Intensive Dose-Dense Compared With Conventionally Scheduled Preoperative Chemotherapy for High-Risk Primary Breast Cancer

Author:

Untch Michael1,Möbus Volker1,Kuhn Walther1,Muck Bernd Rudolph1,Thomssen Christoph1,Bauerfeind Ingo1,Harbeck Nadia1,Werner Christoph1,Lebeau Annette1,Schneeweiss Andreas1,Kahlert Stephen1,von Koch Franz1,Petry Karl Ulrich1,Wallwiener Diethelm1,Kreienberg Rolf1,Albert Ute-Susann1,Lück Hans-Joachim1,Hinke Axel1,Jänicke Fritz1,Konecny Gottfried E.1

Affiliation:

1. From the Helios Klinikum, Campus Berlin Buch, Berlin; Klinikum Frankfurt Höchst, Frankfurt; Bethesda Krankenhaus, Mönchengladbach; University of Halle (Saale), Halle (Saale); Klinikum Landshut, Landshut; Technical University of Munich; Klinikum Grosshadern, University of Munich, Munich; University of Cologne, Cologne; Frauenklinik, Evangelisches Bethesda Krankenhaus, Duisburg; University of Hamburg-Eppendorf, Hamburg; University of Heidelberg, Heidelberg; Städtisches Klinikum, Wolfsburg; University of...

Abstract

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 ≥ 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.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

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