Journal
JOURNAL OF CLINICAL ONCOLOGY
Volume 33, Issue 1, Pages 58-U95Publisher
AMER SOC CLINICAL ONCOLOGY
DOI: 10.1200/JCO.2014.56.3296
Keywords
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Categories
Funding
- Public Health Service Cooperative Agreement - National Cancer Institute, Department of Health and Human Services [CA32102, CA38926,, CA21115, CA21076, CA77597, CA25224, CA77202, CCSRI15469]
- Canadian Cancer Society Research Institute [021039, 015469, CA63844, CA46282, CA20319, CA63848, CA46441, CA35261, CA14028, CA76447, CA58658, CA67575, CA128567, CA04919, CA37981, CA22433, CA35281, CA58882, CA45560]
- Amgen
- [CA45808]
- [CA58861]
- [CA95860]
- [CA45807]
- [CA13612]
- [CA46368]
- [CA27057]
- [CA42777]
- [CA86780]
- [CA35176]
- [CA35178]
- [CA74647]
- [CA68183]
- [CA12644]
- [CA58416]
- [CA67663]
- [CA63845]
- [CA35431]
- [CA11083]
- [CA45377]
- [CA35128]
- [CA35262]
- [CA35090]
- [CA52654]
- [CA45461]
- [CA45450]
- [CA76132]
- [CA35119]
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Purpose To determine the optimal dose and schedule of anthracycline and taxane administration as adjuvant therapy for early-stage breast cancer. Patients and Methods A 2 X 2 factorial design was used to test two hypotheses: (1) that a novel continuous schedule of doxorubicin-cyclophosphamide was superior to six cycles of doxorubicin-cyclophosphamide once every 2 weeks and (2) that paclitaxel once per week was superior to six cycles of paclitaxel once every 2 weeks in patients with node-positive or high-risk node-negative early-stage breast cancer. With 3,250 patients, a disease-free survival (DFS) hazard ratio of 0.82 for each randomization could be detected with 90% power with two-sided alpha = .05. Overall survival (OS) was a secondary outcome. Results Interim analyses crossed the futility boundaries for demonstrating superiority of both once-per-week regimens and once-every-2-weeks regimens. After a median follow-up of 6 years, a significant interaction developed between the two randomization factors (DFS P = .024; OS P = .010) in the 2,716 patients randomly assigned in the original design, which precluded interpretation of the two factors separately. Comparing all four arms showed a significant difference in OS (P= .040) but not in DFS (P = .11), with all treatments given once every 2 weeks associated with the highest OS. This difference in OS seemed confined to patients with hormone receptor-negative/ human epidermal growth factor receptor 2 (HER2) -negative tumors (P = .067), with no differences seen with hormone receptor-positive/HER2-negative (P = .90) or HER2-positive tumors (P = .40). Conclusion Patients achieved a similar DFS with any of these regimens. Subset analysis suggests the hypothesis that once-every-2-weeks dosing may be best for patients with hormone receptor-negative/ HER2-negative tumors.
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