HER-FLOT: Trastuzumab in combination with FLOT as perioperative treatment for patients with HER2-positive locally advanced esophagogastric adenocarcinoma: A phase II trial of the AIO Gastric Cancer Study Group.

Abstract

4073^ Background: Perioperative chemotherapy is a mainstay in the treatment of locally advanced esophagogastric adenocarcinomas (EGA). Trastuzumab improved survival when added to chemotherapy in pts with HER-2-positive metastatic EGA. We investigated the combination of trastuzumab and FLOT as perioperative treatment in pts with locally advanced EGA. Methods: A multicenter phase II study evaluated the efficacy & toxicity of perioperative HER-FLOT (24-h 5-FU 2,600 mg/m², leucovorin 200mg/m², oxaliplatin 85mg/mg², docetaxel 50 mg/m², trastuzumab 6mg/kg then 4 mg/kg d1, repeated d15 for four cycles pre- and postoperatively followed by 9 cycles of trastuzumab monotherapy 6mg/kg 3-weekly) in pts with HER-2 positive EGA (IHC 3+ or IHC 2+/ ISH+). Pts had to have ≥cT2, any N, M0 EGA. The primary endpoint was the rate of centrally tested pathological complete remissions (pCR). Secondary endpoints comprised disease-free and overall survival, R0 resection rate, toxicity and surgical morbidity. Here we report data of ...