度伐利尤单抗联合曲美木单抗治疗不可切除肝细胞癌的早期临床结果：与一线或二线治疗的真实世界比较
Early Clinical Outcomes of Durvalumab Plus Tremelimumab in Unresectable Hepatocellular Carcinoma: A Real-World Comparison with First-Line or Later-Line Treatment.
作者信息
Fujiwara Yudai, Kuroda Hidekatsu, Abe Tamami, Kakisaka Keisuke, Nakaya Ippeki, Ito Asami, Watanabe Takuya, Yusa Kenji, Nagasawa Tomoaki, Sato Hiroki, Suzuki Akiko, Endo Kei, Yoshida Yuichi, Oikawa Takayoshi, Sawara Kei, Miyasaka Akio, Matsumoto Takayuki
机构信息
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Iwate Medical University, 2-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate, 028-3694, Japan.
出版信息
Drugs Real World Outcomes. 2024 Dec;11(4):701-710. doi: 10.1007/s40801-024-00458-7. Epub 2024 Oct 10.
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.
背景与目的
度伐利尤单抗联合曲美木单抗（Durva/Treme）最近在日本被批准用于不可切除肝细胞癌（u-HCC）患者的一线或二线治疗。我们评估了Durva/Treme治疗u-HCC的真实世界疗效，重点关注治疗效果和安全性。
方法
我们回顾性评估了2023年至2024年期间在岩手医科大学接受Durva/Treme治疗的22例u-HCC患者，并比较了接受Durva/Treme一线和二线治疗患者的临床结局。我们还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例患者，二线治疗组有12例患者。在中位随访期7.6个月期间，两组的中位无进展生存期（一线治疗组与二线治疗组：4.7个月对2.9个月，p = 0.85）、客观缓解率（0.0%对16.7%，p = 0.48）、疾病控制率（60.0%对58.4%，p = 1.00）以及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u-HCC患者可能有效且安全，即使是接受Durva/Treme作为二线治疗的患者。
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