Sadahisa, additional, Maruta, Susumu, additional, Iino, Yotaro, additional, Obu, Masamichi, additional, Ishino, Takamasa, additional, Ogawa, Keita, additional, Yumita, Sae, additional, Iwanaga, Terunao, additional, Unozawa, Hidemi, additional, Nakagawa, Miyuki, additional, Fujiwara, Kisako, additional, Sakuma, Takafumi, additional, Fujita, Naoto, additional, Kojima, Ryuta, additional, Kanzaki, Hiroaki, additional, Koroki, Keisuke, additional, Kobayashi, Kazufumi, additional, Inoue, Masanori, additional, Kiyono, Soichiro, additional, Nakamura, Masato, additional, Kondo, Takayuki, additional, Saito, Tomoko, additional, Nakagawa, Ryo, additional, Nakamoto, Shingo, additional, Muroyama, Ryosuke, additional, Chiba, Tetsuhiro, additional, Itobayashi, Ei, additional, Koma, Yoshihiro, additional, Azemoto, Ryosaku, additional, Kato, Jun, additional, and Kato, Naoya, additional

Published
2022
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70. Risk prediction of hepatic encephalopathy after molecular targeted therapy for hepatocellular carcinoma in patients with cirrhosis

Author

Fujiwara, Kisako, primary, Kondo, Takayuki, additional, Yumita, Sae, additional, Ishino, Takamasa, additional, Ogawa, Keita, additional, Nakagawa, Miyuki, additional, Unozawa, Hidemi, additional, Iwanaga, Terunao, additional, Sakuma, Takafumi, additional, Fujita, Naoto, additional, Kanzaki, Hiroaki, additional, Koroki, Keisuke, additional, Kobayashi, Kazufumi, additional, Kiyono, Soichiro, additional, Nakamura, Masato, additional, Kanogawa, Naoya, additional, Saito, Tomoko, additional, Ogasawara, Sadahisa, additional, Nakamoto, Shingo, additional, Chiba, Tetsuhiro, additional, Kato, Jun, additional, and Kato, Naoya, additional

Published
2022
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71. MO5-1 Regorafenib in advanced HCC patients who were not included in the RESORCE trial: first interim analysis

Author

Koroki, Keisuke, primary, Ogasawara, Sadahisa, additional, Terunao, Iwanaga, additional, Unozawa, Hidemi, additional, Fujiwara, Kisako, additional, Nakagawa, Miyuki, additional, Sakuma, Takafumi, additional, Fujita, Naoto, additional, Kanzaki, Hiroaki, additional, Kobayashi, Kazufumi, additional, Kiyono, Soichiro, additional, Nakamura, Masato, additional, Kanogawa, Naoya, additional, Saito, Tomoko, additional, Kondo, Takayuki, additional, Nakagawa, Ryo, additional, Nakamoto, Shingo, additional, Muroyama, Ryosuke, additional, Chiba, Tetsuhiro, additional, and Kato, Naoya, additional

Published
2022
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72. Clinical features of exacerbation of portal vein thrombosis after discontinuation of anticoagulants

Author

Kondo, Takayuki, primary, Fujiwara, Kisako, additional, Yumita, Sae, additional, Ishino, Takamasa, additional, Ogawa, Keita, additional, Nakagawa, Miyuki, additional, Unozawa, Hidemi, additional, Iwanaga, Terunao, additional, Sakuma, Takafumi, additional, Fujita, Naoto, additional, Koroki, Keisuke, additional, Kanzaki, Hiroaki, additional, Kobayashi, Kazufumi, additional, Kiyono, Soichiro, additional, Nakamura, Masato, additional, Kanogawa, Naoya, additional, Saito, Tomoko, additional, Ogasawara, Sadahisa, additional, Nakamoto, Shingo, additional, Chiba, Tetsuhiro, additional, Kato, Jun, additional, and Kato, Naoya, additional

Published
2022
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74. A case of hepatocellular carcinoma followed by asynchronous metastasis to the lung and thoracic spine following radical ablation treatment

Author

Kato Naoya, Saito Tomoko, Kanogawa Naoya, Kato Jun, Ooka Yoshihiko, Nakamoto Shingo, Suzuki Eiichiro, Kusakabe Yuko, Maruta Susumu, Kondo Takayuki, Maruyama Hitoshi, Kobayashi Kazufumi, Yoshino Ichiro, Kanda Tatsuro, Chiba Tetsuhiro, Nakamura Masato, Tawada Akinobu, Kiyono Soichiro, Ogasawara Sadahisa, Kanzaki Hiroaki, Kanayama Kengo, Kooroki Keisuke, Sakuma Takafumi, and Kishimoto Takashi

Subjects
medicine.medical_specialty, Thesaurus (information retrieval), Lung, Hepatology, business.industry, Thoracic spine, medicine.medical_treatment, Ablation, medicine.disease, Metastasis, medicine.anatomical_structure, Hepatocellular carcinoma, medicine, Radiology, business
Published
2021
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75. Phase Ib trial of durvalumab plus tremelimumab in combination with particle radiotherapy in advanced hepatocellular carcinoma patients with macrovascular invasion: DEPARTURE trial

Author

Ogasawara, Sadahisa, Koroki, Keisuke, Hirokazu, Makishima, Masaru, Wakatsuki, Sakuma, Takafumi, Naoto, Fujita, Kanzaki, Hiroaki, Kobayashi, Kazufumi, Kiyono, Souichiro, Masato, Nakamura, Naoya, Kanogawa, Tomoko, Saitou, Kondo, Takayuki, Nakagawa, Ryo, Nakamoto, Shingo, Muroyama, Ryosuke, Chiba, Tetsuhiro, Hideki, Hanaoka, Hiroshi, Tsuji, Kato, Naoya, Ogasawara, Sadahisa, Koroki, Keisuke, Hirokazu, Makishima, Masaru, Wakatsuki, Sakuma, Takafumi, Naoto, Fujita, Kanzaki, Hiroaki, Kobayashi, Kazufumi, Kiyono, Souichiro, Masato, Nakamura, Naoya, Kanogawa, Tomoko, Saitou, Kondo, Takayuki, Nakagawa, Ryo, Nakamoto, Shingo, Muroyama, Ryosuke, Chiba, Tetsuhiro, Hideki, Hanaoka, Hiroshi, Tsuji, and Kato, Naoya

Abstract

Background: Advanced hepatocellular carcinoma (HCC) with macrovascular invasion (MVI) has the worst prognosis among all HCC cases, due to its uniqueness of disease condition. Development of revolutionary therapeutic approaches to improve prognosis in these patients is an essential medical issue. A phase I/II trial demonstrated that treatment with durvalumab, an anti-programmed death-ligand 1 antibody, alone or in combination with tremelimumab, an anti-cytotoxic T-lymphocyte antigen 4 antibody, exhibited potential efficacy in patients with advanced HCC. Conversely, particle radiotherapy, including carbon-ion radiotherapy, has been shown to achieve unique dose distribution by delivering high-dose radiation to the target tumor while reducing the radiation dose to normal tissues due to its physical characteristics. Studies demonstrated that particle radiotherapy could achieve good local control in patients with HCC, including those with MVI. Additionally, particle radiotherapy as well as photon irradiation not only mediate localized tumor killing but also modify the tumor microenvironment, thereby potentiating the efficacy of immune checkpoint inhibitors. The DEPARTURE trial aims to evaluate whether treatment with durvalumab, alone or in combination with tremelimumab, plus particle radiotherapy is a safe and synergistically effective treatment in patients with advanced HCC and MVI. Methods: This is a phase Ib, multi-center, open-label, single-arm, investigator-initiated clinical trial to assess the safety of durvalumab monotherapy in combination with particle radiotherapy (Cohort A) and that of durvalumab plus tremelimumab in combination with particle radiotherapy (Cohort B) in advanced HCC patients with MVI who are ineligible for standard systemic therapy and Child–Pugh A liver disease. Cohort A will receive 1500 mg durvalumab every four weeks in principle. Cohort B will receive 1500 mg durvalumab every four weeks in principle and 300 mg tremelimumab only on day 1 of t

Published
2022

76. Pembrolizumab Monotherapy for Previously Untreated Advanced Hepatocellular Carcinoma: Data from the Open-Label, Phase II KEYNOTE-224 Trial

Author

Verset, Gontran, Borbath, Ivan, Karwal, Mark, Verslype, Chris, Van Vlierberghe, Hans, Kardosh, Adel, Zagonel, Vittorina, Stal, Per, Sarker, Debashis, Palmer, Daniel D.H., Vogel, Arndt, Edeline, Julien, Cattan, Stéphane, Kudo, Masatoshi, Cheng, Ann Lii, Ogasawara, Sadahisa, Daniele, Bruno, Chan, Stephen Lam, Knox, Jennifer, Qin, Shukui, Siegel, Abby A.B., Chisamore, Michael, Hatogai, Ken, Wang, Anran, Finn, Richard R.S., Zhu, Andrew Xiuxuan, Verset, Gontran, Borbath, Ivan, Karwal, Mark, Verslype, Chris, Van Vlierberghe, Hans, Kardosh, Adel, Zagonel, Vittorina, Stal, Per, Sarker, Debashis, Palmer, Daniel D.H., Vogel, Arndt, Edeline, Julien, Cattan, Stéphane, Kudo, Masatoshi, Cheng, Ann Lii, Ogasawara, Sadahisa, Daniele, Bruno, Chan, Stephen Lam, Knox, Jennifer, Qin, Shukui, Siegel, Abby A.B., Chisamore, Michael, Hatogai, Ken, Wang, Anran, Finn, Richard R.S., and Zhu, Andrew Xiuxuan

Abstract

Purpose: KEYNOTE-224 cohort 1 demonstrated that pembrolizumab was efficacious and tolerable in patients with advanced hepatocellular carcinoma (HCC) previously treated with sorafenib. We report results from KEYNOTE-224 (NCT02702414) cohort 2, which enrolled patients with advanced HCC and no prior systemic therapy. Patients and Methods: KEYNOTE-224 was an open-label, multicountry phase II trial. Eligible patients in cohort 2 had advanced HCC not amenable or refractory to locoregional therapy and not previously treated with systemic therapy. Patients received pembrolizumab 200 mg intravenously every 3 weeks for ≤2 years. Primary endpoint was objective response rate (ORR) by central imaging review per RECIST v1.1. Secondary endpoints included duration of response (DOR), disease control rate (DCR), time to progression (TTP), progression-free survival (PFS), overall survival (OS), and safety/tolerability. Results: Between September 4, 2018, and February 20, 2019, 51 patients were allocated in cohort 2. The median time from the first dose to data cutoff (January 19, 2021) was 27 months (range, 23-29). ORR was 16% [95% confidence interval (CI), 7-29] and was similar across key subgroups. Median DOR was 16 months (range, 3-24+), and DCR was 57%. The median PFS was 4 months (95% CI, 2-8), and median TTP was 4 months (95% CI, 3-9). Median OS was 17 months (95% CI, 8-23). Grade ≥3 treatment-related adverse events occurred in 16% of patients. Conclusions: In patients with advanced HCC with no prior systemic therapy, pembrolizumab provided durable antitumor activity, promising OS, and had a safety profile consistent with previous observations. These findings support further evaluation of pembrolizumab-based regimens for HCC., SCOPUS: re.j, info:eu-repo/semantics/published

Published
2022

77. Updated efficacy and safety of KEYNOTE-224: a phase II study of pembrolizumab in patients with advanced hepatocellular carcinoma previously treated with sorafenib

Author

Kudo, Masatoshi, Finn, Richard R.S., Edeline, Julien, Cattan, Stéphane, Ogasawara, Sadahisa, Palmer, Daniel D.H., Verslype, Chris, Zagonel, Vittorina, Fartoux, Laetitia, Vogel, Arndt, Sarker, Debashis, Verset, Gontran, Chan, Stephen Lam, Knox, Jennifer, Daniele, Bruno, Yau, Thomas, Gurary, Ellen E.B., Siegel, Abby A.B., Wang, Anran, Cheng, Ann Lii, Zhu, Andrew Xiuxuan, Kudo, Masatoshi, Finn, Richard R.S., Edeline, Julien, Cattan, Stéphane, Ogasawara, Sadahisa, Palmer, Daniel D.H., Verslype, Chris, Zagonel, Vittorina, Fartoux, Laetitia, Vogel, Arndt, Sarker, Debashis, Verset, Gontran, Chan, Stephen Lam, Knox, Jennifer, Daniele, Bruno, Yau, Thomas, Gurary, Ellen E.B., Siegel, Abby A.B., Wang, Anran, Cheng, Ann Lii, and Zhu, Andrew Xiuxuan

Abstract

Objective: Pembrolizumab, a PD-1 inhibitor, demonstrated anti-tumour activity and tolerability in patients treated with sorafenib and with advanced hepatocellular carcinoma in KEYNOTE-224. Longer-term efficacy and safety after ∼2.5 years of additional follow-up are reported. Patients and methods: Adults with confirmed hepatocellular carcinoma who experienced progression after or intolerance to sorafenib treatment received pembrolizumab 200 mg every 3 weeks for ≤35 cycles or until confirmed progression, unacceptable toxicity, withdrawal of consent or investigator decision. The primary end-point was objective response rate assessed by blinded independent central review per Response Evaluation Criteria in Solid Tumours v1.1. The secondary end-points included duration of response, disease control rate, time to progression, progression-free survival, overall survival and adverse events. Results: Efficacy and safety were assessed in 104 patients. The median time from first dose to data cutoff was 45.1 months (range, 41.3–49.3). Objective response rate was 18.3% (95% CI: 11.4–27.1), and median duration of response was 21.0 months (range, 3.1 to 39.5+). Disease control rate was 61.5%, and median time to progression was 4.8 months (95% CI: 3.9–7.0). Median progression-free survival was 4.9 months (95% CI: 3.5–6.7) and median overall survival was 13.2 months (95% CI: 9.7–15.3). Of 104 patients, 76 (73.1%) patients reported treatment-related adverse events; most were low grade in severity (grade 3–4, n = 26 [25.0%]; grade 5, n = 1 [1.0%]). Immune-mediated hepatitis occurred in 3 patients (all grade 3). No viral-induced hepatitis flares occurred. Conclusions: After ∼2.5 years of additional follow-up, pembrolizumab continued to provide durable anti-tumour activity and no new safety concerns were identified. ClinicalTrials.gov identifier: NCT02702414., SCOPUS: ar.j, info:eu-repo/semantics/published

Published
2022

81. Analysis of hyperprogressive disease due to atezolizumab combined with bevacizumab treatment in patients with advanced hepatocellular carcinoma

Author

Yumita, Sae, primary, Ogasawara, Sadahisa, additional, Nakagawa, Miyuki, additional, Maruta, Susumu, additional, Okubo, Tomomi, additional, Itokawa, Norio, additional, Iino, Yotaro, additional, Oobu, Masamichi, additional, Haga, Yuki, additional, Seki, Atsuyoshi, additional, Kogure, Tadayoshi, additional, Ishino, Takamasa, additional, Ogawa, Keita, additional, Fujiwara, Kisako, additional, Iwanaga, Terunao, additional, Fujita, Naoto, additional, Sakuma, Takafumi, additional, Kojima, Ryuta, additional, Kanzaki, Hiroaki, additional, Koroki, Keisuke, additional, Inoue, Masanori, additional, Kobayashi, Kazufumi, additional, Kiyono, Soichiro, additional, Nakamura, Masato, additional, Kanogawa, Naoya, additional, Saito, Tomoko, additional, Kondo, Takayuki, additional, Nakagawa, Ryo, additional, Nakamoto, Shingo, additional, Muroyama, Ryosuke, additional, Chiba, Tetsuhiro, additional, Itobayashi, Ei, additional, Atsukawa, Masanori, additional, Koma, Yoshihiro, additional, Azemoto, Ryosaku, additional, Ito, Kenji, additional, Mizumoto, Hideaki, additional, Kato, Jun, additional, and Kato, Naoya, additional

Published
2022
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82. Pembrolizumab monotherapy for previously untreated advanced hepatocellular carcinoma (aHCC): 3-year follow-up of the phase 2 KEYNOTE-224 study.

Author

Borbath, Ivan, primary, Van Laethem, Jean-Luc, additional, Karwal, Mark, additional, Verslype, Chris, additional, Van Vlierberghe, Hans, additional, Kardosh, Adel, additional, Bergamo, Francesca, additional, Stål, Per, additional, Sarker, Debashis, additional, Palmer, Daniel H., additional, Edeline, Julien, additional, Cattan, Stéphane, additional, Kudo, Masatoshi, additional, Cheng, Ann-Lii, additional, Ogasawara, Sadahisa, additional, Siegel, Abby B., additional, Hatogai, Ken, additional, Wang, Anran, additional, and Vogel, Arndt, additional

Published
2022
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83. Updated efficacy and safety of KEYNOTE-224: a phase II study of pembrolizumab in patients with advanced hepatocellular carcinoma previously treated with sorafenib

Author

Kudo, Masatoshi, primary, Finn, Richard S., additional, Edeline, Julien, additional, Cattan, Stéphane, additional, Ogasawara, Sadahisa, additional, Palmer, Daniel H., additional, Verslype, Chris, additional, Zagonel, Vittorina, additional, Fartoux, Laetitia, additional, Vogel, Arndt, additional, Sarker, Debashis, additional, Verset, Gontran, additional, Chan, Stephen L., additional, Knox, Jennifer, additional, Daniele, Bruno, additional, Yau, Thomas, additional, Gurary, Ellen B., additional, Siegel, Abby B., additional, Wang, Anran, additional, Cheng, Ann-Lii, additional, and Zhu, Andrew X., additional

Published
2022
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84. Pembrolizumab Monotherapy for Previously Untreated Advanced Hepatocellular Carcinoma: Data from the Open-Label, Phase II KEYNOTE-224 Trial

Author

Verset, Gontran, primary, Borbath, Ivan, additional, Karwal, Mark, additional, Verslype, Chris, additional, Van Vlierberghe, Hans, additional, Kardosh, Adel, additional, Zagonel, Vittorina, additional, Stal, Per, additional, Sarker, Debashis, additional, Palmer, Daniel H., additional, Vogel, Arndt, additional, Edeline, Julien, additional, Cattan, Stephane, additional, Kudo, Masatoshi, additional, Cheng, Ann-Lii, additional, Ogasawara, Sadahisa, additional, Daniele, Bruno, additional, Chan, Stephen L., additional, Knox, Jennifer J., additional, Qin, Shukui, additional, Siegel, Abby B., additional, Chisamore, Michael, additional, Hatogai, Ken, additional, Wang, Anran, additional, Finn, Richard S., additional, and Zhu, Andrew X., additional

Published
2022
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85. Durvalumab with or without tremelimumab combined with particle therapy for advanced hepatocellular carcinoma with macrovascular invasion: protocol for the DEPARTURE phase Ib trial

Author

Ogasawara, Sadahisa, primary, Koroki, Keisuke, additional, Makishima, Hirokazu, additional, Wakatsuki, Masaru, additional, Takahashi, Asahi, additional, Yumita, Sae, additional, Nakagawa, Miyuki, additional, Ishino, Takamasa, additional, Ogawa, Keita, additional, Fujiwara, Kisako, additional, Iwanaga, Terunao, additional, Sakuma, Takafumi, additional, Fujita, Naoto, additional, Kojima, Ryuta, additional, Kanzaki, Hiroaki, additional, Kobayashi, Kazufumi, additional, Kiyono, Soichiro, additional, Nakamura, Masato, additional, Kanogawa, Naoya, additional, Saito, Tomoko, additional, Kondo, Takayuki, additional, Nakagawa, Ryo, additional, Nakamoto, Shingo, additional, Muroyama, Ryosuke, additional, Chiba, Tetsuhiro, additional, Ozawa, Yoshihito, additional, Kawasaki, Yohei, additional, Kurokawa, Tomoya, additional, Hanaoka, Hideki, additional, Tsuji, Hiroshi, additional, and Kato, Naoya, additional

Published
2022
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87. Biologics did not reduce surgery rate but prolonged remission duration in patients with ulcerative colitis: analysis of a large retrospective Japanese cohort

Author

Yokoyama, Yuya, primary, Ohta, Yuki, additional, Ogasawara, Sadahisa, additional, Kato, Jun, additional, Arai, Ryoko, additional, Koseki, Hirotaka, additional, Saito, Masaya, additional, Kaneko, Tatsuya, additional, Tokunaga, Mamoru, additional, Oura, Hirotaka, additional, Oike, Tsubasa, additional, Imai, Yushi, additional, Kanayama, Kengo, additional, Akizue, Naoki, additional, Kumagai, Junichiro, additional, Taida, Takashi, additional, Okimoto, Kenichiro, additional, Saito, Keiko, additional, Ooka, Yoshihiko, additional, Matsumura, Tomoaki, additional, Nakagawa, Tomoo, additional, Arai, Makoto, additional, Katsuno, Tatsuro, additional, Fukuda, Yoshihiro, additional, Kitsukawa, Yoshio, additional, and Kato, Naoya, additional

Published
2022
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88. LEAP-012 trial in progress: Transarterial chemoembolization (TACE) with or without lenvatinib plus pembrolizumab for intermediate-stage hepatocellular carcinoma (HCC)

Author

El-Khoueiry, Anthony B., primary, Llovet, Josep M, additional, Vogel, Arndt, additional, Madoff, David C., additional, Finn, Richard S., additional, Ogasawara, Sadahisa, additional, Ren, Zhenggang, additional, Mody, Kalgi, additional, Li, Jerry J., additional, Siegel, Abby B., additional, Dubrovsky, Leonid, additional, and Kudo, Masatoshi, additional

Published
2022
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89. Transition of the tumor microenvironment with clonal evolution of hepatocellular carcinoma.

Author

Kanzaki, Hiroaki, primary, Ogasawara, Sadahisa, additional, Sakuma, Takafumi, additional, Fujita, Naoto, additional, Kojima, Ryuta, additional, Koroki, Keisuke, additional, Kobayashi, Kazufumi, additional, Nakamura, Masato, additional, Kanogawa, Naoya, additional, Kiyono, Soichiro, additional, Kondo, Takayuki, additional, Saito, Tomoko, additional, Nakagawa, Ryo, additional, Nakamoto, Shingo, additional, Muroyama, Ryosuke, additional, Chiba, Tetsuhiro, additional, Ikeda, Junichiro, additional, Ohtsuka, Masayuki, additional, and Kato, Naoya, additional

Published
2022
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90. Phase Ib trial of durvalumab plus tremelimumab in combination with particle radiotherapy in advanced hepatocellular carcinoma patients with macrovascular invasion: DEPARTURE trial.

Author

Ogasawara, Sadahisa, primary, Koroki, Keisuke, additional, Makishima, Hirokazu, additional, Wakatsuki, Masaru, additional, Sakuma, Takafumi, additional, Fujita, Naoto, additional, Kanzaki, Hiroaki, additional, Kobayashi, Kazufumi, additional, Kiyono, Soichiro, additional, Nakamura, Masato, additional, Kanogawa, Naoya, additional, Saito, Tomoko, additional, Kondo, Takayuki, additional, Nakagawa, Ryo, additional, Nakamoto, Shingo, additional, Muroyama, Ryosuke, additional, Chiba, Tetsuhiro, additional, Hanaoka, Hideki, additional, Tsuji, Hiroshi, additional, and Kato, Naoya, additional

Published
2022
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91. Analysis of the tumor microenvironment in ineffective patients of atezolizumab plus bevacizumab for advanced hepatocellular carcinoma.

Author

Kobayashi, Kazufumi, primary, Ogasawara, Sadahisa, additional, Ishino, Takamasa, additional, Unozawa, Hidemi, additional, Nakagawa, Miyuki, additional, Fujiwara, Kisako, additional, Sakuma, Takafumi, additional, Fujita, Naoto, additional, Kanzaki, Hiroaki, additional, Koroki, Keisuke, additional, Nakamura, Masato, additional, Kiyono, Soichiro, additional, Kanogawa, Naoya, additional, Kondo, Takayuki, additional, Saito, Tomoko, additional, Nakagawa, Ryo, additional, Nakamoto, Shingo, additional, Muroyama, Ryosuke, additional, Chiba, Tetsuhiro, additional, and Kato, Naoya, additional

Published
2022
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92. Impact of acute decompensation on the prognosis of patients with hepatocellular carcinoma

Author

Kondo, Takayuki, primary, Koroki, Keisuke, additional, Kanzaki, Hiroaki, additional, Kobayashi, Kazufumi, additional, Kiyono, Soichiro, additional, Nakamura, Masato, additional, Kanogawa, Naoya, additional, Saito, Tomoko, additional, Ogasawara, Sadahisa, additional, Ooka, Yoshihiko, additional, Nakamoto, Shingo, additional, Chiba, Tetsuhiro, additional, Arai, Makoto, additional, Kato, Jun, additional, Kuboki, Satoshi, additional, Ohtsuka, Masayuki, additional, and Kato, Naoya, additional

Published
2022
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93. Management of Systemic Therapies and Hepatic Arterial Infusion Chemotherapy in Patients with Advanced Hepatocellular Carcinoma Based on Sarcopenia Assessment

Author

Yamasaki, Takahiro, primary, Saeki, Issei, additional, Yamauchi, Yurika, additional, Matsumoto, Toshihiko, additional, Suehiro, Yutaka, additional, Kawaoka, Tomokazu, additional, Uchikawa, Shinsuke, additional, Hiramatsu, Akira, additional, Aikata, Hiroshi, additional, Kobayashi, Kazufumi, additional, Kondo, Takayuki, additional, Ogasawara, Sadahisa, additional, Chiba, Tetsuhiro, additional, Takami, Taro, additional, Chayama, Kazuaki, additional, Kato, Naoya, additional, and Sakaida, Isao, additional

Published
2022
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95. Effect of Atezolizumab plus Bevacizumab in Patients with Hepatocellular Carcinoma Harboring CTNNB1 Mutation in Early Clinical Experience

Author

Ogawa, Keita, primary, Kanzaki, Hiroaki, additional, Chiba, Tetsuhiro, additional, Ao, Junjie, additional, Qiang, Na, additional, Ma, Yaojia, additional, Zhang, Jiaqi, additional, Yumita, Sae, additional, Ishino, Takamasa, additional, Unozawa, Hidemi, additional, Kan, Motoyasu, additional, Iwanaga, Terunao, additional, Nakagawa, Miyuki, additional, Fujiwara, Kisako, additional, Fujita, Naoto, additional, Sakuma, Takafumi, additional, Koroki, Keisuke, additional, Kusakabe, Yuko, additional, Kobayashi, Kazufumi, additional, Kanogawa, Naoya, additional, Kiyono, Soichiro, additional, Nakamura, Masato, additional, Kondo, Takayuki, additional, Saito, Tomoko, additional, Nakagawa, Ryo, additional, Ogasawara, Sadahisa, additional, Suzuki, Eiichiro, additional, Nakamoto, Shingo, additional, Muroyama, Ryosuke, additional, Kanda, Tatsuo, additional, Maruyama, Hitoshi, additional, Mimura, Naoya, additional, Kato, Jun, additional, Motohashi, Shinichiro, additional, and Kato, Naoya, additional

Published
2022
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100. Clinical effects and emerging issues of atezolizumab plus bevacizumab in patients with advanced hepatocellular carcinoma from Japanese real‐world practice.

Author

Nakagawa, Miyuki, Inoue, Masanori, Ogasawara, Sadahisa, Maruta, Susumu, Okubo, Tomomi, Itokawa, Norio, Iino, Yotaro, Obu, Masamichi, Haga, Yuki, Seki, Atsuyoshi, Kikuchi, Yasuharu, Kogure, Tadayoshi, Yumita, Sae, Ishino, Takamasa, Ogawa, Keita, Fujiwara, Kisako, Iwanaga, Terunao, Fujita, Naoto, Sakuma, Takafumi, and Kojima, Ryuta

Subjects
BEVACIZUMAB, HEPATOCELLULAR carcinoma, ATEZOLIZUMAB, VASCULAR endothelial growth factors, FATTY liver, CLINICAL trials
Abstract

Background: Although the efficacy of atezolizumab has been demonstrated in randomized controlled trials, its long‐term efficacy and association with adverse events in real‐world practice are unknown. This study was designed to shed light on these issues. Methods: In this multicenter retrospective study, data were collected from patients with advanced hepatocellular carcinoma treated with atezolizumab plus bevacizumab in seven institutions in Japan. The authors focused on the efficacy and adverse events related to vascular endothelial growth factor (VEGF) inhibition. Results: A total of 123 patients were enrolled in this study. The median progression‐free survival (PFS) for the first‐line treatment group was 8.0 months (95% confidence interval [CI], 6.1–9.9), whereas the median PFS for the second‐ or later‐line treatment group was 4.1 months (95% CI, 2.6–5.7), which was significantly worse than that of the first‐line treatment group (p =.005). Twenty‐seven patients had interrupted bevacizumab treatment. Proteinuria accounted for the largest proportion of bevacizumab treatment interruptions. The cumulative incidence rate of bevacizumab interruption due to anti‐VEGF–related adverse events was significantly higher in patients with hypertension and/or diabetes mellitus than in those without (p =.026). The landmark analysis showed that patients experienced bevacizumab interruption by 24 weeks from treatment initiation had poorer PFS than those who did not (p =.013). Conclusions: The PFS of atezolizumab plus bevacizumab as first‐line treatment mostly replicates that of a global phase 3 trial. Interrupted bevacizumab treatment was more common in patients with hypertension and/or diabetes mellitus, which may be associated with worsening long‐term PFS. Plain language summary: Atezolizumab plus bevacizumab has been the standard front line systemic therapy for advanced hepatocellular carcinoma.With the growing incidence of fatty liver due to metabolic syndrome as a background liver disease for hepatocellular carcinoma, the rate of comorbid hypertension and diabetes mellitus has been increasing accordingly.The present study demonstrated the cumulative incidence rate of bevacizumab interruption due to anti‐VEGF–related adverse events was significantly higher in patients with hypertension and/or diabetes mellitus.The landmark analysis clarified that interruption of bevacizumab might be a risk of impaired efficacy of atezolizumab plus bevacizumab over the long term in patients with advanced hepatocellular carcinoma. This report demonstrated that the cumulative incidence rate of bevacizumab interruption due to anti‐VEGF–related adverse events was significantly higher in patients with comorbid hypertension and/or diabetes mellitus during atezolizumab plus bevacizumab for advanced hepatocellular carcinoma. Interruption of bevacizumab might be a risk of impaired efficacy of atezolizumab plus bevacizumab over the long term in patients with advanced hepatocellular carcinoma. [ABSTRACT FROM AUTHOR]

Published
2023
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