Phase Ⅰ clinical study of concurrent chemoradiation with hydroxycamptothecin for unresectable or locally relapsed rectal cancer
LI Ning, JIN Jing, LI Ye-xiong, WANG Wei-hu, WANG Shu-lian, LIU Yue-ping, SONG Yong-wen, REN Hua, FANG Hui, LIU Xin-fan, YU Zi-hao
Department of Radiation Oncology, Cancer Hospital (Institute), Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing 100021, China Corresponding author:JIN Jing, Email:jingjin25@yahoo.com.cn;LI Ye-xiong, Email:yexiong3@yahoo.com.cn
Abstract：Objective To determine the maximal tolerated dose and the dose-limiting toxicity of hydroxycamptothecin (HCPT) concurrently combined with three-dimensional conformal radiotherapy (3DCRT) for unresectable or locally relapsed rectal cancer. Methods Twenty-two patients with rectal cancer were enrolled into phase Ⅰ study between 2004－2007. HCPT was intravenously administered concurrently with 3DCRT weekly, dose given from 6,8,10 mg/m2 or twice a week, dose given from 4,6,8,10 mg/m2, respectively. Total radiation dose of 50 Gy was delivered to the whole pelvis at a fraction of 2 Gy per day for 5 weeks, with 10－16 Gy subsequent boost to tumor area. Dose-limiting toxicities (DLT) were defined as grade 3 or higher non-hematologic toxicity or grade 4 hematologic toxicity. Results In the twice a week group, DLTs of grade 3 diarrhea were observed in 2 patient treated at dose of 6 mg/m2. In the weekly group, DLTs of grade 3 diarrhea and radiation-induced dermatitis were observed in 1 patient at dose of 8 mg/m2, and were not observed in the next 3 patients at the same dose level. However, at dose of 10 mg/m2, 2 patients had grade 3 diarrhea or nausea. The 5-year overall survival rate was 23% and the median survival time was 18 months. Conclusions HCPT given concurrently with 3DCRT is safe and tolerable for patients with unresectable or locally relapsed rectal cancer. Either 8 mg/m2 weekly or 4 mg/m2 twice a week can be recommended for further study. The dose-limiting toxicities are grade 3 diarrhea, nausea and radiation-induced dermatitis.
LI Ning,JIN Jing,LI Ye-xiong et al. Phase Ⅰ clinical study of concurrent chemoradiation with hydroxycamptothecin for unresectable or locally relapsed rectal cancer[J]. Chinese Journal of Radiation Oncology, 2012, 21(4): 348-351.
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