Kaneko Shun, Tsuchiya Kaoru, Kurosaki Masayuki, Kirino Sakura, Inada Kento, Yamashita Koji, Osawa Leona, Hayakawa Yuka, Sekiguchi Shuhei, Watakabe Keiya, Okada Mao, Wang Wan, Shimizu Takao, Higuchi Mayu, Takaura Kenta, Maeyashiki Chiaki, Tamaki Nobuharu, Yasui Yutaka, Takeguchi Takaya, Takeguchi Yuko, Nakanishi Hiroyuki, Itakura Jun, Takahashi Yuka, Himeno Yoshiro, Izumi Namiki
Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Tokyo, Japan.
Department of Radiology, Musashino Red Cross Hospital, Tokyo, Japan.
Hepatol Res. 2020 Jan;50(1):137-143. doi: 10.1111/hepr.13416. Epub 2019 Sep 6.
Lenvatinib (LEN) is a newly approved, multikinase inhibitor for treating unresectable hepatocellular carcinoma. In the present study, we investigated the impact of three different criteria for evaluating radiological objective response (OR) on overall survival in real-world data.
Consent for LEN therapy was obtained from 51 patients from April 2018 to March 2019. A total of 40 patients who received a minimal cumulative duration of 4 weeks of LEN were included in the analysis. Enhanced computed tomography scan was performed at baseline and every 4-8 weeks after LEN administration. Overall survival and OR were assessed with three different evaluations, as follows: Response Evaluation Criteria in Solid Tumors 1.1, modified Response Evaluation Criteria in Solid Tumors, and Choi criteria.
The average observation period for all participants after LEN introduction was 209.4 ± 77.5 days. The Response Evaluation Criteria in Solid Tumors 1.1, modified Response Evaluation Criteria in Solid Tumors, and Choi criteria identified 10 of 40 (25.0%), 15 of 40 (37.5%), and 18of 40 (45.0%) patients with OR, respectively. The median overall survival in progressive disease evaluated by each criterion was 227 days. This result was significantly shorter than OR. Furthermore, the cumulative duration of LEN administration (>150 days) represented a significant prognostic factor (HR 0.160. 95% CI 0.039-0.646, P = 0.001).
The Response Evaluation Criteria in Solid Tumors 1.1, modified Response Evaluation Criteria in Solid Tumors, and Choi criteria were useful therapeutic evaluation methods in LEN therapy for unresectable hepatocellular carcinoma. LEN's appropriate effect evaluation and management might lead to a better prognosis.
仑伐替尼（LEN）是一种新获批的用于治疗不可切除肝细胞癌的多激酶抑制剂。在本研究中，我们在真实世界数据中调查了三种不同的评估影像学客观缓解（OR）的标准对总生存期的影响。
2018年4月至2019年3月期间，从51例患者处获得了仑伐替尼治疗的知情同意。共有40例接受至少4周仑伐替尼治疗的患者纳入分析。在基线时以及仑伐替尼给药后每4 - 8周进行增强计算机断层扫描。采用以下三种不同的评估方法评估总生存期和OR：实体瘤疗效评价标准1.1版、改良实体瘤疗效评价标准以及Choi标准。
所有参与者在引入仑伐替尼后的平均观察期为209.4±77.5天。实体瘤疗效评价标准1.1版、改良实体瘤疗效评价标准以及Choi标准分别在40例患者中识别出10例（25.0%）、15例（37.5%）和18例（45.0%）达到OR的患者。每种标准评估的疾病进展患者的中位总生存期为227天。这一结果显著短于达到OR的患者。此外，仑伐替尼给药的累积持续时间（>150天）是一个显著的预后因素（HR 0.16，95%CI 0.039 - 0.646，P = 0.001）。
实体瘤疗效评价标准1.1版、改良实体瘤疗效评价标准以及Choi标准是不可切除肝细胞癌仑伐替尼治疗中有用的疗效评估方法。对仑伐替尼进行恰当的疗效评估和管理可能会带来更好的预后。
