Abstract
Open clinical trial data offer many opportunities for the scientific community to independently verify published results, evaluate new hypotheses and conduct meta-analyses. These data provide valuable opportunities for scientific advances in medical research. Herein we present the comparative meta-analysis of different standard of care treatments from newly available comparator arm data from several prostate cancer clinical trials. Comparison of survival rates following treatment with mitoxantrone or docetaxel in combination with prednisone as well as prednisone alone, validated the previously demonstrated superiority of treatment with docetaxel. Additionally, comparison of four testosterone suppression treatments in hormone-refractory prostate cancer revealed that subjects who had undergone surgical castration had significantly lower survival rates than those treated with LHRH, anti-androgen or LHRH plus anti-androgen, suggesting that this treatment option is less optimal. This study illustrates how the use of patient-level clinical trial data enables meta-analyses that can provide new insights into clinical outcomes of standard of care treatments and thus, once validated, has the potential to help optimize healthcare delivery.
Highlights
Prostate cancer is one of the most common malignancies in men and a leading cause of illness and death in industrialized countries[1]
A comparison of chemotherapies combined with prednisone and treatment with prednisone alone We compared the survival of a subset of subjects from three comparator treatment groups, two combining different chemotherapies with prednisone and one of prednisone alone, while controlling for age, race and the study from which the data originated (Fig. 2a)
Comparison of the survival of subjects from different clinical trials but receiving the same treatment showed no significant differences between the trials (Supplementary Fig. 2) suggesting it was safe to combine these data
Summary
Prostate cancer is one of the most common malignancies in men and a leading cause of illness and death in industrialized countries[1]. A small percentage of subjects, are diagnosed or eventually develop an advanced form of the disease; and even though radical prostatectomy and radiation therapy can help control the disease, in over a third of patients elevated prostate-specific antigen (PSA) levels will recur[2,3]. These patients are often treated with hormonal therapy such as Luteinizing Hormone Release Hormone (LHRH) agonists or anti-androgens which reduce the level of serum testosterone. While the benefits of hormonal or surgical castration are well documented, to the best of our knowledge, the different approaches have not been systematically compared to each other
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