Neoadjuvant chemotherapy with epirubicin, cisplatin, and capecitabine (ECX) does not improve survival compared with cisplatin and fluorouracil (CF) among patients with esophageal cancer, according to a study published in The Lancet Oncology.1
Findings from previous studies demonstrated that neoadjuvant CF may improve survival in this setting, but there is no evidence supporting the use of any other chemotherapeutic regimen.
In the phase 3 OE05 (ClinicalTrials.gov Identifier: NCT00041262) trial, researchers enrolled 897 patients with resectable esophageal adenocarcinoma and randomly assigned 451 to receive 2 cycles of CF and 446 to receive 4 cycles of ECX. Median follow-up was 6.4 years, and 93% of patients had at least 3 years of follow-up evaluation.
The overall survival at 3 years was 39% (95% CI, 35%-44%) in the CF arm vs 42% (95% CI, 37%-47%) in the ECX group. Median overall survival in the CF group was 23.4 months (95%, 20.6-26.3) vs 26.1 months (95% CI, 22.5-29.7) in the ECX group (hazard ratio [HR], 0.90; 95% CI, 0.77-1.05; P = .19).
The most frequently observed adverse event (AE) was grade 3 to 4 neutropenia, which occurred in 17% of CF patients and 23% of ECX patients. Twenty-four percent of patients in the ECX group experienced higher rates of serious AEs vs 16% for the CF group.
The authors concluded that “more intensive neoadjuvant chemotherapy with four cycles of ECX provided no overall or disease-free survival advantage over two cycles of CF in 897 patients with oesophageal adenocarcinoma.”
- Alderson D, Cunningham D, Nankivell M, et al. Neoadjuvant cisplatin and fluorouracil versus epirubicin, cisplatin, and capecitabine followed by resection in patients with oesophageal adenocarcinoma (UK MRC OE05): an open-label, randomized phase 3 trial. Lancet Oncol. doi: 10.1016/S1470-2045(17)30447-3 [Epub ahead of print]