Long-Term Survival of Two Versus Three Courses of Preoperative Cisplatin and Fluorouracil Plus Docetaxel for Locally...

Preoperative chemotherapy with cisplatin, fluorouracil, and docetaxel (DCF) is one of the neoadjuvant treatments for locally advanced esophageal squamous cell carcinoma (ESCC). However, the optimal number of DCF cycles remains unknown. This multi-institutional, randomized, phase II trial aimed to investigate the long-term survival outcomes of two versus three courses of DCF.

A total of 180 patients with locally advanced ESCC from six institutions were randomly assigned to receive either two (N = 91) or three (N = 89) courses of DCF administered every 3 weeks prior to surgery. Long-term survival outcomes were compared between the two regimens.

Baseline characteristics were well balanced between the two groups. The 5-year overall survival (OS) and progression-free survival (PFS) rates for the three and two course groups were 70.7% vs. 63.8% (hazard ratio (HR) = 0.91, p = 0.717) and 63.3% vs. 60.0% (HR = 0.94, p = 0.810) respectively, with no significant differences observed. The per-protocol analysis exhibited similar results, with OS rates of 71.1% vs. 68.8% (HR = 0.90, p = 0.702) and PFS rates of 63.6% vs. 65.4% (HR = 0.92, p = 0.773). Recurrence patterns were also similar between the groups. Subgroup analysis revealed that non-responders in the three course DCF group had significantly worse long-term survival outcomes, whereas the two course DCF group exhibited minimal trends in this regard. Conversely, patients aged < 65 years or those with favorable clinical responses in the three course group demonstrated improved long-term survival outcomes.

Two courses of preoperative DCF followed by radical esophagectomy can be one of the potential treatment strategies for locally advanced ESCC.

ClinicalTrials.gov identifier: UMIN 000015788.