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). Th

SUBMITTER: Ma X 

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

REPOSITORIES: biostudies-literature