Department of General Surgery, The Fourth People's Hospital of Yueyang, X022 Yunxi District, Yueyang, 414009, China.
Department of General Surgery, Yueyang Traditional Chinese Medicine Hospital, Yueyang, 414000, China.
Ir J Med Sci. 2023 Jun;192(3):1065-1071. doi: 10.1007/s11845-022-03131-6. Epub 2022 Aug 23.
Programmed cell death protein 1 (PD-1) inhibitor is widely utilized in advanced-stage carcinomas including hepatocellular carcinoma (HCC), while its neoadjuvant application plus transarterial chemoembolization (TACE) in HCC remains unexplored. Thereby, the current study aimed to investigate the efficacy and safety of TACE plus PD-1 inhibitor as neoadjuvant therapy bridging to surgical resection in intermediate-stage HCC patients.
Twenty intermediate-stage HCC (China Liver Cancer (CNLC) stage II) patients treated with neoadjuvant TACE plus PD-1 inhibitor (camrelizumab or sintilimab) bridging to surgery were consecutively enrolled.
The objective response rate (ORR) and disease control rate (DCR) to neoadjuvant therapy were 75.0% and 100.0%, respectively; meanwhile, alpha-fetoprotein (AFP) was decreased after the neoadjuvant therapy (P < 0.001). Moreover, 14 (70.0%) patients had successful downstaging (patients converted to CNLC stage I). Neither median disease-free survival (DFS) nor median overall survival (OS) was reached; additionally, the 1-year accumulating DFS rate was 86.6%; meanwhile, the 1-year and 2-year accumulating OS rates were 100.0% and 76.4%, separately. Moreover, patients with successful downstaging had a prolonged DFS (P = 0.014) compared to patients with failed downstaging; meanwhile, this trend was also observed in assessing accumulating OS (P = 0.067) (without statistical significance). Main adverse events included pain (50.0%), fever (25.0%), neutropenia (25.0%), nausea and vomiting (25.0%), fatigue (25.0%), peripheral neuropathy (20.0%), anemia (15.0%), thrombopenia (15.0%), diarrhea (15.0%), anorexia (15.0%), and rash (15.0%).
Neoadjuvant TACE plus PD-1 inhibitor realizes a satisfying downstaging rate, acceptable survival profile, and tolerance in intermediate-stage HCC patients.
程序性死亡蛋白 1(PD-1)抑制剂广泛应用于包括肝细胞癌(HCC)在内的晚期癌种,但其在 HCC 中的新辅助应用联合肝动脉化疗栓塞(TACE)仍有待探索。因此,本研究旨在探讨 TACE 联合 PD-1 抑制剂作为新辅助治疗桥接手术切除在中期 HCC 患者中的疗效和安全性。
连续纳入 20 例接受新辅助 TACE 联合 PD-1 抑制剂(卡瑞利珠单抗或信迪利单抗)桥接手术治疗的中期 HCC(中国肝癌分期(CNLC)Ⅱ期)患者。
新辅助治疗的客观缓解率(ORR)和疾病控制率(DCR)分别为 75.0%和 100.0%;同时,新辅助治疗后甲胎蛋白(AFP)降低(P<0.001)。此外,14 例(70.0%)患者成功降期(患者转为 CNLC Ⅰ期)。中位无疾病生存(DFS)和中位总生存(OS)均未达到;此外,1 年累积 DFS 率为 86.6%;同时,1 年和 2 年的累积 OS 率分别为 100.0%和 76.4%。此外,成功降期的患者 DFS 更长(P=0.014),与降期失败的患者相比;同时,在评估累积 OS 时也观察到了这一趋势(P=0.067)(无统计学意义)。主要不良反应包括疼痛(50.0%)、发热(25.0%)、中性粒细胞减少(25.0%)、恶心和呕吐(25.0%)、疲劳(25.0%)、周围神经病变(20.0%)、贫血(15.0%)、血小板减少症(15.0%)、腹泻(15.0%)、厌食(15.0%)和皮疹(15.0%)。
新辅助 TACE 联合 PD-1 抑制剂在中期 HCC 患者中实现了令人满意的降期率、可接受的生存情况和耐受性。