Xgeva Delays Bone Metastases in Men with Aggressive Prostate Cancer

Posted on June 7th, 2012 by

Among men with prostate cancer that has aggressive characteristics and has stopped responding to hormonal therapy, the bone drug Xgeva™ (denosumab) delayed the onset of bone metastases by more than seven months. These results were presented at the 2012 Annual Meeting of the American Society of Clinical Oncology.

Androgen deprivation therapy (ADT) often plays an important role in the treatment of prostate cancer. ADT slows or stops prostate cancer growth by reducing the exposure of the prostate to testosterone. Eventually, however, prostate cancer can become resistant to ADT. This is known as hormone-refractory prostate cancer.

Xgeva is a bone drug that targets a protein known as the RANK ligand. This protein regulates the activity of osteoclasts (cells that break down bone). Xgeva has been approved for the prevention of bone complications such as fracture in patients with bone metastases from solid (not blood-related) cancers. Some research has suggested that Xgeva may also have anti-cancer effects in the bone. This could be an important benefit for patients with cancers that tend to spread to the bone, such as prostate and breast cancers.

To evaluate the effect of Xgeva on the occurrence of bone metastases, researchers conducted a Phase III clinical trial among 1,432 men with hormone-refractory prostate cancer. The men had rapidly rising prostate-specific antigen (PSA) levels and/or high PSA levels but were free of bone metastases at the start of the study. Patients received either Xgeva or a placebo.

Earlier reports from this study indicated that Xgeva delayed the occurrence of bone metastases by more than four months. In the current analysis, researchers focused on the subset of patients who had a short PSA doubling time at the start of the study. A short PSA doubling time (defined in this case as PSA levels that double in six months or less) means that PSA levels are rising rapidly; this may indicate more aggressive disease.

  • Men with a short PSA doubling time developed bone metastases more quickly than other men. This confirms that these men are at particularly high risk of bone metastases.
  • Among the men with a short PSA doubling time, Xgeva delayed the onset of bone metastases by more than seven months.

These results indicate that Xgeva significantly delays the development of bone metastases among men at high risk of bone metastases.

Reference: Saad F, Smith MR,ShoreNDet al.Effect of denosumab on prolonging bone-metastasis free survival (BMFS) in men with nonmetastatic castrate-resistant prostate cancer (CRPC) presenting with aggressive PSA kinetics. Paper presented at: 2012 Annual Meeting of the American Society of Clinical Oncology; June 1-5, 2012;Chicago,IL. Abstract 4510.

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Tags: News, Prostate Cancer, Refactory/Recurrent Prostate Cancer, Urology

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