Herceptin Heart Risk Stays The Same In The Long Term
Featured ArticleMain Category: Breast Cancer
Also Included In: Clinical Trials / Drug Trials; Conferences
Article Date: 04 Jun 2007 - 0:00 PDT
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A five year follow up US trial on women receiving trastuzumab (Herceptin) in combination chemotherapy for early-stage breast cancer showed that the risk of congestive heart failure did not increase with time.
The findings of the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-3 trial, which was funded by the National Cancer Institute, were presented by researchers from Pittsburgh University to the 43rd annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago this week.
Herceptin is one of a new class of cancer fighting drugs called monoclonal antibodies and is made by drug company Genentech. It is used to treat patients with HER-2 positive breast cancer, characterized by abnormally high levels of the HER2/neu protein.
Heart damage is the most significant side effect of Herceptin, occurring in around 5 per cent of patients, and women with existing heart conditions cannot take it.
Some women stopped taking Herceptin,fearing that the risk increased in the long term. However, this study shows that not to be the case. The risk in the long term is the same as the risk that is there from the beginning, suggesting that a patient taking the drug is either susceptible to heart problems or they are not.
Using the findings of the trial, the research team have developed a prediction model that will help oncologists assess the risk of heart failure in individual patients before treating them with Herceptin and chemotherapy.
Dr Priya Rastogi, who is assistant professor at the University of Pittsburgh School of Medicine and assistant director of medical affairs, NSABP, and presented the study, said that:
"The information we obtained from this study is essential to understanding women's risks for congestive heart failure associated with adding Herceptin to combination chemotherapy for breast cancer treatment."
"We're encouraged that we found no increase in heart failure risks long-term and now are able to use this knowledge to individualize women's treatment based on their specific cardiac risk factors," she added.
Rastogi and colleagues assessed the cardiac side effects in 1,850 women with HER-2 positive breast cancer over a five year period. The women were randomly assigned to a Herceptin group or a control group.
The control group underwent four cycles of a standard combination chemotherapy regimen, doxorubicin and cyclophosphamide followed by paclitaxel. The Herceptin group was treated with four cycles of doxorubicin and cyclophosphamide followed by paclitaxel and Herceptin.
They compared the incidence of congestive heart failure between the two groups at 3 and 5 years of follow up using a Multiple Gated Acquisition scan (MUGA scan) which shows a moving image of the beating heart. This helped the researchers assess the health of cardiac ventricles non-invasively.
The results showed that:
- Herceptin provides a clear benefit for women with HER-2 positive breast cancer.
- However, at the 3-year follow up, the incidence of congestive heart failure was greater in the Herceptin group than the control group (4.1 per cent versus 0.8 per cent).
- But, at the 5-year follow up, the incidence of congestive heart failure was unchanged (3.8 per cent in the Herceptin group, 0.9 per cent in the control).
Rastogi said they hope the model "will help to individualize care for women in terms of choice of Herceptin-containing treatment regimens based on their personal risk and benefits".
The US Food and Drug Administration approved Herceptin for the treatment of advanced breast cancer in 1998.
The National Cancer Institute estimates that this year in the US, 178,000 women and 2,000 men will be diagnosed with breast cancer and over 40,000 women and 450 men will die of the disease. It is the most commonly diagnosed cancer in women and the second leading cause of cancer-related death in women in the US.
Lymph-node positive breast cancer accounts for about 30 per cent of cases, and between 20 and 30 per cent of these tumours overexpress the HER-2 protein, which Herceptin targets.
Click here for more information about breast cancer (US National Cancer Institute).
Written by: Catharine Paddock
Writer: Medical News Today
Copyright: Medical News Today
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Visitor Opinions In Chronological Order (2)
A Number Of Issues On The Subject Of Herceptin
posted by Gregory D. Pawelski on 4 Jun 2007 at 8:06 amThere are a number of issues on the subject of Herceptin. In addition to taking this drug for a long time, these kind of individual, targeted oral drugs would be taken in addition to an existing repertoire of chemotherapy mixtures a cancer patient is already taking, instead of taking them alone. Adding even more potential toxicities and thousands of dollars to treatment.
Overt congestive heart failure is a very late and serious manifestation of heart muscle damage. For every patient with frank congestive heart failure, there is probably another two, three, four or five patients with heart muscle damage short of congestive heart failure. The sort of heart muscle damage which can cause fatigue and/or shortness of breath with moderate or mild exertion, which otherwise wouldn't occur.
We don't know what will happen 10 or 20 years from now in women who didn't need any adjuvant therapy at all, who would have been cured by surgery alone. Only a minority of patients who receive adjuvant therapy benefit from it. Adjuvant therapy is worth it if the women have to suffer only short term, temporary toxicity, and if it even slightly reduces the probability that their cancers will come back. But if it produces permanent toxicity, whether "chemo brain" or "heart muscle damage," that is a whole different order of magnitude in terms of risk.
Aside from the issue of congestive heart failure, past studies have suggested a potentially very serious weakness in the drug, the problem with central nervous system (CNS) metastasis. A study from the Dana Farber Cancer Institute identified central nervous system (CNS) metastases in women who receive trastuzumab-based (Herceptin) therapy for metastatic breast carcinoma. Central nervous system disease is defined as one or more brain metastases or leptomeningeal carcinomatosis (carcinomatous meningitis).
Central nervous system metastases was identified in 34% of patients at a median of 16 months after diagnosis of metastatic breast cancer and 6 months from the beginning of Herceptin treatment. Patients receiving Herceptin as first-line therapy for metastatic disease frequently developd brain metastases while responding to or stable on Herceptin. The authors of the study say that efforts to characterize other risk factors for development of CNS disease, optimal screening algorithms, and new treatment strategies may be warranted.
The potential benefits and risks of Herceptin have renewed concerns about the reliability of HER2 testing. Some studies have shown that the test produces false positives as often as 26% of the time, and may also carry some risk of false negatives. Herceptin also doesn't offer any benefit to women with HER2-negative cancer.
Lastly, monoclonal antibodies like Herceptin (and Erbitux) are "large" molecules. These very large molecules don't have a convenient way of getting access to the large majority of cells. Plus, there is multicellular resistance, the drugs affecting only the cells on the outside may not kill these cells if they are in contact with cells on the inside, which are protected from the drug. The cells may pass small molecules back and forth.
Exciting results have come from studies of multitargeted tyrosine kinase inhibitors,"small" molecules that act on multiple receptors in the cancerous cells, like Tyberb and Sutent. Targeted "small-molecule" therapies ruled at last years annual ASCO meeting of oncologists. The trend is away from the monoclonals to the small molecules, a trend in which a new predictive test may be able to hasten (The EGFRx Assay).
(Cancer 2003 Jun 15;97(12):2972-7)
Herceptin and Lung Toxicity
posted by Marcia Bloom on 9 Aug 2011 at 12:47 amHerceptin can definitely affect the lungs after a few years of completion of Herceptin therapy. I had a lung biopsy and it was deemed that I do have Pulmonary Fibrosis from the Herceptin. Lung Toxicity is a Black Box Warning on Herceptin. If you develop a bad cough get your lungs checked. There is no cure for Pulmonary Fibrosis.
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