Ⅱ和Ⅲ期胃癌术后IMRT同期卡培他滨化疗前瞻性Ⅱ期研究中期评估

Interim assessment of prospective phase Ⅱ trial evaluating efficacy of intensity-modulated radiotherapy with concurrent capecitabine for stage Ⅱ / Ⅲ gastric cancer after radical surgery

目的 评价Ⅱ、Ⅲ期（AJCC第7版）胃癌根治术后IMRT同期卡培他滨化疗的初步疗效和急性不良反应,以决定是否继续Ⅱ期研究.方法 2009-2011年35例Ⅱ、Ⅲ期（10、25例）胃癌患者进入前瞻性Ⅱ期研究,根治术后给予辅助放化疗或化疗.放疗采用IMRT,靶区包括吻合口、瘤床和区域淋巴结,剂量45 Gy分25次.同期化疗为卡培他滨每天l 600 mg/m2分2次,连续服用5周;辅助化疗为氟尿嘧啶或卡培他滨±奥沙利铂4～8周期.采用Kaplan-Meier法计算生存率并Logrank法单因素预后分析.以DFS 52.9％为继续研究的下限.结果 全组中位随访21个月,随访率94％.3例未完成放疗,2年DFS、OS分别为70％、86％,急性3级胃肠道、血液和总不良反应分别为11％、11％和26％.预后分析显示病理印戒细胞癌成分和淋巴结阳性比是DFS不良预后因素,T4期可预测OS下降.结论 全组胃癌根治术后IMRT同期卡培他滨化疗的2年DFS＞ 52.9％,且不良反应可耐受,可继续Ⅱ期研究.

Objective To evaluate the preliminary efficacy and acute toxicities of intensity- modulated radiotherapy （IMRT） with concurrent eapecitabine for stage Ⅱ/Ⅲ gastric cancer （ AJCC 7＇h ） after radical surgery and to decide whether to continue phase Ⅱ trial. Methods From 2009 to 2011, 35 patients with gastric cancer （10 stage Ⅱ patients and 25 stage ]lI patients） were included in prospective phase Ⅱ trial to receive chemoradiotherapy. In radiotherapy, the patients received IMRT to the anastomosis, tumor bed, and regional lymph nodes at a dose of 45 Gy/25 fractions. In concurrent chemotherapy, the patients received capccitabine at 1 600 mg/m2 in two divided doses per day for 5 weeks; in adjuvant chemotherapy, the patients received fluorouracil or capecitabine ± oxaliplatin （4--8 cycles）. The Kaplan- Meier method was used to calculate survival rates, and the log-rank test was used for univariate prognostic analysis. A disease-free survival （DFS） of 52. 9% was used as the lower limit for continuing study. Results With a median follow-up of 21 months, the follow-up rate was 94%. Radiotherapy was not completed in 3 patients. The 2-year DFS and overall survival （OS） were 70% and 86% , respectively. The incidence rates of grade 3 acute gastrointestinal, hematologic, and overall toxicities were 11%, 11%, and 26%, respectively. The prognostic analysis showed that signet-ring cell carcinoma and positive lymph node ratio were adverse prognostic factors for DFS, and advanced T stage （T4 ） was the adverse prognostic factor for OS. Conclusions The 2-year DFS was greater than 52. 9% among all patients with gastric cancer who received IMRT with concurrent capecitabine after radical surgery, and the toxicities were tolerable. Thus, phase Ⅱ trial could be continued.