Phase II feasibility and biomarker study of neoadjuvant trastuzumab and pertuzumab with chemoradiotherapy for resectable human epidermal growth factor receptor 2–positive esophageal adenocarcinoma: TRAP Study
Journal of Clinical Oncology Feb 13, 2020
Stroes CI, Schokker S, Creemers A, et al. - Since a survival benefit related to dual-agent HER2 (human epidermal growth factor receptor 2) blockade has been reported in breast cancer, researchers assessed trastuzumab and pertuzumab added to neoadjuvant chemoradiotherapy (nCRT) in patients with esophageal adenocarcinoma (EAC) in this phase II feasibility study. Participants were patients having resectable HER2-positive EAC. The treatment regimen employed in this study was as follows: standard nCRT with carboplatin and paclitaxel and 41.4 Gy of radiotherapy, with 4 mg/kg of trastuzumab on day 1, 2 mg/kg per week during weeks 2 to 6, and 6 mg/kg per week during weeks 7, 10, and 13 and 840 mg of pertuzumab every 3 weeks. Feasibility was the primary endpoint and was defined as ≥ 80% completion of therapy with both trastuzumab and pertuzumab. In this patient population, the feasibility of trastuzumab and pertuzumab added to nCRT was evident, as well as the potentially promising activity of this treatment regimen vs historical controls. Survival and treatment response could be potentially predicted by HER2 3+ overexpression and growth factor receptor–bound protein 7 positivity, respectively.
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