在 Lenvatinib 中添加 TACE 可提高肝癌患者的生存率

StephenW

在 Lenvatinib 中添加 TACE 可提高肝癌患者的生存率

Roxanne Nelson，注册护士，BSN

2022 年 1 月 25 日
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旧金山 — 在 3 期 LAUNCH 试验中，在晚期肝细胞癌 (HCC) 患者中，与单独使用乐凡替尼相比，在乐伐替尼 (Lenvima) 治疗中加入经动脉化疗栓塞 (TACE) 显着提高了生存率。

TACE 和 levantinib 的组合“代表了晚期 HCC 患者潜在的新一线治疗选择，”研究作者、医学博士、医学博士、肝胆外科和介入超声教授、第一附属癌症中心主任中山大学附属医院，广州，中国。

他说，这两种方法的结合“对晚期肝细胞癌患者是安全有效的，并且在总生存期、无进展生存期和总反应率以及可接受的毒性方面表现出显着改善”。

接受联合治疗的患者中位总生存期为 17.8 个月，而乐伐替尼组为 11.5 个月（HR，0.45；P < .001）。同样，中位无进展生存期也有利于乐伐替尼加 TACE：10.6 个月 vs 6.4 个月（HR，0.43；P < .001）。

研究结果在 2022 年胃肠癌研讨会 (GICS) 上公布。

在讨论摘要时，来自南加州大学洛杉矶诺里斯综合癌症中心的医学博士 Anthony B. El-Khoueiry 表示，这些结果“具有启发性”，他赞扬了研究人员开展这项研究。

“它加强了联合肝脏定向和全身治疗的可行性，”他说。

“然而，它不会改变美国的护理标准，”他警告说。

“全身治疗骨干不是护理标准，这项研究的设计并不是最佳答案，即在晚期 HCC 中添加肝导向治疗是否可以改善预后的问题，”他补充说。

EL-Khoueiry 指出，LAUNCH 试验的这些新结果与两项研究肝导向加全身治疗的研究形成鲜明对比。之前的两项研究都使用了索拉非尼，一项使用了 Y-90，另一项使用了传统的 TACE。

他说，这两项研究都是负面的。 “但这些研究与 LAUNCH 之间存在差异。”

除了他们使用索拉非尼而不是莱万替尼这一事实之外，另一个区别是 LAUNCH 的患者群体比其他两项研究中的患者群体更年轻。此外，LAUCH 试验中的大多数患者都患有乙型肝炎，并且与之前的研究相比，他们接受了更多的 TACE 治疗。 “人们可以争辩说，也许治疗选择更理想，”El-Khoueiry 评论道。

他还指出，“乐伐替尼的对照组表现不佳，因为在之前的试验中，索拉非尼的中位总生存期为 13-15 个月。我们原本预计乐伐替尼的表现至少一样好或更好。” （中位总生存期为 11.5 个月）。
联合治疗改善结果

LAUNCH 研究涉及来自中国 12 家医院的 338 名初治晚期 HCC 患者，他们被随机分配接受乐伐替尼联合 TACE（n = 170）或单独乐伐替尼（n = 168）。

StephenW

Adding TACE to Lenvatinib Improves Survival in Liver Cancer

Roxanne Nelson, RN, BSN

January 25, 2022
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SAN FRANCISCO — Adding transarterial chemoembolization (TACE) to treatment with lenvatinib (Lenvima) significantly improved survival compared to levantinib alone in patients with advanced hepatocellular carcinoma (HCC) in the phase 3 LAUNCH trial.

The combination of TACE and levantinib "represents a potential new first-line treatment option for patients with advanced HCC," said study author Ming Kuang, MD, PhD, professor in hepatobiliary surgery and interventional ultrasound and director of the cancer center in the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.

The combination of the two approaches was "safe and effective for patients with advanced hepatocellular carcinoma and demonstrated remarkable improvements in overall survival, progression-free survival, and overall response rate, as well as acceptable toxicity," he said.

Patients receiving combination therapy achieved a median overall survival of 17.8 months, compared with 11.5 months in the lenvatinib arm (HR, 0.45; P < .001). Similarly, median progression-free survival also favored lenvatinib plus TACE: 10.6 months vs 6.4 months (HR, 0.43; P < .001).

The study results were presented here at the Gastrointestinal Cancers Symposium (GICS) 2022.

Discussing the abstract, Anthony B. El-Khoueiry, MD, from the University of Southern California, Norris Comprehensive Cancer Center, Los Angeles, said the results are "intruiging," and he commended the researchers on carrying out this study.

"It reinforces the feasibility of combined liver directed and systemic therapy," he said.

"However, it does not change the standard of care in the US," he cautioned.

"Systemic therapy backbone is not the standard of care, and the design of this study was not optimal to answer the question of whether the addition of liver-directed therapy in advanced HCC improves outcomes," he added.

EL-Khoueiry pointed out that these new results from the LAUNCH trial contrast with two studies that looked at liver-directed plus a systemic therapy. Both of those previous studies used sorafenib, one utilizing Y-90 and the other conventional TACE.

Both of those studies were negative, he said. "But there were differences between these studies and LAUNCH."

Aside from the fact that they used sorafenib and not levantinib, another difference was that the patient population of LAUNCH was younger than in the other two studies. In addition, most patients in the LAUCH trial had hepatitis B, and they received a higher number of TACE treatments than in the previous studies. "One can argue that maybe treatment selection was more optimal," El-Khoueiry commented.

He also noted that "the control arm of lenvatinib underperformed, as sorafenib median overall survival in previous trials ranges from 13–15 months. We would have expected lenvatinib to perform at least as well or better." (The median overall survival was 11.5 months).
Improved Outcomes With Combination Therapy

The LAUNCH study involved 338 treatment-naive patients with advanced HCC from 12 hospitals in China who were randomly assigned to receive either lenvatinib plus TACE (n = 170) or lenvatinib alone (n = 168).

StephenW

https://www.medscape.com/viewarticle/967184#vp_1