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Old 04-04-2005, 08:49 PM   #1
*_Merridith_*
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American Pharmaceutical Partners Announces Initiation of a Clinical Study of Abraxane in the Most Widely Used Combination Chemotherapy Regimen of Paclitaxel and Herceptin in HER2-Positive Breast Cancer Patients
April 4, 2005: 7:14 a.m. EST


SCHAUMBURG, Ill. (PRNewswire) - SCHAUMBURG, Ill., April 4 /PRNewswire-FirstCall/ -- American Pharmaceutical Partners, Inc. today announced that American BioScience, Inc. has initiated enrollment in a Phase II study of ABRAXANE™ administered weekly in combination with Herceptin in first-line treatment of metastatic breast cancer. The study will be conducted by International Oncology Network (ION), the nation's premier, and largest, network of community-based oncologists and will include 20 ION sites.

The open-label, non-randomized study will include 70 patients with locally advanced or metastatic breast cancer and will be led by principal investigator Barry C. Mirtsching, M.D., Director of the Center for Oncology Research & Treatment, Medical City Dallas Hospital, Dallas, TX. All patients will receive ABRAXANE at a dose of 125mg/m2 by a 30-minute IV infusion once a week for weeks 1-3 in each 4-week cycle of treatment; the HER2-positive patients will, in addition, receive Herceptin®, which is regularly used in the treatment of these patients. The primary study endpoint is response rate (RR) and the secondary study endpoints are time to tumor progression (TTP), overall survival (OS) and toxicities. Approximately 30% of all metastatic breast cancer patients are HER2-positive.

Dr. Mirtsching said, "We look forward to studying ABRAXANE in previously untreated metastatic breast cancer patients, using a weekly dosing regimen, and combining it with Herceptin in HER2-positive patients."

Jeffrey Scott, M.D., president and national medical director of ION, said, "ABRAXANE has demonstrated superiority over Taxol® in terms of response rate, time to tumor progression and survival. The combination of ABRAXANE with Herceptin in the absence of steroid premedication is an important addition to the armamentarium that oncologists use to treat patients with breast cancer."

ABRAXANE™ was launched on February 7, 2005 by Abraxis Oncology, the proprietary division of APP after having received FDA approval in January. ABRAXANE is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.

About International Oncology Network

International Oncology Network (ION) has become the nation's premier -- and largest -- network of community-based oncologists. Members are committed to helping promote quality cancer care where patients need it the most -- close to home -- in their own communities. By bringing clinical research, educational symposia, information systems, and other innovative services to the local oncology community, ION provides tools to physicians that can help maintain a level of expertise so needed in the rapidly changing environment of oncologic treatment options. ION members range from solo practitioners to some of the country's largest and most renowned private practices -- all committed to improving the quality of patient care in their own communities. For more information, visit http://www.iononline.com/.

About American Pharmaceutical Partners

American Pharmaceutical Partners, Inc. is a specialty drug company that develops, manufactures and markets injectable pharmaceutical products, focusing on the oncology, anti-infective and critical care markets. Abraxis Oncology, the proprietary division of APP, is devoted entirely to developing and promoting innovative, next-generation cancer therapies such as ABRAXANE™, recently launched for the treatment of metastatic breast cancer. For more information, visit APP's website at http://www.appdrugs.com/ and http://www.abraxisoncology.com/.
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Old 04-05-2005, 09:52 AM   #2
Janet/FL
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>>Approximately 30% of all metastatic breast cancer patients are HER2-positive.

If the above is true, and 30% of all breast cancer patients are HER2 +++, wouldn't that mean that their is no difference in the rate of metastasis of HER2 and non HER2 cancers? I thought there was a higher incidence.
Janet/FL
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Old 04-05-2005, 06:04 PM   #3
*_anne_*
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Thank you Janet! You made a great analogy. I wish now that ALL other BC websites would stop treating HER2 like the black sheep of BC. I have read " Her2Positive BC has poor prognosis" ever since my mom got her pathology report. I even had an argument with the designers of another BC support website because they automatically made this HER2 and Stage IV connection. The more I appreciate this website and it's members when I think about that.
Have a great day,
Anne
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Old 04-05-2005, 06:18 PM   #4
al from canada
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Anne,
Here's the thing: just because your primary tumor is not HER2 positive that doesn't mean that the mets aren't. Most recent research has shown that over 50% of mets are HER2 positive and that HER2 status and hormonal status can change with mets.
I also question the "poorer prognosis" argument. If your mets are HER2 positive, have been identified as that and you are on herceptin, then I think you have a survival advantage over HER2 negative. Anyone else want to weigh-in on this one?

Al
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Old 04-06-2005, 02:53 PM   #5
Lolly
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Al, I agree, although I am not able to reference any studies which directly compare survival stats of Her2+/ Herceptin patients against the survival stats of the remaining MBC population; however, here's an excerpt from an interesting article (I've included the link to the complete article); the same article goes on to discuss RESPONSE rates to Herceptin therapy but doesn't show SURVIVAL rates for same....if we could just come up with some stats then we'd be able to cross reference with this article, as it discusses numerous chemo regimes, with overall survival rates included in quite a few. But anyone doing that should be careful they're cross-referencing the studies on breast cancer, as I think all types are referenced in this article.



Recent Advances in the Systemic Therapy of Breast Cancer
http://www.ochsnerjournal.org/ochsonline/?...ue=01&page=0024

Comparative Taxane Responses

Taxanes have shown significant activity compared with other standard chemotherapies. Bishop et al (19) compared P to the cyclophosphamide © methotrexate (M), 5 fluorouracil (F), and P combination (CMFP) in a randomized trial involving 209 patients, none of whom had been previously treated with chemotherapy for metastatic disease. Treatment with P alone demonstrated significantly longer median survival (17.3 months) compared with CMFP (13.9 months; p = 0.025).

In another phase III trial (20), docetaxel (100mg/m2) was compared with intensive single-agent D (75 mg/m2), both administered every 3 weeks. Docetaxel produced a significantly higher response rate (47.8% vs 33.3%; p = 0.008) with lower toxicity but no difference in survival.

Docetaxel has been compared with the combination of mitomycin C and vinblastine in metastatic breast cancer patients who failed prior anthracycline therapy. A significant survival advantage was seen in the docetaxel-treated patients (docetaxel 11.4 months, mitomycin C and vinblastine 8.7 months; p = 0.0097) (21).
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Old 04-06-2005, 09:50 PM   #6
al from canada
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Great Article Lolly,

The stats....I don't know if we will ever get a total statisically sound study; the reason being that the patient would have to take herceptin forever and there are too many doctors still screwing around with dropping it, picking it up again, etc. As well, at this point in time, herceptin hasn't been out long enough to get any results of statistical significance. I'm sure that there are many anecdotal reports addressing this issue; in fact I think Jeff may have access to one or two??? The other confounding factor is the ability of HER2 status to change during mets. I think an example of this may be right in this study:

"The weekly combination of traztuzamab and P has recently been studied by Fornier et al (62) who reported a 71% response in HER2-positive patients (20/28), while only 37.5% of the HER2-negative patients responded. Several adjuvant trials currently underway should help to further define the role of traztuzamab in the treatment of early breast cancer."

Why would HER2 (-) patients respond at all? One plausible answer could be as follows:

The HER2 status was obtained from the primary tumour The 37.5% of HER2 (-) patients who did respond to herceptin did so because the distant mets changed to HER2 (+).

Getting back to the original comparison, how can we compare treatment results based upon HER2 status when HER2 is a moving target? In otherword, we could have 37.5% HER2+++ patients in the HER2 (-) arm of the studyand never know it (without an autopsy).

........................that's all................

Al
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