Safety and short-term efficacy of neoadjuvant FLOT therapy in cisplatin-unfit patients with resectable esophageal squamous cell carcinoma.

BACKGROUNDS: The standard neoadjuvant therapy for resectable locally advanced esophageal squamous cell carcinoma (LA-ESCC) is a combination of docetaxel, cisplatin (CDDP), and 5-fluorouracil in Japan. However, patients with renal or cardiac dysfunction and elderly patients were unfit for CDDP-containing regimens due to toxicity. In this context, 5-fluorouracil and leucovorin, oxaliplatin, docetaxel (FLOT) therapy, which is the standard neoadjuvant therapy for esophagogastric adenocarcinoma in Western countries, offers an alternative that can be administered to the patients who are unfit for CDDP. However, the safety and short-term efficacy of neoadjuvant FLOT therapy in patients with LA-ESCC remain unclear. MATERIALS AND METHODS: This retrospective study analyzed patients with resectable LA-ESCC who received neoadjuvant FLOT from February 2021 to December 2023. Four cycles of FLOT were administered every 2 weeks, and then the subjects underwent esophagectomy. Adverse events were evaluated according to the CTCAE version 5.0, and pathological response and survival outcomes were evaluated for efficacy. RESULTS: Forty-six patients were included in this study. Median age was 76 years (range 57-84 years). Clinical stage III and IVB were the most frequent, at 61% and 20%, respectively. During the neoadjuvant therapy, the most common grade 3 or higher adverse events were neutropenia (65%) and leukopenia (50%). Of 36 patients who underwent surgery, pathologic complete response (ypT0N0) was observed in 5 patients (13.9%). The median progression-free survival and overall survival were 15.0 and 25.2 months, respectively. CONCLUSIONS: Neoadjuvant FLOT demonstrated manageable safety profiles and promising efficacy in patients with resectable LA-ESCC who were CDDP-unfit.