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Re: Cancer incidence of Xolair

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> 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

You are welcome :)

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I think, and so do my doctors, that the only concern here is the

mention of the parotid gland tumors, that is n unusual cancer...but

more " something to watch out for "

There is probably no one on this forum who hasn't had to do the risk

versus benefit calculation. Some of the drugs we take to try to

control our asthma are much more dangerous (methotrexate for example)

or can have very unpleasant side effects (oral steroids). I personally

LIKE breathing <vbg>!!

It is so wonderful to hear that many of you are starting to respond

positively to the drug! I had one of the miracle responses very much

like the person in the ealry study, but even then I have continued to

improve. Hopefully we all will!

I had the rare and wonderful privilege of calling my pulmo on his

beeper to tell him my peak flow was 200; DOWN to 200, that is and we

both laughed when he asked why the heck I was whining about

that...used to be that getting that big a number was cause for a

party. Anyway, I have a chest cold, my peak flow is down but not out,

and with Xolair onboard it is a very ordinary exacerbation, not a ten

day hospital stay.

I'd take the risk of cancer with much worse numbers than that!

Easy breathing to all and thaks for the forum!

P

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