Journal of the National Cancer Institute
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J. Natl. Cancer Inst. · Oct 2007
Androgen deprivation therapy for localized prostate cancer and the risk of cardiovascular mortality.
We investigated whether androgen deprivation therapy (ADT) use is associated with an increased risk of death from cardiovascular causes in patients treated for localized prostate cancer. ⋯ The use of ADT appears to be associated with an increased risk of death from cardiovascular causes in patients undergoing radical prostatectomy for localized prostate cancer.
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J. Natl. Cancer Inst. · Oct 2007
Design of phase II cancer trials using a continuous endpoint of change in tumor size: application to a study of sorafenib and erlotinib in non small-cell lung cancer.
The primary objective of phase II cancer clinical trials is to determine whether a new regimen has sufficient activity to warrant further study, with activity generally defined as tumor shrinkage. However, oncology drug development has been limited by high rates of failure (lack of efficacy) in subsequent phase III testing. This high failure rate may reflect the process by which antineoplastic agents are usually evaluated in phase II trials, i.e., via single-arm studies in which the primary efficacy measure is the proportion of patients who achieve a complete or partial response to the treatment. This design may efficiently eliminate truly ineffective therapy but may not reliably indicate whether subsequent phase III testing is warranted. ⋯ Clinical trial designs that treat change in tumor size as a continuous variable rather than categorizing the changes are feasible, and by inclusion of a prospective control group they offer advantages over conventional single-arm trials.