CapOX as neoadjuvant chemotherapy for locally advanced operable colon cancer patients: a prospective single-arm phase Ⅱ trial  

作　　者：Fangqi Liu Li Yang Yuchen Wu Cong Li Jiang Zhao Adili Keranmu Hongtu Zheng Dan Huang Lei Wang Tong Tong Junyan Xu Ji Zhu Sanjun Cai Ye Xu 

机构地区：[1]Department of Colorectal Surgery, Fudan University Shanghai Cancer Center [2]Department of Oncology, Shanghai Medical College, Fudan University [3]Department of Pathology, Fudan University Shanghai Cancer Center [4]Department of Radiology, Fudan University Shanghai Cancer Center [5]Department of Nuclear Medicine,Fudan University Shanghai Cancer Center [6]Department of Radiation Oncology, Fudan University Shanghai Cancer Center [7]Clinical Statistics Center, Fudan University Shanghai Cancer Center

出　　处：《Chinese Journal of Cancer Research》2016年第6期589-597,共9页中国癌症研究（英文版）

基　　金：supported by grants from the National Natural Science Foundation of China (Grant No. 81472620);Shanghai Science and Technology Planning Fund (No. 13140902100);Shanghai Combination Study Project for Major Diseases (No. 2014ZYJB0101);Shanghai Health and Family Planning Commission (No. JGY1404)

摘　　要：Objective： The aim of this prospective, single-arm phase II trial was to confirm the safety and efficacy of neoadjuvant chemotherapy（NAC） using oxaliplatin plus capecitabine（Cap OX） for patients with operable locally advanced colon cancer（CC）.Methods： Patients with computed tomography-defined T4 or lymph node-positive CCs were enrolled. After radiological staging, patients were treated with at least 2 cycles of NAC consisting of 130 mg/m2 oxaliplatin on d 1,plus 1,000 mg/m2 capecitabine twice daily for 14 d every 3 weeks, followed by surgery, and then with the rest cycles of adjuvant chemotherapy. Radiological response was evaluated after 2 cycles of NAC. Tumor response, treatment toxicity, and surgical complications were recorded. The pathological response to therapy was evaluated according to the tumor regression grade（TRG） score. The primary endpoint was pathologic tumor response. This trial is registered in Clinical Trials.gov（No： NCT02415829）.Results： Forty-seven patients were enrolled in the study. Forty-two patients completed the planned treatments.The total radiological response rate was 68%（32/47）, including complete and partial response rates of 2%（1/47）and 66%（31/47）, respectively. Stable disease was observed in 32%（15/47） and progressive disease was observed in none. Complete pathologic response, major regression, and at least moderate regression were achieved in 1（2%）, 2（4%）, and 29（62%） patients, respectively. Four patients developed grade 3 treatment toxicities. One patient with wound infection occurred after operation（1/47, 2%）. There was no treatment-related death.Conclusions： Our results suggest that NAC with Cap OX is an effective and safe treatment option for patients with locally advanced CCs.Objective： The aim of this prospective, single-arm phase II trial was to confirm the safety and efficacy of neoadjuvant chemotherapy（NAC） using oxaliplatin plus capecitabine（Cap OX） for patients with operable locally advanced colon cancer（CC）.Methods： Patients with computed tomography-defined T4 or lymph node-positive CCs were enrolled. After radiological staging, patients were treated with at least 2 cycles of NAC consisting of 130 mg/m2 oxaliplatin on d 1,plus 1,000 mg/m2 capecitabine twice daily for 14 d every 3 weeks, followed by surgery, and then with the rest cycles of adjuvant chemotherapy. Radiological response was evaluated after 2 cycles of NAC. Tumor response, treatment toxicity, and surgical complications were recorded. The pathological response to therapy was evaluated according to the tumor regression grade（TRG） score. The primary endpoint was pathologic tumor response. This trial is registered in Clinical Trials.gov（No： NCT02415829）.Results： Forty-seven patients were enrolled in the study. Forty-two patients completed the planned treatments.The total radiological response rate was 68%（32/47）, including complete and partial response rates of 2%（1/47）and 66%（31/47）, respectively. Stable disease was observed in 32%（15/47） and progressive disease was observed in none. Complete pathologic response, major regression, and at least moderate regression were achieved in 1（2%）, 2（4%）, and 29（62%） patients, respectively. Four patients developed grade 3 treatment toxicities. One patient with wound infection occurred after operation（1/47, 2%）. There was no treatment-related death.Conclusions： Our results suggest that NAC with Cap OX is an effective and safe treatment option for patients with locally advanced CCs.

关 键 词：Colon cancer neoadjuvant chemotherapy phase II trial SURGERY 

分 类 号：R735.35[医药卫生—肿瘤]