Neoadjuvant chemoradiotherapy versus neoadjuvant chemotherapy followed by minimally invasive esophagectomy for locally advanced esophageal squamous cell carcinoma: A prospective multi-center randomized clinical trial
Mené sur 264 patients atteints d'un carcinome épidermoïde de l'oesophage de stade localement avancé (durée médiane de suivi : 43,9 mois), cet essai randomisé multicentrique compare l'efficacité, du point de vue de la survie globale à 3 ans, d'une chimioradiothérapie néoadjuvante et d'une chimiothérapie suivie d'une oesophagectomie mini-invasive
Background: Neoadjuvant therapy is recommended for locally advanced esophageal cancer, but the optimal strategy remains unclear. We aimed to evaluate the safety and efficacy of neoadjuvant chemoradiotherapy (nCRT) vs neoadjuvant chemotherapy (nCT) followed by minimally invasive esophagectomy (MIE) for locally advanced esophageal squamous cell carcinoma (ESCC). Patients and methods: Eligible patients staged as cT3-4aN0-1M0 ESCC were randomly assigned (1:1) to the nCRT or nCT group stratified by age, cN stage and centers. The chemotherapy, based on paclitaxel and cisplatin, was administered to both groups, while concurrent radiotherapy added for nCRT group; then MIE was performed. The primary endpoint was 3-year overall survival. This study is registered with ClinicalTrials.gov, NCT03001596. Results: A total of 264 patients were eligible for the intention-to-treat analysis. By November 30, 2021, 121 deaths had occurred. The median follow-up was 43.9 months (interquartile range, 36.6-49.3 months). The overall survival in the intention-to-treat population were comparable between nCRT and nCT strategy (hazard ratio [HR], 0.82; 95% CI, 0.58-1.18; P = 0.28), with a 3-year survival rate of 64.1% (95% CI, 56.4% to 72.9%) vs. 54.9% (95% CI, 47.0% to 64.2%), respectively. There were also no differences in progression-free survival (HR, 0.83; 95% CI, 0.59-1.16; P = 0.27) and recurrence-free survival (HR, 1.07; 95% CI, 0.71-1.60; P = 0.75), although the pathological complete response (pCR) in the nCRT group (27.7%, 31/112) was significantly higher than that in the nCT group (2.9%, 3/104) (P < 0.001). Besides, a trend of lower risk of recurrence was observed in the nCRT group (P = 0.063), while the recurrence pattern was similar (P = 0.802). Conclusions: NCRT followed by MIE was not associated with significantly better overall survival than nCT among patients with cT3-4aN0-1M0 ESCC. The results underscore the pending issue of the best strategy of neoadjuvant therapy for locally advanced bulky ESCC.
Annals of Oncology 2022