Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2017 Jul 31;17(1):509.
doi: 10.1186/s12885-017-3497-9.

Randomized controlled trial of S-1 maintenance therapy in metastatic esophagogastric cancer - the multinational MATEO study

Georg-Martin Haag  1 , Gertraud Stocker  2 , Julia Quidde  3 , Dirk Jaeger  4 , Florian Lordick  2
Affiliations

Randomized controlled trial of S-1 maintenance therapy in metastatic esophagogastric cancer - the multinational MATEO study

Georg-Martin Haag et al. BMC Cancer. .

Abstract

Background: The optimal duration of firstline chemotherapy in metastatic esophagogastric cancer is unknown. In most clinical trials therapy was given until tumour progression or limiting toxicity. Maintenance concepts aiming to prolong the duration of response and maintain quality of life have been established in other tumour types but not in esophagogastric cancer. S-1 is an oral fluoropyrimidine with proven efficacy in metastatic esophagogastric cancer.

Methods: The Maintenance Teysuno® (S-1) in esophagogastric cancer (MATEO) trial is a multinational, randomized phase II study that explores the role of S-1 maintenance therapy in Her-2 negative, advanced esophagogastric adenocarcinoma. After a 12-week firstline platinum-fluoropyrimidine-based chemotherapy patients without tumour progression are randomized in a 2:1 allocation to receive S-1 alone or continue with the same regimen as during the primary period. The primary endpoint is overall survival. Secondary endpoints include safety and toxicity, progression-free survival and quality of life. Correlative biomarker analyses focus on the identification of a subgroup of patients with a prolonged benefit from S-1 based maintenance therapy.

Discussion: MATEO will be the first trial to define the role of a S-1 based maintenance therapy in patients having received a platinum-based firstline chemotherapy.

Trial registration: NCT02128243 (date of registration: 29-04-2014).

Keywords: Adenocarcinoma; Chemotherapy; Esophagogastric cancer; Gastric cancer; Maintenance therapy; S-1.

PubMed Disclaimer

Conflict of interest statement

Authors’ information

The study design of this trial has been presented as a poster at the ESMO 2016 congress.

Ethics approval and consent to participate

The study has been approved by the ethics committee (EC) of the University of Heidelberg as the leading EC for Germany in August 2014 (reference number: AFmu210/2014), furthermore approvals in all participating countries have been obtained.

All patients gave their informed consent before any study-related intervention was started.

In October 2016 the trial protocol was amended allowing the inclusion of patients with non-measurable disease and the randomization of patients having received primary chemotherapy outside of the MATEO trial.

Consent for publication

Not applicable.

Competing interests

Financial funding for the MATEO trial is provided by TAIHO pharmaceuticals (Tokio, Japan), study medication is provided by Nordic Pharma (Paris, France); the companies have not been involved in the design of the study and have not peer reviewed the study.

Sponsor of the trial: AIO Studien gGmbH, Berlin/Germany.

GMH reports fees for advisory role from Sanofi, Roche, Taiho, Lilly, Pfizer, Nordic and travel grants from Amgen, Ipsen and Celgene. FL has received research support from Boehringer Ingelheim, GSK and Fresenius Biotech, he has received lecture and advisory honoraria from Amgen, Astra Zeneca, Biontech, BMS, Eli Lilly, Ganymed, Merck-Serono, Merck-MSD, Nordic, and Roche and he has received travel support from Amgen, Bayer, MSD, Roche, and Taiho. The other authors declare no conflict of interest.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study design
See this image and copyright information in PMC

References

    1. Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, et al. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN. Int J Cancer. 2015;136:E359–E386. doi: 10.1002/ijc.29210. - DOI - PubMed
    1. Powell J, McConkey CC. Increasing incidence of adenocarcinoma of the gastric cardia and adjacent sites. Br J Cancer. 1990;62:440–443. doi: 10.1038/bjc.1990.314. - DOI - PMC - PubMed
    1. Devesa SS, Blot WJ, Fraumeni JF., Jr Changing patterns in the incidence of esophageal and gastric carcinoma in the United States. Cancer. 1998;83:2049–2053. doi: 10.1002/(SICI)1097-0142(19981115)83:10<2049::AID-CNCR1>3.0.CO;2-2. - DOI - PubMed
    1. Cunningham D, Allum WH, Stenning SP, Thompson JN, Van de Velde CJ, Nicolson M, et al. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med. 2006;355:11–20. doi: 10.1056/NEJMoa055531. - DOI - PubMed
    1. Ychou M, Boige V, Pignon JP, Conroy T, Bouché O, Lebreton G, et al. Perioperative chemotherapy compared with surgery alone for resectable gastroesophageal adenocarcinoma: an FNCLCC and FFCD multicenter phase III trial. J Clin Oncol. 2011;29:1715–1721. doi: 10.1200/JCO.2010.33.0597. - DOI - PubMed

MeSH terms

Associated data