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November 2, 2005

Life-threatening Complications From Doxorubicin-Docetaxel Chemotherapy for Breast Cancer—Reply

Author Affiliations

Letters Section Editor: Robert M. Golub, MD, Senior Editor.

JAMA. 2005;294(17):2166-2167. doi:10.1001/jama.294.17.2166-b

In Reply: Our understanding is that two trials using docetaxel in the adjuvant setting (National Surgical Adjuvant Breast and Bowel Project [NSABP] B-301 and GEICAM 98052) were amended in 2000 by adding prophylactic G-CSF to the groups combining doxorubicin with docetaxel (either alone or with cyclophosphamide) after interim analyses had shown rates of febrile neutropenia above 20%. Had we been given this information when we interrupted the RAPP-01 trial in 2001 after 2 serious adverse events including 1 death, we would not have reopened it without such preventive measures. The gastrointestinal symptoms focused our attention on colitis. No data were available in the literature at that time to justify systematic addition of G-CSF to the docetaxel-doxorubicin combination. Following the addition of prophylactic G-CSF in the GEICAM trial, the rate of febrile neutropenia associated with the docetaxel-doxorubicin-cyclophosphamide regimen fell below 10%.2

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