Abstract

Abstract Background A phase 2 trial analyzed the safety and efficacy of TPF induction chemotherapy followed by surgery for locally advanced borderline-resectable esophageal squamous cell carcinoma (NEOCRTEC-1601 clinical trial). This study presents updated 3-year analyses to further characterize the impact of TPF chemotherapy followed by surgery. Methods Patients diagnosed with BR-ESCC because of the primary tumor or bulky lymph node that potentially invaded adjacent organs were eligible. The treatment started with TPF chemotherapy, followed by surgery if the cancer was resectable, or by concurrent chemoradiation if it was unresectable. This updated analysis presents the 2- and 3-year overall survival rates and progression-free survival rates. Results A total of 27 patients (57.4%) received surgery and R0 resection was confirmed in 25 patients (53.2%). Pathologic complete response was confirmed in 4 patients (8.5%). The median follow-up time for the patients surviving without death was 44.8 months (range, 3.4–74.6 months). The median OS for all patients was 41.9 months (95% CI 18.6–65.3), with a median PFS of 38.7 months (95% CI 23.5–53.9). The 3-year survival rate of all patients was 54.4%. The OS and PFS for R0 group patients were significantly longer than those in non-R0 group (median OS: undefined vs. 26.5 months, HR 0.38; 95% CI 0.17–0.85, P = 0.010; median PFS: undefined vs. 17.2 months, HR 0.41, 95% CI 0.18–0.91, P = 0.016). The 3-year survival rate was 65.4% for the R0 group patients compared with 40.3% for the non-R0 patients (HR 0.41, 95%CI 0.16–0.91, P = 0.034). Conclusions Long-term follow-up evaluation confirmed that TPF followed by surgery is feasible and promising in terms of survival for BR-ESCC patients.

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