Autologous T-cell therapy for metastatic renal cell carcinoma

At present, no curative treatments exist for metastatic renal cell carcinoma (RCC), a condition with a mean survival of approximately 6-8 months. Autolymphocyte therapy is an alternative form of adoptive immunotherapy, in which peripheral blood-derived autologous T cells are activated ex vivo and delivered on an outpatient basis. Ninety patients with metastatic RCC were randomized to receive either autolymphocyte therapy (ALT) plus cimetidine, or cimetidine alone. At study termination, median survival was 21 months in the ALT arm vs. 8.5 months with cimetidine monotherapy, a 2.5-fold survival advantage. Currently, 5 patients remain alive from the ALT group, with median follow-up of 82 months, while 8 control patients who crossed over to receive ALT at the conclusion of the trial showed a median survival of 40 months. ALT can induce durable tumor responses in 15-20% of patients and is associated with low toxicity.