43 Oligometastatic Disease RENAISSANCE or FLOT5 Study

In this video, Dr. Dan shows the results of the FLOT5/RENAISSANCE phase 3 study recently presented at the ASCO 2024 Annual Meeting. The study enrolled 182 patients with oligometatatic gastroesophageal adenocarcinoma, as defined by the same criteria as the FLOT3 phase 2 study, and treated them with an initial, or induction, 4 cycles of FLOT chemotherapy. Of those patients with stable disease after this induction phase of chemotherapy (141 patients), these were randomized to Arm A: Surgery then more FLOT chemotherapy as tolerated up to 8 cycles, vs Arm B: continuation of standard systemic FLOT chemotherapy up to 8 more cycles. The primary endpoint was Overall survival in the whole group of patients randomized as well as comparing different subgroups of patients with metastatic spread to different areas (Lymph node vs liver vs peritoneum). Unfortunately, the study overall was negative and did not show a survival advantage among the patients proceeding to surgery then chemotherapy vs only chemotherapy, due to post-operative complications/mortality, suspension of active systemic chemotherapy, as well as inability to completely safely and adequately remove both the primary tumor and metastatic sites . However, it is notable, that patients in both arms did relatively well compared to typical outcomes for patients enrolled in first line clinical trials with stage IV disease. Future studies should focus on the subgroup of patients with lymph node only oligometastatic disease, and study peritoneal only disease as a separate entity. A clinical trial that is ongoing for oligometastatic disease for gastroesophageal cancer is discussed - EA2183 (NCT04248452) using radiation rather than surgery as an intervention, with the advantage of having less complications as well as the ability to non-invasively address multiple oligometastatic sites simultaneously without the need to discontinue the systemic chemotherapy for prolonged periods of time compared to surgery.