Phase II study of induction chemotherapy with docetaxel, cisplatin, and 5-fluorouracil for patients with node-positive esophageal cancer.

Abstract

e14535 Background: Despite an extended radical surgery, the prognosis of patients with esophageal cancer is still unsatisfactory, especially in cases with lymph node metastasis. Although the usefulness of neoadjuvant chemotherapy for node-positive esophageal cancer has been reported, an optimal regimen has not yet been established. This phase II study explores the efficacy and toxicity of docetaxel/cisplatin/5-FU (DCF) as induction chemotherapy for node-positive esophageal cancer. Methods: The modified DCF consisted of 60 mg/m2 of docetaxel on day1, given intravenously for 2 hours, 350 mg/m2 of 5-FU on day 1-5 as a 24-hour continuous intravenous infusion, and 6 mg/m2 of cisplatin on day 1-5, given intravenously for 1 hour. The regimen was given every 3 weeks and 2 scheduled courses has completed in all cases. Eligibility criteria were: i) a pathlogically defined esophageal cancer, ii) lymph node metastasis observed with PET/CT or US, iii) no previous treatment, iv) ECOG PS of 0 to 2, v) an age of 20 -80, and iv) adequate bone marrow, renal and hepatic function. Primary endpoint Treatment effect was evaluated according to RECIST v1.0. Changes in SUV with FDG-PET scan and tumor markers (SCC, CEA) were also used for the evaluation of efficacy, while adverse events were assessed according to CTCAE v3.0. Pathological response was evaluated in 26 resected cases. Results: CR and PR were observed in 5 (9.8%) and 25 (49.0%), respectively. SUV of the primary tumors reduced in 46 cases (90.2%) during the chemotherapy and the mean value was decreased from 14.1 to 7.0 (p < 0.0001). SCC was decreased in 25 out of 30 elevated cases (p = 0.029), while CEA reduced in 14 out of 16 elevated cases (p = 0.17). Down-staging was observed in 15 resected cases (57.7%), including 10 cases (38.7%) with pathlogical N0. Pathological complete response was observed in 3 cases. Grade 3 or 4 neutropenia was seen in 43 cases (84.3%), but neither treatment-related death nor delay in the treatment was observed. Conclusions: Induction chemotherapy with modified DCF is highly efficient with acceptable toxicity for patients with node-positive esophageal cancer. No significant financial relationships to disclose.