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Title: Pilot Study Shows Abraxane Safe and Effective in Sequence With Dose-Dense Doxorubicin and Cyclophosphamide: Presented at SABCS

"Pilot Study Shows Abraxane Safe and Effective in Sequence With Dose-Dense Doxorubicin and Cyclophosphamide: Presented at SABCS"

By Cameron Johnston SAN ANTONIO, TX -- December 13, 2005 -- A novel form of paclitaxel, encapsulated in albumin, could represent the first drug designed to treat breast cancer that can truly be said to use the science of "nanotechnology." Each molecule of Abraxane (ABI-007) measures 130 nm in diameter, which permits it to cross blood vessel membranes, pass through the interstitium (the area between blood vessel and the cancerous tumor tissue) and, finally, to be taken up by the tumor itself more readily than standard paclitaxel. Past studies have shown that because Abraxane penetrates the tumor more effectively than standard paclitaxel, it can result in improved response rates and time-to-tumor progression in women with metastatic breast cancer. At the 28[^th Annual San Antonio Breast Cancer Symposium (SABCS), researchers presented a small pilot trial that demonstrated Abraxane to be safe and effective, with a manageable toxicity profile, in women with early stage breast cancer.

The study was presented here on December 9^th by Nicholas Robert, MD, chairman of research and medical oncologist, Inova Fairfax Hospital Cancer Center, Richmond, Virginia.

In the study, treatment consisted of dose-dense doxorubicin and cyclophosphamide (AC) every 2 weeks over 4 cycles, followed by Abraxane 260 mg/m² every 2 weeks over 4 cycles.

All received AC as planned, and 27 out of 29 received Abraxane. One third of subjects received growth-stimulating factors during the Abraxane phase. Nine patients had to reduce their Abraxane dose due to nonhematologic toxicities and 13 had treatment delays.

Grade II and III peripheral neuropathy was seen in 31% and 14% of patients, respectively. However, when the drug was discontinued or the dose reduced, all patients lost at least one grade within the first 28 days. By the end of follow-up, no patients had grade III neuropathy.

William Gradishar, MD, associate professor of medicine, Northwestern University, Chicago, Illinois, commented, "Preclinical models have shown that when you look at equal doses of paclitaxel versus Abraxane, that this isn't all smoke and mirrors, that you actually do end up with 50% more of the drug getting in to the tumor tissue, which is the ultimate goal."

A further benefit to Abraxane, he said, is that patients do not need to be pretreated with steroids in order to reduce hypersensitivity reactions. Therefore, it is possible to administer the dose faster, and without the risks associated with steroids.

In fact, Dr Gradishar added, much of the toxicity seen with standard paclitaxel is not from the drug itself, but from a solvent known as cremophor into which the paclitaxel is dissolved before being administered.

The preliminary results seen here indicate that dose dense therapy with doxorubicin 60 mg/m² IV plus cyclophosphamide 600 mg/m² every 2 weeks for 4 cycles, followed by dose dense Abraxane 260 mg/m² every 2 weeks for 4 weeks is well tolerated in patients with early stage breast cancer, Dr. Robert said.

These data are to be incorporated ultimately into a larger more encompassing trial, he said.

[Presentation title: Pilot Study of Dose Dense Doxorubicin + Cyclophosphamide Followed by ABI-007 in Patients With Early Stage Breast Cancer. Abstract 2073]

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