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Iressa warnings


john

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Remember all the bad press against Iressa in Japan where it was linked to deaths? We don't seem to hear much about it, but anyone considering taking Iressa should at least know there are some risks

It does work for some people, but again everyone should know the pros and cons.

Warnings

1. Interstitial Lung Disease

Interstitial Lung Disease (ILD), which may be acute in onset, has been observed in patients receiving IRESSA, at an overall incidence of about 1%, and some cases have been fatal. Patients with concurrent Idiopathic Pulmonary Fibrosis/Interstitial Pneumonitis/pneumoconiosis/radiation Pneumonitis/drug-induced Pneumonitis have been observed to have an increased rate of mortality from this condition.

Based on 94,847 patients exposed, the world wide frequency of ILD, often severe (CTC grade 3 - 4), in patients treated with IRESSA is about 1% with Japanese patients showing the highest incidence of ILD (1.87%) when compared to patients outside Japan (0.35%). The incidence of ILD remains lower when compared to other forms of treatment (e.g. radiotherapy, chemotherapy). The overall frequency of ILD with fatal outcome is 0.68% for Japanese patients and 0.11% for non-Japanese patients.

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I looked all over for stuff on Transforming Growth Factor and really could not find much. It was pretty successful with glioma (brain cancer).

I have never heard of dosataxol & pt100 or Pitanex. I'll do a search

The only thing I found is that transforming Growth Factor may act like a tumor suppressor gene (I think).

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Pivanex is the name of the chemo, it can be found

at http://www.clinicaltrials.gov

Point Therapeutics makes PT-100 and Docetaxel (Taxotere) is the standard 2nd line chemo for nsclc

http://www.asco.org/ac/1,1003,_12-00248 ... 341,00.asp

If you see a drug with a number and initials, the first initials are usually the manufacturer. CG (Cell Genesys), etc.

Do a search for NSCLC and it shows 158 clinical trials

http://www.clinicaltrials.gov/ct/show/N ... 5?order=86

I guess you are trying to evaluate clinical trials?

http://www.titanpharm.com/press/pivanexpromise.html (this is a press release)

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You don't have to go to Japan to find someone in the 1% who had a bad allergic reaction to Iressa, culminating in bilateral pneumonia. Lucie went through this last August and we almost lost her. It is fine to say, well 99% did not have such reaction, but if you are in the 1%, that statistic is not comforting. I am not advocating that people should not try Iressa -- it has helped many people -- but just be aware that it can have a negative effect as well. Don

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John,

Thanks! I haven't found anything on these drugs either and want to look at options for treatment. It is interesting that "80% of the oncologists treating cancer would not do chemo themselves." Or would they, when faced with zero options, except death. It is even more frightening that the treatment may kill you quicker than the disease. I am in a qandry as to what to do, if anything at all. The most promising treatment GVAX, is so controlled that I do not know of anybody recieving it. Is there anyone out there on the board participating in the GVAX trial?

Cheryl

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Like Don said I am not saying don't use Iressa, just know there are bad effects. Since it seems to affect people with radiation pneumonitis, if I had radiation in the past 11 months or so, I dont know if I (PERSONALLY) would want to take Iressa (since many people develop pneumonitis up to 10-11 months after radiation)

I am not sure if Tarceva or Erbitux has the same problems (I have not heard of any)

Too bad the data doesnt say anything about Iressa and Radiation therapy.

It is unfortunate that it is hard to get some of the experimental drugs, but at the same time since they are experimental know one really knows how safe they are.

It basically just sucks - How are the alternative treatments going?

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It is pretty confusing about Iressa and ILD - Don't have an answer, but be aware.

Cases of interstitial lung disease (ILD) have been observed in patients receiving gefitinib. ILD is a complex disease, described by investigators using different terms. (The sponsor captured cases by a collection of 24 MedDRA [Medical Dictionary for Regulatory Affairs] terms.) The U.S. Food and Drug Administration (FDA) performed a detailed analysis of the sponsor’s drug safety database. This included 50,005 patients (including 18,960 from marketed use in Japan). Four hundred eight cases of ILD (324 from Japan and 84 from the U.S./rest of the world) were identified. The median time to onset of ILD was 24 days in the Japan group and 42 days in the U.S. group. Worldwide, the incidence of ILD associated with gefitinib treatment was about 1% (2% in the Japanese postmarketing experience and about 0.3% in approximately 23,000 patients treated with gefitinib in a U.S. expanded-access program). Approximately one-third of the cases were fatal. Patients often presented with the acute onset of dyspnea, with or without cough or low-grade fever. Symptoms often became severe within a short time and required hospitalization.

ILD occurred in patients who received prior radiation therapy (31% of reported cases), prior chemotherapy (57% of reported cases), and no previous therapy. Patients with concurrent idiopathic pulmonary fibrosis whose condition worsened while receiving gefitinib have been observed to have a greater rate of mortality.

In the randomized studies of gefitinib combined with chemotherapy, the ILD rate was about 1%, but the rate was similar in the gefitinib and control (chemotherapy plus placebo) arms.
In the event of pulmonary symptoms (dyspnea, cough, fever), gefitinib therapy should be interrupted, and a prompt investigation of these symptoms should occur. If interstitial lung disease is confirmed, gefitinib should be discontinued and the patient treated appropriately.

Asymptomatic increases in liver transaminases have been observed in gefitinib-treated patients; therefore, periodic liver function testing (transaminases, bilirubin, and alkaline phosphatase) should be considered. Discontinuation of gefitinib should be considered if changes are severe.

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I know I am probably out of bounds for even thinking this because I am no Dr., but I have been wondering if Iressa was the cause of some or most of BeckyG's problems. No way to tell, but it did cause me to think about it because I had read up on what had happened in Japan and Don had said that Lucy had some problems with it.

Just wondering aloud.

Elaine

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John,

I did my last treatment a couple of weeks ago. After talking to the researchers at Mary Crowley's Research Center at Baylor I decided to stop all immunotherapy because it could interfer with a trial should I chose to do one. I suppose the same concept applies if doing chemo and taking supplements, the supplements make the chemo not as effective. I was told that all of this garbage would come out of your body as you detoxed. I can certainly attest to this. I eat mostly whole, organic foods, lots of veggies, fish and poultry, complex carbs-grains. I still do have some sugar. My onc doesn't believe all the bad hype about it. I will have like a few oatmeal cookies, or sweet tea. I do pretty good, but have my weaknesses like every else. I have convinced myself that I like seaweed- :o NOT! I am still taking supplements and love to walk. I am really interested in therapies to boost the immune system's response to cancer, and hope I can find something that works or me! John thank you for your dedication to lung cancer and to the members of this board. We appreciate you, and your Mom would be so proud.

Cheryl

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Elaine,

I was thinking the same thing. Hopefully the doctors told her about the

pros and cons. It is a difficult choice, but all the pros and cons should be known AND weighed carefully.

I wonder how much data is still being collected for Iressa?

John

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It just seems like one doctor after another failed Becky G.. She had a bronchoscopy on thurs. or Fri., right before she got the collapsed lung and breathing problems. She needed a vent, why was she transfered to a regular room from the ER, and not into the ICU? What went wrong. Just like the mediastinoscopy when her chest was cracked open to stop the bleeding. Then she was overradiated so that surgery was completely out of the question. A case example of the cure being worse than the disease. Her disease had not metastisized. I do believe she had radiation damage, which cause some sort of breathing problems, just like Sam. Any thoughts on this?

Cheryl

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