Conclusions and future

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Our personal experience with allogeneic melanoma lysate vaccines, given to several hundred patients, has convinced us that although the response rates in disseminated disease are at most in the range of 15-20%, there is indeed activity of these preparations even when billions of tumor cells are present. There have been a number of patients with a gratifying dramatic increase in survival lasting 5-10 yr or more. Allogeneic lysates may perhaps be effective in preventing recurrence of melanoma in patients with resected stage III disease, and have been equivalent to toxic four-drug chemotherapy even when given by a suboptimal route of administration in a large multicenter trial. With the same caveat, suboptimal (im) route of administration, a large Southwest Oncology Group phase II study of Melacine vs observation in resected intermediate thickness stage II melanoma was initially positive at a follow-up of 1 yr (p = 0.04), although further follow-up showed no difference. Melacine was approved for use in Canada in November 1999, based primarily upon the data in disseminated melanoma that we have reviewed here, and particularly upon its safety and maintenance of a good quality of life. Regardless of whether Melacine or another allogeneic vaccine is eventually approved in the United States, we will continue to pursue multiantigenic vaccines as a treatment for the various stages of melanoma. More defined vaccines are now possible because of an expansion of knowledge of which antigens are shared among melanomas. Preselection of respond-ers with HLA class I haplotyping also appears feasible.

In the future, vaccines made with a predetermined mixture of peptides, proteins, or the DNA encoding them, may well supplement or supplant lysate vaccines such as Melacine, but for the immediate future the use of lysates injected directly sc into patients or incorporated into dendritic cells injected sc and/or id appears to be a useful approach to melanoma treatment. Combinations of vaccines and cytokines, and vaccines with adoptively transferred in vitro-immunized T cells, are also very promising. However, it is becoming all too clear that the addition of agents that inhibit the tumor's ability to antagonize the immune response will probably be essential in order for any immuno-therapy to be optimally effective, even at early stages in the progression of the tumor.

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