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NCCN Updates Metastatic Guidelines

Breast cancer practice recommendations include eribulin, denosumab, bevacizumab

April 5, 2011

Written By Janine E. Guglielmino, MA, Senior Director, Programs and Partnerships
Reviewed By Generosa Grana, MD

In an update to its clinical practice guidelines, the National Comprehensive Cancer Network added two new therapies, eribulin and denosumab, to its list of acceptable therapies for metastatic breast cancer.

Eribulin (Halaven), a new chemotherapy medicine for treatment-resistant breast cancers, was approved by FDA in November 2010. Denosumab (Xgeva) is a RANKL inhibitor, a medicine that protects the bone from breakdown.

NCCN also affirmed the use of bevacizumab (Avastin) in combination with paclitaxel (Taxol) as an acceptable first or second treatment for metastatic breast cancer.

Power of NCCN Guidelines

The National Comprehensive Cancer Network is one of several groups that release clinical practice guidelines, formal advice for clinicians on appropriate treatment for breast cancer.

NCCN is made up of medical experts from 21 U.S. cancer centers. Providers at these facilities review published studies and discuss potential benefits and harms of new treatments, combinations or tests. When they agree the treatment benefits outweigh possible harms, NCCN revises its guidelines.

Providers nationwide have free access to these guidelines and many use them in their practice. Following guidelines from NCCN or other influential groups helps your providers stay up to date and offer you the latest treatments. You can also read the medical version and layperson version of these guidelines to discuss with your providers. (Free sign-up is required.)

Chemotherapy Update: Eribulin

NCCN added eribulin to its list of chemotherapy medicines available for treatment of metastatic breast cancers that grow despite treatment with two previous therapies, an anthracycline and a taxane. Anthracyclines include doxorubicin (Adriamycin) and epirubicin (Ellence); the taxanes are paclitaxel (Taxol) and docetaxel (Taxotere).

The panel’s recommendation drew heavily from findings of the EMBRACE clinical trial, which showed women who took eribulin lived an average of three months longer than those who received a different chemotherapy of their doctor’s choice.

The most common side effects of eribulin are muscle weakness and fatigue and low white blood cell counts. Eribulin may also cause peripheral neuropathy, injury or damage to nerves that causes pain, numbness or tingling.

Bone Metastasis Update: Denosumab

NCCN added denosumab as an acceptable option to prevent fractures of bone, pain and compression of the spinal cord in breast cancers that metastasized to bone. Denosumab, from a family of medicines called RANKL inhibitors, works by protecting bones from breaking down faster than they should.

Denosumab treats the symptoms of bone metastasis but does not kill the cancer itself, so it should be coupled with medical treatment. Your doctor should also prescribe vitamin D and calcium supplements with denosumab.

The basis for NCCN’s inclusion of denosumab comes from a study that showed it worked as well as or slightly better than zoledronic acid (Zometa) at preventing broken and painful bones. Zoledronic acid is one of two bisphosphonate medicines NCCN considers acceptable for managing bone problems in women with bone mets; the other is pamidronate (Aredia).

Side effects of all three medicines include low calcium levels, kidney problems and osteonecrosis of the jaw, damage to the jawbone. To lower your chances of ONJ, see your dentist before starting these medicines and immediately report symptoms to your doctor.

Update on Bevacizumab

NCCN affirmed that bevacizumab given with paclitaxel is an acceptable first- or second-line treatment for metastatic breast cancer. Bevacizumab works by choking off the nutritional supply tumors need to grow.

Since the FDA withdrew approval for bevacizumab in breast cancer in late 2010, the future of this treatment remains in doubt. Read more about the controversy in Breast Cancer News.

What NCCN Guidelines Mean for You

Your providers may feel more confident offering you a new or cutting-edge therapy that NCCN included in its guideline.

If you believe you may be able to try a treatment but your doctors hesitate, consider sharing the guideline. Print out the pages you need and underline the important sections. It may help your treatment team learn more, or open a discussion of why that treatment may not make sense for you.

Studies mentioned in this article:

Cortes J, O'Shaughnessy J, Loesch D, Blum JL, Vahdat LT, et al. Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. Lancet. 2011 Mar 12;377(9769):878-80.

Stopeck AT, Lipton A, Body JJ, Steger GG, Tonkin K, et al. Denosumab compared with zoledronic acid for the treatment of bone metastases in patients with advanced breast cancer: a randomized, double-blind study. J Clin Oncol. 2010 Dec 10;28(35):5132-9. Epub 2010 Nov 8.