Hello,
It's nice to have found this board. My mother was recently diagnosed with SCC which unfortunately progressed rather quickly from "superficial" (as one doctor referred to it) to stage 4. I'm angry because her dentist and her general practitioner brushed off a persistent sore (that got larger over a period of two months) as nothing more than a cold sore. Finally another dentist suggested that she visit an oral surgeon. A biopsy proved conclusive that SCC was present. I took her to an oncologist who turned her over to an ENT and a radiation oncologist because re-excision or radiation therapy were considered the route to take since there didn't appear to be any node involvement. However, between the time that it took for the tumor board to meet and make recommendations and the date of surgery, two nodes became involved. So much for surgery. She is now in the midst of induction chemo that will be followed by chemo-radiotherapy. In addition, the doctors want her to participate in a study that includes a recently FDA approved drug named Iressa. Iressa, I believe, is a drug that is given to lung cancer patients who have not responded to other therapies. I have several concerns about this drug. It doesn't have a track record. It may have been responsible for the deaths of approximately 180 patients out of a study that included about 20,000 participants, and The Lancet wrote a somewhat unsupportive story about it in its June oncology issue. I'm not sure what to do. I'm talking with her doctors about it and attempting to contact doctors at other hospitals to get their feedback. Has anyone within this group had any experience with Iressa? Thanks.

Didier, first I wish your mother well. I, too, had an uninformed dentist and a time span that allowed two lymph nodes to become involved, so I had the surgery, the rad and the chemo, and today am doing more than fine. Keep that in mind.

Now, about the Iressa, I would not take it on a bet! A dear friend, being treated for lung cancer, and I found out about this some months ago. She brought it to the attention of her doc, who got her into a trial. It did seem to help her, but he pulled her out of the trial because of new information that he felt made it too great a risk. There is some disagreement about whether chemo is effective at all for oral cancer, but if your mother chooses to have it, as I did, there are a number of drugs that have been used for some time that while uncomfortable, do not carry a death risk. I think your concern is warranted and I applaud you for it. Whatever mode of treatment your mother will have is covered somewhere on this site and/or in this forum, so look on us as a resource for you during this difficult time. We are here to help.
Joanna

Hello and welcome,

Sorry to hear about your Mother and I applaud you for doing the research you are now. Whatever treatment is decided upon there are people here to answer questions and hopefully ligthen some burdens and concerns as she goes throught treatment. Right now unfortunately I am not going to help much because I'm going to tell you the other side of the Iressa story.

Sorry to my good friend Joanna - who is one of the most knowledgeable and helpful people I know. This is the first time we disagree. (isn't that what these boards are for) We can all only express our opinions - we aren't doctors. The following is only my story and opinion since you asked if anyone had experience with Iressa.

Yes, the Iressa trials are over and it was approved by the FDA last month or so. I am in a trial for a new drug called Tarceva - it is a sister drug to Iressa. The trial is for SCC cancers (due to the throw off of tumors - not very technical - I never am) It is used with a combination of Carbo/Taxol chemo. I will be very blunt if they discontinue this trial and drug today I will switch to Iressa in a heartbeat.
I was stage four metatastic liver disease (spread from my Scc (4)Tonsil cancer with neck mets. I had Radiation and Surgery and was sent home cured(?)) This round (1 year later)there was no hope given to really help, except this trial. My liver tumors started at 95.6 sq cm (just the ones they measured) they are now 7.2 sq cm and I'm hoping they will do surgery and then the Tarceva will arrest the growth of new tumors. When I started this trial a friend checked with a Fellow in cancer research at a renown Head & Neck Cancer institute and below is the answer we received:

"OSI-774 (Tarceva)is a good drug - there are a couple others very similar to it (C225, PKI-166, Iressa) and you can find general information about all of these drugs on the internet, if you are interested. C225 is the drug that caused the Imclone/Martha Stewert scandal and Iressa is already FDA approved in Japan and is likely to get approved here as well. The general concensus is that eventually all of these drugs will get FDA approved - so that's good information - but none are a "magic bullet". I don't know if she has already been exposed to carbo or taxol yet - but it is always good to combine these new drugs with chemo - it can really improve their efficacy."

My understanding is that although chemo may not be as effective as one would wish against head and neck cancer these new drugs are not only to aid in shrinking tumors but to inhibit the growth of new ones in people with SCC. When I was given no hope and if it would have been Iressa at a lees than 1% death rate that was quoted...I still would do it, just as I did the trial.

As you can tell I am the poster child for these new drugs and their effectiveness...so I am very prejudice...and all of this is just my story and my opinion, and I do think it's great you are doing the research and being an advocate for your Mom. I might not be where today I am if I would have done the same for myself at the beginning.

Good luck to you and your Mom,
Dinah (that is the longest response I believe I've ever given)

My profession for over 20 years has been a regulatory affairs consultant and I can assure you that the US FDA DOES NOT approve of any pharmacueticals for use in foreign countries. To state the obvious - they have no jurisdiction there. Some aspects of clinical trials may be performed in foreign countries but that countries regulatory agency would have to approve of the study. Drugs are only cleared for use in the US when the safety and efficacy scientific studies have been completed (speculation aside).

If a pharmacutical is FDA approved in this country, most foreign countries will accept it. The FDA is the gold standard.

Dinah, my dear, you may disagree with me at any time about anything and I will still think you are the bravest person I know, along with other complimentary adjectives I will not list here. If I were in your position, my attitude about Iressa and related drugs would undoubtedly be different. As with everything, it is the risk/benefit ratio that must be considered. You make a very compelling case for its use. And between the two of us, we must have thoroughly confused Didier.
Joanna, still dancin' up a storm!

Gary,

Thanks for the re-phrasing - I'm sure she miss spoke about the Japan thing...your explanation is appreciated.

Dinah

Joanna hit it on the money! It's all about risk/benefit. That is a very personal decision that each of us have to make regarding our treatment. I studied all the possiblities endlessly in the beginning to insure the lowest risk, highest benefit. I am grateful that my cancer was treated in conventional ways (chemo & radiation). Had I had panceatic cancer, I probably would have sought out a clinical trial -someplace.

Thanks for your responses. I am happy to report that it appears her induction of Carboplatin and Taxol appear to have shrunk the two tumors from about 1.5 cm each to about 1 cm each. Obviously I would like to see them disappear, but I am grateful for any reduction. I'll have a better idea of the actual reduction after the docs review the CT scan with us this week. I'm told the chemo-radiotherapy portion, which starts in a week -- on a daily basis (a week of hospitalized therapy with a week off until sometime in September) should potentially help further reduce them. I am meeting with the doctors this Tuesday to pick their brains further about Iressa as they plan to begin using it next Sunday or Monday. In the meantime, I am continuing to contact some doctors at Sloan Kettering and Anderson for their input, and to see if there is something with a track record that can be used instead of Iressa. Incidentally, I believe Anderson started using Iressa too. I hope they are willing to share some information about the results they have seen. Thanks again. I wish you all the best and look forward to adding whatever I can to this forum in an effort to help and support everyone in any way that I can. Sorry if I've repeated myself. This whole experience has freaked me out a bit and I'm just getting over feeling overwhelmed. I'm trying my best to approach it logically, without allowing my emotions to enter the picture. Sometimes that's easier said than done though. The good news, thus far, is that my mother is dealing with this very well, so that's great because I want her to remain strong emotionally and physically during her treatment.
Thanks again. I'm going to stop rambling now.

Didier, what you are feeling is absolutely normal. That doesn't help, but please know you are not out of bounds in any way. The degree to which you are involved is absolutely fantastic! She is very fortunate to have you out there gathering information and acting as her advocate. It is wonderful news about the shrinking tumors. Please keep us informed of your mother's progress, as well as what information you find. And be assured that as other questions arise, there will always be someone here with some relevant experience. Hang in there!
Joanna