Oncological outcomes of standard versus prolonged time to surgery after neoadjuvant chemoradiotherapy for oesophageal cancer in the multicentre randomised controlled NeoRes II trial
Mené entre 2015 et 2019 sur 249 patients atteints d'un cancer de l'oesophage de stade localement avancé et résécable, cet essai randomisé multicentrique évalue l'effet, sur la réponse pathologique complète, du délai entre la chimioradiothérapie et la chirurgie
Résumé en anglais
Summary: After prolonged delay of up to three months after nCRT. The NeoRes II trial is the first randomised trial to compare standard to prolonged time to surgery after nCRT for oesophageal cancer.
Patients and methods: Patients with resectable, locally advanced oesophageal cancer were randomly assigned to standard delay of surgery of 4-6 weeks or prolonged delay of 10-12 weeks after nCRT. The primary endpoint was complete histological response of the primary tumour in patients with adenocarcinoma. Secondary endpoints included histological tumour response, resection margins, overall and progression-free survival in all patients and stratified by histologic type.
Results: Between February 2015 and March 2019, 249 patients from ten participating centres in Sweden, Norway and Germany were randomised: 125 to standard and 124 to prolonged time to surgery. There was no significant difference in complete histological response between adenocarcinoma patients allocated to standard (21%) compared to prolonged (26%) time to surgery (P=0.429). Tumour regression, resection margins, number of resected lymph nodes, total and metastatic, did not differ between the allocated interventions. First quartile overall survival in patients allocated to standard time to surgery was 26.5 months compared to 14.2 months after prolonged time to surgery (P=0.003) and the overall risk of death during follow-up was 35% higher after prolonged delay (hazard ratio 1.35, 95% CI: 0.94-1.95, P=0.107).
Conclusion: Prolonged time to surgery did not improve histological complete response or other pathological endpoints, while there was a strong trend towards worse survival, suggesting caution in routinely delaying surgery for more than six weeks after nCRT.
