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Breast Cancer Treatment Guidelines Include Ixabepilone: Presented at NCCN

By Ed Susman

HOLLYWOOD, Fla. -- March 10, 2008 -- Ixabepilone, an epothilone B analogue newly approved for the treatment of advanced breast cancer, has been added to the guidelines of the National Comprehensive Cancer Network (NCCN).

The decision was announced in a presentation here on March 8th at the 13th NCCN Conference on Clinical Practice Guidelines and Quality Cancer Care.

The drug was added to the algorithm under the category of "other active options," although the doctors charged with writing the guidelines noted that ixabepilone appears to have modest effects in combating advanced cancer and causes some worrisome adverse effects.

"Ixabepilone does not appear to be susceptible to multiple resistance mechanisms in preclinical models, and was active in phase 2 trials in breast cancer," stated Robert W. Carlson, MD, Professor of Medicine, Stanford University Comprehensive Cancer Center, Stanford, California.

"Ixabepilone also appeared to have preclinical synergy with capecitabine," Dr. Carlson added.

He said that in a clinical trial (Thomas ES et al. J Clin Oncol. 2007;25:5210-5217), researchers observed a statistically significant (P = .0003) improvement in progression-free survival in women with metastatic or locally advanced breast cancer on a combination of ixabepilone and capecitabine compared with those on capecitabine alone. The median time to progression in women on combination treatment was 5.8 months, compared with 4.2 months in women not receiving ixabepilone.

For that reason, said Dr. Carlson, NCCN's Breast Cancer Guidelines Committee decided to include the combination of ixabepilone and capecitabine in its guidelines, and to make ixabepilone one of the "other active options" for treatment.

"We have yet to see any survival data with this drug, however," Dr. Carlson added. He noted that 5 of 16 patients who experienced Grade 2 or higher liver dysfunction while on the combination treatment died of neutropaenia.

Dr. Carlson also noted that the serious complications seen with ixabepilone require it to be used with caution. Treatment with ixabepilone plus capecitabine appeared to increase Grade 3 and 4 peripheral neuropathy and myalgia compared with capecitabine alone.

The NCCN guidelines now list the "preferred single agents" for recurrent or metastatic breast cancer as follows: doxorubicin, epirubicin, pegylated liposomal doxorubicin, paclitaxel, docetaxel, capecitabine, vinorelbine, gemcitabine, and albumin-bound paclitaxel. Paclitaxel is the preferred drug for use with bevacizumab. The guidelines also list several preferred combinations and "other active options" -- where ixabepilone was placed.


[Presentation title: Update: Breast Cancer Guidelines.]

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