2026-04-13T05:53:52Zhttps://recercat.cat/oai/requestoai:recercat.cat:11351/136282025-09-30T02:06:57Zcom_2072_378070com_2072_378040col_2072_378092
RECERCAT
author
de Andrea, Carlos E
author
Díez García, Marc
author
Guardeño, Raquel
author
CALVO, MARIONA
author
Bugés, Cristina
author
García-Galea, Eduardo
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Gros, Alena
author
Vila-Casadesús, Maria
author
López García, Darío
author
Muñoz, Susana
author
Alsina, Maria
author
Villacampa Javierre, Guillermo
author
Vivancos, Ana
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Ponz-Sarvise, Mariano
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Arrazubi, Virginia
author
Tabernero, Josep
author
Navarro Garces, Victor
2025-09-30T02:06:57Z
2025-09-30T02:06:57Z
2025-09-09T08:59:11Z2025-09-09T08:59:11Z2025-07-15
http://hdl.handle.net/11351/13628
Perioperative avelumab; Resectable gastric cancer; Gastroesophageal junction cancerAvelumab perioperatori; Càncer gàstric resecable; Càncer de la unió gastroesofàgicaAvelumab perioperatorio; Cáncer gástrico resecable; Cáncer de la unión gastroesofágicaPurpose: Immune checkpoint inhibitors combined with chemotherapy have provided successful results in patients with gastric and gastroesophageal junction (G/GEJ) cancers in the metastatic setting. Similar strategies have been explored in earlier stages. In this study, we present the final results of the phase II MONEO trial, which evaluated the addition of avelumab to neoadjuvant chemotherapy.
Patients and methods: Patients with untreated, resectable G/GEJ adenocarcinoma received neoadjuvant treatment with four cycles of avelumab plus the FLOT4 regimen, followed by surgery. Upon postoperative recovery, patients underwent four additional adjuvant cycles of the same combination, followed by avelumab monotherapy for up to 1 year. The primary endpoint was pathologic complete response rate. Sequential flow cytometry and cytokine determination were performed in peripheral blood, along with multiplex tissue immunofluorescence and RNA sequencing in tumor specimens.
Results: Forty patients were enrolled, achieving a pathologic complete response rate of 21.1% (95% confidence interval, 10.0-37.0). The major pathologic response rate was 28.9%, more pronounced in patients with tumors expressing PD-L1 before treatment as measured by the combined positive score (cutoff, 10; 33.3% vs. 21.1%). The results propose several potential biomarkers considering tumor immune infiltrate, circulating immune cells, and cytokines. Eighty percent of patients experienced treatment-related grade ≥3 adverse events.
Conclusions: The combination of avelumab plus the FLOT4 regimen showed relatively modest efficacy in resectable G/GEJ adenocarcinoma. Better results were observed in PD-L1 combined positive score ≥10% tumors. Exploratory biomarker analyses provide insights that may help to identify candidates most likely to benefit from chemoimmunotherapy as a neoadjuvant treatment.Avelumab was provided by the healthcare business of Merck KGaA, Darmstadt, Germany (CrossRef Funder ID: 10.13039/100009945). This study was financially supported by the healthcare business of Merck KGaA, Darmstadt, Germany (CrossRef Funder ID: 10.13039/100009945). Vall d’Hebron Institute of Oncology would like to acknowledge the State Agency for Research (Agencia Estatal de Investigación) for the financial support as a Center of Excellence Severo Ochoa (CEX2020-001024-S/AEI/10.13039/501100011033), the Cellex Foundation for providing research facilities and equipment, and the CERCA Program from the Generalitat de Catalunya for their support on this research.
Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ info:eu-repo/semantics/openAccess
Quimioteràpia combinada
Anticossos monoclonals - Ús terapèutic
Esòfag - Càncer - Tractament
Estómac - Càncer - Tractament
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols
DISEASES::Neoplasms::Neoplasms by Site::Digestive System Neoplasms::Gastrointestinal Neoplasms::Esophageal Neoplasms
DISEASES::Neoplasms::Neoplasms by Site::Digestive System Neoplasms::Gastrointestinal Neoplasms::Stomach Neoplasms
Other subheadings::Other subheadings::Other subheadings::/drug therapy
ANATOMY::Digestive System::Gastrointestinal Tract::Upper Gastrointestinal Tract::Esophagus::Esophagogastric Junction
CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Antibodies, Monoclonal::Antibodies, Monoclonal, Humanized
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada
ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias del sistema digestivo::neoplasias gastrointestinales::neoplasias del esófago
ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias del sistema digestivo::neoplasias gastrointestinales::neoplasias gástricas
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
ANATOMÍA::sistema digestivo::tracto gastrointestinal::tracto gastrointestinal superior::esófago::unión esofagogástrica
COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::proteínas::proteínas sanguíneas::inmunoproteínas::inmunoglobulinas::anticuerpos::anticuerpos monoclonales::anticuerpos monoclonales humanizados
A Phase II Study of Perioperative Avelumab plus Chemotherapy for Patients with Resectable Gastric Cancer or Gastroesophageal Junction Cancer - The MONEO Study
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion