Trial reportOncology research and treatment2026
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.
Trial report in Oncology research and treatment, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
<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.
methodsNeoART 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).
resultsIn 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 1-3 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.
conclusionsNeoadjuvant 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. </p>.
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