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

Qinghua Zhou, Mei Hou, Lu Li, Li Ren, Meng Qiu, Yuqiong Yang, Wenxia Huang, Zhen Chen, Zhiqiang Meng, Mingzhi Song, Mingzhong Li, Enxiao Li, Yi Li, Yu Yao, Zhiwen Zheng, Xing Liu, Xiangfu Zhang, Huishan Lu, Maohong Zhang, Xiuwen WangXuejun Yu

Research output: Contribution to journalArticle

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Abstract

Objective: To evaluate and compare the effects and toxicity of the domestic product of nrhTNF combined with chemotherapy in the trial group and chemotherapy alone in the control group in the treatment of patients with non-small cell lung cancer (NSCLC). Methods: Ninety patients with NSCLC in multi-center were randomly divided into trial group and control group. Each group had 45 patients. Chemotherapy with CAP regimen was given for the patients in the trial group. Meanwhile, nrhTNF injection of 4 × 106 U/m2 was also given from the 1st to 7th days, the 11th to 17th days on the chemotherapy course. Twenty-one days were as a cycle, 2 cycles were given each patients. Chemotherapy alone with CAP regimen was given in the control group. The chemothepeutic effects and toxicity were observed and compared between the two groups after the therapy. Results: Of the 90 patients, 3 cases in each group were out of the trial because of economy. The other 84 cases (each group had 42 patients) could be used to analyze and evaluate the clinical effects and toxicity. The response rate of chemotherapy was 47.62% (20/42) in the trial group and 19.05% (8/42) in the control group (P=0. 002) respectively. The KPS was 85.02±10.74 in the trial group, and 81.35±9.63 in the control group (P=0.038). No significant difference of degree III+IV toxicity was observed between the trial group and control group (P<0.05). The side effects related to nrhTNF included slight fever, cold-like symptoms, pain, and red and swelling in injection site. All of them were mild and didn't need any treatment and disappeared after the therapy. Conclusion: The results demonstrate that the effects of domestic nrhTNF combined with chemotherapy can remarkably higher than that of chemotherapy alone in the treatment of NSCLC. It is able to increase the sensitivity to chemotherapy and improve the quality of life of the patients. The toxicity is also slight and is worth to expand clinical use, so as to further evaluate its effect and toxicity.

Original languageEnglish (US)
Pages (from-to)42-45
Number of pages4
JournalChinese Journal of Lung Cancer
Volume6
Issue number1
StatePublished - Feb 1 2003

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Non-Small Cell Lung Carcinoma
Drug Therapy
Control Groups
Therapeutics
Injections
Group Psychotherapy
Fever
Quality of Life
Pain

Keywords

  • Combined chemotherapy
  • Lung neoplasms
  • New recombinant human tumor necrosis factor
  • Phase II clinical trial
  • Randomly trial

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

Cite this

A multicenter randomized phase II trial of domestic product of nrhTNF in the treatment of non-small cell lung cancer. / Zhou, Qinghua; Hou, Mei; Li, Lu; Ren, Li; Qiu, Meng; Yang, Yuqiong; Huang, Wenxia; Chen, Zhen; Meng, Zhiqiang; Song, Mingzhi; Li, Mingzhong; Li, Enxiao; Li, Yi; Yao, Yu; Zheng, Zhiwen; Liu, Xing; Zhang, Xiangfu; Lu, Huishan; Zhang, Maohong; Wang, Xiuwen; Yu, Xuejun.

In: Chinese Journal of Lung Cancer, Vol. 6, No. 1, 01.02.2003, p. 42-45.

Research output: Contribution to journalArticle

Zhou, Q, Hou, M, Li, L, Ren, L, Qiu, M, Yang, Y, Huang, W, Chen, Z, Meng, Z, Song, M, Li, M, Li, E, Li, Y, Yao, Y, Zheng, Z, Liu, X, Zhang, X, Lu, H, Zhang, M, Wang, X & Yu, X 2003, 'A multicenter randomized phase II trial of domestic product of nrhTNF in the treatment of non-small cell lung cancer', Chinese Journal of Lung Cancer, vol. 6, no. 1, pp. 42-45.
Zhou, Qinghua ; Hou, Mei ; Li, Lu ; Ren, Li ; Qiu, Meng ; Yang, Yuqiong ; Huang, Wenxia ; Chen, Zhen ; Meng, Zhiqiang ; Song, Mingzhi ; Li, Mingzhong ; Li, Enxiao ; Li, Yi ; Yao, Yu ; Zheng, Zhiwen ; Liu, Xing ; Zhang, Xiangfu ; Lu, Huishan ; Zhang, Maohong ; Wang, Xiuwen ; Yu, Xuejun. / A multicenter randomized phase II trial of domestic product of nrhTNF in the treatment of non-small cell lung cancer. In: Chinese Journal of Lung Cancer. 2003 ; Vol. 6, No. 1. pp. 42-45.
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abstract = "Objective: To evaluate and compare the effects and toxicity of the domestic product of nrhTNF combined with chemotherapy in the trial group and chemotherapy alone in the control group in the treatment of patients with non-small cell lung cancer (NSCLC). Methods: Ninety patients with NSCLC in multi-center were randomly divided into trial group and control group. Each group had 45 patients. Chemotherapy with CAP regimen was given for the patients in the trial group. Meanwhile, nrhTNF injection of 4 × 106 U/m2 was also given from the 1st to 7th days, the 11th to 17th days on the chemotherapy course. Twenty-one days were as a cycle, 2 cycles were given each patients. Chemotherapy alone with CAP regimen was given in the control group. The chemothepeutic effects and toxicity were observed and compared between the two groups after the therapy. Results: Of the 90 patients, 3 cases in each group were out of the trial because of economy. The other 84 cases (each group had 42 patients) could be used to analyze and evaluate the clinical effects and toxicity. The response rate of chemotherapy was 47.62{\%} (20/42) in the trial group and 19.05{\%} (8/42) in the control group (P=0. 002) respectively. The KPS was 85.02±10.74 in the trial group, and 81.35±9.63 in the control group (P=0.038). No significant difference of degree III+IV toxicity was observed between the trial group and control group (P<0.05). The side effects related to nrhTNF included slight fever, cold-like symptoms, pain, and red and swelling in injection site. All of them were mild and didn't need any treatment and disappeared after the therapy. Conclusion: The results demonstrate that the effects of domestic nrhTNF combined with chemotherapy can remarkably higher than that of chemotherapy alone in the treatment of NSCLC. It is able to increase the sensitivity to chemotherapy and improve the quality of life of the patients. The toxicity is also slight and is worth to expand clinical use, so as to further evaluate its effect and toxicity.",
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author = "Qinghua Zhou and Mei Hou and Lu Li and Li Ren and Meng Qiu and Yuqiong Yang and Wenxia Huang and Zhen Chen and Zhiqiang Meng and Mingzhi Song and Mingzhong Li and Enxiao Li and Yi Li and Yu Yao and Zhiwen Zheng and Xing Liu and Xiangfu Zhang and Huishan Lu and Maohong Zhang and Xiuwen Wang and Xuejun Yu",
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T1 - A multicenter randomized phase II trial of domestic product of nrhTNF in the treatment of non-small cell lung cancer

AU - Zhou, Qinghua

AU - Hou, Mei

AU - Li, Lu

AU - Ren, Li

AU - Qiu, Meng

AU - Yang, Yuqiong

AU - Huang, Wenxia

AU - Chen, Zhen

AU - Meng, Zhiqiang

AU - Song, Mingzhi

AU - Li, Mingzhong

AU - Li, Enxiao

AU - Li, Yi

AU - Yao, Yu

AU - Zheng, Zhiwen

AU - Liu, Xing

AU - Zhang, Xiangfu

AU - Lu, Huishan

AU - Zhang, Maohong

AU - Wang, Xiuwen

AU - Yu, Xuejun

PY - 2003/2/1

Y1 - 2003/2/1

N2 - Objective: To evaluate and compare the effects and toxicity of the domestic product of nrhTNF combined with chemotherapy in the trial group and chemotherapy alone in the control group in the treatment of patients with non-small cell lung cancer (NSCLC). Methods: Ninety patients with NSCLC in multi-center were randomly divided into trial group and control group. Each group had 45 patients. Chemotherapy with CAP regimen was given for the patients in the trial group. Meanwhile, nrhTNF injection of 4 × 106 U/m2 was also given from the 1st to 7th days, the 11th to 17th days on the chemotherapy course. Twenty-one days were as a cycle, 2 cycles were given each patients. Chemotherapy alone with CAP regimen was given in the control group. The chemothepeutic effects and toxicity were observed and compared between the two groups after the therapy. Results: Of the 90 patients, 3 cases in each group were out of the trial because of economy. The other 84 cases (each group had 42 patients) could be used to analyze and evaluate the clinical effects and toxicity. The response rate of chemotherapy was 47.62% (20/42) in the trial group and 19.05% (8/42) in the control group (P=0. 002) respectively. The KPS was 85.02±10.74 in the trial group, and 81.35±9.63 in the control group (P=0.038). No significant difference of degree III+IV toxicity was observed between the trial group and control group (P<0.05). The side effects related to nrhTNF included slight fever, cold-like symptoms, pain, and red and swelling in injection site. All of them were mild and didn't need any treatment and disappeared after the therapy. Conclusion: The results demonstrate that the effects of domestic nrhTNF combined with chemotherapy can remarkably higher than that of chemotherapy alone in the treatment of NSCLC. It is able to increase the sensitivity to chemotherapy and improve the quality of life of the patients. The toxicity is also slight and is worth to expand clinical use, so as to further evaluate its effect and toxicity.

AB - Objective: To evaluate and compare the effects and toxicity of the domestic product of nrhTNF combined with chemotherapy in the trial group and chemotherapy alone in the control group in the treatment of patients with non-small cell lung cancer (NSCLC). Methods: Ninety patients with NSCLC in multi-center were randomly divided into trial group and control group. Each group had 45 patients. Chemotherapy with CAP regimen was given for the patients in the trial group. Meanwhile, nrhTNF injection of 4 × 106 U/m2 was also given from the 1st to 7th days, the 11th to 17th days on the chemotherapy course. Twenty-one days were as a cycle, 2 cycles were given each patients. Chemotherapy alone with CAP regimen was given in the control group. The chemothepeutic effects and toxicity were observed and compared between the two groups after the therapy. Results: Of the 90 patients, 3 cases in each group were out of the trial because of economy. The other 84 cases (each group had 42 patients) could be used to analyze and evaluate the clinical effects and toxicity. The response rate of chemotherapy was 47.62% (20/42) in the trial group and 19.05% (8/42) in the control group (P=0. 002) respectively. The KPS was 85.02±10.74 in the trial group, and 81.35±9.63 in the control group (P=0.038). No significant difference of degree III+IV toxicity was observed between the trial group and control group (P<0.05). The side effects related to nrhTNF included slight fever, cold-like symptoms, pain, and red and swelling in injection site. All of them were mild and didn't need any treatment and disappeared after the therapy. Conclusion: The results demonstrate that the effects of domestic nrhTNF combined with chemotherapy can remarkably higher than that of chemotherapy alone in the treatment of NSCLC. It is able to increase the sensitivity to chemotherapy and improve the quality of life of the patients. The toxicity is also slight and is worth to expand clinical use, so as to further evaluate its effect and toxicity.

KW - Combined chemotherapy

KW - Lung neoplasms

KW - New recombinant human tumor necrosis factor

KW - Phase II clinical trial

KW - Randomly trial

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