1553TiP A phase III study comparing the efficacy of the combination of doxorubicin and the tumor-targeting human antibody-cytokine fusion protein L19TNF to doxorubicin alone as first-line therapy in patients with advanced or metastatic soft tissue sarcoma

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Recombinant human tumor necrosis factor (TNF) is a potent proinflammatory and cytotoxic cytokine that is approved in the EU for the therapy of soft tissue sarcoma (STS) of the limbs, used in combination with melphalan in an isolated-limb perfusion procedure. Although TNF is one of the most potent antitumor cytokines, the considerable therapeutic potential of natural TNF cannot be fully exploited due to severe side effects, which preclude achievement of therapeutically active concentrations in the tumor.