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A multicenter randomized phase III trial of domestic product of rmhTNF in the treatment of non-small cell lung cancer

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). Two hundred patients with NSCLC in multicenter w... Full description

Journal Title: Zhongguo fei ai za zhi = Chinese journal of lung cancer 20 August 2003, Vol.6(4), pp.264-7
Main Author: Zhou, Qinghua
Other Authors: 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
Format: Electronic Article Electronic Article
Language: chi
Subjects:
ID: ISSN: 1009-3419 ; PMID: 21272478 Version:1 ; DOI: 10.3779/j.issn.1009-3419.2003.04.05
Link: http://pubmed.gov/21272478
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title: A multicenter randomized phase III trial of domestic product of rmhTNF in the treatment of non-small cell lung cancer
format: Article
creator:
  • 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
subjects:
  • Medicine
ispartof: Zhongguo fei ai za zhi = Chinese journal of lung cancer, 20 August 2003, Vol.6(4), pp.264-7
description: 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). 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 4×10⁶U/m² 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. 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. 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.
language: chi
source:
identifier: ISSN: 1009-3419 ; PMID: 21272478 Version:1 ; DOI: 10.3779/j.issn.1009-3419.2003.04.05
fulltext: fulltext
issn:
  • 10093419
  • 1009-3419
url: Link


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titleA multicenter randomized phase III trial of domestic product of rmhTNF in the treatment of non-small cell lung cancer
creatorZhou, 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
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descriptionTo 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). 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 4×10⁶U/m² 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. 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. 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.
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8Liu, Luming
9Chen, Zhen
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26Zheng, Rongsheng
27Chen, Yuqing
28Bi, Minghong
titleA multicenter randomized phase III trial of domestic product of rmhTNF in the treatment of non-small cell lung cancer
description
0To 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).
1Two 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 4×10⁶U/m² 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.
2of 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.
3The 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.
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atitleA multicenter randomized phase III trial of domestic product of rmhTNF in the treatment of non-small cell lung cancer
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abstractTo 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).
doi10.3779/j.issn.1009-3419.2003.04.05
pmid21272478
eissn19996187
date2003-08-20