{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,19]],"date-time":"2025-10-19T21:19:04Z","timestamp":1760908744276,"version":"3.33.0"},"reference-count":29,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2012,1,9]],"date-time":"2012-01-09T00:00:00Z","timestamp":1326067200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancer Science"],"published-print":{"date-parts":[[2012,2]]},"abstract":"<jats:p>We previously prepared a tumor necrosis factor (TNF)\u2010\u03b1 mutant (rmhTNF\u2010\u03b1) that showed higher antitumor activity and lower systemic toxicity compared with native TNF\u2010\u03b1. The safety profile and the pharmacokinetic characteristics of rmhTNF\u2010\u03b1 were suited for clinical use according to biological Investigational New Drug application, a standard guideline for new drug investigation in China. Here, we evaluate the activity and safety of rmhTNF\u2010\u03b1 combined with chemotherapies in head\/neck, lung, colorectal, stomach, and renal cancer patients. Ninety\u2010five eligible patients received i.m. rmhTNF\u2010\u03b1 treatment combined with standard chemotherapies. Another 95 patients were treated with standard chemotherapies. After two treatment cycles, one patient achieved a complete response and 24 patients had partial response, yielding an overall response rate (complete response\u2003+\u2003partial response) of 27.47% in the rmhTNF\u2010\u03b1 plus chemotherapy cohort. The chemotherapy alone group acquired only a 11.39% response rate (<jats:italic>P\u2003<\/jats:italic>&lt;\u20030.05). When compared between different cancers, a 48.89% response rate was detected in the 45 lung cancer patients of the combination cohort. The most common grade 1\u20132 adverse events of rmhTNF\u2010\u03b1 were drug\u2010related fever, allergy, flu\u2010like symptoms, and myalgia. No significant difference was found in grade 3\u20134 toxicities between the two cohorts. Based on the results of this research, rmhTNF\u2010\u03b1 can significantly enhance the effectiveness of chemotherapy. An extended phase III trial of rmhTNF\u2010\u03b1 combined with standard chemotherapy is warranted for evaluating its antitumor activity and toxicity in a larger cohort of tumor patients. The studies in this paper were registered with the State Food and Drug Administration of China (No. 2003S00692). (<jats:italic>Cancer Sci<\/jats:italic> 2012; 103: 288\u2013295)<\/jats:p>","DOI":"10.1111\/j.1349-7006.2011.02153.x","type":"journal-article","created":{"date-parts":[[2011,11,16]],"date-time":"2011-11-16T13:08:24Z","timestamp":1321448904000},"page":"288-295","source":"Crossref","is-referenced-by-count":9,"title":["Phase II multicenter, randomized, double\u2010blind study of recombinant mutated human tumor necrosis factor\u2010\u03b1 in combination with chemotherapies in cancer 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