pT2-3N0M0期食管癌根治术后3DRT前瞻性Ⅱ期临床研究

Prospective phase Ⅱ study of three-dimensional radiotherapy after radical surgery for pT2-3N0M0 esophageal cancer

目的 前瞻性非随机Ⅱ期临床研究3DRT （3DCRT、IMRT）在pT2-3N0M0期食管癌术后辅助治疗中的安全性、可行性.方法 2004-2011年共96例患者入组.放疗靶区按病变部位包括瘤床＋相应高危淋巴引流区.处方剂量95％ PTV 50 ～60 Gy,1.8～2.0 Gy/次,5次/周.结果 平均靶区覆盖度为（94.9±0.7）％.双肺V20为23.6％（9.8％ ～29.7％）,胸胃V50为9.4％ （0～39.2％）,心脏V30为33.3％ （0～67.6％）、V40为17.1％（0 ～42.0％）,脊髓Dmax为40.4 Gy （32.9～45.5 Gy）.5年样本量为35例.5年OS率和DFS率分别为74％和71％.3级总不良反应发生率为26％（25例）.共22例（23％）发生复发转移,其中局部区域复发18例（19％）,远处转移11例（12％）.结论 pT2-3N0M0期食管癌根治术后3DRT安全可行,且复发率及生存率均优于既往文献报道,值得进一步研究.

Objective This non-randomized prospective phase Ⅱ study was designed to investigate the safety and feasibility of adjuvant intensity-modulated radiotherapy or three-dimensional conformal radiotherapy （IMRT/3DCRT） after radical surgery for pT2-3N0M0 thoracic esophageal squamous cell carcinoma （TESCC）.Methods Ninety-six patients were enrolled from 2004 to 2011.The prescribed dose was 50-60 Gy in 1.8-2.0 Gy per fraction （5 days per week） to 95％ of the planning target volume （PTV）,encompassing the tumor bed and lymphatic drainage regions at high risk according to the primary tumor location.The survival rate was calculated by Kaplan-Meier method.Results The average PTV coverage of the prescribed dose was （94.9 ±0.7）％.The median bilateral lung V20 was 23.6％ （9.8％-29.7％） ;the median stomach V50 was 9.4％ （0-39.2％） ;the median heart V30 and V40 were 33.3％ （0-67.6％） and 17.1％ （0-42.0％）,respectively; the median maximal dose to the spinal cord was 40.4 Gy （32.9-45.5 Gy）.The number of samples at 5 years was 35.The 5-year overall survival rate and disease-free survival rate were 74％ and 71％,respectively.Grade 3 and 4-5 toxicities occurred in 25（26％） and 0 patients,respectively.Recurrence and metastasis were seen in 22 （23％） patients,of whom 18 （19％） and 11 （12％） had locoregional recurrence and distant metastasis,respectively.Conclusions Adjuvant IMRT/3DCRT for pT2-3N0M0 TESCC is tolerable and clinically feasible,and provides exccllent local control and favorable survival.Further confirmation in a randomized trial is merited.