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Background <p>Immune-mediated adverse events (imAEs) are a significant concern in patients with unresectable hepatocellular carcinoma (uHCC) undergoing combination immunotherapy with durvalumab and tremelimumab (Dur/Tre). This study aimed to investigate the potential association of risk factors, particularly nutrition and immune markers, associated with the development of imAEs.</p> Methods <p>Between November 2022 and December 2024, 312 patients with uHCC treated with Dur/Tre were enrolled and retrospectively analyzed. Clinical characteristics, inflammatory markers, and nutritional indices (Geriatric Nutritional Risk Index [GNRI], body mass index, Prognostic Nutritional Index-Onodera, C-reactive protein-to-albumin ratio, neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio) were evaluated to identify predictors for imAE development.</p> Results <p>The imAEs occurred in 122 patients (39.1%), most commonly affecting dermatological, gastrointestinal, and endocrine systems. On multivariate analysis, only normal GNRI (≥ 98) was independently associated with a higher incidence of imAE (odds ratio: 1.99, 95% confidence interval: 1.05–3.79, <i>P</i> = 0.036). Patients with GNRI ≥ 98 also showed better overall survival (OS) than those with GNRI &lt; 98 (not reached vs. 12.5 months, <i>P</i> &lt; 0.001). Among patients who developed imAEs, no significant differences were observed in the imAE types or high-dose steroid use between the GNRI ≥ 98 group (<i>n</i> = 66) and the GNRI &lt; 98 group (<i>n</i> = 56) (40.9% vs. 58.9%, <i>P</i> = 0.069).</p> Conclusions <p>Normal GNRI status (≥ 98) was associated with an increased risk of imAE development and improved OS in patients with uHCC receiving Dur/Tre therapy. GNRI may be a useful clinical factor for identifying patients at higher risk of developing imAEs.</p>

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Potential role of Geriatric Nutritional Risk Index as a risk factor for immune-mediated adverse events during durvalumab plus tremelimumab therapy in unresectable hepatocellular carcinoma

  • 期刊论文

  • 发表日期：

    2025年8月20日

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  • Hideko Ohama,
  • Atsushi Hiraoka,
  • Toshifumi Tada,
  • Masashi Hirooka,
  • Kazuya Kariyama,
  • Joji Tani,
  • Masanori Atsukawa,
  • Koichi Takaguchi,
  • Ei Itobayashi,
  • Shinya Fukunishi,
  • Kunihiko Tsuji,
  • Toru Ishikawa,
  • Kazuto Tajiri,
  • Hironori Tanaka,
  • Hidenori Toyoda,
  • Chikara Ogawa,
  • Takashi Nishimura,
  • Takeshi Hatanaka,
  • Satoru Kakizaki,
  • Kazuhito Kawata,
  • Atsushi Naganuma,
  • Hisashi Kosaka,
  • Tomomitsu Matono,
  • Hidekatsu Kuroda,
  • Yutaka Yata,
  • Hiroki Nishikawa,
  • Michitaka Imai,
  • Tomoko Aoki,
  • Hironori Ochi,
  • Hideyuki Tamai,
  • Shohei Komatsu,
  • Fujimasa Tada,
  • Shinichiro Nakamura,
  • Yoshiko Nakamura,
  • Teruki Miyake,
  • Osamu Yoshida,
  • Kazuhiro Nouso,
  • Asahiro Morishita,
  • Norio Itokawa,
  • Tomomi Okubo,
  • Taeang Arai,
  • Akemi Tsutsui,
  • Takuya Nagano,
  • Kazunari Tanaka,
  • Takanori Matsuura,
  • Yuichi Koshiyama,
  • Yuki Kanayama,
  • Hidenao Noritake,
  • Hirayuki Enomoto,
  • Kosuke Matsui,
  • Masaki Kaibori,
  • Takumi Fukumoto,
  • Yoichi Hiasa,
  • Masatoshi Kudo,
  • Takashi Kumada

摘要

Background

Immune-mediated adverse events (imAEs) are a significant concern in patients with unresectable hepatocellular carcinoma (uHCC) undergoing combination immunotherapy with durvalumab and tremelimumab (Dur/Tre). This study aimed to investigate the potential association of risk factors, particularly nutrition and immune markers, associated with the development of imAEs.

Methods

Between November 2022 and December 2024, 312 patients with uHCC treated with Dur/Tre were enrolled and retrospectively analyzed. Clinical characteristics, inflammatory markers, and nutritional indices (Geriatric Nutritional Risk Index [GNRI], body mass index, Prognostic Nutritional Index-Onodera, C-reactive protein-to-albumin ratio, neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio) were evaluated to identify predictors for imAE development.

Results

The imAEs occurred in 122 patients (39.1%), most commonly affecting dermatological, gastrointestinal, and endocrine systems. On multivariate analysis, only normal GNRI (≥ 98) was independently associated with a higher incidence of imAE (odds ratio: 1.99, 95% confidence interval: 1.05–3.79, P = 0.036). Patients with GNRI ≥ 98 also showed better overall survival (OS) than those with GNRI < 98 (not reached vs. 12.5 months, P < 0.001). Among patients who developed imAEs, no significant differences were observed in the imAE types or high-dose steroid use between the GNRI ≥ 98 group (n = 66) and the GNRI < 98 group (n = 56) (40.9% vs. 58.9%, P = 0.069).

Conclusions

Normal GNRI status (≥ 98) was associated with an increased risk of imAE development and improved OS in patients with uHCC receiving Dur/Tre therapy. GNRI may be a useful clinical factor for identifying patients at higher risk of developing imAEs.