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1000 Titel
  • Patient-reported outcomes from the phase II FAST trial of zolbetuximab plus EOX compared to EOX alone as first-line treatment of patients with metastatic CLDN18.2+ gastroesophageal adenocarcinoma
1000 Autor/in
  1. Lordick, Florian |
  2. Al-Batran, Salah-Eddin |
  3. Ganguli, Arijit |
  4. Morlock, Robert |
  5. Sahin, Ugur |
  6. Türeci, Özlem |
1000 Erscheinungsjahr 2021
1000 Publikationstyp
  1. Artikel |
1000 Online veröffentlicht
  • 2021-03-23
1000 Erschienen in
1000 Quellenangabe
  • 24(3):721-730
1000 Copyrightjahr
  • 2021
1000 Lizenz
1000 Verlagsversion
  • https://doi.org/10.1007/s10120-020-01153-6 |
  • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8064997/ |
1000 Publikationsstatus
1000 Sprache der Publikation
1000 Abstract/Summary
  • Background!#!Zolbetuximab plus first-line EOX (epirubicin, oxaliplatin, capecitabine; ZOL/EOX) significantly prolonged progression-free survival and overall survival in the FAST trial vs EOX alone. We report the patient-reported outcomes (PROs) of FAST in patients with advanced gastroesophageal adenocarcinoma.!##!Methods!#!Patients were randomized to ZOL/EOX or EOX alone. Patients could receive ≤ 8 EOX cycles and remained on zolbetuximab until disease progression. PROs were collected using the EORTC QLQ-C30 and QLQ-STO22 before drug administration at day 1/cycle 1, day 1/cycle 5, end of EOX treatment, and q12w thereafter until disease progression. Time to deterioration (TTD), defined as the first meaningful worsening from baseline, in the individual QLQ-C30/QLQ-STO22 scores was analyzed. Longitudinal changes in scores from baseline were analyzed using a mixed-effects model for repeated measures (MMRM).!##!Results!#!The per protocol population included 143 (ZOL/EOX: 69; EOX: 74) patients. Baseline QLQ-C30 and STO22 scores were comparable between arms and denoted intermediate-to-high quality of life (QoL), intermediate-to-low global health status (GHS) and low symptom burden. Descriptive analyses showed no differences between arms until end of EOX but maintenance therapy with zolbetuximab was associated with better QoL and less symptom burden thereafter. TTD for most scores favored ZOL/EOX over EOX and reached statistical significance for GHS (p = 0.008). MMRM results support TTD findings; no statistically significant differences were observed between arms in any score except for nausea and vomiting (p = 0.0181 favoring EOX).!##!Conclusions!#!ZOL/EOX allowed patients to maintain good QoL and low symptom burden for longer than EOX alone.
1000 Sacherschließung
lokal Surveys and Questionnaires [MeSH]
lokal Biomarkers
lokal Antibodies, Monoclonal/therapeutic use [MeSH]
lokal Epirubicin/therapeutic use [MeSH]
lokal Progression-Free Survival [MeSH]
lokal Oxaliplatin/therapeutic use [MeSH]
lokal Esophageal Neoplasms/pathology [MeSH]
lokal Esophageal Neoplasms/drug therapy [MeSH]
lokal Original Article
lokal Adenocarcinoma/secondary [MeSH]
lokal Male [MeSH]
lokal Stomach Neoplasms/secondary [MeSH]
lokal Adenocarcinoma/drug therapy [MeSH]
lokal Stomach Neoplasms/drug therapy [MeSH]
lokal Antibodies
lokal Female [MeSH]
lokal Capecitabine/therapeutic use [MeSH]
lokal Patient-reported outcomes
lokal Monoclonal
lokal Humans [MeSH]
lokal Neoplasm Metastasis [MeSH]
lokal Treatment Outcome [MeSH]
lokal Middle Aged [MeSH]
lokal Antineoplastic Combined Chemotherapy Protocols/therapeutic use [MeSH]
lokal Patient Reported Outcome Measures [MeSH]
lokal Stomach cancer
lokal Quality of life
lokal Antineoplastic Agents/therapeutic use [MeSH]
lokal Claudins/metabolism [MeSH]
1000 Liste der Beteiligten
  1. https://frl.publisso.de/adhoc/uri/TG9yZGljaywgRmxvcmlhbg==|https://frl.publisso.de/adhoc/uri/QWwtQmF0cmFuLCBTYWxhaC1FZGRpbg==|https://frl.publisso.de/adhoc/uri/R2FuZ3VsaSwgQXJpaml0|https://frl.publisso.de/adhoc/uri/TW9ybG9jaywgUm9iZXJ0|https://frl.publisso.de/adhoc/uri/U2FoaW4sIFVndXI=|https://frl.publisso.de/adhoc/uri/VMO8cmVjaSwgw5Z6bGVt
1000 Hinweis
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1000 Erstellt am 2023-05-04T10:46:41.363+0200
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1000 Zuletzt bearbeitet 2023-10-20T23:57:11.945+0200
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