Objective: To compare the efficacy and feasibility of neoadjuvant chemoradiotherapy with docetaxel plus cisplatin or with cisplatin plus fluorouracil in the treatment of local advanced esophageal squamous cell carcinoma.
Methods: A total of 154 cases in the stage of cT3N0-1M0 were randomly assigned to two arms. The arm A received 2 cycles of doctaxel 75 mg/m(2) plus cisplatin 25 mg/m(2) d1-3 and 40 Gy of radiation therapy, and the arm B received 2 cycles of cisplatin 25 mg/m(2) d1-3 plus fluorouracil 600 mg/m(2) d1 ∼ 5 and 40 Gy of radiation therapy. The surgery was performed 3 - 4 weeks later.
Results: Grade 3/4 toxicities occurred in 53.2% of the patients in arm A and in 36.4% of the patients in arm B (P = 0.035). Neutropenia occurred in 20.7% of the patients in arm A and 5.6% of the patients in arm B (P = 0.004). Nine patients aborted surgery due to tumor progression. 71 patients underwent resection in 73 cases of the arm A and 69 patients underwent complete resection, 70 patients underwent resection in 72 cases and 70 complete resection of the arm B, respectively (P > 0.05). No mortality was noted. The overall complication rate was similar in the two arms (21.9% vs. 23.6%). Pathological complete response was achieved in 27 patients (35.1%) in the arm A and 16 patients (20.8%) in the arm B (P = 0.048).
Conclusions: Neoadjuvant chemoradiotherapy with docetaxel plus cisplatin can be well tolerated and achieves a higher pathological complete response rate than with cisplatin plus fluorouracil.