1424MO - Perioperative FLOT plus ramucirumab versus FLOT alone for resectable esophagogastric adenocarcinoma– Updated results and subgroup analyses of the randomized phase II/III trial RAMSES/FLOT7 of the German AIO and Italian GOIM(ESMO 2020)
This is a prospective, international, randomized, investigator-initiated phase II/III trial. Patients (pts) with resectable, Her2-negative EGA(≥ cT2 or cN+) were randomized to 4 pre-and post-operative cycles of FLOT (docetaxel 50 mg/m2; oxaliplatin 85 mg/m2; leucovorin 200 mg/m2; 5-FU 2600 mg/m2, q2w) alone (Arm A) or FLOT with RAM 8mg/kg q2w, followed by 16 cycles RAM (Arm B, FLOT-RAM). Here, we report the main results along with the subgroup analysis explaining the higher rate of R0-resection in the FLOT-RAM arm...In total, 180 pts (FLOT, 91; FLOT-RAM, 89) were randomized. Baseline characteristics were similar between arms (male, 73%; median age, 60y; cT3/T4, 83%; cN+, 78%; GEJ, 54%). The rate of signet-ring cell cancer was high (40%). As reported at ASCO, no difference in path response rates was seen (FLOT, 30%; FLOT-RAM, 27%). However, FLOT-RAM significantly improved R0-resection rate (FLOT, 82%; FLOT-RAM, 96%, p=0.0078). This difference was due to less pts in the FLOT-RAM arm with disease progression prior to operation (FLOT, 6%; FLOT-RAM, 1%), more pts proceeding to operation (FLOT, 93%; FLOT-RAM, 97%), more pts receiving resectional surgery (FLOT, 88%; FLOT-RAM, 97%), and less pts having residual tumor out of the resected pts (FLOT, 4; FLOT-RAM, 1).