Provacative message on cure of her2 after 5 year DFS....

RobinP · 06-01-2006, 07:09 AM

I thought this article below was very presumptious claiming a cure for her2 bc after 5 years survival. Still, I wonder if it is true that the chance for her2 relapse is really only 25% after 5 years. It probably goes along with some other data that I have read for her2+ hormonal negative; although, I don't know the relapse rate after five years for hormonal positives that are her2+.

News this month
Using Herceptin in some breast cancer patients cuts recurrence

Results of a study published in the October 20, 2005, New England Journal of Medicine have concluded that one year of treatment with trastuzumab (Herceptin), starting concurrently with or after adjuvant chemotherapy, significantly improves disease-free survival among women with HER2-positive breast cancer.

An antibody against HER2
Some women's breast cancer overproduces a receptor protein called HER2. When this happens, it signals cells to grow, including cancer cells.

Herceptin is an antibody against HER2. Previous studies showed it to have an effect in advanced breast cancer that overexpresses -- or overproduces -- HER2. It was investigated by the North Central Cancer Treatment Group and the National Surgical Adjuvant Breast and Bowel Project for its efficacy and safety after the early-stage breast cancer was removed and chemotherapy completed.

The study, which opened in 2000, was conducted at multiple centers around the world, and was a randomized trial that compared one year of Herceptin added to standard adjuvant therapy versus the same standard therapy alone in patients with HER2-positive breast cancer.

Almost 4,000 women studied
Almost 4,000 women were studied in two groups. Group one consisted of 1,694 women who were treated for one year with Herceptin and a second group of 1,693 women who were not. At the first median follow-up of one year, 127 recurrences of breast cancer or death were observed in the Herceptin group vs. 220 recurrences in the control group. This represents an absolute benefit in terms of disease-free survival for women treated with Herceptin.

There is a concern about developing heart problems among women who received Herceptin. The study reports that 4 percent of the women who were treated with Herceptin developed heart problems compared to about 1 percent in the control group. However, the statistical risks were not high enough to offset the benefits of the treatment.

Herceptin cuts recurrence by approximately 50 percent
This study concludes that Herceptin can decrease the rate of recurrence of HER2 breast cancer in women by approximately 50 percent. As noted in the study, this degree of benefit in early breast cancer is the largest to be reported since the introduction of tamoxifen in hormone-receptor–positive disease.

Most exciting study ever for oncologists

After being involved with this study at Yale New Haven Hospital, I can say with confidence that this trial gives oncologists a lot to be happy about. It is as big a result as we've ever gotten in a breast cancer treatment study. It means that we can now improve the cure rate for some women with
early-stage breast cancer.

Herceptin can reduce the chance of relapse by 50 percent
This large study found that adding Herceptin to standard treatment for early-stage breast cancer, as an adjuvant therapy concurrently with or after chemotherapy, can reduce the chance of relapse by 50 percent.

...this trial gives oncologists a lot to be happy about. It is as big a result as we've ever gotten in a breast cancer treatment study.
While all breast tumors have HER2, only in some will it be overproduced. This growth factor receptor is normal in the development of many systems, but isn't a good thing in cases of cancer when we don't want cancer cells to grow.

Herceptin isn't new. Prior to this recent study, it was first tested and approved in 1998 as a treatment in metastatic breast cancer, where the cancer had spread beyond the breast. While it wasn't a cure, it helped women with HER2-positive metastatic disease live longer. Now, this new study shows how valuable Herceptin is as an adjuvant therapy given after surgery and chemotherapy.

Herceptin — another tool to use in women whose cancer is fueled by HER2
Many women may be familiar with the drug Tamoxifen, since it has been widely publicized. Given after chemotherapy, Tamoxifen helps prevent relapse in women whose breast cancer was estrogen-dependent. Herceptin is now another tool to use in women whose cancer is fueled by HER2.

Herceptin is given intravenously weekly or every three weeks for a year. While researchers aren't really certain how long it should be continued, a year has been shown to be of benefit in these first trials. Everyone with the HER2-positive type of breast cancer is a candidate, except perhaps for cases when the tumor is very tiny and there has been no spread to lymph nodes.

Side effects are also few. Women with pre-existing heart problems need to be watched, as it can exacerbate heart problems.

Herceptin can help improve cure rate
Having Herceptin in our arsenal of treatment tools means we can improve the cure rate. Chemotherapy after a tumor is removed can reduce recurrence by more than 30 percent. Giving an anti-estrogen treatment, such as Tamoxifen, further reduces it by 50 percent for tumors that are estrogen-dependent. Herceptin cuts recurrence by another 50 percent in HER2-positive tumors. Now, that's good news.

We know that 75 percent of recurrences happen in the first five years, so if a woman can go five years without a recurrence, we can say that she's probably "cured."
We know that 75 percent of recurrences happen in the first five years, so if a woman can go five years without a recurrence, we can say that she's probably "cured." We don't often use the word "cure" when it comes to cancer, as women always live with the fear that breast cancer could come back. But I believe that with new tools like Herceptin, and aromatase inhibitors, which help fight estrogen-dependent cancers, we can help cure the majority of people. There's always a chance of recurrence, but we're decreasing the odds more and more each day.

There's always a chance of recurrence, but we're decreasing the odds more and more each day.
Women who participate in trials and studies are the real heroes in this process. Supporting research is very important in advancing treatment and eventually finding a cure. I encourage all patients to consider being part of a trial. Not only does it help the greater good, you'll feel good about yourself and receive cutting-edge treatments.

For more information on this treatment, or to discuss this trial, call 203-785-6221.

Dr. DiGiovanna, MD, PhD, an oncologist at Yale-New Haven Hospital and the Yale Cancer Center, is an associate professor at the Yale University School of Medicine.

AlaskaAngel · 06-01-2006, 03:10 PM

I'd like to buy it, but I am skeptical. I'd love it if anyone would poke holes in my logic about this.

I can't tell from the phrasing of the commentary just when the speaker is referring to statistics about bc in general vs HER2 bc. I remember reading that over half of all recurrences happen after 10 years (which actually makes a lot of sense, considering that chemo primarily is used to delay recurrence and thus can push it farther out in time, and also because if one lives 12 more years or 20 more years without recurrence there are just more years beyond 10 years to count). We are learning that doxorubicin may work especially well for topo II/HER2's and that too could delay recurrence longer for HER2's.

Also, IF most HER2's do die off early, that in itself would only leave a smaller pool of HER2s to recur later.

Out of all those with bc, only 1/3 are HER2 positive (and is it true that some of those are HER2++ and not HER2+++?) Out of those who are genuinely HER2+++, is it true that only about 30% benefit from traztuzumab?

If Adjuvant! isn't ready to separate out HER2 as a factor we can enter into recurrence or mortality rates for treatment, then, how accurate would one researcher's prediction be? Especially considering that even Adjuvant! doesn't predict beyond 10 years....

AlaskaAngel

aquinis2000 · 06-01-2006, 05:13 PM

here is a different way to read the reporting percentiles. only this slant gives it too us in an honestly eye opening way/. what do you think about what it says?
i have to agree that the "cure " word should never be used., giving false hope to people already kicked in the teeth!

Herceptin will work wonders, not miracles

Gavyn Davies
Thursday June 1, 2006
The Guardian

The revolutionary drug Herceptin was this week licensed by the European Commission to fight early-stage breast cancer, and it now seems probable that it will shortly be cleared for clinical use in the UK. This will be a huge relief to many cancer sufferers, some of whom have conducted prolonged public campaigns to access the drug on the NHS (at an estimated cost of £20,000 per person per year, or £100m in total, or one-quarter of the total national bill for cancer drugs). One sufferer even won an Appeal Court ruling to establish her right to the drug. Herceptin has become the arch- example of the NHS postcode lottery, something we all hate.

Article continues

Studies in the US show that the use of Herceptin, along with conventional chemotherapy, reduces the mortality rate of users, three years after treatment, by 33%, and reduces the cancer recurrence rate by more than 50%. Put like that, it is scarcely a surprise that so many breast cancer patients are demanding access to the drug on an accelerated basis. In their shoes, I'm certain I would have done the same.

But before we get carried away with what has been called a "miracle drug", let us examine those statistics a little more carefully. About 40,000 people are newly diagnosed with breast cancer in the UK each year. Of these, around 10,000 have the type of tumours (known as HER2 positive) on which Herceptin works. So the drug is sadly irrelevant for 75% of breast cancer patients.

For the remainder, US studies suggest that the three-year, disease-free survival rate will be 75.4% for those on conventional treatment, and 87.1% for those on Herceptin. Subtracting these numbers from 100, we obtain the advertised 50% improvement in disease-free survival rates (from 24.6% to 12.9%). But another way of looking at it is that about 12 out of every 100 users of Herceptin, or about three out of every 100 breast cancer patients, will be helped by the drug to remain disease-free after three years. This sounds less dramatic, though of course it is still very worthwhile.

Moving to life expectancy, Herceptin improves the chances of survival after three years from 91.7% to 94.3%. So the reduction in the death rate is indeed one-third (from 8.3% to 5.7%). But in less dramatic language, Herceptin keeps about three people out of every 100 alive after three years for those who take the drug. This amounts to less than one extra person per 100 among all breast cancer patients.

I am emphatically not arguing that the drug is ineffective, or that it is too costly to prescribe in the NHS. But what I am arguing is that it has been too easy to conclude from sensational press stories on the drug that its benefits will be more widespread than they might actually be. This has greatly increased the political intensity of the issue, and the distress for those patients who have been unable to get hold of the drug. One very intelligent breast cancer sufferer, Lisa Jardine, appeared on Radio 4 on Sunday to argue that "for women like myself, the new drug seems to promise a smallish reduction of an already lowish chance" of the disease recurring. She is absolutely right.

RobinP · 06-02-2006, 08:17 AM

I know that Dr. DiGiovanna is a leading her2 researcher from a respected institution, Yale, so that is why I posted this controversial article of his. And I don't think he should have used the word cure either. Lets face it, even after five years, there's still relapse risk, albiet somewhat less than the first few years after diagnosis. I posted an article earlier this year, where Dr. Winer believes 1/3 of her2+ relapse the first few years.