{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T17:00:42Z","timestamp":1784912442029,"version":"3.55.0"},"reference-count":21,"publisher":"S. Karger AG","license":[{"start":{"date-parts":[[2026,5,29]],"date-time":"2026-05-29T00:00:00Z","timestamp":1780012800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,5,29]],"date-time":"2026-05-29T00:00:00Z","timestamp":1780012800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Oncol Res Treat"],"abstract":"<jats:p>Introduction: Despite advances in the multimodal treatment of resectable esophagogastric adenocarcinoma (EGA), relapse rates remain high. No human epidermal growth factor receptor 2 (HER2)-targeted treatment is yet established in the perioperative setting. While trastuzumab deruxtecan (T-DXd) has compelling efficacy and is now a well-established drug in the treatment of advanced HER2-positive EGA, safety and efficacy data from the perioperative setting are still lacking. Methods: NeoART is a phase Ib\/II platform trial evaluating the safety and efficacy of neoadjuvant T-DXd-containing combination regimens for patients with HER2-positive EGA. We report about the safety, feasibility, and preliminary antitumor activity from the safety run-in cohort of the NeoART trial in which patients with locally advanced resectable EGA received three cycles of preoperative T-DXd (5.4 mg\/kg, Q3W) combined with 5-fluorouracil (5-FU; 2,600 mg\/m2 24 h, Q2W) and folinic acid (FA; 200 mg\/m2, Q2W). Results: In the preplanned safety analysis of the first 6 patients recruited to NeoART, no serious adverse events (SAEs) or dose-limiting toxicities (DLTs) were reported during neoadjuvant treatment. Relevant treatment-related adverse events of grades 1\u20133 were diarrhea, mucositis, and nausea, but none fulfilled the criteria of DLTs. No relevant hematologic toxicity was observed. Five of six patients underwent curative-intent oncologic resection. In one patient, peritoneal carcinomatosis was detected at the time of surgery; therefore, the tumor was not resected. Two patients experienced grade 3 postoperative complications according to Clavien-Dindo classification, including one anastomotic leakage which was classified as an SAE. R0 resection was accomplished in four out of five resected patients. Histopathological complete remission (pCR; ypT0 N0) was observed in two patients. Conclusions: Neoadjuvant treatment with T-DXd plus 5-FU\/FA was found to be well tolerated and showed preliminary signs of activity during the safety run-in period of the NeoART study.<\/jats:p>","DOI":"10.1159\/000552693","type":"journal-article","created":{"date-parts":[[2026,5,29]],"date-time":"2026-05-29T16:01:10Z","timestamp":1780070470000},"page":"1-8","source":"Crossref","is-referenced-by-count":0,"title":["Safety and Preliminary Activity of Neoadjuvant Trastuzumab Deruxtecan plus 5-Fluorouracil and Folinic Acid for HER2-Positive, Resectable Esophagogastric Adenocarcinoma: Results from the Safety Run-In Cohort of the Phase Ib\/II UCCL-AIO-STO0124-IKF072 NeoART Trial"],"prefix":"10.1159","author":[{"given":"Gertraud","family":"Stocker","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jack","family":"Chater","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7654-2442","authenticated-orcid":false,"given":"Thomas J.","family":"Ettrich","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thorsten O.","family":"Goetze","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Reinhard 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