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- W4283770123 abstract "Objective: To study the surgical safety and efficacy of preoperative neoadjuvant therapy with immune checkpoint inhibitors combined with anti-angiogenic drugs in patients with China liver cancer staging(CNLC)-Ⅱb and Ⅲa resectable hepatocellular carcinoma. Methods: The data of 129 patients with Ⅱb and Ⅲa hepatocellular carcinoma who underwent surgery at the First Affiliated Hospital of Nanjing Medical University from January 2018 to December 2020 were analyzed. All patients were divided into two groups: the neoadjuvant therapy group(n=14,13 males and 1 female,aged (55.4±12.6)years(range:34 to 75 years)) received immune combined targeted therapy before surgery,immune checkpoint inhibitor camrelizumab was administered intravenously at a dose of 200 mg each time,every 2 weeks for 3 cycles,anti-angiogenesis drug apatinib was taken orally and continuously with a dose of 250 mg for 3 weeks and the conventional surgery group(n=115,103 males and 12 females,aged (55.8±12.0)years(range:21 to 83 years)) did not receive antitumor systemic therapy before surgery. There were 3 patients with CNLC-Ⅱb,11 with CNLC-Ⅲa in the neoadjuvant group;28 patients with CNLC-Ⅱb,87 with CNLC-Ⅲa in the conventional group. Student's t test or rank-sum test was used to compare the differences between two groups for quantitative data, Fisher's exact probability method was used to compare the differences of proportions between two groups, and Log-rank test was used to compare survival differences between two groups. Results: The 1-year recurrence rate in the neoadjuvant group was 42.9%,and the 1-year recurrence rate in the conventional group was 64.0%,with a statistically significant difference between the two groups(χ²=3.850,P=0.050);The 1-year survival rate in the neoadjuvant group was 100% and that in the conventional group was 74.2%,with a statistically significant difference between the two groups(χ²=5.170,P=0.023). According to the stratified analysis of the number of tumors,for single tumor,the 1-year recurrence rate in the neoadjuvant group was 25.0%,and that in the conventional surgery group was 71.0%,and the difference between the two groups was statistically significant(χ²=5.280, P=0.022). For multiple tumors, the 1-year recurrence rate in the neoadjuvant group was 66.7%,and the 1-year recurrence rate in the conventional surgery group was 58.9%,with no significant difference between the two groups(χ²=0.110,P=0.736). The operative time,intraoperative blood loss,and postoperative hospital stay in the neoadjuvant group were similar to those in the conventional group,and their differences were not statistically significant. Conclusions: Immune checkpoint inhibitors combined with anti-angiogenic targeted drugs as a neoadjuvant therapy for resectable hepatocellular carcinoma can reduce the 1-year recurrence rate and improve the 1-year survival rate,especially for those with solitary tumor. Limited by the sample size of the neoadjuvant group,the safety of immune combined targeted therapy before surgery cannot be observed more comprehensively,and further studies will be explored.目的: 探讨中国肝癌的分期方案(CNLC)Ⅱb、Ⅲa期可切除性肝细胞癌患者术前接受免疫检查点抑制剂联合抗血管生成靶向药物新辅助治疗的安全性及有效性。 方法: 回顾性分析2018年1月至2020年12月于南京医科大学第一附属医院肝胆中心经手术切除的129例CNLC Ⅱb、Ⅲa期肝细胞癌患者的资料。按照是否接受新辅助治疗分为两组,新辅助组14例患者,男性13例,女性1例,年龄(55.4±12.6)岁(范围:34~75岁),术前接受免疫联合靶向治疗,免疫检查点抑制剂为卡瑞利珠单抗(200 mg静脉滴注,每2周1次,连续使用3次),抗血管生成靶向药物为阿帕替尼(250 mg口服,1次/d,连续服用3周);常规手术组115例患者,男性103例,女性12例,年龄(55.8±12.0)岁(范围:21~83岁),术前未接受抗肿瘤治疗。新辅助组中,CNLC Ⅱb期3例,CNLC Ⅲa期11例;常规组中,CNLC Ⅱb期28例,CNLC Ⅲa期87例。定量资料的组间比较采用t检验或秩和检验,定性资料的组间比较采用Fisher确切概率法,采用Log-rank检验比较不同组别间的生存差异。 结果: 新辅助组患者的1年复发率为42.9%,常规组为64.0%,差异有统计学意义(Log-rank检验:χ²=3.850,P=0.050);新辅助组患者的1年生存率为100%,常规组为74.2%,差异有统计学意义(χ²=5.170,P=0.023)。按肿瘤数目分层分析,新辅助组中单发肿瘤患者的1年复发率为25.0%,常规手术组为71.0%,两组差异有统计学意义(χ²=5.280,P=0.022);新辅助组中多发肿瘤患者的1年复发率为66.7%,常规手术组为58.9%,两组差异无统计学意义(χ²=0.110,P=0.736)。新辅助组和常规组患者的手术时间、术中出血量、术中输血量、术后住院时间和术后并发症发生率等的差异均无统计学意义(P值均>0.05)。 结论: 免疫检查点抑制剂联合抗血管生成靶向药物作为可切除性肝细胞癌的新辅助方案,可降低肿瘤的术后1年复发率,提高患者的1年生存率,尤其适用于单发病灶的患者。受限于新辅助组的样本量,无法更全面地观察免疫联合靶向治疗的安全性,留待后期进一步研究。." @default.
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- W4283770123 title "[Efficacy and safety of neoadjuvant immunotherapy for hepatocellular carcinoma]." @default.
- W4283770123 doi "https://doi.org/10.3760/cma.j.cn112139-20220408-00150" @default.
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