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Adverse Events as Potential Predictive Factors of Activity in Patients with Advanced HCC Treated with Atezolizumab Plus Bevacizumab

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2024年4月30日

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  • Mara Persano,
  • Margherita Rimini,
  • Toshifumi Tada,
  • Goki Suda,
  • Shigeo Shimose,
  • Masatoshi Kudo,
  • Federico Rossari,
  • Changhoon Yoo,
  • Jaekyung Cheon,
  • Fabian Finkelmeier,
  • Ho Yeong Lim,
  • José Presa,
  • Gianluca Masi,
  • Francesca Bergamo,
  • Elisabeth Amadeo,
  • Francesco Vitiello,
  • Takashi Kumada,
  • Naoya Sakamoto,
  • Hideki Iwamoto,
  • Tomoko Aoki,
  • Hong Jae Chon,
  • Vera Himmelsbach,
  • Massimo Alberto Iavarone,
  • Giuseppe Cabibbo,
  • Margarida Montes,
  • Francesco Giuseppe Foschi,
  • Caterina Vivaldi,
  • Caterina Soldà,
  • Takuya Sho,
  • Takashi Niizeki,
  • Naoshi Nishida,
  • Christoph Steup,
  • Mariangela Bruccoleri,
  • Masashi Hirooka,
  • Kazuya Kariyama,
  • Joji Tani,
  • Masanori Atsukawa,
  • Koichi Takaguchi,
  • Ei Itobayashi,
  • Shinya Fukunishi,
  • Kunihiko Tsuji,
  • Toru Ishikawa,
  • Kazuto Tajiri,
  • Hironori Ochi,
  • Satoshi Yasuda,
  • Hidenori Toyoda,
  • Chikara Ogawa,
  • Takashi Nishimura,
  • Takeshi Hatanaka,
  • Satoru Kakizaki,
  • Noritomo Shimada,
  • Kazuhito Kawata,
  • Atsushi Hiraoka,
  • Fujimasa Tada,
  • Hideko Ohama,
  • Kazuhiro Nouso,
  • Asahiro Morishita,
  • Akemi Tsutsui,
  • Takuya Nagano,
  • Norio Itokawa,
  • Tomomi Okubo,
  • Michitaka Imai,
  • Hisashi Kosaka,
  • Atsushi Naganuma,
  • Yohei Koizumi,
  • Shinichiro Nakamura,
  • Masaki Kaibori,
  • Hiroko Iijima,
  • Yoichi Hiasa,
  • Silvia Foti,
  • Silvia Camera,
  • Fabio Piscaglia,
  • Mario Scartozzi,
  • Stefano Cascinu,
  • Andrea Casadei-Gardini

摘要

Background

In the context of patients with hepatocellular carcinoma (HCC) treated with systemic therapy, the correlation between the appearance of adverse events (AEs) and reported efficacy outcomes is well-known and widely investigated. From other pathological settings, we are aware of the prognostic and predictive value of the occurrence of immune-related AEs in patients treated with immune-checkpoint inhibitors.

Objective

This retrospective multicenter real-world study aims to investigate the potential prognostic value of AEs in patients with HCC treated with atezolizumab plus bevacizumab in the first-line setting.

Patients and methods

The study population consisted of 823 patients from five countries (Italy, Germany, Portugal, Japan, and the Republic of Korea).

Results

Of the patients, 73.3% presented at least one AE during the study period. The most common AEs were proteinuria (29.6%), arterial hypertension (27.2%), and fatigue (26.0%). In all, 17.3% of the AEs were grade (G) 3. One death due to bleeding was reported. The multivariate analysis confirmed the appearance of decreased appetite G < 2 [versus G ≥ 2; hazard ratio (HR) 0.60; 95% confidence interval (CI) 0.13–0.90; p < 0.01] and immunotoxicity G < 2 (versus G ≥ 2; HR: 0.70; 95% CI 0.24–0.99; p = 0.04) as independent prognostic factors for overall survival, and the appearance of decreased appetite G < 2 (versus G ≥ 2; HR: 0.73; 95% CI 0.43–0.95; p = 0.01), diarrhea (yes versus no; HR: 0.57, 95% CI 0.38–0.85; p = 0.01), fatigue (yes versus no; HR: 0.82, 95% CI 0.65–0.95; p < 0.01), arterial hypertension G < 2 (versus G ≥ 2; HR: 0.68, 95% CI 0.52–0.87; p < 0.01), and proteinuria (yes versus no; HR: 0.79, 95% CI 0.64–0.98; p = 0.03) as independent prognostic factors for progression-free survival.

Conclusions

As demonstrated for other therapies, there is also a correlation between the occurrence of AEs and outcomes for patients with HCC for the combination of atezolizumab plus bevacizumab.