Fujian Cancer Hospital, Clinical Oncology School of Fujian Medical University, 420 Fuma Road, Jin'an District, Fuzhou, Fujian, 350014, China.
Department of Radiation Oncology, The Second Affiliated Hospital of Fujian Medical University, Quanzhou, Fujian, 362000, China.
BMC Cancer. 2024 Nov 18;24(1):1421. doi: 10.1186/s12885-024-13196-4.
In this study, we aimed to evaluate the real-world efficacy and safety of camrelizumab and identify clinicolaboratory factors that predict treatment outcomes in patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) receiving camrelizumab.
Herein, 174 patients with unresectable advanced, recurrent, or metastatic ESCC treated with camrelizumab monotherapy (n = 30), camrelizumab + chemotherapy (CT; n = 91), and camrelizumab + radiotherapy (RT; n = 53) between October 1, 2019 and October 1, 2022 were included.
The median follow-up time was 20 months (range, 1-34 months). The median progression-free survival (PFS) and overall survival (OS) of the whole cohort were 8 months [95% confidence interval (CI), 6.5-9.5 months] and 14 months (95% CI, 11.2-16.8 months), respectively. After multivariate analysis, receiving > 4 cycles of camrelizumab was identified as an independent predictor of better PFS [hazard ratio (HR), 0.56; 95% CI, 0.38-0.827; P = 0.004] and OS (HR, 0.532; 95% CI, 0.341-0.83; P = 0.005). An intermediate-to-poor lung immune prognostic index (LIPI) was identified as an independent predictor of worse PFS (HR, 1.505; 95% CI, 1.032-2.196; P = 0.034) and OS (HR, 1.657; 95% CI, 1.094-2.51; P = 0.017). The disease control rate of patients in the camrelizumab monotherapy group, camrelizumab + CT group, and camrelizumab + RT group was 92.3% (95% CI, 74.9-99.1%), 90.6% (95% CI, 82.3-95.9%), and 96.1% (95% CI, 86.8-99.5%), respectively. The treatment-related adverse events (AEs) of grade 3 or higher were reported in 67 patients (38.5%). The most common treatment-related AEs were decreased neutrophil count (23.0%), decreased white blood cell count (19.5%), anemia (7.5%), and pneumonitis (4.6%). One patient (0.6%) died from a treatment-related AE of immune checkpoint inhibitor-induced myocarditis.
Camrelizumab was safe and effective as both monotherapy and part of a combination therapy. Longer PFS and OS were associated with receiving > 4 cycles of camrelizumab and having a good LIPI. LIPI can be used as a prognostic biomarker for ESCC patients receiving camrelizumab + RT.
ClinicalTrial.gov Identifier: CHICTR2000039499. Registered: 19th October 2020.
本研究旨在评估卡瑞利珠单抗在不可切除的晚期、复发性或转移性食管鳞状细胞癌（ESCC）患者中的真实世界疗效和安全性，并确定预测治疗结果的临床实验室因素。
本研究纳入了 2019 年 10 月 1 日至 2022 年 10 月 1 日期间接受卡瑞利珠单抗单药治疗（n=30）、卡瑞利珠单抗联合化疗（CT；n=91）或卡瑞利珠单抗联合放疗（RT；n=53）的 174 例不可切除的晚期、复发性或转移性 ESCC 患者。
中位随访时间为 20 个月（范围，1-34 个月）。全队列的中位无进展生存期（PFS）和总生存期（OS）分别为 8 个月[95%置信区间（CI）：6.5-9.5 个月]和 14 个月（95%CI：11.2-16.8 个月）。多变量分析后，接受>4 个周期的卡瑞利珠单抗治疗是 PFS（风险比[HR]，0.56；95%CI，0.38-0.827；P=0.004）和 OS（HR，0.532；95%CI，0.341-0.83；P=0.005）的独立预测因素。中高危肺免疫预后指数（LIPI）被确定为 PFS（HR，1.505；95%CI，1.032-2.196；P=0.034）和 OS（HR，1.657；95%CI，1.094-2.51；P=0.017）的独立预测因素。卡瑞利珠单抗单药组、卡瑞利珠单抗联合 CT 组和卡瑞利珠单抗联合 RT 组的疾病控制率分别为 92.3%（95%CI：74.9-99.1%）、90.6%（95%CI：82.3-95.9%）和 96.1%（95%CI：86.8-99.5%）。67 例患者（38.5%）报告了 3 级或更高的治疗相关不良事件（AE）。最常见的治疗相关 AE 为中性粒细胞计数减少（23.0%）、白细胞计数减少（19.5%）、贫血（7.5%）和肺炎（4.6%）。1 例患者（0.6%）死于免疫检查点抑制剂诱导的心肌炎相关治疗相关 AE。
卡瑞利珠单抗作为单药治疗和联合治疗的一部分是安全有效的。更长的 PFS 和 OS 与接受>4 个周期的卡瑞利珠单抗治疗和具有良好的 LIPI 相关。LIPI 可作为接受卡瑞利珠单抗联合 RT 治疗的 ESCC 患者的预后生物标志物。
ClinicalTrials.gov 标识符：CHICTR2000039499。注册日期：2020 年 10 月 19 日。
