Effect of the chemotherapy alone vs. chemotherapy followed by surgical resection on survival and quality of life in patients with limited-metastatic adenocarcinoma of the stomach or esophagogastric junction - a phase III trial of the AIO/CAO-V/CAOGI
Final Report Abstract
Chemotherapy is the standard treatment for metastatic gastric and adenocarcinoma of the gastroesophageal junction (GEJ). However, patients currently have a low chance of long-term survival, and an improvement of this situation by means of new chemotherapies is unlikely. Therefore, individualised and extended therapy concepts are needed, e.g. additional surgery. Results from a previous study (FLOT3 study) indicated a beneficial role of surgery in selected patients with limited metastatic disease. The RENAISSANCE trial investigated whether chemotherapy according to the so-called FLOT regimen, followed by surgical removal of the main tumour and metastases, if possible, and subsequent continuation of chemotherapy prolongs overall survival compared to FLOT chemotherapy alone in previously untreated patients. The safety of this treatment was also investigated. The results of the study aimed at clarifying the open question of whether patients with limited metastases benefit from additional surgery or not. If successful, this could lead to a new standard therapy with direct benefit for cancer patients, which could help to maintain the quality of life of these patients and might save costs for the public and private health insurance systems. Data from 139 patients were analysed in the RENAISSANCE study. The results did not show a general advantage for patients from addition of surgery. However, there are indications that patients could benefit from surgery if they have certain disease characteristics. This will be analysed further and might lead to future studies.
Publications
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The RENAISSANCE (AIO-FLOT5) trial: effect of chemotherapy alone vs. chemotherapy followed by surgical resection on survival and quality of life in patients with limited-metastatic adenocarcinoma of the stomach or esophagogastric junction – a phase III trial of the German AIO/CAO-V/CAOGI. BMC Cancer, 17(1).
Al-Batran, Salah-Eddin; Goetze, Thorsten O.; Mueller, Daniel W.; Vogel, Arndt; Winkler, Michael; Lorenzen, Sylvie; Novotny, Alexander; Pauligk, Claudia; Homann, Nils; Jungbluth, Thomas; Reissfelder, Christoph; Caca, Karel; Retter, Steffen; Horndasch, Eva; Gumpp, Julia; Bolling, Claus; Fuchs, Karl-Hermann; Blau, Wolfgang; Padberg, Winfried ... & Moenig, Stefan P.
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Late-Breaking Abstract at ASCO Conference, Chicago 2024, presented in the Oral Abstract Session: "Effect of chemotherapy/targeted therapy alone vs. chemotherapy/targeted therapy followed by radical surgical resection on survival and quality of life in patients with limited-metastatic adenocarcinoma of the stomach or esophagogastric junction: The IKF-575/RENAISSANCE phase III trial.
Al-Batran, Salah-Eddin et al.
