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| |  Febrile Neutropenia Occurs More Frequently in Real World Setting Than in Clinical Trials: Presented at SABCS By Ed Susman SAN ANTONIO, Tex -- December 11, 2009 -- A potent adjuvant therapy for breast cancer appears to have far greater incidence of febrile neutropenia when it is used in the real world compared with what was seen in clinical trials, researchers said here at the 32nd Annual San Antonio Breast Cancer Symposium (SABCS). “We saw febrile neutropenia in 6 of our first 12 patients [who received] the regimen of docetaxel and cyclophosphamide,” said Robert Myers, MD, Peel Regional Cancer Centre, Mississauga, Ontario, during his poster presentation here today. Because treatment with cyclophosphamide/docetaxel was shown to produce a survival advantage in women at intermediate risk of breast cancer recurrence during a phase 3 trial comparing doxorubicin plus cyclophosphamide with docetaxel plus cyclophosphamide as adjuvant therapy for operable breast cancer(1), physicians at the community hospital began treating women with this combination. However, after the 6 women developed febrile neutropenia, the hospital routinely began administering growth factors or dose reduction (but not antibiotics) as a prophylactic treatment in these women. Of the 89 women who were treated using the docetaxel/cyclophosphamide regimen, 70 were treated with upfront growth factors -- either filgrastim or pegfilgrastim. Dr. Myers said 37% of the other women developed febrile neutropenia required readmission to the hospital. The average age of the women in the study was 57 years. Of the women, 69 were node negative and 20 were node positive. All had stage T1 or T2 breast cancer. “Other groups in Canada have seen the same thing,” Dr. Myers said. “In our experience, the docetaxel/cyclophosphamide protocol when given without primary prophylaxis is associated with a high rate of febrile neutropenia. Our initial experience is vastly different than the original published data that indicated a febrile neutropenia rate of about 5%.” By administering upfront growth factor treatment, he added, the incidence of febrile neutropenia dropped to less than 2%. “When adopting new treatment protocols into clinical practice,” Dr. Myers said, “caution must be used in determining specific care protocols used in the trial setting. Presented data and even published reports often lack this key information needed to deliver therapy safely and effectively in the community.” Funding for this study was provided by the University of Texas Health Science at San Antonio, Baylor College of Medicine, and the American Association for Cancer Research. 1. Jones SE et al. J Clin Oncol. 2006:24:5381-5387.
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