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Title: | 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. | Authors: | Briggs P. ;Brettell M.;Juneja S.;Wolf M.;Januszewicz E.H.;Richardson G.;Scarlett J.;Prince H.M.;Rischin D.;Toner G.C.;Seymour J.F.;Blakey D.;Gates P.;Eerhard S.;Chapple P.;Quinn M. | Institution: | (Prince, Rischin, Toner, Seymour, Blakey, Gates, Eerhard, Chapple, Quinn, Brettell, Juneja, Wolf, Januszewicz) Blood and Marrow Transplant Service, Division of Haematology and Medical Oncology, Peter MacCallum Cancer Institute, Melbourne, Vic., Australia (Richardson, Scarlett, Briggs) Department of Medical Oncology and Clinical Haematology, Monash Medical Centre, Melbourne, Vic., Australia | Issue Date: | 20-Oct-2012 | Copyright year: | 2000 | Publisher: | Nature Publishing Group (Houndmills, Basingstoke, Hampshire RG21 6XS, United Kingdom) | Place of publication: | United Kingdom | Publication information: | Bone Marrow Transplantation. 26 (9) (pp 955-961), 2000. Date of Publication: 2000. | 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 restaging 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). | DOI: | http://monash.idm.oclc.org/login?url=http://dx.doi.org/10.1038/sj.bmt.1702650 | PubMed URL: | 11100274 [http://www.ncbi.nlm.nih.gov/pubmed/?term=11100274] | ISSN: | 0268-3369 | URI: | https://repository.monashhealth.org/monashhealthjspui/handle/1/33380 | Type: | Article | Subjects: | advanced cancer/th [Therapy] article bone scintiscanning *breast cancer/dt [Drug Therapy] *breast cancer/th [Therapy] breast metastasis/dt [Drug Therapy] breast metastasis/th [Therapy] cancer localization cancer regression cancer staging cancer survival clinical article clinical trial cohort analysis controlled clinical trial controlled study cytapheresis diarrhea/si [Side Effect] dose response *hematopoietic stem cell transplantation human interstitial pneumonia/si [Side Effect] mucosa inflammation/si [Side Effect] *peripheral blood stem cell phase 1 clinical trial positron emission tomography priority journal rash/si [Side Effect] *cyclophosphamide/ae [Adverse Drug Reaction] *cyclophosphamide/ct [Clinical Trial] *cyclophosphamide/do [Drug Dose] *cyclophosphamide/dt [Drug Therapy] *docetaxel/ae [Adverse Drug Reaction] *docetaxel/ct [Clinical Trial] *docetaxel/do [Drug Dose] *docetaxel/dt [Drug Therapy] mesna/do [Drug Dose] mesna/dt [Drug Therapy] *recombinant granulocyte colony stimulating factor/ct [Clinical Trial] *recombinant granulocyte colony stimulating factor/sc [Subcutaneous Drug Administration] *thiotepa/ae [Adverse Drug Reaction] *thiotepa/ct [Clinical Trial] *thiotepa/do [Drug Dose] *thiotepa/dt [Drug Therapy] follow up adult advanced cancer/dt [Drug Therapy] clinical trial cohort analysis controlled clinical trial controlled study cytapheresis diarrhea / side effect dose response follow up *hematopoietic stem cell transplantation human interstitial pneumonia / side effect mucosa inflammation / side effect *peripheral blood stem cell phase 1 clinical trial positron emission tomography priority journal article advanced cancer / drug therapy / therapy adult rash / side effect bone scintiscanning *breast cancer / *drug therapy / *therapy breast metastasis / drug therapy / therapy cancer localization cancer regression cancer staging cancer survival clinical article |
Type of Clinical Study or Trial: | Observational study (cohort, case-control, cross sectional or survey) |
Appears in Collections: | Articles |
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