Referencing for people who value simplicity, privacy, and speed.

Epirubicin, Oxaliplatin, And Capecitabine With Or Without Panitumumab For Advanced Esophagogastric Cancer: Dose-Finding Study For The Prospective Multicenter, Randomized, Phase II/III REAL-3 Trial

Alicia F.C. Okines, Sue E. Ashley, David Cunningham, Jacqueline Oates, Andrea Turner, Janine Webb, Claire Saffery, Yu Jo Chua, Ian Chau

Save to my Library

Download PDF

Analyze on Scholarcy Visualize in Litmaps

Reduce the time it takes to create your bibliography by a factor of 10 by using the world’s favourite reference manager

Time to take this seriously.

Get Citationsy

Purpose Epirubicin, oxaliplatin, and capecitabine (EOC) is a standard treatment in advanced esophagogastric cancer. Panitumumab (P) is a fully human, immunoglobulin G2 monoclonal antibody targeting epidermal growth factor receptor. Randomized Trial of EOC ± Panitumumab for Advanced and Locally Advanced Esophagogastric Cancer (REAL-3) will evaluate whether the addition of P to EOC improves survival in patients with advanced esophagogastric adenocarcinoma and undifferentiated carcinoma. Patients and Methods The original design of REAL-3 added P 9 mg/kg to the standard dose of EOC (dose level [DL] + 1). Due to toxicity, a dose de-escalation was made to EOC + P DL − 1 (epirubicin 50 mg/m2, oxaliplatin130 mg/m2, capecitabine 1,000 mg/m2/d + P 9 mg/kg every 3 weeks). After additional toxicity was observed, the study was amended to include two additional EOC + P dose levels. Using a 3 + 3 design, dose-limiting toxicities (DLTs) were assessed weekly during cycle 1. Patients were randomly assigned 1:1 to EOC ± P. Results Between July 2008 and October 2009, 29 patients were randomly selected for standard-dose EOC (n = 13) or EOC + P (n = 16). Five patients were treated at DL + 1, with grade 3 diarrhea in four of five patients by cycle 4. At DL − 1, one patient had grade 3 diarrhea and grade 5 infection. Three patients were treated at DL − 3, and then six were treated at DL − 2, without DLTs. Conclusion The recommended dose for EOC + P is epirubicin 50 mg/m2, oxaliplatin 100 mg/m2, capecitabine 1,000 mg/m2/d, and P 9 mg/kg every 3 weeks. This dose has been selected for the ongoing phase II/III REAL-3 study.