Clinical Outcomes Of Nedaplatin-based Regimens As First-line Chemotherapy Concurrent With Radiotherapy For Stage Ⅱ-Ⅲ Esophageal Squamous Cell Carcinoma On Basis Of Endoscopic Ultrasonography

Objective: Using elective nodal irradiation(ENI),a prospective study about concurrent chemoradiotherapy(CCRT)for esophageal squamous cell carcinoma(ESCC)was conducted based on endoscopic ultrasonography(EUS).The purpose of this phase II study was to explore the efficacy and safety of Nedaplatin(NDP)-based regimens as first-line chemotherapy in CCRT of esophageal cancer.Methods: Patients with Stage II-III ESCC were included,and all patients received EUS before treatment starting.Drugs were given as follows: 1)100 mg/m2 of NDP intravenously used on day 1 and 70 mg/m2 of egafur gimeracil oteracil potassium capsule(S1)continuously delivered orally twice a day for two weeks;2)50 mg/m2 of NDP intravenously used on day 1 and 2 and 35 mg/m2 of docetaxel(DOC)taken intravenously on day 1 and 8;3)60 mg/m2 of NDP intravenously used on day 1 and 2,to a subgroup of patients with elder age,poor PS or earlier clinical stage.Using Intensity Modulated Radiation Therapy(IMRT),a total dose of 60-66 Gy was administered at 1.8-2.0 Gy per fraction for the primary tumor while 45-50 Gy for subclinical regional.Results: From 1 January 2012 and 31 May 2016,70 patients were enrolled.The median age was 66 years ranged from 50 to 81 years.Based on EUS,T4 were found in 45(64.3%)patients.All patients completed radiotherapy and received at least 2 cycles of chemotherapy.Estimated 1-,2-,and 3-year overall survival(OS)rates of all the 70 CCRT patients were 82.9%,53.9%,and 31.4%,respectively.Significant differences in OS and progression free survival(PFS)occurred between clinical stage II and III(P <0.0001),among T stage 1,2,3 and 4(P =0.007),between N stage 1-3 and 0(P =0.004).No significant differences were found in OS and PFS among the three treatment groups.Grade 3 and 4 hematological toxicities were seen in 35(50%)patients during concurrent radiochemotherapy.Serious treatment-related toxicities were seen most commonly in group DOC+NDP,but no significant difference was found.Conclusions: NDP-based chemotherapy were effective and safe in CCRT of thoracic esophageal cancer.With similar survival rates and disease responses but lower hematological toxicities,NDP/S1 and NDP single-agent regimens are more feasible than NDP/DOC.