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Initial clinical experience with durvalumab plus tremelimumab in patients with unresectable hepatocellular carcinoma in real‑world practice

  • Authors:
    • Shigeo Shimose
    • Issei Saeki
    • Tetsu Tomonari
    • Takanori Ito
    • Joji Tani
    • Yasuto Takeuchi
    • Naoki Yoshioka
    • Takehito Naito
    • Mamiko Takeuchi
    • Satoru Kakizaki
    • Takeshi Hatanaka
    • Kyo Sasaki
    • Tetsuya Yasunaka
    • Masahiro Sakata
    • Hideki Iwamoto
    • Satoshi Itano
    • Tomotake Shirono
    • Norikazu Tanabe
    • Takafumi Yamamoto
    • Atsushi Naganuma
    • Soji Nishina
    • Motoyuki Otsuka
    • Hiroki Kawashima
    • Tetsuji Takayama
    • Taro Takami
    • Takumi Kawaguchi
  • View Affiliations / Copyright

    Affiliations: Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Fukuoka 830‑0011, Japan, Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine, Ube, Yamaguchi 755‑8505, Japan, Department of Gastroenterology and Oncology, Institute of Biomedical Sciences, Tokushima University Graduate School of Medicine, Tokushima 770‑8504, Japan, Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Aichi 466‑8560, Japan, Department of Gastroenterology and Neurology, Kagawa University, Faculty of Medicine, Takamatsu, Kagawa 761‑0793, Japan, Department of Regenerative Medicine, Center for Innovative Clinical Medicine, Okayama University Hospital, Okayama 700‑8558, Japan, Department of Gastroenterology and Hepatology, Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital, Nagoya, Aichi 453‑8511, Japan, Department of Gastroenterology, Toyohashi Municipal Hospital, Toyohashi, Aichi 441‑8570, Japan, Department of Gastroenterology, Anjo Kosei Hospital, Anjo, Aichi 446‑8602, Japan, Department of Clinical Research, National Hospital Organization Takasaki General Medical Center, Takasaki, Gunma 370‑0829, Japan, Department of Gastroenterology, Gunma Saiseikai Maebashi Hospital, Maebashi, Gunma 371‑0821, Japan, Department of Gastroenterology, Kawasaki Medical School, Kurashiki, Okayama 701‑0192, Japan, Department of Gastroenterology, Fukuyama City Hospital, Fukuyama, Okayama 721‑8511, Japan, Department of Gastroenterology, Fukuyama Medical Center, Fukuyama, Okayama 720‑8520, Japan, Department of Gastroenterology and Hepatology, Kurume Central Hospital, Kurume, Fukuoka 830‑0001, Japan, Division of Laboratory, Yamaguchi University Hospital, Ube, Yamaguchi 755‑8505, Japan, Department of Gastroenterology, National Hospital Organization Takasaki General Medical Center, Takasaki, Gunma 370‑0829, Japan, Department of Gastroenterology and Hepatology, Okayama University Hospital, Okayama 700‑8558, Japan
    Copyright: © Shimose et al. This is an open access article distributed under the terms of Creative Commons Attribution License.
  • Article Number: 397
    |
    Published online on: June 25, 2024
       https://doi.org/10.3892/ol.2024.14530
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Abstract

Although durvalumab plus tremelimumab (Dur/Tre) has been approved as first‑line therapy for patients with unresectable hepatocellular carcinoma (u‑HCC), its outcomes in real‑world clinical practice are unclear. The present study aimed to evaluate the efficacy and safety of Dur/Tre treatment. This multicenter study was conducted between March 2023 and January 2024, and included 120 patients with u‑HCC treated with Dur/Tre. Among the patients, 44 had no history of systemic treatment. Progression‑free survival (PFS), therapeutic response and adverse events (AEs) were assessed. The objective response rate (ORR) and disease control rates (DCR) were 15.8 and 53.3%, respectively. The median PFS was 3.9 months. The incidence rates of AEs of any grade and those grade 3 or higher were 83.3 and 36.7%, respectively. Liver injury was the most frequent AE of any grade and grade 3 or higher. Although there was no significant difference in ORR and PFS between the first and later line groups (ORR 15.8 vs. 15.7%, P=0.986; PFS 4.5 vs. 3.6 months, P=0.213), there was a significant difference in DCR between the two groups (65.8 vs. 45.9%, P=0.034). No significant differences were noted between the first‑ and later‑line treatment groups regarding the incidence rate of AEs. Decision tree analysis revealed that poor liver function and advanced age were significant variables for discontinuation owing to AEs. In conclusion, Dur/Tre as first‑line therapy had better disease control responses compared with later‑line therapy; however, this regimen should be carefully administered to patients with deteriorating hepatic function or advanced ag9
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Copy and paste a formatted citation
Spandidos Publications style
Shimose S, Saeki I, Tomonari T, Ito T, Tani J, Takeuchi Y, Yoshioka N, Naito T, Takeuchi M, Kakizaki S, Kakizaki S, et al: Initial clinical experience with durvalumab plus tremelimumab in patients with unresectable hepatocellular carcinoma in real‑world practice. Oncol Lett 28: 397, 2024.
APA
Shimose, S., Saeki, I., Tomonari, T., Ito, T., Tani, J., Takeuchi, Y. ... Kawaguchi, T. (2024). Initial clinical experience with durvalumab plus tremelimumab in patients with unresectable hepatocellular carcinoma in real‑world practice. Oncology Letters, 28, 397. https://doi.org/10.3892/ol.2024.14530
MLA
Shimose, S., Saeki, I., Tomonari, T., Ito, T., Tani, J., Takeuchi, Y., Yoshioka, N., Naito, T., Takeuchi, M., Kakizaki, S., Hatanaka, T., Sasaki, K., Yasunaka, T., Sakata, M., Iwamoto, H., Itano, S., Shirono, T., Tanabe, N., Yamamoto, T., Naganuma, A., Nishina, S., Otsuka, M., Kawashima, H., Takayama, T., Takami, T., Kawaguchi, T."Initial clinical experience with durvalumab plus tremelimumab in patients with unresectable hepatocellular carcinoma in real‑world practice". Oncology Letters 28.2 (2024): 397.
Chicago
Shimose, S., Saeki, I., Tomonari, T., Ito, T., Tani, J., Takeuchi, Y., Yoshioka, N., Naito, T., Takeuchi, M., Kakizaki, S., Hatanaka, T., Sasaki, K., Yasunaka, T., Sakata, M., Iwamoto, H., Itano, S., Shirono, T., Tanabe, N., Yamamoto, T., Naganuma, A., Nishina, S., Otsuka, M., Kawashima, H., Takayama, T., Takami, T., Kawaguchi, T."Initial clinical experience with durvalumab plus tremelimumab in patients with unresectable hepatocellular carcinoma in real‑world practice". Oncology Letters 28, no. 2 (2024): 397. https://doi.org/10.3892/ol.2024.14530
Copy and paste a formatted citation
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Spandidos Publications style
Shimose S, Saeki I, Tomonari T, Ito T, Tani J, Takeuchi Y, Yoshioka N, Naito T, Takeuchi M, Kakizaki S, Kakizaki S, et al: Initial clinical experience with durvalumab plus tremelimumab in patients with unresectable hepatocellular carcinoma in real‑world practice. Oncol Lett 28: 397, 2024.
APA
Shimose, S., Saeki, I., Tomonari, T., Ito, T., Tani, J., Takeuchi, Y. ... Kawaguchi, T. (2024). Initial clinical experience with durvalumab plus tremelimumab in patients with unresectable hepatocellular carcinoma in real‑world practice. Oncology Letters, 28, 397. https://doi.org/10.3892/ol.2024.14530
MLA
Shimose, S., Saeki, I., Tomonari, T., Ito, T., Tani, J., Takeuchi, Y., Yoshioka, N., Naito, T., Takeuchi, M., Kakizaki, S., Hatanaka, T., Sasaki, K., Yasunaka, T., Sakata, M., Iwamoto, H., Itano, S., Shirono, T., Tanabe, N., Yamamoto, T., Naganuma, A., Nishina, S., Otsuka, M., Kawashima, H., Takayama, T., Takami, T., Kawaguchi, T."Initial clinical experience with durvalumab plus tremelimumab in patients with unresectable hepatocellular carcinoma in real‑world practice". Oncology Letters 28.2 (2024): 397.
Chicago
Shimose, S., Saeki, I., Tomonari, T., Ito, T., Tani, J., Takeuchi, Y., Yoshioka, N., Naito, T., Takeuchi, M., Kakizaki, S., Hatanaka, T., Sasaki, K., Yasunaka, T., Sakata, M., Iwamoto, H., Itano, S., Shirono, T., Tanabe, N., Yamamoto, T., Naganuma, A., Nishina, S., Otsuka, M., Kawashima, H., Takayama, T., Takami, T., Kawaguchi, T."Initial clinical experience with durvalumab plus tremelimumab in patients with unresectable hepatocellular carcinoma in real‑world practice". Oncology Letters 28, no. 2 (2024): 397. https://doi.org/10.3892/ol.2024.14530
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