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Annals of Oncology 10:479-481, 1999
© 1999 European Society for Medical Oncology

brief-report

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

H. M. Prince1,, M. J. Millward1, D. Rischin1, D. Blakey2, P. Francis1, P. Gates1, P. Chappie1, M. Quinn1, S. Juneja1, M. Wolf1, E. H. Januszewicz1, J. F. Seymour1, M. Brettell1, A. Strickland1, J. Zalcberg1, G. Richardson3, J. Scarlett3, P. Briggs3 and G. C. Toner1

1Blood and Marrow Transplant Service, Division of Haematology and Medical Oncology Victoria, Australia
2Division of Radiation Oncology, Peter MacCallum Cancer Institute Victoria, Australia
3Department of Medical Oncology and Clinical Haematology, Monash Medical Centre Melbourne, Victoria, Australia

Correspondence to: Dr. H. M. Prince, Blood and Marrow Transplant Service, Division of Haematology and Medical, Oncology, Peter MacCallum Cancer Institute, Locked Bag 1, A'Beckett St., Melbourne 3000, Victoria, Australia. E-mail: mprincefg{at}petermac.unimelb.edu.au

Background: 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).

Patients and methods: The planned treatment was three cycles of high-dose ifosfamide, thiotepa and conventional-dose paclitaxel delivered every 28 days with progressive dose-escalation in successive cohorts. Each cycle was supported by peripheral blood progenitor cells (PBPC) and filgrastim.

Results: Twenty-three patients were entered into this trial. Of the planned 69 treatment cycles, 59 were delivered and fifteen patients completed all three cycles. The dose-limiting toxicities were renal tubular acidosis, encephalopathy, mucositis and enterocolitis. There was one treatment-related hemorrhagic death.

Conclusions: The recommended doses for phase II or III studies are ifosfamide (10 g/m2), thiotepa (350 mg/m2) and paclitaxel (175 mg/m2).

high-dose therapy, ifosfamide, paclitaxel, thiotepa, transplantation


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