Prednimustine, methotrexate, 5-fluorouracil, mitoxantrone and tamoxifen for advanced breast cancer in postmenopausal women. A phase II trial.
A phase II trial in postmenopausal women with advanced breast cancer naive to cytotoxic treatment for recurrent disease was performed with a combinated chemo-endocrine regimen of prednimustine, methotrexate, mitoxantrone, 5-fluorouracil, and tamoxifen. Thus we replaced the most toxic agents--cyclophosphamide and doxorubicin often used in combinations--with prednimustine and mitoxantrone respectively, which are supposed to be equally efficient but less toxic. Seventy-seven patients were registered but 6 were ineligible. Complete response was obtained in 11%, partial response in 29%, no change in 29%, and progressive disease in 31%. Median duration of response was 18.5 months, time to disease progression 9.2 months, and survival 16.0 months. Toxicity was modest; 61% had no or only moderate alopecia not necessitating a wig, 59% had no or only moderate, if any, nausea. Bone marrow suppression, especially thrombopenia, was a major dose limiting factor. This regimen seems to be effective and have low toxicity in advanced breast cancer in postmenopausal women.
Department of Oncology ONA, Finsen Institute, Copenhagen, Denmark.
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M
Andersson
H T
HT
Mouridsen
D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy / Q000601:surgery; D004341:Drug Evaluation; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005500:Follow-Up Studies; D006801:Humans; D008593:Menopause; D008727:Methotrexate / Q000008:administration & dosage; D008875:Middle Aged; D008942:Mitoxantrone / Q000008:administration & dosage; D011238:Prednimustine / Q000008:administration & dosage; D013629:Tamoxifen / Q000008:administration & dosage
D013629:Tamoxifen; D011238:Prednimustine; D008942:Mitoxantrone; D005472:Fluorouracil; D008727:Methotrexate