Abstract
In 1982 a prospective, multicentre randomized trial of breast preserving surgery for invasive histopathological stage I breast cancer was started in the Uppsala-Orebro health care region in Sweden. After identical preoperative investigation and surgical treatment, patients are randomly allocated to receive postoperative radiation with 54 Gy to the remaining breast for five weeks, or to serve as controls. The primary aim of the trial is to determine whether a standardized surgical technique aiming at local tumour radicality can reduce the rate of local recurrence to an acceptable level without postoperative radiotherapy. In December 1987 a second trial was initiated, with an almost identical design but including women with tumours mammographically 21-30 mm in diameter and with histopathologically negative nodes. The first trial is near the termination of patient accrual. Studies of the cosmetic result and of the psychosocial adjustment after breast conserving therapy as compared with mastectomy have been coupled to the trials. Among 263 patients who answered a questionnaire, 96.5% found the new appearance of the treated breast good or acceptable. The psychosocial adjustment was assessed in semi-structured interviews 4 and 13 months postoperatively in 99 women, 37 of whom underwent breast conserving surgery and the remainder modified radical mastectomy. There was a consistent but statistically non-significant tendency for the conservatively treated women to adjust better. Overall 5% of the women in the conservatively treated group and 22% of the mastectomized women are still suffering substantial psychosocial disturbance after 13 months.