In the July 1 issue of Clinical Cancer Research, a journal of the American Association for Cancer Research, a team of National Cancer Institute researchers asks a fundamental question: are we looking at cancer vaccine trials the wrong way".

In a review of five prostate cancer vaccine trials, NCI researchers offer evidence that patients who receive vaccines may respond better to subsequent chemotherapy or hormone treatment.

The specific results – or endpoints – of these clinical trials, however, were not the long term survival of patients, but rather the degree to which the vaccine caused tumors to shrink. According to the researchers, since they didn’t achieve their primary endpoints, these vaccines may be abandoned as dead-ends, despite their real therapeutic value in terms of prolonging patient survival.

“Clinical data are providing evidence that patients are living longer following vaccination, de-spite the fact that trials do not show the vaccines can induce the immune system into shrinking tumors,” said Jeffrey Schlom, Ph.D., chief of the Laboratory of Tumor Immunology and Biology at the National Cancer Institute.

“The data suggests that the scientific community and regulatory committees ought to rethink the design of clinical vaccine trials and our current approach to measuring the effectiveness of a cancer vaccine.”