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After FEC, weekly docetaxel with capecitabine (wTX), both given every 21 D x 4 as: docetaxel 35 mg/m2 on D1 & D8, capecitabine 825 mg/m2 PO BID D1-14; and, if HER2+, H given as in part I. After CT, definitive local therapy (mastectomy or lumpectomy & axillary dissection) was done.
The research findings indicated that 185 patients with a median age of
50 years (range, 24-84) were treated; 179 underwent definitive surgery.
Results are summarized in the table below:
Subset Number of Patients Percentage pCR
Breast/Ax
All patients with surgery
post CT 179 34 (27-41)
ER or PR+ HER2- 80 24 (16-34)
FR-, PR-, HER2- 63 23 (31-55)
HER2-, no H 143 32 (25-40)
HER2+, received FEC 75+H 36 39 (25-55)
The most frequent Grade 3-4 toxicities were neutropenia (77 percent), diarrhea (9 percent), hand-foot syndrome (8 percent), and stomatitis (7 percent).
Decreased left ventricular ejection fraction (LVEF) <50 percent occurred in 4 of 40 pts receiving FEC75+H but there was no heart failure & repeat LVEFs were >50 percent in all 4 patients.
Of 143 non-H treated patients, two had LVEFs <50 percent (one each: 25
percent, 44 percent). Microarray: 107/192 specimens generated less than or
equal to 10 mcg cRNA, median 35 mcg, which was hybridized to Affymetrix HG-
U133A gene chips successfully in 101 specimens. The success rate was 35
percent in the first 80 cases and 65 percent in the last 112 cases. Sample
attrition precluded separate discovery/validation cohorts so data combined
with two MDA
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