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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
任骅, 王鑫, 房辉, 李宁, 金晶, 刘跃平, 王维虎, 王淑莲, 宋永文, 李晔雄,
100021 北京协和医学院中国医学科学院肿瘤医院放疗科
Interim assessment of prospective phase Ⅱ trial evaluating efficacy of intensity-modulatedradiotherapy with concurrent capecitabine for stage Ⅱ/Ⅲ gastric cancer after radical surgery
Ren Hua, Wang Xin, Fang Hui, Li Ning, Jin Jing, Liu Yueping, Wang Weihu, Wang Shulian, Song Yongwen, Li Yexiong
Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing 100021, China
Abstract：Objective To evaluate the preliminary efficacy and acute toxicities of intensity-modulated radiotherapy (IMRT) with concurrent capecitabine for stage Ⅱ/Ⅲ gastric cancer (AJCC 7th) 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 Ⅲ 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 capecitabine at 1600 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.
Ren Hua,Wang Xin,Fang Hui et al. Interim assessment of prospective phase Ⅱ trial evaluating efficacy of intensity-modulatedradiotherapy with concurrent capecitabine for stage Ⅱ/Ⅲ gastric cancer after radical surgery[J]. Chinese Journal of Radiation Oncology, 2014, 23(2): 104-107.
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