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According to the results of a phase II clinical trial published in the Annals of Oncology, the chemotherapy combination of Alimta® (pemetrexed) and Gemzar® (gemcitabine) produced a reduction in detectable disease in 24% of women with metastatic breast cancer.

Breast cancer is one of the most common cancers diagnosed in women. It is estimated that approximately 250,000 women are diagnosed annually in the United States, and 40,000 deaths are attributed to breast cancer each year.

Metastatic breast cancer refers to cancer that has spread to distant sites in the body, often invading vital organs. Standard treatment for metastatic breast cancer typically includes chemotherapy. Researchers continue to evaluate novel agents or therapeutic approaches for the treatment of metastatic breast cancer in order to improve long-term outcomes, as well as quality of life, for these patients.

When evaluated individually, the chemotherapy drugs Alimta and Gemzar have each produced treatment responses in some women with metastatic breast cancer. Laboratory studies suggest that the combination of these two drugs may be even more effective.

To evaluate the combination of Alimta and Gemzar for the treatment of metastatic breast cancer, researchers conducted a phase II clinical trial among 59 women. A majority of the women were postmenopausal, and all had previously received chemotherapy with an anthracyline and a taxane.

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  • A partial reduction in detectable cancer was experienced by 24% of the women.
  • 15% of women had cancer that remained stable for at least six months.
  • 49% of women survived for at least one year.
  • Cancer worsened after a median of 3.7 months.
  • Neutropenia (a reduction in neutrophils-a type of white blood cell) was the most common severe adverse effect of treatment. Sixty-six percent of women developed grade 4 (the most serious) neutropenia.

The researchers conclude that the combination of Alimta and Gemzar for treatment of metastatic breast cancer produces results that are comparable to other available chemotherapy regimens. This combination may provide another treatment option for women with previously-treated metastatic breast cancer.

Women with metastatic breast cancer may wish to talk with their doctor about the risks and benefits of participating in a clinical trial further evaluating these or other novel therapeutic approaches.

Reference: Ma CX, Steen P, Rowland KM et al. A Phase II Trial of a Combination of Pemetrexed and Gemcitabine in Patients with Metastatic Breast Cancer: An NCCTG Study. Annals of Oncology. 2006;17:226-231.

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