A multicenter randomized phase Ⅲ trial of domestic product of rmhTNF in the treatment of non-small cell lung cancer
ZHOU Qinghua , YAN Xi, REN Li, LI Lu, QIU Meng, YANG Yuqiong, LUO Deyun, HUANG Wenxia, LIU Luming, CHEN Zhen, MENG Zhiqiang, WANG Yajie, FU Qiang, XU Yang, YANG Linjun, LI Mingzhong, LI Enxiao, LI Yi, YAO Yu, ZHANG Xiangfu, LIU Xing, LU Huishan, ZHANG Maohong, WANG Xiuwen, YU Xuejun, QIN Fengzhan, ZHENG Rongsheng, CHEN Yuqing, BI Minghong. Cancer Center, West China Hopital, Sichuan University, Chengdu, Sichuan 610041, P.R.China
Objective To evaluate and compare the effects and toxicity of the domestic product of recombinant mutant human tumor necrosis factor (rmhTNF) combined with chemotherapy and chemotherapy alone in the treatment of patients with non small cell lung cancer (NSCLC). Methods Two hundred patients with NSCLC in multicenter were randomly devided into trial group (150 cases) and control group (50 cases). Chemotherapy with CAP regimen was given to the patients. Meanwhile, rmhTNF injection of 4×10 6 U/m 2 was also given from the 1st to 7th days, the 11th to 17th days on the chemotherapy cycle in the trial group. The control patients received chemotherapy alone. Twenty one days were as a cycle, 2 cycles were given to each patient. The chemotherapeutic effects and toxicity were observed and compared between the two groups after the therapy. Results of the 200 patients, 5 cases in the trial group and 3 cases in the control group were out of the trial because of economy. The other 192 cases (145 cases in the trial group and 47 cases in the control group) could be analyzed and evaluated the clinical effects and toxicity. The response rate of chemotherapy was 46.90% (68/145) in the trial group and 17.02% (8/47) in the control group respectively ( P =0.001). The KPS scores was 86.02±9.74 in the trial group, and 80.14±9.10 in the control group ( P =0.025). No significant difference of degree Ⅲ+Ⅳ toxicity was observed between the two groups ( P 0.05). The side effects related to rmhTNF included slight fever, cold like symptoms, pain and red and swelling in the injection site. All of them were mild and didn't need any treatment and disappeared after the therapy. There were no severe abnormality of liver and kidney function and ECG in both groups. Conclusion The results demonstrate that the effects of domestic rmhTNF combined with chemotherapy are remarkably higher than that of chemotherapy alone in the treatment of NSCLC. rmhTNF can increase the sensitivity to chemotherapy and improve the quality of life of the patients with slight toxicity. Hence rmhTNF is worth expanding clinical use.
【CateGory Index】： R734.2