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

IF 4.4 3区医学 Q2 ONCOLOGY Targeted Oncology Pub Date : 2024-04-30 DOI:10.1007/s11523-024-01061-0

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..

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Abstract

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.

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不良事件是阿特珠单抗联合贝伐单抗治疗晚期肝癌患者的潜在活性预测因素

背景在接受全身治疗的肝细胞癌（HCC）患者中，不良事件（AEs）的出现与所报告的疗效结果之间的相关性是众所周知的，并且得到了广泛的研究。这项回顾性多中心真实世界研究旨在探讨阿特珠单抗联合贝伐单抗一线治疗 HCC 患者的 AEs 的潜在预后价值。结果73.3%的患者在研究期间至少出现过一次AE。最常见的不良反应是蛋白尿（29.6%）、动脉高血压（27.2%）和疲劳（26.0%）。总共有 17.3% 的 AE 为 3 级（G）。多变量分析证实出现了食欲下降 G < 2 [与 G ≥ 2 相比；危险比 (HR) 0.60; 95% 置信区间 (CI) 0.13-0.90; p < 0.01]和免疫毒性 G < 2 (与 G ≥ 2 相比；HR：0.70; 95% CI 0.24-0.99; p = 0.04)为总生存期的独立预后因素，出现食欲下降 G < 2 (versus G ≥ 2; HR: 0.73; 95% CI 0.43-0.95; p = 0.01)、腹泻 (有与无; HR: 0.57, 95% CI 0.38-0.85; p = 0.01）、乏力（是与否；HR：0.82，95% CI 0.65-0.95；p <；0.01）、动脉高血压 G <；2（与 G ≥ 2；HR：0.68，95% CI 0.52-0.87；p <；0.01）和蛋白尿（是与否；HR：0.79，95% CI 0.64-0.98；p = 0.结论正如其他疗法一样，阿特珠单抗联合贝伐珠单抗治疗HCC患者的AEs发生率与预后之间也存在相关性。

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来源期刊

Targeted Oncology 医学-肿瘤学

CiteScore

8.40

自引率

3.70%

发文量

审稿时长

>12 weeks

期刊介绍： Targeted Oncology addresses physicians and scientists committed to oncology and cancer research by providing a programme of articles on molecularly targeted pharmacotherapy in oncology. The journal includes: Original Research Articles on all aspects of molecularly targeted agents for the treatment of cancer, including immune checkpoint inhibitors and related approaches. Comprehensive narrative Review Articles and shorter Leading Articles discussing relevant clinically established as well as emerging agents and pathways. Current Opinion articles that place interesting areas in perspective. Therapy in Practice articles that provide a guide to the optimum management of a condition and highlight practical, clinically relevant considerations and recommendations. Systematic Reviews that use explicit, systematic methods as outlined by the PRISMA statement. Adis Drug Reviews of the properties and place in therapy of both newer and established targeted drugs in oncology.