S-1 maintenance therapy in Caucasian patients with metastatic esophagogastric adenocarcinoma: final results of the randomized AIO MATEO phase II trial
Purpose - Platinum-fluoropyrimidine combinations are standard of care for treatment of metastatic esophagogastric adenocarcinoma. The optimal duration of first-line chemotherapy is unknown, however, and maintenance strategies have not yet been established. - Design - MATEO is an international random...
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| Hauptverfasser: | , , , , , , , , , , , , , , , , , , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
2 June 2023
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| In: |
ESMO open
Year: 2023, Jahrgang: 8, Heft: 3, Pages: 1-9 |
| ISSN: | 2059-7029 |
| DOI: | 10.1016/j.esmoop.2023.101572 |
| Online-Zugang: | Resolving-System, kostenfrei: https://doi.org/10.1016/j.esmoop.2023.101572 Verlag, lizenzpflichtig, Volltext: https://www.sciencedirect.com/science/article/pii/S2059702923008037 
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| Verfasserangaben: | G. Stocker, S. Lorenzen, T. Ettrich, A.-L. Herz, F. Longo, A. Kiani, M. Venerito, J. Trojan, R. Mahlberg, N. Moosmann, B. Chibaudel, S. Kubicka, R. Greil, S. Daum, M. Geissler, J. Larcher-Senn, G. Keller, F. Lordick & G.M. Haag |
| Zusammenfassung: | Purpose - Platinum-fluoropyrimidine combinations are standard of care for treatment of metastatic esophagogastric adenocarcinoma. The optimal duration of first-line chemotherapy is unknown, however, and maintenance strategies have not yet been established. - Design - MATEO is an international randomized phase II trial exploring efficacy and safety of S-1 maintenance therapy in human epidermal growth factor receptor 2 (HER2)-negative advanced esophagogastric adenocarcinoma. After 3 months of first-line platinum-fluoropyrimidine-based induction therapy, patients without progression were randomized in a 2 : 1 allocation to receive S-1 monotherapy (arm A) or to continue combination chemotherapy (arm B). The primary objective was to show non-inferiority of overall survival in the S-1 maintenance group. Progression-free survival, adverse events, and quality of life were secondary endpoints. - Results - From 2014 to 2019, 110 and 55 patients were randomized in arm A and arm B, respectively (recruitment closed prematurely). Median overall survival from randomization was 13.4 months for arm A and 11.4 months for arm B [hazard ratio 0.97 (80% confidence interval 0.76-1.23), P = 0.86]. Median progression-free survival from randomization was 4.3 and 6.1 months for arm A versus arm B, respectively [hazard ratio 1.10 (80% confidence interval 0.86-1.39), P = 0.62]. Patients in arm A had numerically fewer treatment-related adverse events (84.9% versus 93.9%) and significantly less peripheral sensory polyneuropathy ≥grade 2 (9.4% versus 36.7%). - Conclusions - S-1 maintenance following platinum-based induction therapy leads to non-inferior survival outcomes compared with the continuation of platinum-based combination. Toxicity patterns favor a fluoropyrimidine maintenance strategy. These data challenge the continued use of platinum combination chemotherapy after response to 3 months induction therapy in patients with advanced human epidermal growth factor receptor 2-negative esophagogastric adenocarcinoma. |
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| Beschreibung: | Interim results of this trial have been presented at ESMO Congress 2020 and DGHO Congress 2020 Gesehen am 06.10.2023 |
| Beschreibung: | Online Resource |
| ISSN: | 2059-7029 |
| DOI: | 10.1016/j.esmoop.2023.101572 |