Real-world evaluation of the efficacy of neoadjuvant DCF over CF in esophageal squamous cell carcinoma: propensity score matched analysis from 85 authorized institute for esophageal cancer in Japan

Objective:

We aimed to evaluate the efficacy of neoadjuvant docetaxel, cisplatin, and 5-fluorouracil (DCF) therapy over cisplatin, and 5-fluorouracil (CF) in patients with surgically resectable advanced esophageal squamous cell carcinoma (ESCC), using real-world data from 85 esophageal centers.

我们的目的是评估新辅助多西他赛、顺铂和5-氟尿嘧啶(DCF)相对于顺铂和5-氟尿嘧啶（CF）在可手术切除的晚期食管鳞癌(ESCC)患者中的疗效，我们使用了来自85个食管中心的真实世界数据。Summary Background Data: 背景资料总结

JCOG1109 trial, which assessed the superiority of DCF over CF, and the superiority of chemoradiotherapy with CF over CF alone demonstrated the significant survival advantage of neoadjuvant DCF in overall survival over CF for ESCC.

JCOG1109试验评估了DCF相对于CF的优势，以及CF联合放化疗相对于单独CF的优势，显示了ESCC中新辅助DCF相对于CF的总生存期显著优势。

Methods:

The ESCC patients who received neoadjuvant CF or DCF at 85 Japanese esophageal centers certified by Japan Esophageal Society were retrospectively reviewed. After propensity score (PS) matching, the overall survival (OS) and recurrence free survival (RFS) were compared bet ween CF and DCF.

回顾性分析85例经日本食管协会认证的食管中心接受新辅助CF或DCF治疗的ESCC患者。经倾向评分(PS)匹配后，比较CF和DCF的总生存期(OS)和无复发生存期(RFS)。

Results:

We initially enrolled 4781 patients. After data cleaning and PS matching using pretreatment variables, 1074 patients for each group were selected for subsequent analysis. There was no significant difference in the incidence of postoperative pneumonia and anastomotic leakage. In the survival analysis, OS was significantly longer in DCF group than CF group (HR, 0.868; 95% CI, 0.770 –0.978; p=0.02), as well as RFS (HR, 0.850; 95% CI, 0.761–0.949; p=0.004). The survival advantage of DCF was not observed in patients with 76 years old or older.

我们最初入组了4781名患者。采用预处理变量进行数据清洗和PS匹配后，每组选取1074例患者进行后续分析。两组术后肺炎、吻合口漏发生率比较，差异无统计学意义。生存分析中，DCF组的OS明显长于CF组(HR, 0.868;95%可信区间，0.770 -0.978;p=0.02)， RFS (HR, 0.850;95%可信区间0.761 - 0.949;p = 0.004)。在76岁及以上的患者中没有观察到DCF的生存优势。

Conclusion:

Neoadjuvant DCF therapy showed remarkable survival advantage in surgically resectable ESCC patients especially in patients who were 75 years old or younger. The current real-world evidence will encourage recommendations for DCF as a standard regimen in NAC based treatment strategy for ESCC.

对于可手术切除的ESCC患者，尤其是75岁及以下的患者，新辅助DCF治疗具有显著的生存优势。当前真实世界的证据将鼓励推荐DCF作为基于NAC的ESCC治疗策略的标准方案。