
For patients with resectable esophageal adenocarcinoma, survival outcomes appear to be better with perioperative chemotherapy with FLOT vs preoperative chemoradiotherapy, according to a phase III study.
The study included 438 patients with a primary tumour that was clinically staged as cT1 cN+, cT2–4a cN+, or cT2–4a cN0 and that had no evidence of metastatic spread. These patients were randomly assigned to receive perioperative chemotherapy with FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) plus surgery (n=221) or preoperative chemoradiotherapy (radiotherapy at a dose of 41.4 Gy and carboplatin and paclitaxel) plus surgery (n=217).
Over a median follow-up of 55 months, the primary endpoint of overall survival at 3 years was 57.4 percent (95 percent confidence interval [CI], 50.1–64.0) in the FLOT arm and 50.7 percent (95 percent CI, 43.5–57.5) in the chemoradiotherapy arm. Perioperative chemotherapy with FLOT was associated with 30-percent lower risk of death (hazard ratio [HR], 0.70, 95 percent CI, 0.53–0.92; p=0.01).
The 3-year progression-free survival was 51.6 percent (95 percent CI, 44.3–58.4) in the FLOT arm vs 35.0 percent (95 percent CI, 28.4–41.7) in the chemoradiotherapy arm (HR, 0.66, 95 percent CI, 0.51–0.85).
Among the patients who started the assigned treatment, grade 3 or higher adverse events occurred in 58.0 percent of those in the FLOT arm and in 50.0 percent of those in the chemoradiotherapy arm. Serious adverse events were documented in 47.3 percent and 41.8 percent of patients, respectively. Mortality at 90 days after surgery was 3.1 percent in the FLOT arm and 5.6 percent in the chemoradiotherapy arm.