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Randomized Trial of Single Compared With Tandem High-Dose Chemotherapy Followed by Autologous Stem-Cell Transplantation in Patients With Chemotherapy-Sensitive Metastatic Breast Cancer

Nicolaus Kröger, Markus Frick, Oleg Gluz, Svjetlana Mohrmann, Bernd Metzner, Christian Jackisch, Yon Ko, Hans-Walter Lindemann, Carl Richard Meier, Hans Peter Lohrmann, Ute Ruffert, Matthias Hänel, Heinrich Bodenstein, Andreas Neubauer, Gerhard Ehninger, Hans-Heinrich Wolf, Kathrin Kolbe, Karin Burock, Axel R. Zander, Ulrike Nitz

From the Bone Marrow Transplantation, University Hospital Hamburg-Eppendorf, Hamburg; Department of Transfusion Medicine, and Department of Gynecology and Obstetrics, Breast Centre, University Hospital Düsseldorf, Düsseldorf; Department of Oncology/Hematology, Klinikum Oldenburg, Oldenburg; Department of Gynecology and Obstetrics, University Hospital Münster, Münster; Department of Oncology/ Hematology, University Hospital Bonn, Bonn; Department of Hematology/ Oncology, Catholic Hospital, Hagen, University Witten-Herdecke, Witten; Department of Oncology/Hematology, Zentralkrankenhaus St Jürgensstraße, Bremen; Department of Oncology/ Hematology, Klinikum Lippe-Lemgo, Lemgo; Thüringer Institut für Blutzellanalyse und therapy (IBAT), Jena; Department of Oncology/Hematology, Klinikum Chemnitz, Chemnitz; Department of Hematology/Oncology, Klinikum Minden, Minden; Department of Hematology/Oncology, University Hospital Marburg, Marburg; Department of Oncology/ Hematology, University Hospital Dresden, Dresden; Department of Hematology/Oncology, University Hospital Halle, Halle; Department of Hematology/Oncology, University Hospital Mainz, Mainz; and WISP Research Institute, Langenfeld, Germany

Address reprint requests to Nicolaus Kröger, MD, Bone Marrow Transplantation, University Hospital Hamburg-Eppendorf, Martinistrasse 52, D-20246 Hamburg, Germany; e-mail: nkroeger{at}uke.uni-hamburg.de

PURPOSE: To compare progression-free survival between single and tandem high-dose chemotherapy (HDT) followed by autologous stem-cell transplantation in chemotherapy-sensitive metastatic breast cancer patients.

PATIENTS AND METHODS: Between February 1997 and June 2001, 187 patients with complete and partial remission were randomly assigned to receive either one or two cycles of HDT, consisting of thiotepa (125 mg/m²/d for 4 days), cyclophosphamide (1,500 mg/m²/d for 4 days), and carboplatin (200 mg/m²/d for 4 days), followed by autologous stem-cell transplantation.

RESULTS: One hundred seventy one of 187 randomly assigned patients completed first HDT, but only 52 of 85 completed the second HDT cycle in the tandem HDT arm. The rate of complete remission on an intent-to-treat-basis was 33% in the single-dose HDT arm and 37% in the tandem HDT arm (P = .48). The median progression-free survival times in single and tandem HDT arms were 9.4 and 11.2 months, respectively (one-sided P = .06; two one-sided P = .12), whereas median overall survival time tended to be greater after single versus tandem HDT (29 v 23.5 months, respectively; P = .4). In a multivariate analysis for progression-free survival, tandem HDT (hazard ratio [HR] = 0.71; 95% CI, 0.52 to 0.98; P = .03) and achievement of complete remission after induction chemotherapy (HR = 0.59; 95% CI, 0.37 to 0.96; P = .03) were factors for a better progression-free survival, whereas the factor of three or more sites of metastases (HR = 1.66; 95% CI, 1.12 to 2.47; P = .01) was associated with a worse progression-free survival.

CONCLUSION: Despite a trend of improved progression-free survival, tandem HDT cannot be recommended for patients with chemotherapy-sensitive metastatic breast cancer because of a trend for shorter overall survival and higher toxicity compared with single HDT.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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