1. A randomized clinical trial of neoadjuvant chemotherapy versus neoadjuvant chemoradiotherapy for cancer of the oesophagus or gastro-oesophageal junction
- Author
-
Magnus Nilsson, Anne-Birgitte Jacobsen, Fredrik Klevebro, Nils Glenjen, Lars Lundell, Gjermund Johnsen, Jon A. Tsai, Signe Friesland, Ingunn Hatlevoll, Pehr Lind, G. Alexandersson von Döbeln, and N. Wang
- Subjects
Oncology ,medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,Hematology ,Esophageal cancer ,medicine.disease ,Chemotherapy regimen ,Clinical trial ,Radiation therapy ,03 medical and health sciences ,0302 clinical medicine ,030220 oncology & carcinogenesis ,Internal medicine ,Concomitant ,medicine ,030211 gastroenterology & hepatology ,Lymphadenectomy ,business ,Neoadjuvant therapy ,Chemoradiotherapy - Abstract
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 multicentre 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 end point was histological complete response after neoadjuvant treatment, which has been shown to be correlated with increased long-term survival. Study participants were randomized to nCT or nCRT, followed by surgery with two-field lymphadenectomy. Three cycles of platin/5-fluorouracil were administered in both arms, whereas 40 Gy of concomitant radiotherapy was added in the nCRT arm. Results The trial met the primary end point, 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. clinicaltrials.gov NCT01362127 (https://clinicaltrials.gov; The full study protocol was registered in the Clinical Trials Database).
- Published
- 2016