Long-term efficacy and progression patterns of paclitaxel plus cisplatin and 5-fluorouracil induction chemotherapy for locally advanced, borderline-resectable esophageal squamous cell carcinoma: results from a phase II NEOCRTEC1601 study.

Abstract

Introduction: The NEOCRTEC1601 trial aimed to evaluate the efficacy and safety of paclitaxel in combination with cisplatin and 5-fluorouracil (TPF) as an induction chemotherapy for borderline-resectable esophageal squamous cell carcinoma (BR-ESCC). This study presents an updated 5-year analysis to further elucidate the impact of TPF chemotherapy followed by surgery.

Method: This study was conducted as a single-center, phase II clinical trial. Eligibility was extended to patients diagnosed with BR-ESCC, characterized by a primary tumor or bulky lymph nodes with potential invasion into adjacent organs. The treatment protocol commenced with TPF chemotherapy, followed by surgery, if the tumor was deemed resectable, or by concurrent chemoradiation in cases where resection was not feasible. This updated report delineates the 5-year overall survival (OS) and progression-free survival (PFS) rates.

Result: Surgery was performed on 27 patients (57.4%), and R0 resection was observed in 26 patients (53.2%). Pathologic complete response was confirmed in four patients (8.5%). Following a minimum follow-up period exceeding 60 months for all patients, the total number of deaths was 31 (65.96%). The OS and PFS for the R0 group were significantly longer than those for the non-R0 group (median OS: 53.0 months vs. 13.9 months, HR: 0.36, 95% confidence interval [CI]: 0.17-0.76, P = 0.0032; median PFS: 50.84 months vs. 5.42 months, HR: 0.40, 95% CI 0.19-0.84, P = 0.0076). The 5-year OS rate was 50.0% (34.0%-73.4%) for the R0 group compared to 19.0% (7.9%-46.0%) for the non-R0 group (HR: 0.36, 95% CI: 0.17-0.79, P = 0.0041).

Conclusion: Long-term follow-up confirmed that the OS and PFS were significantly improved in patients who underwent R0 resection compared to those who did not. The 5-year OS rate for patients who achieved R0 resection was 50.0%. R0 resection might be an independent prognostic factor for OS. To further improve the R0 resection rate and prognosis, more effective induction treatment regimens need to be explored.