709TiP - Randomized controlled phase II trial of S-1 maintenance therapy in Caucasian population with metastatic esophagogastric cancer– the multinational M...

Date 08 October 2016
Event ESMO 2016 Congress
Session Poster Display
Presenter Georg Martin Haag
Citation Annals of Oncology (2016) 27 (6): 207-242. 10.1093/annonc/mdw371
Authors G.M. Haag1, G. Stocker2, J. Quidde3, D. Jaeger4, F. Lordick2
  • 1Nct - Med. Oncology, University Hospital Heidelberg, D-69120 - Heidelberg/DE
  • 2University Cancer Center Leipzig, University Clinic Leipzig, 04103 - Leipzig/DE
  • 3Universitiy Cancer Center Hamburg, UKE Universitätsklinikum Hamburg-Eppendorf KMTZ, 20246 - Hamburg/DE
  • 4Nct - Med. Oncology, University Hospital Heidelberg, Heidelberg/DE

Abstract

Background

Chemotherapy including a fluoropyrimidine and a platinum compound is still the mainstay for the majority of patients with esophagogastric adenocarcinoma. The optimal duration of firstline chemotherapy is unknown. In most clinical trials therapy is given until tumor progression or dose-limiting toxicity. Maintenance concepts have been established in other tumor types but not in esophagogastric cancer. S-1 is an oral fluoropyrimidine with proven efficacy in metastatic esophagogastric cancer. Given as a monotherapy S-1 showed a beneficial toxicity pattern.

Trial design

MATEO is a randomized, multinational, phase II trial in patients with previously untreated, Her-2 negative metastatic esophagogastric adenocarcinoma. After having completed, without tumor progression, a 12-week induction chemotherapy (including a platinum compound, a fluoropyrimidine with or without a taxane or an anthracycline), 297 patients will be randomized in a 2:1 allocation to receive S-1 monotherapy or to continue the same polychemotherapy until progression or limiting toxicities. Patients will be stratified according to the response to the induction therapy at the time of randomization (CR/PR vs. SD) and the polychemotherapy used during the induction phase (doublet vs. triplet regimen). The primary endpoint is overall survival, secondary endpoints include progression-free survival, safety and quality of life. Sample size estimation is based on the statistical goal to allow for a first formal within-study comparison of efficacy and to exclude any increase of risk of death due to de-escalation with S-1 by more than 33% compared to continuation of polychemotherapy. A non-inferiority testing approach on a 10% significance level will be used. Tissue- and blood based translational analysis will focus on the identification of a subgroup with a sustained benefit from S-1 based maintenance therapy. This trial is lead by the Gastric Cancer Group and Young Medical Oncologists group of the AIO (Arbeitsgemeinschaft Internistische Onkologie) with the participation of sites in 6 European countries.

Clinical trial identification

EudraCT-Number: 2013-002742-37; ClinicalTrials.gov NCT02128243

Legal entity responsible for the study

AIO-Studien-gGmbH Kuno-Fischer-Straße 8 14057 Berlin Germany

Funding

TAIHO Pharmaceuticals

Disclosure

G.M. Haag: GMH has received support for participation in scientific congresses from Ipsen and Celgene. He receives research support from Taiho and Nordic. He has also served on advisory boards for Sanofi, Eli Lilly, Roche and Taiho.

D. Jaeger: Consulting or Advisory Role: Bristol-Myers Squibb Travel, Accommodations, Expenses: Amgen; Bristol-Myers Squibb; Roche Pharma AG.

F. Lordick: Lectured/chaired symposia: Amgen, Celgene, Lilly, Elsevier, Roche, Taiho. Travel costs: Amgen, Bayer, Lilly, Merck-Serono, Roche, Taiho. Research support: Fresenius, GSK, Nordic, Roche, Taiho, Merck- Serono. Adv. role: BMS, Lilly, Nordic, Roche, Taiho.

All other authors have declared no conflicts of interest.