Long-Term Outcomes of Induction Chemotherapy Followed by Chemo-Radiotherapy as Intensive Neoadjuvant Protocol in Patients with Esophageal Cancer.

Abstract

Simple SummaryNeoadjuvant chemo-radiotherapy (nCRT) represents a standard approach for both Squamous Cell Carcinoma (SCC) and Adenocarcinoma (ADC) of the esophagus, leading to a 10–15% improvement in survival rate as compared with surgery alone in clinical trials. In this observational study, we report the efficacy and safety of an intensive nCRT protocol in the daily clinical practice, including 122 patients treated with induction chemotherapy, followed by concomitant chemo-radiotherapy, and surgery. Our findings showed good long-term survival and high pathological complete response (pCR) rates, with acceptable side-effects. Notably, the oncological outcome was the same in ADC and SCC responder patients. Although the nCRT protocol here reported represents a distinctive single-center experience, our results contribute to better define the role of an intensive neoadjuvant approach as a reliable therapy for the treatment of locally advanced esophageal cancer, and enrich the current literature on this challenging context.Background: A phase II intensive neoadjuvant chemo-radiotherapy (nCRT) protocol for esophageal cancer (EC) was previously tested at our Center with promising results. We here present an observational study to evaluate the efficacy of the protocol also in “real life” patients. Methods: We retrospectively reviewed 122 ECs (45.1% squamous cell (SCC) and 54.9% adenocarcinoma (ADC)) treated with induction docetaxel, cisplatin, and 5-fluorouracil (TCF), followed by concomitant TCF and radiotherapy (50–50.4 Gy/25–28 fractions), between 2008 and 2017. Primary endpoints were overall survival (OS), event-free survival (EFS) and pathological complete response (pCR). Results: With a median follow-up of 62.1 months (95% CI 50–67.6 months), 5-year OS and EFS rates were 54.8% (95% CI 44.7–63.9) and 42.7% (95% CI 33.1–51.9), respectively. A pCR was observed in 71.1% of SCC and 37.1% of ADC patients (p = 0.001). At multivariate analysis, ypN+ was a significant prognostic factor for OS (Hazard Ratios (HR) 4.39 [95% CI 2.36–8.18]; p < 0.0001), while pCR was a strong predictor of EFS (HR 0.38 [95% CI 0.22–0.67]; p < 0.0001). Conclusions: The nCRT protocol achieved considerable long-term survival and pCR rates also in “real life” patients. Further research is necessary to evaluate this protocol in a watch-and-wait approach.