Medical Forum / Diseases and Disorders / Breast Cancer / February 2006
Need to find a solicitor in SW UK, Re:Herceptin
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Bizkaz - 08 Feb 2006 22:32 GMT Hi, Having been refused funding by the local PCT/SHA, my Mum is appealing the decision. In the hearing a person may speak on her behalf for ten minutes, and we feel that whilst family members are willing, perhaps a professional would be more appropriate (and maybe make clear the lengths to which she will go if necessary). Does anybody out there know of a solicitor in the South West, who has experience in this area? Thanks, Mark.
J - 09 Feb 2006 00:00 GMT > Hi, > Having been refused funding by the local PCT/SHA, my Mum is appealing [quoted text clipped - 6 lines] > Thanks, > Mark. So your mother's tumour(s) overexpress HER2 (Grade 2 or 3) or if grade 2, a FISH has been done and she's FISH positive or has 3+ intensity staining on immunohistochemistry ? and has metastatic (spread) breast cancer ? and has received at least two courses of a taxane or anthracycline containing chemotherapy regimens previously (ie proven she cannot tolerate these drugs).? and has had an echocardiogram and/or MUGA scan ? and she has no underlying heart or lung problem.?
Perhaps I can find another newsgroup where to ask, if she meets the criteria. J
Tim Jackson - 09 Feb 2006 08:31 GMT >>Hi, >> Having been refused funding by the local PCT/SHA, my Mum is appealing [quoted text clipped - 18 lines] > Perhaps I can find another newsgroup where to ask, if she meets the criteria. > J Bizkaz - You are probably more likely to find lawyers on a uk legal newsgroup - mainly read by lawyers and people who have an interest in the law, some of whom may have a passing interest in cancer, rather than looking on an international cancer newsgroup in the hope that someone with an interest in cancer might also happen to be or know a practising lawyer in your country and area.
J - I would think this is a stage III cancer. There is an issue going on which recently came to court and was in the news. NICE, the UK's drug approval body has not yet approved Herceptin for early-stage cancers, and some women who, or who's oncologists, feel they would benefit from it are taking issue as to whether the NHS should pay for it.
NICE have yet to decide whether the risks involved in prescribing Herceptin to eligible early-stage breast cancer patients are sufficiently outweighed by the benefits to justify the not inconsiderable cost.
In view of this situation there is probably a significant number of women (presumably including the OP) who have been diagnosed Stage III, HER+ (and probably ER-) who would like to seek a treatment which is perceived to be more effective, albeit with increased risks attached.
Legally the NHS trusts are pretty much compelled to provide NICE-approved treatments if clinically appropriate, the lack of approval does not bar them, but leaves the choice up to the individual authority.
Tim Jackson
J - 09 Feb 2006 11:29 GMT > > Does anybody out there know of a solicitor in the South West, who has > >>experience in this area? [quoted text clipped - 10 lines] > > J - I would think this is a stage III cancer. Tim, with respect, you don't know that anymore than I. Surely Mark can speak up himself re; his mother's situation? People have to be careful what they ask for. None of the UK news stories (that I've seen and there are many) specify the woman's cancer situation.
Lawyers are all too ready to speak out without knowing the issues. Or gaining clients without considering or warning about the issues. Then if heart-related matters occur, they can say "the trials results were early". Or they help the patient sue (again). It's a win-win for lawyers.
I'm wary of medicines that have been approved (in the US) for long term use. Also remember that people in clincial trials do better than (sometimes even people on placebo) because they're followed more closely. If there's troubles on medicines, they pull them out. See next post - 1 in 5 (in one trial) - that's 20% ! J
Tim Jackson - 09 Feb 2006 14:13 GMT >>J - I would think this is a stage III cancer. > > Tim, with respect, you don't know that anymore than I. True, but I would be surprised if a PCT would refuse to fund Herceptin against clinical recommendations in an approved scenario. That is a pretty straightforward matter legally and shouldn't take much arguing.
> Surely Mark can speak up himself re; his mother's situation? No doubt, but you appeared to be making the unwarranted assumption this was a stage IV case.
> None of the UK news stories (that I've seen and there are many) specify the woman's > cancer situation. Here is an article on the recent news story I was referring to http://news.bbc.co.uk/1/hi/programmes/breakfast/4684502.stm
> I'm wary of medicines that have been approved (in the US) for long term use.... I was carefully avoiding taking sides on the actual issue. The real issue before NICE I think is to determine whether it is possible to identify the patients most likely to benefit well enough to tip the risk-benefit-cost balance. The HER2 test is only the start, Herceptin is still only effective in a fraction of HER2+ patients, although in some cases it is very effective indeed.
Tim
J - 10 Feb 2006 10:52 GMT > >>J - I would think this is a stage III cancer. > > [quoted text clipped - 3 lines] > against clinical recommendations in an approved scenario. That is a > pretty straightforward matter legally and shouldn't take much arguing. And if it was Stage II ?
> > Surely Mark can speak up himself re; his mother's situation? > > > No doubt, but you appeared to be making the unwarranted assumption this > was a stage IV case. No assumption. I framed it as a question.
> > None of the UK news stories (that I've seen and there are many) specify the woman's > > cancer situation. > > Here is an article on the recent news story I was referring to > http://news.bbc.co.uk/1/hi/programmes/breakfast/4684502.stm Thanks Tim, I've read so many, over the past 24 hours, my head is spinning. I did want to make 2 points. Roche has not requested licensing for UK for early stage cancers.
http://news.bbc.co.uk/1/hi/health/4684852.stm Monday, 6 February 2006, 10:24 GMT "When will it be licensed for use in early stage breast cancer? NICE has said that it will fast-track the review of the drug, but manufacturers Roche still have to submit an application to European licensing authorities before NICE can consider it. "
and the other point, I cannot say, because I lost my source So unless I find it again, I'm leaving this issue. Thanks for exchanges J
> > I'm wary of medicines that have been approved (in the US) for long term use.... > > [quoted text clipped - 6 lines] > > Tim J - 09 Feb 2006 11:29 GMT > NICE have yet to decide whether the risks involved in prescribing > Herceptin to eligible early-stage breast cancer patients are > sufficiently outweighed by the benefits to justify the not > inconsiderable cost. I'm okay with it, if they only want it for 9 weeks. See here: http://www.breastcancercare.org/index.php?module=announce&ANN_user_op=view&ANN_id=168
Longer.... All the trials were for women who had breast cancer that tested positive for HER2. And most of them had cancer spread to their lymph nodes. This meant that these women had a high risk of their breast cancer coming back. Their doctors recommended that they have chemotherapy to lower the risk of the cancer coming back. In these trials the women either had Herceptin after their chemotherapy or at the same time.
The trial results The results of these trials seem to be quite startling. They all showed that the cancer came back in about half as many women when compared to chemotherapy given without Herceptin. This roughly means that with adjuvant chemotherapy the cancer came back in about 1 in 3 women within 4 years. With Herceptin and chemotherapy, the cancer came back in about 1 in 6 women within 4 years.
But do remember these are very early results. Some of the women who took part in these trials only finished their treatment a year ago or even less. So well have to wait a few more years yet to get the longer term results for all the women who took part.
Important things to know about these trial results There are some important points to remember
* These are very early trial results * About 1 woman in 5 with breast cancer will respond to Herceptin there is a test that can be done on your breast cancer cells to show whether you are one of the women likely to respond * Herceptin can cause heart problems for some women * It is possible that the treatment is delaying the breast cancer coming back, but may not be preventing it altogether we just dont know yet
The follow up period is only a year for one of the trials and 4 years or less for the other two. It is generally much longer before researchers release trial results. They have published early results in these trials because the effect of Herceptin seems to be so impressive. They will continue to follow the progress of all the women who took part in all 3 trials and see how they do.
Without following these women for a longer time, we dont really know whether their cancer will come back at some point or not.
Herceptin is known to cause heart problems in some women. This is more likely if you have had chemotherapy with a drug that also causes heart problems. Doxorubicin (Adriamycin) is one such drug and it was used with Herceptin in these trials because it is particularly good at preventing breast cancer recurrence. In one of the trials, almost 1 in 5 women who started Herceptin had to stop before the end of the treatment because they had signs of heart trouble. Its too early to know what the long term effects of this will be.
What we dont know yet These are such early trial results that there is a lot still to be settled. We dont know
* When to prescribe Herceptin * How long to prescribe Herceptin * Whether any long term risks of this treatment could outweigh the benefits for some women
The HERA trial is comparing treatment for a year with treatment for two years and the trial hasnt been running long enough to have any of these results yet. When the trial results were published, doctors were discussing whether shorter treatment may be as good, but there is no evidence for that one way or the other yet.
One of the American trials is also comparing Herceptin given after chemotherapy has finished with treatment with Herceptin and chemotherapy at the same time. Even early results of this part of the trial are not yet available. http://www.cancerhelp.org.uk/help/default_printer_friend.asp?page=12797
Bizkaz - 09 Feb 2006 23:27 GMT > Longer.... > All the trials were for women who had breast cancer that tested positive for HER2. [quoted text clipped - 3 lines] > back. In these trials the women either had Herceptin after their chemotherapy or at > the same time. Thanks for both your replies - I appreciate your points, but are actually irrelevant to my mum, who has been recieving herceptin for the last 12 weeks. The information you have supplied is of course great, but we have already covered this with oncologists etc in the difficult period of decision making leading up to her present position. I take the point, that uk.legal (or similar) may be more relevant, and will act on that - so thanks Tim, and repeating myself thanks J, as I am sure the info will be useful to others viewing....
Cheers, Mark
nora - 15 Feb 2006 11:43 GMT I just want to mention that there are a couple of articles about the struggle for herceptin in the bmj now. http://bmj.bmjjournals.com/cgi/content/full/332/7537/368 http://bmj.bmjjournals.com/cgi/content/full/332/7537/320-a
nora
Pam Cook - 09 Feb 2006 23:26 GMT > > Hi, > > Having been refused funding by the local PCT/SHA, my Mum is appealing [quoted text clipped - 18 lines] > Perhaps I can find another newsgroup where to ask, if she meets the criteria. > J Hi.... the criteria must be different in different parts of the uk...my friend was dx'ed 6 months ago, had mastectomy followed by a course of chemo (not sure which. but can find out) starts radiation on 27th feb, and she told me last week that she's been prescribed herceptin... She also has heart problems ..they tried to regulate her heart 5 times and gave up.....Ithink she said congestive heart desease??? at some point i think she had too much chemo..and she thinks this contributed to the heart problems..... I'm in the east of the country (England)
Just shows how things vary from trust to trust..... Pam
J - 09 Feb 2006 23:43 GMT > Hi.... the criteria must be different in different parts of the uk...my > friend was dx'ed 6 months ago, had mastectomy followed by a course of chemo [quoted text clipped - 7 lines] > Just shows how things vary from trust to trust..... > Pam Hi Pam, They're giving her Herceptin even though she's in congestive heart failure? J
J - 10 Feb 2006 00:24 GMT http://www.abreastinthewest.ca/medical2.cfm?Num=71 Winter 2006 Vol. 7 No.1 The Latest Advances in Adjuvant Therapy Dr. Susan Ellard Chair, Breast Systemic, BC Cancer Agency (British Columbia, Canada)
The Buzz about Herceptin The treatment policy using Herceptin is directed at the 15% of women whose breast cancers are her2/neu positive. Women who are her2/neu positive would ordinarily face a higher risk for breast cancer relapse after chemotherapy and other treatments. Three large, international trials have shown that the addition of Herceptin to chemotherapy can reduce the risk of breast cancer relapse in the affected group by about 50%. In one trial, with the longest follow-up, there was a finding of improved survival with Herceptin. Since these findings, the Breast Tumour Group has obtained additional funding to offer this therapy to patients who are her2/neu positive and receiving chemotherapy, or to patients who have completed chemotherapy since July, 2004.
For patients newly diagnosed with her2/neu positive breast cancer, it's recommended that Herceptin be added to chemotherapy treatments, usually in the second 3 months in combination with paclitaxel or docetaxel, and then continued after chemotherapy for one-year. With Herceptin there have been some allergic reactions, but these seem to diminish after the first treatment. There's also a remote possibility of heart failure, so heart function should be tested before and during treatment. For patients who finished their chemotherapy since July of 2004, Herceptin is being recommended for 1 year. Unfortunately, at this time there are no trials using Herceptin for less than 1 year and results are awaited on a trial using Herceptin for 1 versus 2 years. There's also no evidence that Herceptin can be substituted for chemotherapy, so it is being recommended only to patients who will also receive chemotherapy.
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