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[48] Phase III study of doxorubicin-cyclophosphamide followed by paclitaxel or docetaxel given every 3 weeks or
weekly in patients with axillary node-positive or high-risk node-negative breast cancer: results of North American
Breast Cancer Intergroup Trial E1199.
Sparano JA, Wang M, Martino S, Jones V, Perez EA, Saphner T, Wolff AC, Sledge GW, Wood WC, Davidson NE.
From the Eastern Cooperative Oncology Group (ECOG), Southwest Oncology Group (SWOG), Cancer and Acute
Leukemia Group B (CALBG), and the North Central Cancer Treatment Group (NCCTG)
Purpose: To compare the effectiveness of adjuvant paclitaxel with docetaxel, and the effectiveness of every 3 week with
weekly adjuvant taxane therapy in patients with operable breast cancer.
Methods: Eligibility criteria included axillary lymph node positive or high-risk (tumor at least 2 cm) node-negative breast
cancer. All patients received 4 cycles of AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2) every 3 weeks,
followed by either: (1) paclitaxel 175 mg/m2 every 3 weeks x 4 (P3), (2) paclitaxel 80 mg/m2 weekly x 12 (P1), (3)
docetaxel 100 mg/m2 every 3 weeks x 4 (D3), or (4) docetaxel 35 mg/m2 weekly x 12 (D1). All patients with estrogen
and/or progesterone receptor (ER/PR)-positive disease received a 5 year or longer course of adjuvant hormonal therapy,
consisting either of tamoxifen (20 mg daily), an aromatase inhibitor (AI; for post-menopausal women beginning in 2003 at
the discretion of the treating physician), or tamoxifen followed by an AI. The primary comparisons included taxane (P vs. D)
and schedule (every 3 weeks vs. weekly). The trial had 86% power to detect a 17.5% reduction in failure for either primary
comparison. The primary endpoint was disease-free survival (DFS), defined as local, regional, and/or distant relapse,
second primary breast cancer, or death without recurrence.
Results: A total of 4988 eligible patients were accrued between October 1999 and January 2002. The ECOG Data
Monitoring Committee advised release of the data after 856 DFS events (82% of total information) occurred after a median
follow-up was 46.5 months at the fourth planned interim analysis, including the following number of DFS events (and
relapses) for each arm: P3-230 (197), P1-195 (168), D3-206 (163), D1-225 (185). For the primary analyses, there were no
significant differences in the hazard ratios (HR) comparing taxane (0.985; p=0.83) or schedule (1.043; p=0.54) for DFS,
and it is unlikely that either comparison could become significant after full planned information is obtained. When
comparing the standard arm (P3) to the other arms (with a HR > 1 favoring the experimental arms), the HRs were 1.20
(95% confidence intervals [CI] 0.99, 1.46; p = 0.06) for arm P1, 1.13 (95% CI 0.94, 1.36; p=0.20) for arm D3, and 1.03
(95% CI 0.85, 1.23; p=0.78) for arm D1. The incidence of worst grade toxicity (grade 3/4) was 24%/6% for arm P3, 24%/4%
for arm P1, 21%50% for arm D3, and 39%/6% for arm D1.
Conclusions: There were no differences in DFS when comparing taxane or schedule, the primary study endpoints. There
was a trend toward improved DFS associated with weekly paclitaxel compared with the standard treatment arm.
Thursday, December 8, 2005 3:30 PM
General Session 2 (1:30 PM-3:30 PM)
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