Perioperative FLOT plus anti-PD-L1 avelumab (FLOT-A) in resectable oesophagogastric adenocarcinoma (OGA): Interim safety analysis results from the ICONIC trial.

• DOI: 10.1200/jco.2021.39.3_suppl.201
• Publication Date: 2021-01-22T19:59:19Z
• Authors: Avani Athauda; Naureen Starling; Ian Chau; David Cunningham; David J. Watkins; Sheela Rao; Eleftheria Kalait...; Elli Bourmpaki; Michael Davidson; Angela Gillbanks; Retchel Lazaro-Al...; Michael Moneypenny; Ruwaida Begum; Katharina von Loga; Isma Rana; Pranav Patel; Sophie Doran; Sacheen Kumar; Asif Chaudry; Marco Gerlinger
• Keywords: Interim analysis; Avelumab

201 Background: ICONIC is a single-arm phase II trial investigating the safety and efficacy of perioperative FLOT-A in resectable OGA. Following 3+3 design run-in phase, standard dose FLOT with 10mg/kg IV avelumab (dose level 0) q2weeks was taken forward into main study. The aims this pre-planned interim analysis were to assess R0 resection rates. Methods: occurred once 15th patient treated at 0 reached 30 days post-surgery. Results: At data cut-off, 15 patients had received least one cycle undergone resection. median age 63y (range: 25 – 73). 71% an ECOG PS 0. 60% tumours staged as T3 baseline 40% T2; 67% N0, 7% N1 27% N2. Due 5-FU related cardiac toxicity, two switched alternative chemotherapy without avelumab. 13/15 (87%) completed 4 cycles pre-operative FLOT-A; these, five omitted for toxicity evaluation management. 9/15 (60%) experienced G3/4 adverse event (AE). These FLOT-A-related 8/15 (53.3%). commonest AEs febrile neutropenia, neutropenia diarrhoea. Median time from last surgery 6.4 weeks. No delays or failure proceed due avelumab-related complications. American Society Anaesthesiologists (ASA) preoperative risk score I, 47% III. 73% operations involving thoracic approach (10 minimally invasive Ivor-Lewis oesophagogastrectomy field radical lymphadenectomy, 1 left thoracoabdominal gastrectomy D2 lymphadenectomy). extubation 6h (IQR: 4-24). Acute Physiology Chronic Health Evaluation (APACHE) day post-op 12 10-15) 3 2-4) CCU care. unexpected complications reported intra-operatively during post-operative recovery patients. 5/14 evaluable cut-off (35.7%) Clavien-Dindo grade 3/14 (21.4%) IIIa complications; these anastomotic leak that endoscopically. There no emergency re-operations. All achieved resections discharged home after 13d 11-16) hospital. Conclusions: To date, has not led unusually severe context major complex upper GI Clinical information: NCT03399071.