Clinical effects of exogenous / endogenous TNF therapy on metastatic lesions of 34 colorectal cancer patients

Background: We performed endogenous/exogenous TNF (EET) therapy using, as a primer recombinant TNF-S AM2 (rTNF-S) as a premier; it has a broader anti- cancer spectrum and is less toxic than conventional TNF, and OK-432 as a trigger in patients with metastasis of colorectal cancer to the lung and/or liver. Methods: The subjects consisted of 34 patients of whom 8 had lung metastasis, 17 liver metastasis, and 9 lung and liver metastasis. EET therapy was performed without chemotherapy in 11 patients and with anti-cancer drugs such as mitomycin-C (MMC) and 5-FU in the other 23. Results: No patients showed a complete response. Partial response was observed in 10 patients (29.4%), minor response in 8 (23.5%), no change in 14 (41.2%), and progressive disease in 2 (5.8%). The response rate was 29. 4%. A greater effect was observed in patients treated with EET in combination with anti-cancer drugs than those treated with EET alone. No serious side effects were observed, although all patients developed a fever above 38°C, chill, and shiver. Conclusions: EET therapy with rTNF-S combined with anti cancer drugs chemotherapy may be effective, and further studies are needed to select the most suitable anticancer drugs for combination with, and to determine the effective frequency of treatment.