1. Adding preoperative radiotherapy plus cetuximab to perioperative chemotherapy for resectable esophageal adenocarcinoma: a single-center prospective phase II trial.
- Author
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Ubink I, van der Sluis P, Schipper M, Reerink O, Voest E, Borel-Rinkes I, Wijrdeman H, Vleggaar F, Agterof M, Overkleeft E, Siersema P, van Hillegersberg R, and Lolkema MP
- Subjects
- Adenocarcinoma drug therapy, Adenocarcinoma radiotherapy, Adenocarcinoma surgery, Aged, Antibodies, Monoclonal, Humanized administration & dosage, Antibodies, Monoclonal, Humanized adverse effects, Capecitabine, Cetuximab, Chemoradiotherapy, Cisplatin administration & dosage, Deoxycytidine administration & dosage, Deoxycytidine analogs & derivatives, Epirubicin administration & dosage, Esophageal Neoplasms drug therapy, Esophageal Neoplasms radiotherapy, Esophageal Neoplasms surgery, Female, Fluorouracil administration & dosage, Fluorouracil analogs & derivatives, Humans, Male, Middle Aged, Neoadjuvant Therapy, Neoplasm Recurrence, Local prevention & control, Perioperative Care methods, Preoperative Care methods, Prospective Studies, Survivors, Adenocarcinoma therapy, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Esophageal Neoplasms therapy
- Abstract
Background: Local and systemic recurrence are important sources of treatment failure following surgical resection of esophageal adenocarcinoma. We hypothesized that adding preoperative cetuximab and radiotherapy (cetux-RT) to perioperative chemotherapy would increase treatment efficacy with acceptable toxicity., Methods: In this prospective phase II trial, patients were treated with three cycles of epirubicin, cisplatin, and capecitabine (ECX), followed by cetux-RT. After surgery with curative intent, patients received three more cycles of ECX. Primary endpoints were efficacy, determined by histopathological complete response (pCR) rate, and safety, which was assessed with resectability rate., Results: Of the 12 patients enrolled in this trial, six received at least one dose of cetux-RT. In five patients, cetux-RT was not started because of adverse events (AEs) related to preoperative chemotherapy; one patient had progressive disease. Addition of cetux-RT was well tolerated and did not interfere with the resectability rate (100%). However, the pCR rate was 0, and 50% of patients experienced serious adverse events (SAEs) postoperatively., Conclusion: With 12 patients enrolled, the lack of initial signs of efficacy and a high incidence of postoperative SAEs prompted us to end this study prematurely. Perioperative ECX was associated with considerable toxicity, and further treatment intensification is problematic.
- Published
- 2014
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