New Herceptin results confirm impressive reduction in risk

leo · Owner Joined: 23 Sep 2004 Posts: 1574

Roche announced today that a fourth large phase III trial in early-stage HER2-positive breast cancer has shown that adding Herceptin to chemotherapy significantly reduces the risk of cancer coming back compared to chemotherapy alone. This study follows three earlier phase III studies which also confirmed Herceptin's superiority to chemotherapy alone in early-stage breast cancer. HER2-positive breast cancer is a particularly aggressive form of the disease which affects approximately 20 - 30% of women with breast cancer.

[url=http://www.eurekalert.org/pub_releases/2005-09/k-nhr091405.php]Read more...[/url]
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Disclaimer: this information is for informational purposes only. It is not medical advice.

gdpawel · Posted: Wed Nov 02, 2005 10:01 am Post subject: Herceptin

There are a number of other issues on the subject of Herceptin. Take notice that these kind of individual, targeted oral drugs are "added" to the repertoire of chemotherapy mixtures a cancer patient is already taking, "instead of" taking them alone?

The Katharina Pachmann, et al study in the May 2005 issue of Oncology News International reports about neoadjuvant Taxol chemotherapy causing the release of cancer cells into the blood, I'm not so sure that Herceptin is taking care of what Taxol never accomplished in the first place. It has been shown that Herceptin treatment was to reduce circulating tumor cells in patients. However, does it?

A study from Dana Farber Cancer Institute identified as many as 34% central nervous system metastases in women who receive Herceptin therapy for metastatic breast carcinoma. Patients receiving Herceptin as first-line therapy frequently develop brain metastases while responding to or stable on Herceptin.

Herceptin though, is only for the estimated 20% of breast cancer women at risk for recurrence. However, gene expression assays are panels of markers that can predict the likelihood of cancer recurrence in various populations. By testing the gene expression markers of a patient, oncologists can identify those patients unlikely to benefit from chemotherapy from those that would, saving the other 80% of cancer patients the added expense, suffering and even death from having to take chemotherapy.

Whether a patient would benefit from adjuvant therapy depends on two things: (1) whether the tumor is "destined" to come back in the first place and (2) whether the tumor is sensitive to drugs which might be used to keep it from coming back.

What a cancer patient would like ideally, is to know whether they would benefit from chemotherapy (gene expression assays). If so, which active drugs have the highest probability of working (cell culture assays), and are relatively non-toxic in a given patient (pharmacogenomic testing).

Sources:
Human Genome Project Information
Human Tumor Assay Journal
ACGT, Inc.

gdpawel

Central nervous system metastases in women who receive trastuzumab-based therapy for metastatic breast carcinoma.

Bendell JC, Domchek SM, Burstein HJ, Harris L, Younger J, Kuter I, Bunnell C, Rue M, Gelman R, Winer E Department of Adult Oncology, Dana Farber Cancer Institute, Boston, Massachusetts 02115, USA.

BACKGROUND: Women with HER-2 overexpressing metastatic breast carcinoma benefit from trastuzumab-based therapy, but trastuzumab does not cross the blood-brain barrier. The authors characterized central nervous system (CNS) disease in these women.

METHODS: Using pharmacy records, the authors retrospectively identified 153 women treated with trastuzumab alone or with chemotherapy for HER-2-positive metastatic breast carcinoma at Dana-Farber Partners Cancer Care from June 1998 to December 2000.

A study cohort of 122 patients was identified after excluding patients without adequate clinical follow-up or who had CNS disease before trastuzumab treatment. Central nervous system disease was defined as one or more brain metastases or as leptomeningeal carcinomatosis.

The median follow-up of this cohort was 23 months.

RESULTS: Central nervous system metastases were identified in 34% of patients (95% confidence interval, 26-44%) at a median of 16 months after diagnosis of metastatic breast carcinoma and 6 months from the beginning of trastuzumab therapy.

Ninety-three percent of patients with CNS disease presented with clinical symptoms. Five percent of patients with CNS disease had leptomeningeal involvement alone, although 14% had leptomeningeal involvement and parenchymal brain metastases.

Fifty percent of patients were responding or had stable disease while receiving trastuzumab at other disease sites at the time of diagnosis of CNS metastasis. The median survival period after CNS metastases was 13 months. Fifty percent of patients died of progressive CNS disease.

Patients receiving trastuzumab as first-line therapy for metastatic disease frequently developed brain metastases while responding to or stable on trastuzumab at other disease sites.

CONCLUSIONS: Metastatic breast carcinoma to the CNS is common among patients receiving trastuzumab-based therapy, including patients responding to therapy outside the CNS.

This may be due either to predilection for the CNS by HER-2-positive tumor cells and/or poor penetration of the CNS by trastuzumab or to improved visceral disease control leading to a longer life and onset of late tumor spread to the CNS.

Efforts to characterize other risk factors for development of CNS disease, optimal screening algorithms, and new treatment strategies may be warranted.

Cancer 2003 Jun 15;97(12):2972-7

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