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Intensive dose-dense compared with conventionally scheduled preoperative chemotherapy for high-risk primary breast cancer
Journal of Clinical Oncology, 06/22/09
Untch M et al. – Phase III trial shows the efficacy and short-term safety of intense dose-dense (IDD) as preoperative chemotherapy. It was less well tolerated compared to standard treatment, but improved clinical outcomes in patients with noninflammatory high-risk primary breast cancer.
Methods- Aim was to compare preoperative IDD chemotherapy with conventionally scheduled preoperative chemotherapy in high-risk primary BCa
- 668 pts stratified for tumors ≥3 cm (n=567) or inflammatory BCa (n=101) randomly assigned to receive:
- Concurrent preoperative epirubicin/paclitaxel every 3 wks or
- Dose-dense and dose-escalated sequential epirubicin followed by paclitaxel every 2 wks
- All patients received 3 cycles of cyclophosphamide, methotrexate, and fluorouracil chemotherapy after surgery
- IDD treatment improved pathologic complete response rate, disease-free survival, and overall survival vs epirubicin/paclitaxel
- Pts with inflammatory BCa had a particularly poor prognosis and did not appear to benefit from IDD therapy in this trial
- In contrast, pts with noninflammatory BCa benefited from IDD treatment
- Treatment effects in multivariate analysis were for noninflammatory BCa, but not for all pts
- IDD therapy was associated with more nonhematologic toxicities, anemia, and thrombocytopenia, but with similar neutropenia and infection rates
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