Background/Objectives: Durvalumab plus Tremelimumab (Dur/Tre) therapy is expected to have good therapeutic efficacy for patients with advanced hepatocellular carcinoma (HCC). However, the predictors of clinical response and prognosis have not been established. Here, we retrospectively investigated the predictors for therapeutic response and clinical prognosis of Dur/Tre therapy. Methods: This retrospective single-center study, which included 30 patients, aimed to evaluate predictors of treatment efficacy of Dur/Tre therapy for advanced HCC. Factors associated with an objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and immune-mediated adverse events (imAEs) were examined. We especially focused on the initial change in peripheral lymphocyte count at 2 weeks after Dur/Tre introduction from baseline (Δlymphocyte). Results: Seventeen patients (56.7%) diagnosed with HCC BCLC stage C were enrolled. The median observational period was 11 months. The ORR and disease control rate (DCR) were 30.0% and 53.3%, respectively. The median PFS was 3.7 months and OS was not reached. The high Δlymphocyte was an independent predictor of objective response (hazard ratio [HR], 1.004;p= 0.016). The high Δlymphocyte (above +245/µL) was an independent predictive factor for better PFS (HR, 0.308; 95% CI, 0.095–0.998;p= 0.049), and the median PFS was significantly prolonged in the high Δlymphocyte (above +245/µL) compared to low Δlymphocyte (less than +245/µL) (not reached vs. 1.96 months, log-rankp= 0.003). Conclusions: In Dur/Tre therapy, the early increase in peripheral blood lymphocyte count was useful for predicting clinical response and prognosis.
背景/目的:度伐利尤单抗联合替西木单抗(Dur/Tre)疗法对晚期肝细胞癌(HCC)患者预期具有良好的治疗效果,但其临床反应与预后的预测因子尚未明确。本研究回顾性探讨了Dur/Tre疗法治疗反应及临床预后的预测因素。方法:这项回顾性单中心研究纳入了30例患者,旨在评估Dur/Tre疗法治疗晚期HCC疗效的预测因子。研究分析了与客观缓解率(ORR)、无进展生存期(PFS)、总生存期(OS)及免疫介导不良事件(imAEs)相关的因素,特别关注了Dur/Tre治疗开始后2周外周血淋巴细胞计数相较于基线的早期变化(Δ淋巴细胞)。结果:研究共纳入17例(56.7%)诊断为BCLC C期HCC的患者,中位观察期为11个月。客观缓解率(ORR)和疾病控制率(DCR)分别为30.0%和53.3%。中位无进展生存期(PFS)为3.7个月,总生存期(OS)尚未达到。较高的Δ淋巴细胞是客观缓解的独立预测因子(风险比[HR]为1.004,p=0.016)。高Δ淋巴细胞(高于+245/µL)是改善PFS的独立预测因素(HR为0.308;95% CI为0.095–0.998;p=0.049),且与低Δ淋巴细胞(低于+245/µL)组相比,高Δ淋巴细胞组的中位PFS显著延长(未达到 vs. 1.96个月,对数秩检验p=0.003)。结论:在Dur/Tre疗法中,外周血淋巴细胞计数的早期升高有助于预测临床反应和预后。