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Abstract：
UNASSIGNED: We investigated the efficacy and safety of immune checkpoint inhibitor (ICI) rechallenge in patients with hepatocellular carcinoma (HCC) who received ICI-based therapies in a previous systemic line.
UNASSIGNED: In this international, retrospective multicenter study, patients with HCC who received at least two lines of ICI-based therapies (ICI-1, ICI-2) at 14 institutions were eligible. The main outcomes included best overall response and treatment-related adverse events.
UNASSIGNED: Of 994 ICI-treated patients screened, a total of 58 patients (male, n = 41; 71%) with a mean age of 65.0±9.0 years were included. Median systemic treatment lines of ICI-1 and ICI-2 were 1 (range, 1-4) and 3 (range, 2-9), respectively. ICI-based therapies used at ICI-1 and ICI-2 included ICI alone (ICI-1, n = 26, 45%; ICI-2, n = 4, 7%), dual ICI regimens (n = 1, 2%; n = 12, 21%), or ICI combined with targeted therapies/anti-VEGF (n = 31, 53%; n = 42, 72%). Most patients discontinued ICI-1 due to progression (n = 52, 90%). Objective response rate was 22% at ICI-1 and 26% at ICI-2. Responses at ICI-2 were also seen in patients who had progressive disease as best overall response at ICI-1 (n = 11/21; 52%). Median time-to-progression at ICI-1 and ICI-2 was 5.4 (95% CI 3.0-7.7) months and 5.2 (95% CI 3.3-7.0) months, respectively. Treatment-related adverse events of grade 3-4 at ICI-1 and ICI-2 were observed in 9 (16%) and 10 (17%) patients, respectively.
UNASSIGNED: ICI rechallenge was safe and resulted in a treatment benefit in a meaningful proportion of patients with HCC. These data provide a rationale for investigating ICI-based regimens in patients who progressed on first-line immunotherapy in prospective trials.
UNASSIGNED: Therapeutic sequencing after first-line immune checkpoint inhibitor (ICI)-based therapy for advanced hepatocellular carcinoma (HCC) remains a challenge as no available second-line treatment options have been studied in immunotherapy-pretreated patients. Particularly, the role of ICI rechallenge in patients with HCC is unclear, as data from prospective trials are lacking. We investigated the efficacy and safety of ICI-based regimens in patients with HCC pretreated with immunotherapy in a retrospective, international, multicenter study. Our data provide the rationale for prospective trials investigating the role of ICI-based regimens in patients who have progressed on first-line immunotherapy.
UNASSIGNED: In this international, retrospective multicenter study, patients with HCC who received at least two lines of ICI-based therapies (ICI-1, ICI-2) at 14 institutions were eligible. The main outcomes included best overall response and treatment-related adverse events.
UNASSIGNED: Of 994 ICI-treated patients screened, a total of 58 patients (male, n = 41; 71%) with a mean age of 65.0±9.0 years were included. Median systemic treatment lines of ICI-1 and ICI-2 were 1 (range, 1-4) and 3 (range, 2-9), respectively. ICI-based therapies used at ICI-1 and ICI-2 included ICI alone (ICI-1, n = 26, 45%; ICI-2, n = 4, 7%), dual ICI regimens (n = 1, 2%; n = 12, 21%), or ICI combined with targeted therapies/anti-VEGF (n = 31, 53%; n = 42, 72%). Most patients discontinued ICI-1 due to progression (n = 52, 90%). Objective response rate was 22% at ICI-1 and 26% at ICI-2. Responses at ICI-2 were also seen in patients who had progressive disease as best overall response at ICI-1 (n = 11/21; 52%). Median time-to-progression at ICI-1 and ICI-2 was 5.4 (95% CI 3.0-7.7) months and 5.2 (95% CI 3.3-7.0) months, respectively. Treatment-related adverse events of grade 3-4 at ICI-1 and ICI-2 were observed in 9 (16%) and 10 (17%) patients, respectively.
UNASSIGNED: ICI rechallenge was safe and resulted in a treatment benefit in a meaningful proportion of patients with HCC. These data provide a rationale for investigating ICI-based regimens in patients who progressed on first-line immunotherapy in prospective trials.
UNASSIGNED: Therapeutic sequencing after first-line immune checkpoint inhibitor (ICI)-based therapy for advanced hepatocellular carcinoma (HCC) remains a challenge as no available second-line treatment options have been studied in immunotherapy-pretreated patients. Particularly, the role of ICI rechallenge in patients with HCC is unclear, as data from prospective trials are lacking. We investigated the efficacy and safety of ICI-based regimens in patients with HCC pretreated with immunotherapy in a retrospective, international, multicenter study. Our data provide the rationale for prospective trials investigating the role of ICI-based regimens in patients who have progressed on first-line immunotherapy.
摘要：
UNASSIGNED：我们研究了免疫检查点抑制剂（ICI）再激发在先前的全身性治疗中接受基于ICI治疗的肝细胞癌（HCC）患者的疗效和安全性。
未经评估：在这个国际上，回顾性多中心研究，在14个机构接受至少两行基于ICI的治疗(ICI-1,ICI-2)的HCC患者符合资格.主要结果包括最佳总体反应和治疗相关不良事件。
未经证实：在994名接受ICI治疗的患者中，共有58名患者(男性，n=41；71％），平均年龄为65.0±9.0岁。ICI-1和ICI-2的系统治疗线中位数为1（范围，1-4）和3（范围，2-9),分别。ICI-1和ICI-2使用的基于ICI的治疗包括单独的ICI（ICI-1，n=26，45％；ICI-2，n=4，7％），双重ICI方案（n=1，2%；n=12，21%），或ICI联合靶向治疗/抗VEGF（n=31，53％；n=42，72％）。大多数患者因进展而停用ICI-1（n=52，90%）。ICI-1的客观反应率为22％，ICI-2的客观反应率为26％。在患有进行性疾病的患者中，ICI-2的反应也是ICI-1的最佳总体反应（n=11/21;52％）。ICI-1和ICI-2的中位进展时间分别为5.4(95%CI3.0-7.7)个月和5.2(95%CI3.3-7.0)个月，分别。在9例（16%）和10例（17%）患者中观察到ICI-1和ICI-2的治疗相关不良事件为3-4级，分别。
UNASSIGNED：ICI再激发是安全的，并且在相当比例的HCC患者中获得了治疗益处。这些数据为在前瞻性试验中一线免疫治疗进展的患者中研究基于ICI的方案提供了理论基础。
UNASSIGNED：基于一线免疫检查点抑制剂（ICI）的晚期肝细胞癌（HCC）治疗后的治疗测序仍然是一个挑战，因为在免疫治疗预处理患者中没有研究可用的二线治疗方案。特别是,ICI再激发在HCC患者中的作用尚不清楚，由于缺乏前瞻性试验的数据.我们调查了ICI为基础的方案的疗效和安全性在肝癌患者的免疫治疗前，国际,多中心研究。我们的数据为研究基于ICI的治疗方案在一线免疫治疗进展患者中的作用的前瞻性试验提供了理论基础。
未经评估：在这个国际上，回顾性多中心研究，在14个机构接受至少两行基于ICI的治疗(ICI-1,ICI-2)的HCC患者符合资格.主要结果包括最佳总体反应和治疗相关不良事件。
未经证实：在994名接受ICI治疗的患者中，共有58名患者(男性，n=41；71％），平均年龄为65.0±9.0岁。ICI-1和ICI-2的系统治疗线中位数为1（范围，1-4）和3（范围，2-9),分别。ICI-1和ICI-2使用的基于ICI的治疗包括单独的ICI（ICI-1，n=26，45％；ICI-2，n=4，7％），双重ICI方案（n=1，2%；n=12，21%），或ICI联合靶向治疗/抗VEGF（n=31，53％；n=42，72％）。大多数患者因进展而停用ICI-1（n=52，90%）。ICI-1的客观反应率为22％，ICI-2的客观反应率为26％。在患有进行性疾病的患者中，ICI-2的反应也是ICI-1的最佳总体反应（n=11/21;52％）。ICI-1和ICI-2的中位进展时间分别为5.4(95%CI3.0-7.7)个月和5.2(95%CI3.3-7.0)个月，分别。在9例（16%）和10例（17%）患者中观察到ICI-1和ICI-2的治疗相关不良事件为3-4级，分别。
UNASSIGNED：ICI再激发是安全的，并且在相当比例的HCC患者中获得了治疗益处。这些数据为在前瞻性试验中一线免疫治疗进展的患者中研究基于ICI的方案提供了理论基础。
UNASSIGNED：基于一线免疫检查点抑制剂（ICI）的晚期肝细胞癌（HCC）治疗后的治疗测序仍然是一个挑战，因为在免疫治疗预处理患者中没有研究可用的二线治疗方案。特别是,ICI再激发在HCC患者中的作用尚不清楚，由于缺乏前瞻性试验的数据.我们调查了ICI为基础的方案的疗效和安全性在肝癌患者的免疫治疗前，国际,多中心研究。我们的数据为研究基于ICI的治疗方案在一线免疫治疗进展患者中的作用的前瞻性试验提供了理论基础。
