Persano Mara, Casadei-Gardini Andrea, Tada Toshifumi, Suda Goki, Shimose Shigeo, Kudo Masatoshi, Rossari Federico, Yoo Changhoon, Cheon Jaekyung, Finkelmeier Fabian, Lim Ho Yeong, Presa José, Masi Gianluca, Bergamo Francesca, Amadeo Elisabeth, Vitiello Francesco, Kumada Takashi, Sakamoto Naoya, Iwamoto Hideki, Aoki Tomoko, Chon Hong Jae, Himmelsbach Vera, Iavarone Massimo Alberto, Cabibbo Giuseppe, Montes Margarida, Foschi Francesco Giuseppe, Vivaldi Caterina, Soldà Caterina, Sho Takuya, Niizeki Takashi, Nishida Naoshi, Steup Christoph, Bruccoleri Mariangela, Hirooka Masashi, Kariyama Kazuya, Tani Joji, Atsukawa Masanori, Takaguchi Koichi, Itobayashi Ei, Tsuji Kunihiko, Ishikawa Toru, Tajiri Kazuto, Ochi Hironori, Yasuda Satoshi, Toyoda Hidenori, Ogawa Chikara, Nishimura Takashi, Hatanaka Takeshi, Kakizaki Satoru, Shimada Noritomo, Kawata Kazuhito, Hiraoka Atsushi, Tada Fujimasa, Ohama Hideko, Nouso Kazuhiro, Morishita Asahiro, Tsutsui Akemi, Nagano Takuya, Itokawa Norio, Okubo Tomomi, Imai Michitaka, Kosaka Hisashi, Naganuma Atsushi, Koizumi Yohei, Nakamura Shinichiro, Kaibori Masaki, Iijima Hiroko, Hiasa Yoichi, Mascia Luigi, Foti Silvia, Camera Silvia, Piscaglia Fabio, Scartozzi Mario, Cascinu Stefano, Rimini Margherita
Medical Oncology, A. Businco Cancer Center, A. R. N. A. S. Brotzu, Cagliari, Italy.
Department of Biomedical Sciences, University of Cagliari, Cagliari, Italy.
Oncology. 2025;103(6):456-468. doi: 10.1159/000541018. Epub 2024 Oct 11.
INTRODUCTION: The most frequently used first-line treatment in patients with advanced hepatocellular carcinoma (HCC) is atezolizumab plus bevacizumab. Upon progression after this treatment, the standard of care in many countries is sorafenib, due to the lack of reimbursement for other drugs. Several randomized trials are currently underway to clarify the best second-line therapy in patients with HCC. This real-world study aimed to compare outcomes reached by lenvatinib and sorafenib second-line therapy in this setting. METHODS: The overall cohort included 891 patients with HCC from 5 countries treated with atezolizumab plus bevacizumab in first-line setting between October 2018 and April 2022. At the data cut-off (May 2022), 41.5% of patients were continuing a first-line treatment, 5.5% were lost at follow-up, and 53.0% of patients had progressive disease after first-line therapy. 51.5% of patients with progressive disease received a second-line treatment, while 48.5% did not receive any subsequent therapy. Between patients receiving second-line treatment, 11.1% of patients underwent transarterial chemoembolization, 21.0% received sorafenib, 35.4% underwent lenvatinib, and 32.5% were treated with other drugs. RESULTS: Lenvatinib second-line subgroup achieved a median overall survival (mOS) of 18.9 months, significative longer (p = 0.01; hazard ratio [HR]: 2.24) compared to sorafenib subgroup that reached a mOS of 14.3 months. The multivariate analysis highlighted albumin-bilirubin 1 grade (p < 0.01; HR: 5.23) and lenvatinib second-line therapy (p = 0.01; HR: 2.18) as positive prognostic factors for OS. The forest plot highlighted a positive trend in terms of OS in favor of patients treated with lenvatinib second-line regardless of baseline characteristics before first-line therapy. CONCLUSION: These results suggest that, in patients with HCC progressed to first-line atezolizumab plus bevacizumab, lenvatinib second-line therapy is associated to an improved survival compared to sorafenib.
引言：晚期肝细胞癌（HCC）患者最常用的一线治疗方案是阿替利珠单抗联合贝伐珠单抗。该治疗进展后，由于其他药物未纳入医保报销范围，许多国家的标准治疗方案是索拉非尼。目前正在进行多项随机试验，以明确HCC患者的最佳二线治疗方案。这项真实世界研究旨在比较乐伐替尼和索拉非尼在这种情况下二线治疗的疗效。 方法：整个队列包括来自5个国家的891例HCC患者，他们在2018年10月至2022年4月期间接受了一线阿替利珠单抗联合贝伐珠单抗治疗。在数据截止时（2022年5月），41.5%的患者继续接受一线治疗，5.5%的患者失访，53.0%的患者在一线治疗后出现疾病进展。51.5%的疾病进展患者接受了二线治疗，而48.5%的患者未接受任何后续治疗。在接受二线治疗的患者中，11.1%的患者接受了经动脉化疗栓塞，21.0%的患者接受了索拉非尼治疗，35.4%的患者接受了乐伐替尼治疗，32.5%的患者接受了其他药物治疗。 结果：乐伐替尼二线治疗亚组的中位总生存期（mOS）为18.9个月，显著长于索拉非尼亚组的14.3个月（p = 0.01；风险比[HR]：2.24）。多因素分析显示，白蛋白-胆红素1级（p < 0.01；HR：5.23）和乐伐替尼二线治疗（p = 0.01；HR：2.18）是总生存期的阳性预后因素。森林图显示，无论一线治疗前的基线特征如何，接受乐伐替尼二线治疗的患者在总生存期方面呈阳性趋势。 结论：这些结果表明，在一线阿替利珠单抗联合贝伐珠单抗治疗进展的HCC患者中，乐伐替尼二线治疗与索拉非尼相比可改善生存期。
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