Trastuzumab in combination with 5‐fluorouracil, leucovorin, oxaliplatin and docetaxel as perioperative treatment for patients with human epidermal growth factor receptor 2‐positive locally advanced esophagogastric adenocarcinoma: A phase <scp>II</scp> trial of the Arbeitsgemeinschaft Internistische Onkologie Gastric Cancer Study Group

Perioperative chemotherapy with 5-fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) is a mainstay in the treatment of esophagogastric adenocarcinomas (EGA). Trastuzumab improved survival when added to patients HER-2-positive metastatic EGA. We investigated combination trastuzumab FLOT as perioperative locally advanced A multicenter phase II study evaluated efficacy toxicity (24-hours 5-FU 2600 mg/m2, leucovorin 200 85 mg/mg2, 50 6 mg/kg then 4 d1, repeated d15 for four cycles preoperatively postoperatively followed by 9 monotherapy) HER-2 positive Patients had ≥cT2, any N, M0 The primary endpoint was rate centrally assessed pathological complete response (pCR). Secondary endpoints comprised disease-free (DFS) overall (OS), R0 resection rate, surgical morbidity. Fifty-six evaluable (median age 62 years) were included; n = 40 tumors originating from junction; T stage (cT2/3/4/unknown): 4/42/8/2; cN+ disease. Main adverse events grades 3-4: leukopenia (17.9%), neutropenia (46.6%) diarrhea (17.0%). All underwent tumor resections. 92.9%. Eight anastomotic leakage. One postoperative death occurred. pCR found 12 (21.4%) further 14 (25.0%) near response. Median DFS 42.5 months 3-year OS 82.1%. achieving >20% reached. No unexpected safety issues observed. Survival data are promising.