Early Clinical Outcomes of Durvalumab Plus Tremelimumab in Unresectable Hepatocellular Carcinoma: A Real-World Comparison with First-Line or Later-Line Treatment.

IF 1.9 Q3 PHARMACOLOGY & PHARMACY

Drugs - Real World Outcomes Pub Date : 2024-10-10 DOI:10.1007/s40801-024-00458-7

Yudai Fujiwara, Hidekatsu Kuroda, Tamami Abe, Keisuke Kakisaka, Ippeki Nakaya, Asami Ito, Takuya Watanabe, Kenji Yusa, Tomoaki Nagasawa, Hiroki Sato, Akiko Suzuki, Kei Endo, Yuichi Yoshida, Takayoshi Oikawa, Kei Sawara, Akio Miyasaka, Takayuki Matsumoto

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引用次数: 0

Abstract

Background and objective: Durvalumab plus tremelimumab (Durva/Treme) has recently been approved as a first-line or later-line treatment for patients with unresectable hepatocellular carcinoma (u-HCC) in Japan. We assessed the real-world outcomes of Durva/Treme for u-HCC, with a focus on treatment efficacy and safety.

Methods: We retrospectively evaluated 22 patients with u-HCC treated with Durva/Treme at Iwate Medical University during the period from 2023 to 2024, with a comparison of the clinical outcomes between patients who received Durva/Treme as first-line and later-line treatments. We further evaluated changes in the modified albumin-bilirubin (mALBI) grade during treatment.

Results: There were 10 patients in the first-line group and 12 patients in the later-line treatment group. During the follow-up with a median duration of 7.6 months, the median progression-free survival (first-line versus later-line: 4.7 months versus 2.9 months, p = 0.85), the objective response rate (0.0% versus 16.7%, p = 0.48), the disease control rate (60.0% versus 58.4%, p = 1.00), and the incidence of any adverse event (50.0% versus 75.0%, p = 0.38) were not statistically different between the two groups. The changes in the mALBI scores were not statistically significant (p = 0.75).

Conclusions: Durva/Treme may be effective and safe for patients with u-HCC, even in patients who receive Durva/Treme as a later-line treatment.

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Durvalumab联合Tremelimumab治疗不可切除肝细胞癌的早期临床疗效：与一线治疗或后线治疗的真实世界比较。

背景和目的：最近，日本批准了Durvalumab加tremelimumab（Durva/Treme）作为不可切除肝细胞癌（u-HCC）患者的一线或二线治疗方案。我们评估了Durva/Treme治疗u-HCC的实际疗效，重点关注疗效和安全性：我们对岩手医科大学在 2023 年至 2024 年期间接受 Durva/Treme 治疗的 22 例 u-HCC 患者进行了回顾性评估，比较了接受 Durva/Treme 一线治疗和二线治疗患者的临床疗效。我们进一步评估了治疗期间改良白蛋白胆红素（mALBI）分级的变化：结果：一线治疗组有 10 名患者，后期治疗组有 12 名患者。在中位持续时间为 7.6 个月的随访期间，两组患者的中位无进展生存期（一线组对后线组：4.7 个月对 2.9 个月，p = 0.85）、客观反应率（0.0% 对 16.7%，p = 0.48）、疾病控制率（60.0% 对 58.4%，p = 1.00）和任何不良事件的发生率（50.0% 对 75.0%，p = 0.38）均无统计学差异。mALBI评分的变化无统计学意义（p = 0.75）：结论：Durva/Treme对尿毒症肝癌患者可能有效且安全，即使是作为后期治疗接受Durva/Treme的患者也是如此。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Drugs - Real World Outcomes PHARMACOLOGY & PHARMACY-

CiteScore

3.60

自引率

5.00%

发文量

审稿时长

8 weeks

期刊介绍： Drugs - Real World Outcomes targets original research and definitive reviews regarding the use of real-world data to evaluate health outcomes and inform healthcare decision-making on drugs, devices and other interventions in clinical practice. The journal includes, but is not limited to, the following research areas: Using registries/databases/health records and other non-selected observational datasets to investigate: drug use and treatment outcomes prescription patterns drug safety signals adherence to treatment guidelines benefit : risk profiles comparative effectiveness economic analyses including cost-of-illness Data-driven research methodologies, including the capture, curation, search, sharing, analysis and interpretation of ‘big data’ Techniques and approaches to optimise real-world modelling.