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Breast Cancer

Repetitive high-dose therapy with cyclophosphamide, thiotepa and docetaxel with peripheral blood progenitor cell and filgrastim support for metastatic and locally advanced breast cancer: results of a phase I study

Bone Marrow Transplantation volume 26, pages 955–961 (2000)Cite this article

Abstract

This phase I study was designed to determine the optimal dosages of a novel repetitive high-dose therapy regimen for patients with metastatic breast cancer (MBC). The planned treatment was three cycles of high-dose cyclophosphamide, thiotepa and docetaxel delivered every 35 days with progressive dose-escalation in successive cohorts. Each cycle was supported by peripheral blood progenitor cells (PBPC) and filgrastim. Eighteen patients were entered into this trial. Of the planned 54 treatment cycles, 44 were delivered and 11 patients completed all three cycles. The dose-limiting toxicities were interstitial pneumonitis and mucositis with moderately severe diarrhea (n = 3) and rash (n = 3). There were no treatment-related deaths. Of the 17 patients with evaluable disease, 16 patients responded with six patients achieving a complete remission and an additional four patients achieving no detectable disease (negative re-staging including PET scan) but a persistently abnormal bone scan. At a median follow-up of 12 months, median progression-free survival was 11 months with the median overall survival not reached. The recommended doses for phase II/III studies are cyclophosphamide (4 g/m2), thiotepa (300 mg/m2) and docetaxel (100 mg/m2). Bone Marrow Transplantation (2000) 26, 955–961.

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Acknowledgements

We wish to thank Rhône-Poulenc Rorer Australia, Pty Ltd for their generous support of this study. We also wish to thank the research nurses, apheresis nurses, visiting nursing service, allied health staff and the nursing staff on the Hematology and Day Wards at Peter MacCallum Cancer Institute for their commitment, dedication and expert patient care.

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Authors and Affiliations

  1. Division of Haematology and Medical Oncology, Blood and Marrow Transplant Service, Peter MacCallum Cancer Institute, Melbourne, Victoria, Australia

    HM Prince, D Rischin, GC Toner, JF Seymour, D Blakey, P Gates, S Eerhard, P Chapple, M Quinn, M Brettell, S Juneja, M Wolf & EH Januszewicz

  2. Department of Medical Oncology and Clinical Haematology, Monash Medical Centre, Melbourne, Victoria, Australia

    G Richardson, J Scarlett & P Briggs

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Prince, H., Rischin, D., Toner, G. et al. Repetitive high-dose therapy with cyclophosphamide, thiotepa and docetaxel with peripheral blood progenitor cell and filgrastim support for metastatic and locally advanced breast cancer: results of a phase I study. Bone Marrow Transplant 26, 955–961 (2000). https://doi.org/10.1038/sj.bmt.1702650

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