Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan; Graduate Institute of Oncology, National Taiwan University College of Medicine, Taipei, Taiwan.
Department of Medical Imaging, National Taiwan University Hospital, Taipei, Taiwan; Department of Medical Imaging, National Taiwan University Hospital, Hsin-Chu Branch, Hsinchu, Taiwan.
J Hepatol. 2014 Feb;60(2):313-8. doi: 10.1016/j.jhep.2013.08.027. Epub 2013 Sep 12.
BACKGROUND & AIMS: No approved therapy is available for patients with advanced hepatocellular carcinoma (HCC) who fail first-line therapy. The prognosis of these patients, especially those eligible for clinical trials of second-line therapy, is unclear.
All patients who participated in clinical trials of first-line systemic therapy for metastatic or locally advanced HCC in a referral center of Taiwan between 2005 and 2011 were included. Their clinicopathologic characteristics, when the first-line treatment failed, were analyzed and correlated with the overall survival (OS) from the date of first-line treatment failure.
A total of 192 patients were included. Before the start of the first-line therapy, all patients had Child-Pugh class A liver reserves and Cancer of the Liver Italian Program (CLIP) scores ≤4. After the failure of the first-line therapy, the median OS of the entire group was 4.0 months. Patients with Child-Pugh class A liver reserves, when the first-line treatment failed, had significantly better OS than patients with Child-Pugh class B or C liver reserves (median, A vs. B vs. C=7.5 vs. 1.3 vs. 1.0 month, p<0.001). According to the key eligibility criteria of 3 published clinical trials for second-line therapy, 41%-56% of patients were potentially eligible. Compared to patients who were ineligible for clinical trials, potentially eligible patients had longer OS with a median of 7.8-8.6 months.
Patients with advanced HCC who failed first-line therapy could have substantially improved prognosis if they had Child-Pugh A liver reserves or were potentially eligible for clinical trials.
对于一线治疗失败的晚期肝细胞癌（HCC）患者，尚无获批的治疗方法。这些患者的预后，尤其是那些有资格参加二线治疗临床试验的患者，尚不清楚。
本研究纳入了 2005 年至 2011 年期间在台湾某转诊中心参加转移性或局部晚期 HCC 一线系统治疗临床试验的所有患者。分析了他们在一线治疗失败时的临床病理特征，并与从一线治疗失败日期开始的总生存期（OS）相关联。
共纳入 192 例患者。在开始一线治疗之前，所有患者均具有 Child-Pugh 分级 A 的肝脏储备和癌症意大利方案（CLIP）评分≤4。一线治疗失败后，全组患者的中位 OS 为 4.0 个月。一线治疗失败时具有 Child-Pugh 分级 A 肝脏储备的患者的 OS 明显优于具有 Child-Pugh 分级 B 或 C 肝脏储备的患者（中位数，A 级 vs. B 级 vs. C 级=7.5 个月 vs. 1.3 个月 vs. 1.0 个月，p<0.001）。根据 3 项发表的二线治疗临床试验的关键入组标准，41%-56%的患者有潜在入组资格。与不符合临床试验入组条件的患者相比，潜在入组患者的 OS 更长，中位 OS 为 7.8-8.6 个月。
对于一线治疗失败的晚期 HCC 患者，如果具有 Child-Pugh A 级肝脏储备或有资格参加临床试验，则其预后可能会得到显著改善。
