Lingzhan Meng, Hu Li, Yingjie Ji, Peng Yu, Zizheng Wang, Li Cao, Bin Shi, Yanling Shao, Jin Yan, Yinjie Gao, Zhenyu Zhu
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Overall survival (OS), progression-free survival (PFS), objective response rate (ORR) and disease control rate (DCR) were evaluated by modified Response Evaluation Criteria in Solid Tumors criteria. Exploratory biomarker analysis was conducted.</p><p><strong>Results: </strong>The study included 70 patients with unresectable HCC, predominantly male and infected with Hepatitis B. The median follow-up duration for the whole cohort was 13.8 months (95% CI 11.08-16.7). The ORR was 61.4% (95% CI, 49.0%-72.8%) and the DCR was 68.6% (95%CI, 56.4%-79.2%). The median PFS was 13.2 months (95% CI 11.0-NA), with a corresponding 1-year PFS rate of 50.3% (95% CI 39.7%-65.5%). The median OS was not reached, and the 1-year OS rate was 89.3% (95% CI 81.4%-97.9%). The most common treatment-related adverse events (TRAEs) were fatigue 38.6% (27/70), hypertension 32.9% (23/70), and hand-foot syndrome 31.4% (22/70). Most TRAEs were mild-to-moderate and manageable. In addition, significant predictive value was found in alpha-fetoprotein levels (AFP), with patients showing a level of decrease post-treatment having better PFS.</p><p><strong>Conclusion: </strong>The combination regimen demonstrated promising efficacy in treating unresectable HCC, accompanied by manageable safety profiles. 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However, there is limited evidence evaluating the combination of TACE with the systemic regimen of anti-PD-1/L1 inhibitor plus lenvatinib. This study aims to assess the efficacy and safety of TACE combined with lenvatinib and sintilimab in unresectable HCC patients.</p><p><strong>Methods: </strong>Unresectable HCC patients who received TACE in combination with sintilimab plus Lenvatinib as first-line treatment from 1 January 2020 to 31 March 2023 were included for the analysis. Overall survival (OS), progression-free survival (PFS), objective response rate (ORR) and disease control rate (DCR) were evaluated by modified Response Evaluation Criteria in Solid Tumors criteria. Exploratory biomarker analysis was conducted.</p><p><strong>Results: </strong>The study included 70 patients with unresectable HCC, predominantly male and infected with Hepatitis B. The median follow-up duration for the whole cohort was 13.8 months (95% CI 11.08-16.7). The ORR was 61.4% (95% CI, 49.0%-72.8%) and the DCR was 68.6% (95%CI, 56.4%-79.2%). The median PFS was 13.2 months (95% CI 11.0-NA), with a corresponding 1-year PFS rate of 50.3% (95% CI 39.7%-65.5%). The median OS was not reached, and the 1-year OS rate was 89.3% (95% CI 81.4%-97.9%). The most common treatment-related adverse events (TRAEs) were fatigue 38.6% (27/70), hypertension 32.9% (23/70), and hand-foot syndrome 31.4% (22/70). Most TRAEs were mild-to-moderate and manageable. In addition, significant predictive value was found in alpha-fetoprotein levels (AFP), with patients showing a level of decrease post-treatment having better PFS.</p><p><strong>Conclusion: </strong>The combination regimen demonstrated promising efficacy in treating unresectable HCC, accompanied by manageable safety profiles. 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引用次数: 0
摘要
背景:经动脉化疗栓塞术(TACE)与全身治疗的结合改善了不可切除肝细胞癌(HCC)患者的生存预后。然而,目前评估TACE与抗PD-1/L1抑制剂加来伐替尼的全身治疗方案联合应用的证据有限。本研究旨在评估TACE联合来伐替尼和辛替利单抗治疗不可切除的HCC患者的有效性和安全性:纳入2020年1月1日至2023年3月31日期间接受TACE联合来伐替尼和辛替利单抗一线治疗的不可切除HCC患者进行分析。总生存期(OS)、无进展生存期(PFS)、客观反应率(ORR)和疾病控制率(DCR)按照修改后的实体瘤反应评估标准进行评估。研究还进行了探索性生物标志物分析:研究纳入了70例无法切除的HCC患者,其中男性居多,且感染了乙肝。ORR为61.4%(95%CI,49.0%-72.8%),DCR为68.6%(95%CI,56.4%-79.2%)。中位 PFS 为 13.2 个月(95% CI 11.0-NA),相应的 1 年 PFS 率为 50.3%(95% CI 39.7%-65.5%)。未达到中位OS,1年OS率为89.3%(95% CI 81.4%-97.9%)。最常见的治疗相关不良事件(TRAEs)为疲劳 38.6%(27/70)、高血压 32.9%(23/70)和手足综合征 31.4%(22/70)。大多数 TRAE 为轻度至中度,可控。此外,甲胎蛋白水平(AFP)具有重要的预测价值,治疗后水平下降的患者PFS更佳:结论:联合疗法在治疗不可切除的 HCC 方面具有良好的疗效,同时安全性可控。此外,这项研究结果表明,甲胎蛋白有望成为这种治疗策略的预测性生物标志物。
Efficacy, safety, and biomarker analysis of TACE combined with lenvatinib plus sintilimab in unresectable hepatocellular carcinoma: a real-world study.
Background: The integration of transarterial chemoembolization (TACE) with systemic therapy has demonstrated improved survival outcomes in patients with unresectable hepatocellular carcinoma (HCC). However, there is limited evidence evaluating the combination of TACE with the systemic regimen of anti-PD-1/L1 inhibitor plus lenvatinib. This study aims to assess the efficacy and safety of TACE combined with lenvatinib and sintilimab in unresectable HCC patients.
Methods: Unresectable HCC patients who received TACE in combination with sintilimab plus Lenvatinib as first-line treatment from 1 January 2020 to 31 March 2023 were included for the analysis. Overall survival (OS), progression-free survival (PFS), objective response rate (ORR) and disease control rate (DCR) were evaluated by modified Response Evaluation Criteria in Solid Tumors criteria. Exploratory biomarker analysis was conducted.
Results: The study included 70 patients with unresectable HCC, predominantly male and infected with Hepatitis B. The median follow-up duration for the whole cohort was 13.8 months (95% CI 11.08-16.7). The ORR was 61.4% (95% CI, 49.0%-72.8%) and the DCR was 68.6% (95%CI, 56.4%-79.2%). The median PFS was 13.2 months (95% CI 11.0-NA), with a corresponding 1-year PFS rate of 50.3% (95% CI 39.7%-65.5%). The median OS was not reached, and the 1-year OS rate was 89.3% (95% CI 81.4%-97.9%). The most common treatment-related adverse events (TRAEs) were fatigue 38.6% (27/70), hypertension 32.9% (23/70), and hand-foot syndrome 31.4% (22/70). Most TRAEs were mild-to-moderate and manageable. In addition, significant predictive value was found in alpha-fetoprotein levels (AFP), with patients showing a level of decrease post-treatment having better PFS.
Conclusion: The combination regimen demonstrated promising efficacy in treating unresectable HCC, accompanied by manageable safety profiles. Furthermore, the results of this investigation suggest that AFP holds promise as predictive biomarkers for this treatment strategy.
期刊介绍:
Cancer Immunology, Immunotherapy has the basic aim of keeping readers informed of the latest research results in the fields of oncology and immunology. As knowledge expands, the scope of the journal has broadened to include more of the progress being made in the areas of biology concerned with biological response modifiers. This helps keep readers up to date on the latest advances in our understanding of tumor-host interactions.
The journal publishes short editorials including "position papers," general reviews, original articles, and short communications, providing a forum for the most current experimental and clinical advances in tumor immunology.