Neoadjuvant chemoradiotherapy for esophageal cancer using weekly Paclitaxel and Carboplatin plus infusional...

To evaluate neoadjuvant therapy with weekly paclitaxel/carboplatin plus 5-fluorouracil (5-FU) with conformal radiotherapy in a phase II trial in resectable esophageal carcinoma.

Twenty-four patients with T2-4N0-1M0-1a esophageal carcinoma were treated with paclitaxel 45 mg/m(2) intravenously over 1 hour and carboplatin at an area under the concentration-time curve (AUC) of 2 intravenously over 30 minutes on days 1, 8, 15, 22, and 29. 5-Fluorouracil 225 mg/m(2) was delivered as a continuous infusion on days 1-33. Concurrent conformal radiation was delivered to a dose of 45 Gy. Responders underwent surgical resection within 8 weeks of completing chemoradiotherapy. Kaplan-Meier survival analysis and log-rank test of survival dependent on pathologic response were performed.

Progressive disease was discovered at surgery in three patients. Of the remaining 21 patients, pathologic complete response (pCR) was demonstrated in 12 (pCR rate of 57%) and partial response (PR) occurred in 9, including 4 with near complete response. Median follow-up in all patients was 23 months. Overall survival among all 24 patients was 48% at 3 years, with a median of 31 months. Disease-free survival was 57% at 3 years, with a median of 38 months. Differences in survival time based on pCR vs. PR showed a trend favoring pCR for disease-free survival (P = .12) but not overall survival (P > .20). Grade 3/4 toxicities included esophagitis in 33% of patients, hypotension in 29%, stomatitis in 25%, neutropenia in 13%, and anemia in 8%.

This study demonstrates the activity of neoadjuvant paclitaxel, carboplatin, 5-FU, and conformal radiotherapy in the treatment of localized esophageal cancer. Evaluation with a larger number of patients and longer follow-up will be required to definitively assess the long-term efficacy of this regimen.