Overestimating the Benefit of Cancer Drugs—Reply

In Reply For reference, we consider all initial, anticancer drug authorizations, and report mean treatment effects. Fojo et al consider initial and extension drug authorizations for only solid tumors, and instead report medians. We present drug overall survival (OS) benefits individually. Unlike Fojo et al, we then estimate the total impact on patient OS between 2003 and 2013. Where appropriate, OS benefits were combined sequentially to reflect drug development—we intentionally did not divide by 2. For example, within this period, lapatinib's approval was based on a comparison against capecitabine monotherapy; T-DM1 was later compared against lapatinib + capecitabine. Drug OS gains were 0.3 to 2.4 and 5.8 months, respectively. Eligible patients would have therefore seen an expected OS increase of 6.1 to 8.2 months between 2003 and 2013. Dividing by 2 would redundantly estimate average OS benefits per new drug.

http://ift.tt/2udrskU