Efficient reduction of loco-regional recurrences but no effect on mortality twenty years after postmastectomy radiation in premenopausal women with stage II breast cancer - a randomized trial from the South Sweden Breast Cancer Group.
OBJECTIVE
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.


METHODS
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.


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.


CONCLUSIONS
Post-mastectomy radiotherapy reduced loco-regional recurrences in this premenopausal population, but no effect was seen on mortality with 20 years follow-up.
Killander
Fredrika
F
Department of Oncology, Lund University Hospital, Lund, Sweden. fredrika.killander@med.lu.se
Anderson
Harald
H
Rydén
Stefan
S
Möller
Torgil
T
Hafström
L O
LO
Malmström
Per
P
D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage; D001943:Breast Neoplasms / Q000401:mortality / Q000532:radiotherapy* / Q000601:surgery; D003131:Combined Modality Therapy; D003520:Cyclophosphamide / Q000008:administration & dosage; D019583:Dose Fractionation, Radiation; D005260:Female; D006801:Humans; D015411:Mastectomy, Modified Radical; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000453:epidemiology / Q000517:prevention & control*; D016019:Survival Analysis; D013548:Sweden / Q000453:epidemiology
D018906:Antineoplastic Agents, Alkylating; D003520:Cyclophosphamide