Wang Ruifeng, Guo Tianhui, Wang Qi, Gao Wen, Yu Yimiao, Zhang Jun, Fu Wenqian, Wang Haiji, Zhang Biyuan
Department of Radiation Oncology, The Affiliated Hospital of Qingdao University, No. 59 Haier Road, Laoshan District, Qingdao, Shandong Province, China.
BMC Cancer. 2025 Jan 16;25(1):97. doi: 10.1186/s12885-025-13457-w.
To evaluate the efficacy and safety of induction chemotherapy combined with programmed death protein 1 (PD-1) inhibitor (sintilimab) followed by concurrent chemoradiotherapy (CCRT) plus sintilimab, and subsequent maintenance with sintilimab (IC-ICCRT-IO) for patients with unresectable locally advanced esophageal squamous cell carcinoma (ESCC) in a retrospective study.
Data from patients with histologically confirmed, locally advanced, inoperable ESCC who received IC-ICCRT-IO were retrospectively analyzed. Treatment effects were evaluated after 2 cycles of induction therapy and after CCRT by contrast-enhanced CT scans and esophagograms, followed by subsequent evaluations every 3 months post-treatment. The primary endpoints included progression-free survival (PFS) and PFS rates at 6, 12, and 18 months. Secondary endpoints involved overall response rate (ORR), disease control rate (DCR), overall survival (OS), and safety. The influence of the expression level of programmed death ligand-1 (PD-L1) as well as neutrophil-to-lymphocyte ratio (NLR) on efficacy of the IC-ICCRT-IO was analyzed.
In total, 29 eligible patients were enrolled and analyzed. The median follow-up time was 20.5 months. The median PFS was not reached; the 6-, 12-, and 18-month PFS rates were 100.0%, 93.1%, and 82.8%, respectively. The median OS was not reached, and the 6-, 12-, and 18-month OS rates were all 100.0%. The ORR and DCR were 89.7% and 100.0%. Adverse events (AEs) were manageable, with grade 3 or higher AEs observed in 48.2% of patients, primarily nonimmune-related and clinically manageable. Hematologic toxicity was predominant. Two patients developed grade 3 immune-related rash, and two patients developed grade 3 radiation pneumonitis, all of whom were managed with appropriate symptomatic treatment. No significant differences in survival outcomes were observed with respect to PD-L1 and NLR.
Our results indicated that the IC-ICCRT-IO regimen for unresectable locally advanced ESCC provided a survival benefit with manageable safety profile. More prospective clinical studies should be warranted.
2024-04-22, No. QYFY WZLL 28,684, retrospectively registered.
在一项回顾性研究中，评估诱导化疗联合程序性死亡蛋白1（PD-1）抑制剂（信迪利单抗），随后序贯同步放化疗（CCRT）加信迪利单抗，以及后续信迪利单抗维持治疗（IC-ICCRT-IO）方案治疗不可切除的局部晚期食管鳞状细胞癌（ESCC）患者的疗效和安全性。
回顾性分析经组织学确诊、局部晚期、不可手术切除的ESCC患者接受IC-ICCRT-IO治疗的数据。在诱导治疗2个周期后和CCRT后，通过增强CT扫描和食管造影评估治疗效果，治疗后每3个月进行后续评估。主要终点包括无进展生存期（PFS）以及6、12和18个月时的PFS率。次要终点包括总缓解率（ORR）、疾病控制率（DCR）、总生存期（OS）和安全性。分析程序性死亡配体-1（PD-L1）表达水平以及中性粒细胞与淋巴细胞比值（NLR）对IC-ICCRT-IO疗效的影响。
总共纳入并分析了29例符合条件的患者。中位随访时间为20.5个月。中位PFS未达到；6、12和18个月时的PFS率分别为100.0%、93.1%和82.8%。中位OS未达到，6、12和18个月时的OS率均为100.0%。ORR和DCR分别为89.7%和100.0%。不良事件（AE）可控，48.2%的患者出现3级或更高等级AE，主要为非免疫相关且临床可控。血液学毒性为主。2例患者出现3级免疫相关皮疹，2例患者出现3级放射性肺炎，所有患者均接受了适当的对症治疗。在PD-L1和NLR方面，生存结果未观察到显著差异。
我们的结果表明，IC-ICCRT-IO方案治疗不可切除的局部晚期ESCC可带来生存获益，且安全性可控。需要更多前瞻性临床研究。
2024年4月22日，编号QYFY WZLL 28684，回顾性注册。
