European journal of cancer : official journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)
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Randomized Controlled Trial Multicenter Study Clinical Trial
Quality of life of early-stage breast cancer patients treated with radical mastectomy or breast-conserving procedures: results of EORTC Trial 10801. The European Organization for Research and Treatment of Cancer (EORTC), Breast Cancer Co-operative Group (BCCG).
In 1980 the EORTC-BCCG initiated a multicentre randomised clinical trial comparing modified radical mastectomy (MRM) with breast-conserving therapy (BCT) in stage I and II breast cancer. The main endpoint of the trial was survival. A brief quality of life (QoL) questionnaire consisting of two multi-item scales (body image and fear of recurrence) and two single items (satisfaction with treatment and cosmetic result) was included in the trial. ⋯ Ratings of cosmetic results decreased with time, in line with clinical observations of long-term side-effects of radiotherapy. Wide excision appeared to be the most important predictive factor for poor cosmetic result. In this multicentre randomised study, BCT helped to maintain the patients' body image, resulted in higher satisfaction with treatment and yielded no significant difference from MRM with respect to fear of recurrence.