University of California, San Francisco, San Francisco, CA.
American Society of Clinical Oncology, Alexandria, VA.
J Clin Oncol. 2020 Dec 20;38(36):4317-4345. doi: 10.1200/JCO.20.02672. Epub 2020 Nov 16.
To develop an evidence-based clinical practice guideline to assist in clinical decision making for patients with advanced hepatocellular carcinoma (HCC).
ASCO convened an Expert Panel to conduct a systematic review of published phase III randomized controlled trials (2007-2020) on systemic therapy for advanced HCC and provide recommended care options for this patient population.
Nine phase III randomized controlled trials met the inclusion criteria.
Atezolizumab + bevacizumab (atezo + bev) may be offered as first-line treatment of most patients with advanced HCC, Child-Pugh class A liver disease, Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1, and following management of esophageal varices, when present, according to institutional guidelines. Where there are contraindications to atezolizumab and/or bevacizumab, tyrosine kinase inhibitors sorafenib or lenvatinib may be offered as first-line treatment of patients with advanced HCC, Child-Pugh class A liver disease, and ECOG PS 0-1. Following first-line treatment with atezo + bev, and until better data are available, second-line therapy with a tyrosine kinase inhibitor may be recommended for appropriate candidates. Following first-line therapy with sorafenib or lenvatinib, second-line therapy options for appropriate candidates include cabozantinib, regorafenib for patients who previously tolerated sorafenib, or ramucirumab (for patients with α-fetoprotein ≥ 400 ng/mL), or atezo + bev where patients did not have access to this option as first-line therapy. Pembrolizumab or nivolumab are also reasonable options for appropriate patients following sorafenib or lenvatinib. Consideration of nivolumab + ipilimumab as an option for second-line therapy and third-line therapy is discussed. Further guidance on choosing between therapy options is included within the guideline. Additional information is available at www.asco.org/gastrointestinal-cancer-guidelines.
制定基于循证医学的临床实践指南,以协助为晚期肝细胞癌(HCC)患者做出临床决策。
ASCO 召集专家小组,对发表于 2007 年至 2020 年的晚期 HCC 系统治疗的 III 期随机对照试验进行系统评价,并为该患者人群提供推荐的护理方案。
符合纳入标准的 III 期随机对照试验有 9 项。
对于大多数晚期 HCC、Child-Pugh 肝功能 A 级、ECOG PS 0-1,以及根据机构指南处理存在的食管静脉曲张后患者,可选择阿替利珠单抗联合贝伐珠单抗(atezo + bev)作为一线治疗方案。对于存在阿替利珠单抗和/或贝伐珠单抗禁忌证的患者,可选择索拉非尼或仑伐替尼作为一线治疗方案。一线治疗后,根据患者情况,可考虑用酪氨酸激酶抑制剂作为二线治疗方案。在接受 atezo + bev 一线治疗后,在更好的数据出现之前,建议适当的患者选择酪氨酸激酶抑制剂进行二线治疗。在接受索拉非尼或仑伐替尼一线治疗后,适当的患者二线治疗方案包括卡博替尼、曾耐受索拉非尼的患者使用regorafenib,或阿特珠单抗(对于 AFP≥400ng/mL 的患者),或在一线治疗中未使用该方案的患者使用 atezo + bev。对于适当的患者,帕博利珠单抗或纳武利尤单抗也是合理的选择。讨论了 nivolumab + ipilimumab 作为二线和三线治疗方案的选择。该指南中还包括了在治疗方案选择之间的进一步指导。更多信息可在 www.asco.org/gastrointestinal-cancer-guidelines 上获取。