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Abstract
Fifty patients with histologically confirmed stage III breast cancer were enrolled
in this study of doxorubicin 50 mg/m2 and docetaxel 75 mg/m2 intravenously infused over 1 hour every 21 days with granulocyte colonystimulating
factor for 4 cycles. This was followed by surgery (mastectomy or lumpectomy) and 4
more cycles of doxorubicin/docetaxel postoperatively, then radiation and tamoxifen
as indicated. Forty-six of the 50 patients (92%) completed neoadjuvant chemotherapy,
and 38 patients (76%) completed adjuvant chemotherapy. Clinical response (defined
as > 50% decrease in size of tumor) was achieved after 2 cycles in 37 patients (74%)
and after 4 cycles in 42 of the 46 patients (91%) who finished neoadjuvant chemotherapy.
Pathologic complete response (pCR; no pathologic invasive cancer) at the primary site
was obtained in 7 of 46 patients (15%); 11 had no residual gross disease but did have
microscopic persistence or microscopic complete response (mCR), for a combined pCR
and mCR of 18 of 46 patients (39%). No treatment-related deaths occurred, but 3 patients
died during treatment: 1 from progressive disease, 1 from a gastrointestinal bleeding,
and 1 from unexplained sudden cardiac death. Dose-limiting toxicities were hematologic
(grade 3 neutropenia in 5 patients and grade 4 in 23 patients). Congestive heart failure
developed in 4 of 50 patients (8%), with a mean decrease in left ventricular ejection
fraction (LVEF) of 20% in affected patients and 1 asymptomatic decrease in LVEF of
25%. At last follow-up, 10 patients had died of progressive disease, and 1 each from
sudden cardiac death and lower gastrointestinal bleeding. In locally advanced breast
cancer, neoadjuvant doxorubicin/docetaxel is a very active regimen that achieved pCR
of 15% and a combined pCR and mCR of 39%, for an overall clinical response rate of
91%. Adjuvant chemotherapy was complicated by dropouts and congestive heart failure.
This regimen should be used with close monitoring of cardiac function.
Key words
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Article info
Publication history
Accepted:
August 5,
2004
Received in revised form:
July 27,
2004
Received:
July 14,
2003
Identification
Copyright
© 2004 Elsevier Inc. Published by Elsevier Inc. All rights reserved.