Abstract
Cancer incidence is growing worldwide, boosting substantial investment in research and development for ever better therapies. The present study aims to evaluate the benefits from innovative drugs for oncology in terms of overall survival (OS, a gold standard), updating former publication findings on this issue. Survival gain was defined as the difference in median OS between research and control arms, respectively. Starting from regulatory approvals for reimbursement issued by AIFA (Agenzia Italiana del Farmaco) and officially published between January 2010 and July 2013, 39 pivotal trials were identified on antineoplastic agents (21 related to new chemical entities and 18 to therapeutic extensions). In seven studies, OS data was not reported nor could be reconstructed; so they were not included in the analysis. Among the remaining 32 studies, the survival gain was statistically significant (p
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