Dataset Information

Recombinant mutated human TNF in combination with chemotherapy for stage IIIB/IV non-small cell lung cancer: a randomized, phase III study.

ABSTRACT: Tumor necrosis factor (TNF), an anti-angiogenic agent in cancer treatment, is limited to isolated limb perfusion due to systemic toxicities. We previously prepared a TNF mutant (rmhTNF) that significantly improved responses in lung cancer patients and exhibited a promising safety profile in phase I and II studies. To further investigate whether rmhTNF with standard chemotherapy provides a survival benefit, 529 patients with stage IIIB/IV non-small cell lung cancer (NSCLC) were randomly assigned to receive docetaxel plus carboplatin/cisplatin with rmhTNF (265) or chemotherapy alone (264). After four cycles of treatment, the median overall survival was 13.7 months in the chemotherapy plus rmhTNF group compared with 10.3 months in the chemotherapy group (hazard ratio (HR) 0.75, P = 0.001). The median progression-free survival in the chemotherapy plus rmhTNF group and the chemotherapy group was 8.6 and 4.5 months (HR 0.76, P = 0.001), respectively, with corresponding response rates of 38.5% and 27.7% (P = 0.008). Increased hyperpyrexia and pulmonary hemorrhage were associated with rmhTNF, but most effects were well tolerated. The results indicated that rmhTNF effectively potentiated chemotherapy in patients with advanced NSCLC and was comparable with bevacizumab, an angiogenesis inhibitor approved by the Food and Drug Administration (FDA) for NSCLC.

SUBMITTER: Ma X

PROVIDER: S-EPMC4404801 | biostudies-literature | 2015 Apr

REPOSITORIES: biostudies-literature

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Recombinant mutated human TNF in combination with chemotherapy for stage IIIB/IV non-small cell lung cancer: a randomized, phase III study.

Ma Xiaowen X Song Yang Y Zhang Kuo K Shang Lei L Gao Yuan Y Zhang Wei W Xue Xiaochang X Jia Huimin H Geng Jian J Zhou Wei W Dang Yazheng Y Li Enxiao E Ti Xinyu X Fan Fulin F Zhang Yingqi Y Li Meng M

Scientific reports 20150421

Tumor necrosis factor (TNF), an anti-angiogenic agent in cancer treatment, is limited to isolated limb perfusion due to systemic toxicities. We previously prepared a TNF mutant (rmhTNF) that significantly improved responses in lung cancer patients and exhibited a promising safety profile in phase I and II studies. To further investigate whether rmhTNF with standard chemotherapy provides a survival benefit, 529 patients with stage IIIB/IV non-small cell lung cancer (NSCLC) were randomly assigned ...[more]

PMID: 25897826

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Dataset Information

Recombinant mutated human TNF in combination with chemotherapy for stage IIIB/IV non-small cell lung cancer: a randomized, phase III study.

Publications

Recombinant mutated human TNF in combination with chemotherapy for stage IIIB/IV non-small cell lung cancer: a randomized, phase III study.

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