I read the very interesting article by Finn1 about sorafenib, the first systemic agent showing a survival advantage when it is used to treat patients with hepatocellular carcinoma.
Finn1 pointed out common and predictable toxicities, including hand-skin reactions, anorexia, and diarrhea, which were experienced by 15% to 40% of the treated patients.
However, Finn1 did not mention the importance of health-related quality of life (HRQOL) with respect to the potential side effects of hepatocellular carcinoma treatment and wrote only a few words about the cost of the drug. The growth of health care costs continues to outpace our ability to pay for health care in the future. We need to know not only the clinical efficacy of the drug but also its cost-effectiveness and the HRQOL of patients randomized between a placebo and sorafenib.
Studies of HRQOL may add value in a variety of ways, including the provision of data that may contrast with or support the primary outcome and sometimes change a study's interpretation.
Studies of cost-effectiveness and HRQOL may provide valuable sources of additional information useful to both the clinician and the patient when treatment decisions are being made, and they are considered important endpoints together with traditional measures.2
I think that their assessment is particularly worthwhile for trials in which survival rates are low.