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 Dec 14, 2019
Stroes CI, Schokker S, Creemers A, et al. - By performing this phase II feasibility study, researchers tested trastuzumab and pertuzumab added to neoadjuvant chemoradiotherapy (nCRT) in patients with esophageal adenocarcinoma (EAC), as a survival benefit with dual-agent human epidermal growth factor receptor 2 (HER2) blockade has been reported in breast cancer. The treatment regimen administered to patients with resectable HER2-positive EAC 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, defined as ≥ 80% completion of treatment with both trastuzumab and pertuzumab, was assessed as the primary endpoint. They found that it was feasible to add trastuzumab and pertuzumab to nCRT for treating patients with HER2-positive EAC and this treatment regimen displayed potentially promising activity than historical controls. The potential predictor for survival was HER2 3+ overexpression and for treatment response was growth factor receptor–bound protein 7 positivity.
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