Full Name: Fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel for Gastric or Gastroesophageal Junction Cancer – AIO Study
Type of Study:
- Phase II/III, randomized, multicenter clinical trial
- Conducted in Germany (AIO Group)
Purpose:
- To compare perioperative FLOT chemotherapy versus ECF/ECX in patients with resectable gastric or GEJ adenocarcinoma.
- Goal: Evaluate whether FLOT improves overall survival (OS), progression-free survival (PFS), and pathologic response.
Patient Population:
- Resectable gastric or gastroesophageal junction adenocarcinoma
- Stages: Locally advanced (cT2-4 and/or N+)
- Good performance status (ECOG 0–1)
Treatment Arms:
- FLOT (experimental arm)
- Docetaxel 50 mg/m² IV day 1
- Oxaliplatin 85 mg/m² IV day 1
- Leucovorin 200 mg/m² IV day 1
- 5-FU 2600 mg/m² IV continuous infusion over 24 h day 1
- Every 2 weeks, 4 cycles pre-op + 4 cycles post-op
- ECF/ECX (control arm)
- Epirubicin + Cisplatin + 5-FU (ECF) or Capecitabine (ECX)
- Every 3 weeks, 3 cycles pre-op + 3 cycles post-op
Key Outcomes:
- Overall Survival (OS):
- Pathologic Response / R0 Resection Rate:
- Higher complete pathologic response with FLOT
- Similar R0 resection rates, but more tumor regression
- Toxicity:
- FLOT: more neutropenia and gastrointestinal toxicity vs ECF/ECX
- Manageable with supportive care (G-CSF, antiemetics, hydration)
Pharmacist Implications:
- FLOT is now the preferred perioperative regimen for fit patients with resectable gastric/GEJ adenocarcinoma.
- Close monitoring for:
- Myelosuppression (especially neutropenia, febrile neutropenia)
- Peripheral neuropathy (oxaliplatin)
- GI toxicities (5-FU continuous infusion, docetaxel)
- Fluid retention and mucositis (docetaxel)
- Supportive care: antiemetics, G-CSF, electrolyte monitoring, and hydration.
Bottom Line:
- FLOT4-AIO established FLOT as superior to ECF/ECX in perioperative treatment of gastric/GEJ adenocarcinoma: better OS, higher pathologic response, acceptable toxicity.