Many studies have shown that cyclic androgen deprivation is associated with a reduction in toxic effects in patients with prostate cancer. Results of a new international study show that the use of intermittent androgen treatment after radiotherapy in patients with elevated prostate-specific antigen (PSA) levels is noninferior to continuous androgen treatment and leads to improvements in some QOL measures (Crook JM, et al. N Engl J Med. 2012;367:895-903).
The FDA approval of new drugs for advanced solid tumors is relying heavily on demonstration of increased survival duration in phase 3 clinical trials. Most trials, however, are not designed to detect differences in quality of life (QOL) or in toxicity levels. A new meta-analysis reviewed pivotal clinical trials that have led to FDA approval of new anticancer drugs focusing on QOL outcomes in 3 areas—treatment-related differences in grade 3 or 4 adverse events (AEs), treatment discontinuation, and toxic deaths (Niraula S, et al. J Clin Oncol. 2012;30:3012-3019).
