2026-04-17T14:35:59Zhttps://recercat.cat/oai/request

oai:recercat.cat:11351/136282025-09-30T02:06:57Zcom_2072_378070com_2072_378040col_2072_378092

00925njm 22002777a 4500 dc de Andrea, Carlos E author Díez García, Marc author Guardeño, Raquel author CALVO, MARIONA author Bugés, Cristina author García-Galea, Eduardo author Gros, Alena author Vila-Casadesús, Maria author López García, Darío author Muñoz, Susana author Alsina, Maria author Villacampa Javierre, Guillermo author Vivancos, Ana author Ponz-Sarvise, Mariano author Arrazubi, Virginia author Tabernero, Josep author Navarro Garces, Victor author 2025-09-09T08:59:11Z 2025-09-09T08:59:11Z 2025-07-15 Perioperative avelumab; Resectable gastric cancer; Gastroesophageal junction cancer Avelumab perioperatori; Càncer gàstric resecable; Càncer de la unió gastroesofàgica Avelumab perioperatorio; Cáncer gástrico resecable; Cáncer de la unión gastroesofágica Purpose: 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. http://hdl.handle.net/11351/13628 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