In brief


1. A study published online today by The Lancet shows Xgeva (denosumab) is better at treating and preventing bone complications than Zometa (zoledronic acid), a current standard treatment for men with advanced, hormone-resistant prostate cancer. Xgeva was approved back in November to prevent bone complications in breast and prostate cancer patients whose cancer had spread and damaged the bone. In the randomized phase 3 study, researchers followed more than 1,900 patients from 39 countries and found that the RANKL inhibitor Xgeva prolonged the time to first skeletal-related event by more than three months when compared with Zometa, a bisphosphonate. Hypocalcaemia (low calcium) was seen in both groups, and rare incidences of osteonecrosis of the jaw were also reported (1 percent with Zometa compared with 2 percent for Xgeva). Read about the study here.2. Traditional thinking is that men with a rapid change in PSA--known as PSA velocity--should have a biopsy for prostate cancer, even when other indications are absent (including a high PSA level or positive digital rectal exam). However, new research indicates PSA velocity alone may be a poor predictor of cancer and could lead to unnecessary biopsies. In response to the findings, researchers of the study, which was published online today in the Journal of the National Cancer Institute, recommend that cancer organizations issuing policy statements related to PSA and prostate cancer detection remove references to PSA velocity. Read about the study here.3. Long-term results of the HERA study, a large phase 3 trial that helped establish Herceptin (trastuzumab) as a treatment in HER2-positive, early-stage breast cancer, show the benefit of the targeted agent continues to last for years after treatment ends. The study compared 5,000 women with HER2-positive breast cancer from 39 countries between December 2001 and June 2005. Previous results showed an improvement in recurrence risk, overall survival and disease-free survival with Herceptin following anthracycline-based chemotherapy. The latest results of the study, released online today by The Lancet Oncology, followed the women for a median of four years--an additional two more years from the initial results--and found the benefits of Herceptin extended well after treatment ended. The outcome of the study also addresses Herceptin used concurrently with anthracycline-based chemotherapy, in light of the fact that both therapies increase the risk of cardiac toxicity. The authors indicate that to validate the sequential use of Herceptin after chemotherapy, there should be another phase 3 trial that considers sequential versus concurrent administration of Herceptin and anthracycline-based chemotherapy.Read about the study here.

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