STUDY presented by Dr Jens Hoeppner from the University of Bielefeld at the American Society of Clinical Oncology 2024 (ASCO) annual meeting, found that perioperative FLOT chemotherapy significantly improves survival rates in patients with resectable locally advanced oesophageal adenocarcinoma (EAC), compared to neoadjuvant chemoradiation therapy.
Effective multimodal treatment approaches for EAC have been a topic of ongoing debate. The ESOPEC phase III multicenter prospective randomized study presented at ASCO, compared the efficacy of neoadjuvant CROSS (chemoradiation with carboplatin/paclitaxel followed by surgery) against FLOT (5-FU/leucovorin/oxaliplatin/docetaxel) and surgery for the curative treatment of EAC.
Eligible patients included those with resectable EAC classified as cT1 cN+ cM0 or cT2-4a cNany cM0. The primary endpoint was overall survival (OS), analysed in all randomized patients using Cox regression, stratified by study site, N stage, and age.
438 patients from 25 sites in Germany between February 2016 and April 2020 were randomly assigned to two treatment groups: 221 to FLOT and 217 to CROSS. Baseline characteristics were balanced between the two treatment groups. While 403 (207 FLOT; 196 CROSS) patients underwent neoadjuvant treatment and 371 (191 FLOT; 180 CROSS) patients underwent surgery, achieving R0 resection in 351 patients. Post-surgical 90-day mortality was slightly lower in the FLOT group (3.2%) compared to CROSS (5.6%).
After a median follow-up of 55 months, 218 patients had died (97 in FLOT, 121 in CROSS). Median overall survival rate (OS) was significantly longer in the FLOT group (66 months) compared to the CROSS group (37 months). The three-year OS rates were 57.4% for FLOT and 50.7% for CROSS, with a hazard ratio of 0.70 (p=0.012). The pathological complete response was achieved in 19.3% of FLOT patients and 13.5% of CROSS patients.
These results indicate that treatment with perioperative FLOT chemotherapy provides an advantage over neoadjuvant CROSS improves survival rates in patients with resectable EAC.
Reference:
Hoeppner J. Prospective randomized multicenter phase III trial comparing perioperative chemotherapy (FLOT protocol) to neoadjuvant chemoradiation (CROSS protocol) in patients with adenocarcinoma of the esophagus (ESOPEC trial). Abstract LBA1. ASCO Annual Meeting. 2024.
