A Randomised Clinical Trial of Neoadjuvant Chemotherapy vs. Neoadjuvant Chemoradiotherapy for Cancer of the Oesophagus or Gastro-Oesophageal Junction
Mené sur 181 patients atteints d'un carcinome de l'œsophage ou de la jonction gastro-œsophagienne, cet essai multicentrique évalue, du point de vue de la réponse complète histologique, l'intérêt d'ajouter une radiothérapie à une chimiothérapie néoadjuvante par sels de platine et 5-fluorouracile dans le cadre d'un traitement chirurgical avec lymphadénectomie
Background : Neoadjuvant therapy improves long-term survival after oesophagectomy treating oesophageal cancer, but the evidence to date is insufficient to determine which of the two main neoadjuvant therapy types, chemotherapy (nCT) or chemoradiotherapy (nCRT), is more beneficial. We aimed to compare the effects of nCT with those of nCRT. Patients and methods : This multicenter trial, which was conducted in Sweden and Norway, recruited 181 patients with carcinoma of the oesophagus or the gastro-oesophageal junction who were candidates for curative-intended treatment. The primary endpoint was histological complete response after neoadjuvant treatment, which has been shown to be correlated to increased long-term survival. Study participants were randomised to nCT or nCRT, followed by surgery with two-field lymphadenectomy. Three cycles of platin/5-fluorouracil were administered in both arms, while 40 Gy of concomitant radiotherapy was added in the nCRT arm. Results : The trial met the primary endpoint, histological complete response being achieved in 28% after nCRT, versus 9% after nCT (p=0.002). Lymph-node metastases were observed in 62% in the nCT group, versus 35% in the nCRT group (p=0.001). The R0 resection rate was 87% after nCRT and 74% after nCT (p=0.04). There was no difference in overall survival between the treatment arms. Conclusion : The addition of radiotherapy to neoadjuvant chemotherapy results in higher histological complete response rate, higher R0 resection rate and a lower frequency of lymph node metastases, without significantly affecting survival.