Department of Thoracic Surgery, People's Hospital of Yangzhong, China.
Adv Clin Exp Med. 2024 Jun;33(6):573-581. doi: 10.17219/acem/170265.
Esophageal cancer (EC) is a major cause of cancer-related deaths worldwide, bringing tremendous pressure to the healthcare system and patients. Esophageal squamous cell carcinoma (ESCC) is the main subtype of EC in the Chinese population.
This study aimed to extend the neoadjuvant therapy cycle to 4 cycles and evaluate the efficacy and safety of neoadjuvant camrelizumab combined with chemotherapy for the treatment of resectable ESCC.
The enrolled patients received neoadjuvant camrelizumab (200 mg, day 1), nab-paclitaxel (260 mg/m2, day 1) and carboplatin (area under curve; 5 mg/mL/min) every 21 days for 4 cycles, and surgery was performed within 4-6 weeks after the first day of the 4th treatment cycle. The primary endpoint of the study was the pathological complete response (pCR) rate.
From December 15, 2021, to October 1, 2022, a total of 35 patients were enrolled in the study. All patients completed the full 4-cycle treatment and were deemed fit for surgical intervention. Thirty-four (97.1%) patients achieved R0 resection, 18 (51.4%) showed a pCR rate, and 27 (77.1%) achieved a major pathological response (MPR). Tumor degradation was observed in 30 out of 35 patients (85.7%). Multivariate logistic regression analyses further confirmed that age (odds ratio (OR) = 6.710, 95% confidence interval (95% CI): 3.512-44.403) and programmed death-ligand 1 (PD-L1) (OR = 2.855, 95% CI: 1.181-3.079) were independent predictors of pCR. The most prevalent adverse event (AE) was leukopenia, which was experienced by 23 out of 35 patients (65.7%). Grade 3 or higher AEs included leukopenia in 2 cases (5.7%) and neutropenia in 12 cases (34.3%). No delays in surgery were observed.
As demonstrated in this study, the 4 cycles of camrelizumab combined with nab-paclitaxel and carboplatin, which exhibited a relatively high pCR rate and acceptable safety, suggest a strong rationale for its further evaluation in resectable ESCC.
食管癌（EC）是全球癌症相关死亡的主要原因，给医疗系统和患者带来了巨大压力。食管鳞状细胞癌（ESCC）是中国人群中 EC 的主要亚型。
本研究旨在将新辅助治疗周期延长至 4 个周期，并评估新辅助卡瑞利珠单抗联合化疗治疗可切除 ESCC 的疗效和安全性。
入组患者接受新辅助卡瑞利珠单抗（200mg，第 1 天）、白蛋白紫杉醇（260mg/m²，第 1 天）和卡铂（曲线下面积；5mg/mL/min），每 21 天为 1 个周期，共 4 个周期，第 4 个周期治疗的第 1 天开始后 4-6 周内进行手术。研究的主要终点是病理完全缓解（pCR）率。
从 2021 年 12 月 15 日至 2022 年 10 月 1 日，共纳入 35 例患者。所有患者均完成了完整的 4 个周期治疗，且适合手术干预。34 例（97.1%）患者达到 R0 切除，18 例（51.4%）pCR 率，27 例（77.1%）达到主要病理缓解（MPR）。35 例患者中有 30 例（85.7%）观察到肿瘤降级。多因素逻辑回归分析进一步证实，年龄（比值比（OR）=6.710，95%置信区间（95%CI）：3.512-44.403）和程序性死亡配体 1（PD-L1）（OR=2.855，95%CI：1.181-3.079）是 pCR 的独立预测因素。最常见的不良事件（AE）是白细胞减少症，35 例患者中有 23 例（65.7%）出现该症状。3 级或更高级别的 AE 包括白细胞减少症 2 例（5.7%）和中性粒细胞减少症 12 例（34.3%）。未观察到手术延迟。
本研究显示，卡瑞利珠单抗联合 nab-紫杉醇和卡铂的 4 个周期治疗，具有较高的 pCR 率和可接受的安全性，为其在可切除 ESCC 中的进一步评估提供了有力依据。
