Abstract： Objective To investigate the maximum-tolerated dose (MTD) and target volume of postoperative prophylactic concurrent radiochemotherapy for lymph node-positive esophageal squamous cell carcinoma. Methods In this phase Ⅰ clinical study,the 33 patients who had middle-lower thoracic esophageal squamous cell carcinoma with lymph node metastasis and received radical surgery in our hospital from July 25,2007 to December 31,2011 were enrolled. The median age was 52 years. The patients of T3+T4 stage were 76%.The 33 patients were randomly divided into 60 Gy/2.0 Gy/30f (n=18) and 54 Gy/1.8 Gy/30f (n=15) for radiotherapy,and cis-platinum 20 mg/m2 per week+Taxol 20,30,40,50 mg/m2 per week (1 weeks and 3 patients,respectively) were used in 5-6 consecutive weeks for concurrent chemotherapy. MTD was determined when grade 4 leucopenia,grade ≥3 reduction in hemoglobin and platelet,or grade ≥3 non-hematological toxicities occurred with CTCAE3.0 standard. Results In the group with a dose of 60 Gy/2.0 Gy/30f for radiotherapy,the initial dose of paclitaxel was 20 mg/m2 per week for concurrent chemotherapy,one patient experienced a dose-limiting toxicity (DLT) of grade 3 loss of body weight,and then another three patients experienced the same toxicity,among whom one experienced grade 4 leucopenia;thus,the dose escalation study failed. In the group with a dose of 54 Gy/1.8 Gy/30 f for radiotherapy,one patient experienced paclitaxel allergy and discontinued chemotherapy,and the dose of 20-40 mg/m2 per week escalation study was successful for each dose group;however,a paclitaxel dose of 50 mg/m2 per week,2 out of 3 patients experienced grade 4 leucopenia and grade 3 decrease in platelet,and therefore,the dose escalation study was terminated;MTD was determined as paclitaxel 40 mg/m2 per week plus cisplatin 20 mg/m2 per week for 5-6 consecutive weeks. CTV was also reduced,with the superior border of the thoracic vertebra T1 as the upper boundary and 3 cm below the tumor bed as the lower boundary,and the radiotherapy dose was 60 Gy/2.0 Gy/30f;none of the 12 patients in dose escalation study experienced DLT,and the dose escalation study was successfully completed. The average planning target volume and the mean dose to the remnant stomach were reduced significantly after adjustment of the radiation field (P=0.006 and 0.013,respectively). Conclusions The regimen of paclitaxel plus cisplatin in the postoperative prophylactic concurrent radiochemotherapy for middle-lower thoracic esophageal squamous cell carcinoma is safe and effective when CTV is reduced reasonably.
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