Screening Patients with Esophageal Cancer to Determine Eligibility for Adjuvant Treatment Trials

Background: The tolerability of adjuvant chemotherapy in esophageal cancer is unclear. Patients and Methods: This was a phase II trial of adjuvant paclitaxel in patients with esophageal cancer after trimodality treatment. Patients with residual viable tumor after resection were eligible for study inclusion. Treatment was 80 mg/m(2) paclitaxel intravenously on days 1, 8, and 15 every 28 days for total of two cycles. The primary objective was to determine whether 75% or more of the patients would tolerate 240 mg/m(2) or more of paclitaxel, which corresponded to 50% or more of the total planned dose. Results: Eleven out of the 12 enrolled patients (92%, 95% confidence interval (CI)=62-100%) were able to complete at least 50% of the planned paclitaxel dose. Median progression free survival was 7 months (95% CI=2-28 months). Median overall survival was 28 months (95% CI=12-36 months). Only one patient experienced a grade 4 adverse event. Conclusion: Screening patients with esophageal cancer after trimodality treatment might improve completion of adjuvant trials.