News Clipping: Benefits of Taxol Questioned

by Katrina Kahl

Adding Taxol (paclitaxel) after adjuvant chemotherapy does not benefit women with the most common form of breast cancer, according to a study published in the October 2007 edition of theNew England Journal of Medicine.1 The study reports that the drug helps only women with HER2-positive breast cancer and not those with the more prevalent HER2-negative, estrogen-receptor-positive disease. According to the study, HER2-positive breast cancer accounts for as few as 15-20 percent of breast cancer cases.

The study was based on a retrospective analysis of the Cancer and Leukemia Group B (CALGB) 9344 trial. The original CALGB 9344 trial enrolled women with node-positive breast cancer and randomly assigned them to receive doxorubicin plus cyclophosphamide followed by either Taxol or observation. The researchers for the study presented their results at a 1998 meeting of the American Society of Clinical Oncology. They reported that adding Taxol after adjuvant chemotherapy improved both disease-free survival and overall survival for the women in the trial. Consequently, the use of Taxol for breast cancer increased even though the results were not published until 2003. Additionally, the researchers had not investigated whether the drug was effective across different forms of breast cancer.

Researchers for the current study hypothesized that HER2 status could help determine the effectiveness of Taxol for breast cancer patients. They established the HER2 status of 1,322 women from the original CALGB 9344 trial using stored tissue samples. Their results showed that women with HER2-positive breast cancer benefited from the addition of Taxol regardless of estrogen-receptor status. However, no benefit was observed for women with HER2-negative, estrogen-receptor-positive disease.

The results of this study suggest that fewer than 20 percent of women with breast cancer have benefited from adding Taxol to adjuvant chemotherapy. Because Taxol is an aggressive drug with toxic side effects, steps must be taken by the oncology community to incorporate this information into clinical practice. Let’s hope it’s done as quickly as the drug was embraced.

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1 Daniel F. Hayes, et al., “HER2 and Response to Paclitaxel in Node-Positive Breast Cancer,” New England Journal of Medicine, 2007; 357(15), November 27, 2007.

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