Author(s): Killander F, Anderson H, Rydn S, Mller T, Hafstrm LO,
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Abstract PURPOSE: To study long term loco-regional and distant recurrence rate and survival after post-mastectomy radiotherapy in combination with oral cyclophosphamide in premenopausal women with stage II breast cancer. STUDY DESIGN: A three-armed randomized multicenter phase III trial comparing 1) Radiotherapy (RT) 2) RT+ oral cyclophosphamide for one year (RT+C) and 3) Oral cyclophosphamide only (C). Radiotherapy was administered, in 20 fractions, to 48Gy to the axilla and parasternal lymph nodes, 45Gy to infra- and supraclavicular fossae and 38Gy to the chest wall. Cyclophosphamide was prescribed as 12 courses of 130mg/m(2) od for 14 days every 4 weeks. PATIENTS AND METHODS: 367 patients from 15 surgical departments in Southern Sweden, representing 80\% of all eligible patients, were included in the trial between 1978-1983. Median age was 47 years, median tumour size was 25mm, and 33\% of the patients were lymph node negative. Median follow-up time was 24 years. RESULTS: RT reduced the risk at twenty years for loco-regional recurrence in C-treated patients at twenty years with 75\% (13.9\% vs. 3.5\%). The risk reduction was highly significant in both N0 and N+ patients. No reduction in systemic disease or mortality was observed. CONCLUSION: Post-mastectomy radiotherapy reduced loco-regional recurrences in this premenopausal population, but no effect was seen on mortality with 20 years follow-up.
This article was published in Breast
and referenced in Atherosclerosis: Open Access