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Review
and to test for significant differences in the times
to events. A post hoc analysis of outcomes according
to hormone receptor status and HER2 status
was performed.
Study Results
Between October 1999 and January 2002, 5052
patients were enrolled, of whom 4950 were eligible.
The benefit of weekly paclitaxel was
seen in patients with HER2-negative
disease irrespective of their
hormone receptor status.
There were no significant differences among the
patient groups. The median age was 51 years, and
the majority of patients were hormone receptor positive
(69.5%) and HER2 negative (67.5%). Most
patients (97%) received all four cycles of doxorubicin
and cyclophosphamide. The proportions of patients
who received all taxane doses were 95% (paclitaxel
Table 1
5-Year Disease-Free Survival and Overall Survival in Four Treatment Arms
12 The American Journal of Hematology/Oncology
every 3 weeks), 88% (paclitaxel weekly), 87% (docetaxel
every 3 weeks), and 75% (docetaxel weekly).
The proportions of patients who required dose modification
of the taxane were 22%, 29%, 28%, and 40%,
respectively.
At a median follow-up of 63.8 months, 1048
patients had a recurrence of breast cancer or cancer
in the contralateral breast, and 686 had died. The
estimated 5-year disease-free survival rates were
76.9% for the patients receiving every-3-week paclitaxel,
81.5% for patients receiving weekly paclitaxel,
81.2% for patients receiving every-3-week docetaxel,
and 77.6% for patients receiving weekly docetaxel
(Table 1). The study met its end point and demonstrated
a significant improvement in disease-free survival
in the group receiving weekly paclitaxel and in
the group receiving docetaxel every 3 weeks (Table
2). Weekly paclitaxel compared with standard therapy
was associated with an improved overall survival
(hazard ratio, 1.32, P=0.01) that was not seen in the
patients receiving weekly docetaxel or every-3-week
docetaxel (Table 3).
Recent data have suggested that patients with
hormone receptor–positive and HER2-negative
breast cancer may not derive a benefit from adjuvant
taxane therapy. 7 Therefore, the investigators analyzed
the effect of hormone receptor status and
HER2 expression on the efficacy of weekly paclitaxel
Treatment Arm 5-Year Disease-Free Survival 5-Year Overall Survival
Every-3-week paclitaxel 76.9% 86.5%
Weekly paclitaxel 81.5% 89.7%
Every-3-week docetaxel 81.2% 87.3%
Weekly docetaxel 77.6% 86.2%
Table 2
Hazard Ratio for Disease-Free Survival in the Experimental Treatment Arms Compared With
Standard Every-3-Week Paclitaxel
Treatment Arm Hazard Ratio 95% CI P Value
Weekly paclitaxel 1.27 1.03-1.57 0.006
Every-3-week docetaxel 1.23 1.00-1.52 0.02
Weekly docetaxel 1.09 0.89-1.34 0.29