JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL

Intensive dose-dense compared with conventionally scheduled preoperative chemotherapy for high-risk primary breast cancer

Michael Untch, Volker Möbus, Walther Kuhn, Bernd Rudolph Muck, Christoph Thomssen, Ingo Bauerfeind, Nadia Harbeck, Christoph Werner, Annette Lebeau, Andreas Schneeweiss, Stephen Kahlert, Franz von Koch, Karl Ulrich Petry, Diethelm Wallwiener, Rolf Kreienberg, Ute-Susann Albert, Hans-Joachim Lück, Axel Hinke, Fritz Jänicke, Gottfried E Konecny
Journal of Clinical Oncology 2009 June 20, 27 (18): 2938-45
19364964

PURPOSE: To compare preoperative intense dose-dense (IDD) chemotherapy with conventionally scheduled preoperative chemotherapy in high-risk primary breast cancer (BC).

PATIENTS AND METHODS: In this randomized phase III trial a total of 668 eligible primary BC patients stratified for tumors > or = 3 cm (n = 567) or inflammatory BC (n = 101) were randomly assigned to receive concurrent preoperative epirubicin/paclitaxel every 3 weeks or dose-dense and dose-escalated sequential epirubicin followed by paclitaxel every 2 weeks. All patients received three cycles of cyclophosphamide, methotrexate, and fluorouracil chemotherapy after surgery.

RESULTS: IDD treatment significantly improved pathologic complete response rate (18% v 10%; odds ratio [OR] 1.89; P = .008), disease-free survival (DFS; hazard ratio [HR], 0.71; P = .011), and overall survival (OS; HR, 0.83; P = .041) compared to epirubicin/paclitaxel. Patients with inflammatory BC had a particularly poor prognosis and did not appear to benefit from IDD therapy in this trial (DFS HR, 1.10; P = .739; OS HR, 1.25; P = .544). In contrast, patients with noninflammatory BC significantly benefited from IDD treatment (DFS HR, 0.65, P = .005; OS HR, 0.77, P = .013). Treatment effects in multivariate analysis were significant for noninflammatory BC (DFS HR, 0.65, P = .015; OS HR, 0.79, P = .034), but not for all patients (DFS HR, 0.76; P = .088; OS HR, 0.82; P = .059). IDD therapy was associated with significantly more nonhematologic toxicities, anemia, and thrombocytopenia, but with similar neutropenia and infection rates.

CONCLUSION: Our results support the efficacy and short-term safety of IDD as preoperative chemotherapy. IDD was less well tolerated compared to standard treatment, but improved clinical outcomes in patients with noninflammatory high-risk primary BC.

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