Prednimustine, methotrexate, 5-fluorouracil, mitoxantrone and tamoxifen for advanced breast cancer in postmenopausal women. A phase II trial
Abstract
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.
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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