A prospective phase II trial of a S-1/cisplatin-based chemoradiotherapy for locoregionally advanced esophageal cancer.

Abstract

e14559 Background: Concurrent chemoradiation has similar efficacy as surgery for esophageal cancer. Phase II trial was carried out to evaluate the efficacy and safety of chemoradiation with S-1 and cisplatin in locoregionally advanced esophageal cancer. Methods: Eligible patients had stage IIA-IVA esophageal cancer. Patients received two cycles of S-1 (days 1 to 14 and 22 to 35) and cisplatin (day 1 and 22) with concurrent radiotherapy (50.4 Gy total: 1.8 Gy/fraction). Esophagectomy was performed between week 12 and 18 as determined by the specialist multidisciplinary team meeting. Results: Sixty patients were enrolled between March 2008 and August 2011. Of the 60 patients entered, 59 patients were eligible. Clinical stage was ≥T3 in 28 patients (47%) and N1 in 43 patients (73%), with squamous cell carcinoma histology in 57 patients (97%). Fifty-four patients (90%) completed the planned treatment. After the chemoradiation, clinical tumor response rate was 62.7%. The primary grade 3/4 toxicities included neutropenia (24%) and esophagitis (8.5%). All three patients died during chemoradiation (two from pneumonia and one from gastrointestinal origin septic shock). Twenty-five patients (42%) underwent esophagectomy following chemoradiation and 15 (60%) achieved complete pathologic regression. At the median follow-up duration of 34.6 months, the estimated overall survival and progression-free survival rate at 2-year was 56.5% and 45.9%, respectively. Conclusions: Concurrent chemoradiation with S-1 and cisplatin showed an encouraging activity with high complete pathologic regression. Survival data was promising compared with historical data with 5-FU/cisplatin and should be confirmed in a randomized phase III trial. Toxicities were significant but clinically manageable.