2569 Background: Metastatic melanoma is seldom cured, even in patients who achieve a complete remission, because new sites of disease emerge. Autologous, proliferating, self-renewing tumor cells (putative tumor stem cells and/or early progenitor cells), are critical to establishment of new depots of metastatic cancer, and may be excellent sources of antigen for vaccines. These trials addressed the impact on survival from immunizing with antigens from such cells. Methods: Data was pooled from 3 successive phase II trials, all of which included patients with documented metastatic melanoma, who were treated in protocols that utilized antigens from cell cultures of autologous tumor cells. S.C. injections were given weekly for 3 weeks, then monthly for 5 months. 1992-2000: 74 patients were injected with irradiated tumor cells (TC). 2000-2006: 54 patients were injected with autologous dendritic cells (DC) that had been co-cultured with irradiated autologous tumor cells (NCI-V01-1646). 2007-2011: in a randomized phase II trial, 24 patients were injected with TC, and 18 with DC (NCT00436930). Results: The table summarizes overall survival (OS) in each trial. In the pooled analysis there were 98 TC and 72 DC patients. Characteristics were similar in terms of age (51, 52), male gender (62%, 62%), no evidence of disease at the time of treatment (46%, 47%), and presence of M1c visceral disease at the time of treatment (13%, 14%). OS was longer in patients treated with DC (median 63.1 vs 20.2 months, 5-year OS 51% vs 26%, p=0.0002 Mantle-Cox log-rank test). The difference in OS in the randomized trial is also significant (p=0.007). Conclusions: Patient-specific DC vaccines primed with antigens from autologous proliferating, self-renewing tumor cells are associated with encouraging long-term survival rates, and are superior to patient-specific TC vaccines in populations of patients who have been diagnosed with metastatic melanoma. [Table: see text]
Granulocyte-macrophage colony-stimulating factor alone or with dacarbazine in metastatic melanoma: a randomized phase II trial
