Novick Diego, Cho Jae Min, Colman Sam, Szende Agota
GPORWE International, Eli Lilly and Company Limited, Erl Wood Manor, Sunninghill Road, Windlesham, GU20 6PH, Surrey, UK.
Eli Lilly and Company, Seoul, South Korea.
Drugs Real World Outcomes. 2022 Jun;9(2):263-274. doi: 10.1007/s40801-021-00286-z. Epub 2021 Dec 14.
BACKGROUND: European, US, Asian and Korean treatment guidelines all recommend sorafenib as first-line systemic therapy in patients with hepatocellular carcinoma (HCC). However, due to the emergence of several new treatments, post-sorafenib treatment patterns in real-world clinical practice are less well understood. OBJECTIVE: This study aimed to characterize current treatment patterns and healthcare resource utilization (HRU) in patients with HCC following the failure of first-line sorafenib in a real-world setting in Korea. PATIENTS AND METHODS: A chart review was conducted in 127 HCC patients who received systemic therapy or best supportive care following failure of first-line systemic treatment with sorafenib (2016-2018). Anonymized data on patient characteristics, treatment patterns, and survival were abstracted by 37 physicians in Korea. RESULTS: The mean (range) age of patients was 60 (37-79) years; 63 patients had low alpha-fetoprotein (AFP < 400 ng/mL), 64 patients had high alpha-fetoprotein (AFP ≥ 400 ng/mL). Post-sorafenib, 64 (50%) patients had systemic therapy. Regorafenib, used by 54 (84%) patients in second-line, and nivolumab monotherapy, by ten (56%) patients in third-line, were the most common therapies. Hepatologist visits and hospitalizations, at an average rate of 6.89 (95% CI 6.37-7.45) and 2.24 (95% CI 1.95-2.57) per patient-year, respectively, were the key contributors of HRU. The median overall survival (95% CI) from discontinuation of sorafenib was 13.0 (9.8-20.7), 6.5 (5.0-9.5) and 9.5 (6.7-12.3) months in the low AFP, high AFP and overall group, respectively. CONCLUSION: This real-world evidence research on treatment patterns reflected current clinical guidelines and highlighted fast progressing nature and continuing high mortality in HCC, especially among the high AFP group, underlying a need for new treatments that can lengthen survival. Results from this real-world chart review, together with existing clinical trial data, can inform future evaluations of new HCC treatments that estimate their health economic impact in Korea.
背景：欧洲、美国、亚洲和韩国的治疗指南均推荐索拉非尼作为肝细胞癌（HCC）患者的一线全身治疗药物。然而，由于几种新疗法的出现，在现实世界临床实践中索拉非尼治疗后的治疗模式尚不太清楚。 目的：本研究旨在描述韩国现实环境中一线索拉非尼治疗失败后HCC患者的当前治疗模式和医疗资源利用（HRU）情况。 患者和方法：对127例在一线使用索拉非尼进行全身治疗失败后接受全身治疗或最佳支持治疗的HCC患者进行了病历回顾（2016 - 2018年）。韩国的37名医生提取了关于患者特征、治疗模式和生存情况的匿名数据。 结果：患者的平均（范围）年龄为60（37 - 79）岁；63例患者甲胎蛋白水平低（AFP < 400 ng/mL），64例患者甲胎蛋白水平高（AFP≥400 ng/mL）。索拉非尼治疗后，64例（50%）患者接受了全身治疗。二线治疗中54例（84%）患者使用瑞戈非尼，三线治疗中10例（56%）患者使用纳武单抗单药治疗，是最常见的治疗方法。肝病专家门诊和住院治疗分别以每位患者每年平均6.89（95%CI 6.37 - 7.45）次和2.24（95%CI 1.95 - 2.57）次的频率，成为医疗资源利用的主要因素。从停用索拉非尼开始计算，低AFP组、高AFP组和总体组的中位总生存期（95%CI）分别为13.0（9.8 - 20.7）个月、6.5（5.0 - 9.5）个月和9.5（6.7 - 12.3）个月。 结论：这项关于治疗模式的现实世界证据研究反映了当前临床指南，并突出了HCC进展迅速和死亡率持续居高不下的特点，尤其是在高AFP组中，这表明需要能够延长生存期的新疗法。这项现实世界病历回顾的结果，与现有的临床试验数据一起，可以为未来评估新的HCC治疗方法提供参考，这些评估将估计它们在韩国的健康经济影响。
Curr Med Res Opin. 2020-11
N Engl J Med. 2018-7-5
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