Benefits of new bone drug Xgeva (denosumab) questioned

[JimJimJimJim]

In an article on MedPageToday, the cost/benefits of Xgeva (denosumab) was discussed:

"Denosumab does not provide a significant delay in the median time to first and subsequent SRE versus zoledronic acid, even after long-term continuous and expensive monthly therapy," George Dranitsaris, M.Pharm, DPH, of Augmentium Pharma Consulting in Toronto, concluded in a poster presentation.

"The reported trial endpoints may be difficult to translate into potential clinical benefits on a peer-patient level."

"These marginal benefits need to be considered alongside the safety profile and cost of denosumab, as well as patient preference, treatment guidelines, and the physician's clinical judgment," he added.

Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

Explain that an analysis found that the number needed to treat with denosumab to prevent any skeletal-related event (SRE) in patients with advanced cancer -- compared with zoledronic acid treatment -- was 21, but was much higher to prevent the most serious SREs.

Note that denosumab is more expensive than zoledronic acid and showed no benefit over the latter for prevention of spinal cord compression in advanced cancer patients.

It is my understanding that Xgeva (denosumab) is only available in Australia currently (as of Monday, 10 October 2011) in trials.

Note that the measure used in the article (Number Needed to Treat, NNT) is not usually used in reporting the effectiveness of one drug compared to another.

It is more often used in dealing with the economics.

The number needed to treat to prevent one cardiovascular event with a common statin, Lipitor (Atorvastatin) would be 99.7 for 3.3 years. (see Wikipedia for an explanation of "number needed to treat").

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http://www.medpageto...ECCO-ESMO/28820