Long-term results of a phase II trial of neoadjuvant chemotherapy followed by esophagectomy for locally advanced esophageal neoplasm.

BACKGROUND: Effective systemic therapy is considered essential to improve the outcome for patients with surgically resectable locally advanced esophageal carcinoma. We report the long-term results of our phase II study of neoadjuvant chemotherapy, followed by esophagectomy and adjuvant chemotherapy for potentially resectable esophageal carcinoma.
METHODS: Patients were staged with computed tomography scan (n = 70), endoscopic ultrasonography (n = 63), and laparoscopy with or without thoracoscopy (n = 70). The pretreatment stages were T2N0 (n = 1), T2N1 (n = 15), T3N0 (n = 13), and T3N1 (n = 41). Chemotherapy consisted of 2 or 3 cycles of cisplatin, 5-fluorouracil, and paclitaxel followed by esophagectomy and adjuvant chemotherapy. Patients were monitored for recurrence and survival.
RESULTS: A total of 70 patients were enrolled (66 adenocarcinoma, 4 squamous cell carcinoma; 64 men and 6 women; median age, 60 years). Esophagectomy was performed in 63 patients. Operative mortality was 0%. The median overall survival of the entire group was 27.4 months. Seventeen patients were alive at a median follow-up of 62.8 months (range, 39.1 to 142). Fourteen patients were alive without recurrence at a median follow-up of 79 months (range, 39 to 138). Nodal status was an important predictor of overall survival. Patients who were downstaged experienced a significantly improved median survival of 63.4 months versus 21.5 months and overall survival (p = 0.005).
CONCLUSIONS: This prospective study for esophageal carcinoma demonstrates encouraging long-term results. In particular, downstaging of the tumor with preoperative chemotherapy is predictive of better long-term outcome. Our results support the role for perioperative chemotherapy for locally advanced resectable esophageal cancer.