Herceptin® Plus Doxil® Safe and Effective in Metastatic Breast Cancer

Herceptin® Plus Doxil® Safe and Effective in Metastatic Breast Cancer

According to an early online publication in the Journal of Clinical Oncology, the treatment combination consisting of Herceptin® (trastuzumab) plus Doxil® (pegylated liposomal doxorubicin) is well tolerated and effective in the treatment of HER2-positive, metastatic breast cancer.

A significant portion of women diagnosed with breast cancer have what is called HER2-positive breast cancer. Patients with HER2-positive breast cancer have cancer that has one or more mutations (genetic alteration) within the human epidermal growth factor receptor-2 (HER2) pathway.

Mutations within the HER2 result in overproduction of the HER2 receptor, which is found on the outside of cancer cells. Patients who have an excess amount of these receptors are referred to as HER2-positive.

All women with breast cancer should undergo testing to determine if their cancer is HER2-positive.

Herceptin is a monoclonal antibody (protein) that is targeted against HER2. It binds to the receptors, which stops them from stimulating the spread of cancer cells that overexpress HER2. Herceptin is currently approved for the treatment of HER2-postivive, metastatic breast cancer (cancer that has spread to distant sites in the body) in combination with the chemotherapy agent Taxol® (paclitaxel) or as a single agent in women whose breast cancer has recurred following previous therapy.

Adriamycin® (doxorubicin) is one of the most effective chemotherapy agents in the treatment of breast cancer. However, its use, particularly when combined with Herceptin, results in unacceptable levels of damage to the heart. Therefore, Herceptin is instead used with other classes of chemotherapy agents.

Doxil is a chemotherapy agent that fights cancer in the same way as Adriamycin. However, Doxil is associated with fewer risks to the heart. Therefore, researchers from Canada recently conducted a clinical trial to evaluate the combination of Doxil and Herceptin in women with HER2-positive, metastatic breast cancer. This trial included 30 women; 13 had received prior therapy with anthracyclines (class of chemotherapy agents to which Adriamycin and Doxil belong).

  • Cancer regressed in 52% patients.
  • Disease stabilized in 38% of patients.
  • At a median follow-up of nearly 14 months, median progression-free survival was 12 months; median duration of survival has not yet been reached.
  • No patient developed congestive heart failure that was symptomatic.
  • At one year, the survival rate was 77%.
  • Three patients developed side effects to the heart.
  • The most common serious side effects were low levels of immune cells and redness, blistering, pain, or numbness of the palms of the hands or soles of the feet.

The researchers concluded that the treatment combination consisting of Herceptin and Doxil appears active in the treatment of HER2-positive, metastatic breast cancer. Furthermore, side effects to the heart seemed greatly reduced compared to Adriamycin.

Reference: Chia S, Clemons M, Martin L-A, et al. Pegylated Liposomal Doxorubicin and Trastuzumab in HER-2 Overexpressing Metastatic Breast Cancer: A Multi-Center Phase II Trial. Early online publication May 8, 2006. DOI: 10.1200/*JCO.*2005.03.8331.

Related News:Additional Evidence that Herceptin® Benefits Women with HER2-Positive Breast Cancer(4/17/2006)

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