PDF(Pubmed)
Abstract：
UNASSIGNED: The aim of the study was to evaluate the efficacy and safety of adjuvant sorafenib treatment compared with placebo in patients with hepatocellular carcinoma who underwent local ablation.
UNASSIGNED: The SORAMIC trial is a randomised controlled trial with diagnostic, local ablation, and palliative sub-study arms. After initial imaging within the diagnostic study, patients were assigned to local ablation or palliative arms. In the local ablation cohort, patients were randomised 1:1 to local ablation + sorafenib vs. local ablation + placebo. The primary endpoint was time-to-recurrence (TTR). Secondary endpoints were local control rate and safety in terms of adverse events and quality-of-life.
UNASSIGNED: The recruitment was terminated prematurely after 104 patients owing to slow recruitment. One patient was excluded because of a technical failure. Fifty-four patients were randomised to local ablation + sorafenib and 49 to local ablation + placebo. Eighty-eight patients who underwent standardised follow-up imaging comprised the per-protocol population. The median TTR was 15.2 months in the sorafenib arm and 16.4 months in the placebo arm (hazard ratio 1.1; 95% CI 0.53-2.2; p = 0.82). Out of 136 lesions ablated within the trial, there was no difference in local recurrence rate between sorafenib (6/69, 8.6%) and placebo groups (5/67, 5.9%; p = 0.792).Overall (92.5% vs. 71.4%, p = 0.008) and drug-related (81.4% vs. 55.1%, p = 0.003) adverse events were more common in the sorafenib arm compared with the placebo arm. Dose reduction because of adverse events were common in the sorafenib arm (79.6% vs. 30.6%, p <0.001).
UNASSIGNED: Adjuvant sorafenib did not improve in TTR or local control rate after local ablation in patients with hepatocellular carcinoma within the limitations of an early terminated trial.
UNASSIGNED: Local ablation is the standard of care treatment in patients with early stages of hepatocellular carcinoma, along with surgical therapies. However, there is a risk of disease recurrence during follow-up. Sorafenib, an oral medication, is a routinely used treatment for patients with advanced hepatocellular carcinoma. This study found that sorafenib treatment after local ablation in people with early hepatocellular carcinoma did not significantly improve the disease-free period compared with placebo.
UNASSIGNED: EudraCT 2009-012576-27, NCT01126645.
UNASSIGNED: The SORAMIC trial is a randomised controlled trial with diagnostic, local ablation, and palliative sub-study arms. After initial imaging within the diagnostic study, patients were assigned to local ablation or palliative arms. In the local ablation cohort, patients were randomised 1:1 to local ablation + sorafenib vs. local ablation + placebo. The primary endpoint was time-to-recurrence (TTR). Secondary endpoints were local control rate and safety in terms of adverse events and quality-of-life.
UNASSIGNED: The recruitment was terminated prematurely after 104 patients owing to slow recruitment. One patient was excluded because of a technical failure. Fifty-four patients were randomised to local ablation + sorafenib and 49 to local ablation + placebo. Eighty-eight patients who underwent standardised follow-up imaging comprised the per-protocol population. The median TTR was 15.2 months in the sorafenib arm and 16.4 months in the placebo arm (hazard ratio 1.1; 95% CI 0.53-2.2; p = 0.82). Out of 136 lesions ablated within the trial, there was no difference in local recurrence rate between sorafenib (6/69, 8.6%) and placebo groups (5/67, 5.9%; p = 0.792).Overall (92.5% vs. 71.4%, p = 0.008) and drug-related (81.4% vs. 55.1%, p = 0.003) adverse events were more common in the sorafenib arm compared with the placebo arm. Dose reduction because of adverse events were common in the sorafenib arm (79.6% vs. 30.6%, p <0.001).
UNASSIGNED: Adjuvant sorafenib did not improve in TTR or local control rate after local ablation in patients with hepatocellular carcinoma within the limitations of an early terminated trial.
UNASSIGNED: Local ablation is the standard of care treatment in patients with early stages of hepatocellular carcinoma, along with surgical therapies. However, there is a risk of disease recurrence during follow-up. Sorafenib, an oral medication, is a routinely used treatment for patients with advanced hepatocellular carcinoma. This study found that sorafenib treatment after local ablation in people with early hepatocellular carcinoma did not significantly improve the disease-free period compared with placebo.
UNASSIGNED: EudraCT 2009-012576-27, NCT01126645.
摘要：
■该研究的目的是评估与安慰剂相比，索拉非尼辅助治疗在接受局部消融的肝细胞癌患者中的疗效和安全性。
■SORAMIC试验是一项随机对照试验，局部消融,和姑息性子研究组。在诊断研究中的初始成像后，患者被分配到局部消融或姑息治疗组.在局部消融队列中,患者被随机分为1:1，接受局部消融+索拉非尼与局部消融+安慰剂。主要终点是复发时间（TTR）。次要终点是在不良事件和生活质量方面的局部控制率和安全性。
■104例患者由于募集缓慢而过早终止募集。一名患者因技术故障被排除在外。54例患者随机接受局部消融+索拉非尼治疗，49例患者接受局部消融+安慰剂治疗。接受标准化随访成像的88例患者包括符合方案的人群。索拉非尼组的中位TTR为15.2个月，安慰剂组为16.4个月（风险比1.1；95%CI0.53-2.2；p=0.82）。在试验中消融的136个病灶中，索拉非尼(6/69,8.6%)和安慰剂组(5/67,5.9%;p=0.792)的局部复发率无差异.总体而言（92.5%与71.4%,p=0.008）和药物相关（81.4%vs.55.1%,p=0.003）与安慰剂组相比，索拉非尼组的不良事件更常见。由于不良事件导致的剂量减少在索拉非尼组很常见(79.6%vs.30.6%,p<0.001)。
■在早期终止试验的限制范围内，肝细胞癌患者局部消融后，辅助索拉非尼的TTR或局部控制率没有改善。
■局部消融是早期肝细胞癌患者的标准治疗方法，以及手术治疗。然而,随访期间存在疾病复发的风险.索拉非尼,口服药物,是晚期肝细胞癌患者的常规治疗方法。这项研究发现，与安慰剂相比，早期肝细胞癌患者局部消融后的索拉非尼治疗并未显着改善无病期。
■欧盟2009-012576-27，NCT01126645。
■SORAMIC试验是一项随机对照试验，局部消融,和姑息性子研究组。在诊断研究中的初始成像后，患者被分配到局部消融或姑息治疗组.在局部消融队列中,患者被随机分为1:1，接受局部消融+索拉非尼与局部消融+安慰剂。主要终点是复发时间（TTR）。次要终点是在不良事件和生活质量方面的局部控制率和安全性。
■104例患者由于募集缓慢而过早终止募集。一名患者因技术故障被排除在外。54例患者随机接受局部消融+索拉非尼治疗，49例患者接受局部消融+安慰剂治疗。接受标准化随访成像的88例患者包括符合方案的人群。索拉非尼组的中位TTR为15.2个月，安慰剂组为16.4个月（风险比1.1；95%CI0.53-2.2；p=0.82）。在试验中消融的136个病灶中，索拉非尼(6/69,8.6%)和安慰剂组(5/67,5.9%;p=0.792)的局部复发率无差异.总体而言（92.5%与71.4%,p=0.008）和药物相关（81.4%vs.55.1%,p=0.003）与安慰剂组相比，索拉非尼组的不良事件更常见。由于不良事件导致的剂量减少在索拉非尼组很常见(79.6%vs.30.6%,p<0.001)。
■在早期终止试验的限制范围内，肝细胞癌患者局部消融后，辅助索拉非尼的TTR或局部控制率没有改善。
■局部消融是早期肝细胞癌患者的标准治疗方法，以及手术治疗。然而,随访期间存在疾病复发的风险.索拉非尼,口服药物,是晚期肝细胞癌患者的常规治疗方法。这项研究发现，与安慰剂相比，早期肝细胞癌患者局部消融后的索拉非尼治疗并未显着改善无病期。
■欧盟2009-012576-27，NCT01126645。
