Cancer incidence of Xolair

[Guest guest]

From the Xolair web site:

WARNINGS

Malignancy

Malignant neoplasms were observed in 20 of 4127 (0.5%) Xolair-

treated patients compared with 5 of 2236 (0.2%) control patients in

clinical studies of asthma and other allergic disorders. The

observed malignancies in Xolair-treated patients were a variety of

types, with breast, non-melanoma skin, prostate, melanoma, and

parotid occurring more than once, and five other types occurring

once each. The majority of patients were observed for less than 1

year. The impact of longer exposure to Xolair or use in patients at

higher risk for malignancy (e.g., elderly, current smokers) is not

known.

According to the CDC, the rate of cancer among the population of the

U.S. as reported in 2000 is 463.6 per 100,000, or 0.46%.

Therefore, the rate among the test subjects (actually 0.48% rounded

to 0.5%) is not statistically significant relative to the population

as a whole. It was only significant related to the control group,

which, in fact, was statistically significantly lower than the

overall population.

A research group would have to be cautiously concerned about this,

but a statistician (and eventually the FDA) was content to consider

this a statistical anomaly.

Interestingly, the testing on Zenapax (which is endorsed by our

friend, Dr. Lisberg), showed malignancy rates of 1.5% at one year

post-transplant and 6.7% at three years, which seems awfully high.

This is according to the prescribing information found at:

http://www.fda.gov/medwatch/SAFETY/2003/zenapax_PI.pdf

Thanks, Doug, for setting up this group.

Greg