Men With High Risk of Skeletal Complications More Likely to Develop Fractures After ADT (Onclive)
“Our findings suggest that treating men having a high baseline risk of fracture with long-term androgen deprivation therapy may have serious adverse consequences,” said senior author Grace Lu-Yao, PhD, MPH, cancer epidemiologist at The Cancer Institute of New Jersey and professor of medicine at Robert Wood Johnson Medical School, in a press release.
Researchers looked at information from 75,994 men aged 66 years and older from the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database from 1992 to 2007. Data regarding the use of bisphosphonates, which prevent bone loss in prostate cancer patients receiving ADT, as well as height and weight data was not available in the SEER-Medicare database.
The study found that men with high baseline risk were more likely to receive ADT compared to men with low baseline risk (52.1% vs 38.2%, P
less than 0.001) and that over 58% of men with high baseline risk of skeletal complications sustained at least one fracture after ADT during the 12-year follow up period.
Among patients with low baseline risk, 38% developed at least one fracture following ADT. In addition to the increased risk of fractures, those who experienced a fracture had a 1.38-fold higher mortality risk than those who did not (95% Cl, 1.34-1.43). The mortality risk for men who experienced a fracture in the first 48 months was 40% higher than those who did not.
This suggests that Cabo, Alpharadin, or XGeva could nicely complement the side effects of ADT by preventing SRE's in vulnerable patients. It may also complement potential side effects of antiandrogen drugs like Enzalutamide and Zytiga. It maybe that the total effect of combos in the planned Cabo + antiandrogen drug trials will be larger than the sum of its parts.
It's also interesting to note that the initial trial rationale for combining Abi w/ Cabo had less to do w/ bone management than it had to do w/ Abi's notable side effect of MET overexpression. The fact that EXEL has quickly decided to go forward w/ this combination in a pre-chemo setting is very good news indeed.
Lots happening right now. A quick cruise of clinicaltrialsdotgov shows lots of recent updates to recruiting activity...(pancreatic neuroendocrine & adolescent solid tumors have both begun recruiting this past week)
Next round of short interest/ institutional holdings revisions should be revealing.