Liu Shiliang, Chen Baoqing, Zhu Yujia, Wang Sifen, Cheng Xingyuan, Wang Ruixi, Hu Yonghong, Liu Hui, Li Qiaoqiao, Zhang Li, Zhao Lei, Liu Mengzhong, Xi Mian
State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangdong Esophageal Cancer Institute, Guangzhou, China.
Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.
Oncologist. 2025 Jul 4;30(7). doi: 10.1093/oncolo/oyae295.
Previous results of our trial demonstrated that the addition of induction chemotherapy (IC) prior to definitive chemoradiotherapy (CRT) failed to significantly improve the response rate or 3-year survival in patients with locally advanced esophageal squamous cell carcinoma (ESCC). Here, we report long-term results and exploratory analyses to further evaluate the therapeutic value of IC.
Patients with previously untreated, unresectable, stage II-IVA ESCC were randomly assigned to receive IC followed by CRT or CRT alone. The relationship between tumor response to IC and long-term survival was analyzed. Baseline tumor biopsies were collected for RNA-Seq to identify patients who may benefit from IC.
Eligible patients were randomized to either the IC + CRT group (n = 55) or the CRT group (n = 55). With a median follow-up of 74.9 months, the 5-year overall survival rate was 31.8% in the IC + CRT group and 29.1% in the CRT group (P =.675; HR, 0.91; 95% CI, 0.58-1.43). Similarly, no significant differences were identified in 5-year progression-free survival between groups (30.5% vs 25.5%, P =.508; HR, 0.86; 95% CI, 0.56-1.34). Patients who responded to IC had significantly better survival than nonresponders. A risk-score model incorporating 6 key genes to predict IC efficacy was also constructed.
Compared with definitive CRT alone, the addition of IC before CRT still failed to demonstrate superior survival in patients with unselected ESCC, based on long-term follow-up. However, because IC responders were associated with more favorable survival, potential molecular biomarkers were identified for selection of benefit population from IC.
NCT02403531.
我们试验之前的结果表明，在确定性放化疗（CRT）之前加用诱导化疗（IC）未能显著提高局部晚期食管鳞状细胞癌（ESCC）患者的缓解率或3年生存率。在此，我们报告长期结果和探索性分析，以进一步评估IC的治疗价值。
将先前未治疗、不可切除的II-IVA期ESCC患者随机分配接受IC序贯CRT或单纯CRT。分析肿瘤对IC的反应与长期生存之间的关系。收集基线肿瘤活检组织进行RNA测序，以识别可能从IC中获益的患者。
符合条件的患者被随机分配至IC+CRT组（n=55）或CRT组（n=55）。中位随访74.9个月，IC+CRT组的5年总生存率为31.8%，CRT组为29.1%（P=0.675；HR，0.91；95%CI，0.58-1.43）。同样，两组间5年无进展生存率无显著差异（30.5%对25.5%，P=0.508；HR，0.86；95%CI，0.56-1.34）。对IC有反应的患者生存率显著优于无反应者。还构建了一个包含6个关键基因的风险评分模型来预测IC疗效。
基于长期随访，与单纯确定性CRT相比，在CRT前加用IC仍未显示出在未选择的ESCC患者中具有更高的生存率。然而，由于IC反应者的生存情况更有利，因此确定了潜在的分子生物标志物，用于从IC中选择受益人群。
NCT02403531。
