ESMO 2017: Docetaxel-based triplet therapy in gastric cancer: results from the FLOT4 trial confirm superiority over standard care


  • Oncology Conference Roundups
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Takeaway

  • The superiority of docetaxel-based triplet pre-operative therapy (docetaxel., oxaliplatin, leucovorin, and 5-fluorouracil [FLOT regimen]) over standard care (epirubicin, cisplatin, and 5- fluorouracil or capecitabine [ECF/ECX regimen]) in patients with resectable gastric cancer has been confirmed by a multivariate, subgroup, and sensitivity analysis of the FLOT4 study.
  • FLOT regimen should be considered the new standard of care in the perioperative treatment of patients with resectable gastric or gastroesophageal junction adenocarcinoma.

Why this matters

  • In previous studies, FLOT was superior to ECF/ECX for all efficacy endpoints, including curative resection rates, progression-free survival, and overall survival.
  • This study demonstrates that there are benefits also for older patients and patients with small tumours, nodal negative status, or signet cell cancer.

Study design

  • In FLOT4 study, 716 patients with resectable gastric or gastroesophageal junction adenocarcinoma of stage ≥cT2 and/or cN+ were randomly assigned into 2 perioperative groups of treatment.
  • Group 1 received 3 pre-operative and 3 post-operative 3-week cycles of ECF/ECX.
  • Group 2 received 4 pre-operative and 4 post-operative 2-week cycles of FLOT.
  • The primary endpoint was overall survival.

Key results

  • FLOT was associated with a 1% of progressive disease during or after pre-operative therapy, ECF regimen with 5% (P<.001).
  • FLOT guaranteed a larger number of free of disease resections (84% versus 77%; P=.011), longer progression-free time (30 months versus 18 months; HR, 0.75; P=.001) and overall survival (50 months versus 35 months; HR, 0.77; P=.012).