Zhou Jialiang, Bao Erwen, Wu Gang, Fan Qiang, Zhao Yutian, Zhang Yunxia, Wu Wei, Wang Zhenwu, Zhang Fuzheng, Zhao Kuaile
Department of Radiation Oncology, Affiliated Hospital of Jiangnan University, Wuxi, China.
Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
J Gastrointest Oncol. 2025 Jun 30;16(3):791-801. doi: 10.21037/jgo-22-524. Epub 2025 Jun 23.
Neoadjuvant concurrent chemoradiotherapy (CCRT) has become the preferred modality for patients with inoperable locally advanced esophageal squamous cell carcinoma (ESCC). To investigate whether the CCRT regimen of paclitaxel plus 5-fluorouracil (TF) increases the efficacy when compared with a regimen of cisplatin plus 5-fluorouracil (PF) in the locally advanced ESCC patient treatment.
A total of 103 ESCC patients were randomly divided into study group (TF, n=52) and control group (PF, n=51), treated in Affiliated Hospital of Jiangnan University from July 2014 to June 2016. These patients were followed up for 2 years in our department by performing certain examinations to evaluate their survival state. The primary endpoint was overall survival (OS). Local control (LC), progression-free survival (PFS) and adverse effects were secondary endpoints.
A total of 103 patients were enrolled. The 1-, 2-year OS for TF group was 76.9%, 59.6% versus 74.5% (χ=0.134, P=0.72), 56.9% (χ=0.151, P=0.70) for PF group. The 1-, 2-year LPS for TF group and PF group were 71.2%, 61.5% and 66.7% (χ=0.065, P=0.80), 58.8% (χ=0.079, P=0.78) respectively. The serious leukopenia (grade 3-4) incidence rate for TF group was 36.5% versus 17.6% for PF group (χ=4.642, P<0.05).
When compared with the PF regimen, the TF regimen shows no survival benefit but exhibited a trend to a better control rate and a decreased distant metastasis rate. Both regimens showed tolerable toxicity.
Chinese Clinical Trial Registry ChiCTR2500100712.
新辅助同步放化疗（CCRT）已成为无法手术的局部晚期食管鳞状细胞癌（ESCC）患者的首选治疗方式。旨在研究在局部晚期ESCC患者治疗中，与顺铂联合5-氟尿嘧啶（PF）方案相比，紫杉醇联合5-氟尿嘧啶（TF）的CCRT方案是否能提高疗效。
2014年7月至2016年6月，江南大学附属医院共纳入103例ESCC患者，随机分为研究组（TF组，n = 52）和对照组（PF组，n = 51）。在我科对这些患者进行了2年的随访，通过进行某些检查来评估他们的生存状态。主要终点是总生存期（OS）。局部控制（LC）、无进展生存期（PFS）和不良反应为次要终点。
共纳入103例患者。TF组1年、2年总生存率分别为76.9%、59.6%，PF组分别为74.5%（χ = 0.134，P = 0.72）、56.9%（χ = 0.151，P = 0.70）。TF组和PF组1年、2年局部控制率分别为71.2%、61.5%和66.7%（χ = 0.065，P = 0.80）、58.8%（χ = 0.079，P = 0.78）。TF组严重白细胞减少（3 - 4级）发生率为36.5%，PF组为17.6%（χ = 4.642，P < 0.05）。
与PF方案相比，TF方案未显示出生存获益，但显示出更好的控制率趋势和远处转移率降低。两种方案均显示出可耐受的毒性。
中国临床试验注册中心ChiCTR2500100712
