Therapeutic cancer vaccines: Why so few randomised phase III studies reflect the initial optimism of phase II studies

Immunotherapy is showing promise for the treatment of a range of tumours including prostate cancer, melanoma and non small-cell lung cancer. Phase II trial data has been extremely encouraging with regards both clinical outcome and the investigation of the underlying immunological mode-of-action. However, despite the positive phase II data there remains a high failure rate in late stage clinical trials which, in many cases can be ascribed to inappropriate trial design, poor patient selection and inconsistency in patient management. The potential impact of standard cancer treatments and other factors which may vary within patient populations is discussed. A perspective is provided on the failure of late-stage clinical trials across a range of platforms focusing particularly on melanoma and prostate cancer. (C) 2011 Elsevier Ltd. All rights reserved.