High dose versus low dose medroxyprogesterone acetate: a randomized trial in advanced breast cancer |
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| Affiliation: | 1. Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA;2. Department of Pathology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA;3. Department of Dermatology, Yale University, New Haven, Connecticut, USA;4. Department of Biochemistry and Molecular Genetics, Feinberg School of Medicine, Chicago, Illinois, USA;5. Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA;6. Robert H. Lurie Cancer Center, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA;1. Division of Cardiology, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, USA;2. Department of Clinical Pharmacy, University of Michigan, Ann Arbor, Michigan, USA;3. Department of Pharmacology and Clinical Investigation Centre, Pitié-Salpêtrière Hospital, Sorbonne Universite, Paris, France;4. Rogel Cancer Center, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, USA;1. TU Bergakademie Freiberg, Institute of Mineral Processing Machines, Lampadiusstraße 4, D-09599 Freiberg, Germany;2. Loesche GmbH, Hansaallee 243, D-40549 Düsseldorf, Germany;3. LKAB, SE-98186 Kiruna, Sweden;1. Department of Medical Oncology, The Royal Marsden NHS Foundation Trust, London, UK;2. Department of Medical Oncology, Laura and Isaac Perlmutter Cancer Center, NYU Langone Health, New York, NY, USA;3. Unit of Melanoma Medical Oncology, Department of Medical Oncology and Hematology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy;4. Department of Internal Medicine, National and Kapodistrian University of Athens, Athens, Greece;5. Department of Medical Oncology, Hospital Clínic de Barcelona-IDIBAPS, Barcelona, Spain;6. Department of Dermatology, Hospices Civils de Lyon, Pierre Bénite, France;7. Department of Medical Oncology, Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, TX, USA;8. Department of Medical Oncology Oncology Center Sf Nectarie, Craiova, Romania;9. Department of Dermatology, Aix-Marseille University, Hôpital de La Timone, Marseille, France;10. Melanoma Oncology Unit, Veneto Institute of Oncology IOV – IRCCS, Padua, Italy;11. Department of Medical Oncology, General University Hospital Gregorio Marañón and CIBERONC, Madrid, Spain;12. Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, Toronto, ON, Canada;13. Center for Immuno-Oncology, University Hospital of Siena, Siena, Italy;14. Department of Oncology, Churchill Hospital, Oxford, UK;15. Department of Clinical Oncology, Hospital University Virgen Macarena, Seville, Spain;p. Department of Dermatology, Charles University Third Faculty of Medicine and University Hospital Kralovske Vinohrady, Prague, Czech Republic;q. Division of Cancer Services, Gallipoli Medical Research Foundation, University of Queensland, Brisbane, QLD, Australia;r. Department of Medical Oncology, Tasman Health Care, Southport, QLD, Australia;s. Department of Internal Medicine, University of Michigan Rogel Cancer Center, Ann Arbor, MI, USA;t. Department of Internal Medicine, University of Western Australia and Sir Charles Gairdner Hospital, Nedlands, WA, Australia;u. Department of Cutaneous Oncology, H. Lee Moffitt Cancer Center, Tampa, FL, USA;v. Medical Oncology of Melanoma, Sarcoma and Rare Tumors, IEO European Institute of Oncology IRCCS, Milan, Italy;w. Melanoma Institute Australia, The University of Sydney, and Royal North Shore and Mater Hospitals, Sydney, NSW, Australia;x. Oncology Clinical Development, Bristol Myers Squibb, Princeton, NJ, USA;y. Melanoma Cancer Immunotherapy and Development Therapeutics Unit, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples, Italy;z. Oncology Unit, University of Perugia, Perugia, Italy;1. Department of Neurology, University of Heidelberg, Heidelberg, Germany;2. Department of Neurology, University of Halle-Wittenberg, Halle-Saale, Germany;3. Department of Medicine V, Hematology, Oncology and Rheumatology, University of Heidelberg, Heidelberg, Germany;4. Department of Dermatology, University of Heidelberg, Heidelberg, Germany;5. Clinical Cooperation Unit Neurooncology, German Cancer Consortium (DKTK), German Cancer Research Center (DKFZ), Heidelberg, Germany;6. Department of Hematology, Oncology and Palliative Medicine, Ernst von Bergmann Hospital, Potsdam, Germany |
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| Abstract: | ![]()
One hundred and twenty-four patients with advanced breast cancer were randomly allocated to treatment with either low dose (300 mg/day) or high dose (1000 mg/day) oral medroxyprogesterone acetate. The objective response rate was 24% for both treatment groups. For premenopausal patients, responses were achieved in two out of four on low dose and three out of six on high dose therapy (overall 5 out of 10 responders). No significant differences in response were seen in relation to previous endocrine therapy or site of disease. Both treatments were associated with a high incidence of bone pain relief (43 and 52%) but a low objective response rate (13%) in bone. Median response duration (10 vs. 11 months) and survival (13 vs. 11 months) were not significantly different for the two treatments. Both treatments were in general well tolerated, but toxicity was greater with the high dose treatment. Low dose oral medroxyprogesterone acetate is as effective as high dose therapy in the treatment of advanced breast cancer, and is cheaper and less toxic. |
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