Recurrence patterns after neoadjuvant chemoradiotherapy compared with surgery alone in oesophageal squamous cell carcinoma: results from the multicenter phase III trial NEOCRTEC5010.

BACKGROUND: The aim of this study was to compare recurrence patterns and prognostic factors for developing recurrences in patients with oesophageal squamous cell carcinoma (ESCC) who received neoadjuvant chemoradiotherapy (CRT) followed by surgery or surgery alone from a multicenter phase III trial NEOCRTEC5010. PATIENTS AND METHODS: Patients with locally advanced ESCC were randomly assigned in a 1:1 ratio to receive neoadjuvant CRT plus surgery (CRT + S group) or surgery alone (S group). CRT consisted of two cycles of vinorelbine and cisplatin with concurrent radiotherapy of 40.0 Gy in 20 fractions. Recurrence patterns, sites, frequency, and timing and potential prognostic factors were compared.
RESULTS: Of the 451 patients enrolled from 2007 to 2014, 411 patients who underwent resection were analysed. After a median follow-up of 51.9 months, 62 patients (33.7%) in the CRT + S group versus 104 patients (45.8%) in the S group experienced recurrences (P = 0.013). The CRT + S group demonstrated a significantly better locoregional failure-free survival (P = 0.012) and a more favourable distant metastasis-free survival (P = 0.028) than the S group. Recurrences occurred earlier in the S group (P = 0.053), and late relapses were much more frequent in the CRT + S group (P = 0.029). On multivariate analysis, R1 resection and surgery alone were adverse factors for developing locoregional recurrences, whereas R1 resection was the only independent factor associated with distant metastases.
CONCLUSIONS: The neoadjuvant CRT regimen was associated with significantly reduced locoregional and distant recurrences compared with surgery alone. Recurrence patterns, sites and frequency were different between groups. TRIAL REGISTRATION CLINICALTRIALS. GOV IDENTIFIER: NCT01216527.

RCT Entities:   Population Interventions Outcomes