Abstract

Abstract Background Neoadjuvant therapy is in common clinical practice in the treatment of patients with esophageal cancer. In our department a phase 2 clinical trial was conducted for a neoadjuvant chemoradiotherapy protocol in patients under 75 with ECOG grade 0–2. At the end of the study, which led to encouraging results, the criteria for inclusion of patients in a neoadjuvant therapy protocol were extended. The aim of this work is to compare the results of the historical group of selected patients (protocol group) with the group of patients treated at the end of the study (real life group). Methods two groups of patients were considered: a historical group from 2003 to 2011 and a more recent group, from 2012 to 2018. The patients of the historical group (protocol group) were selected according to the precise inclusion criteria. The recent group (real life group) includes all patients who, by extension of disease and by comorbidity, could enter into a multimodal strategy in an intention to treat perspective. these two groups were compared for: protocol type, protocol completion, surgery rate, surgery radicality, pathological response and survival. Results In the real life group, 99 patients were referred to protocols different from the protocol considered standard in our department, because they were deemed not able to tolerate the treatment; the rate of completion of intention to treat strategy was 84,5 in the protocol group compared to 80,5 of the real life group (P = 0.326). Rate of radicality were 93,9 vs 92,4 in the protocol group vs to the real life group (P = 0.311). PCR was 49,6 and 35,9 respectively (P = 0.001). 5y disease relate survival was 51,3% for protocol group compared to 42,8 of the real life group in operated on patients (P = 0.467). Considering patient in the real life group that would have been within the inclusion criteria of the protocol group, R0 was 92,9, CPR 35,5 and 5y DRS 49,6 (P = 0581). Conclusion multimodal therapy is certainly the standard of care in these patients, but real life is not as bright as we would like to believe Disclosure All authors have declared no conflicts of interest.

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