Elsevier

European Journal of Cancer

Volume 34, Issue 3, February 1998, Pages 307-314
European Journal of Cancer

Original Paper
Quality of life of early-stage breast cancer patients treated with radical mastectomy or breast-conserving procedures: results of EORTC trial 10801

https://doi.org/10.1016/S0959-8049(97)00312-2Get rights and content

Abstract

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. A cosmetic evaluation of the breast after conservative surgery was also performed. This report concentrates on the results of the QoL study and the cosmetic evaluation. Multitrait scaling analysis was employed to verify the hypothesised scale structure of the questionnaire. Treatment comparison of the QoL scores at 2 years post-treatment was performed using a stratified Wilcoxon rank sum test. Both patients’ and doctors’ ratings of the cosmetic result were documented on the clinical follow-up form. A multivariate analysis was performed to identify which factors influenced the cosmetic outcome. In total, 127 patients in the MRM arm and 151 in the BCT arm completed a QoL questionnaire at approximately 2 years after randomisation (months 25–36). The Cronbach’s alpha coefficients were 0.79 and 0.73 for the body image and fear of recurrence scales, respectively. Significant benefit in body image and satisfaction with treatment was observed in the BCT patients. No significant difference was observed in fear of recurrence between the two groups. 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.

Introduction

Breast-conserving therapy (BCT) is now a well-established alternative to mastectomy for the treatment of early-stage breast cancer. Several randomised clinical trials from Europe and North America have confirmed that BCT and more radical procedures yield similar results for survival1, 2, 3, 4, 5, 6. An overview, which included almost 5000 patients, demonstrated that the 10-year survival was approximately equivalent for the two treatment strategies[7]. Breast irradiation after lumpectomy reduces the risk of a recurrence of tumour in the breast[6]. In addition, contrary to the thinking of Halsted[8], adjuvant chemotherapy has been confirmed to prolong disease-free survival and overall survival[9].

Since the first publication of clinical trials describing no difference between BCT and modified radical mastectomy (MRM) with respect to duration of survival10, 11, the discussion of the physical, psychological, social, occupational, and sexual impact of the different modalities of treatment has continued. Initially, the general belief was that BCT would provide more benefits because of the physical and emotional importance a woman attaches to her breasts[12]. However, in reviews of the literature13, 14, conflicting results regarding psychological well-being, fear of recurrence, social adjustment and physical dysfunction were reported for these two patient populations. An extensive overview of previous studies comparing BCT and MRM, which were limited by the relatively small numbers of patients included and by the percentage of non-randomised trials, has been previously published13, 14. These studies were primarily single-institution trials in which the selection of patients, eligibility criteria and surgical procedures were variable. In addition, most of the studies were retrospective evaluations with a wide range of instruments being used to assess quality of life (QoL).

In 1978 Pierquin and associates[15]and Calle and associates[16]demonstrated promising possibilities for BCT in both stage I and II breast cancer. Considering these results were shown in large tumours as well15, 16, the European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Cooperative Group (BCCG) initiated a prospective, randomised, multicentre clinical trial (EORTC trial 10801) comparing mastectomy with BCT (lumpectomy, axillary clearance and radiotherapy of the breast: 50 Gy external irradiation in 5 weeks followed by boost with an iridium implant of 25 Gy) in patients with both stage I and II breast cancer. 902 patients were entered in the study between 1980 and 1986. To date, the survival duration and local recurrence rates are not significantly different for the two treatment arms. A detailed description of the study design, eligibility criteria, patient characteristics and clinical treatment comparisons have been previously published[4]. The purpose of this paper is to describe the experience of the EORTC-BCCG with respect to assessing QoL in this trial. The focus is mainly on body image, fear of recurrence of the disease, satisfaction with treatment and the cosmetic results as judged both by the patient and the physician.

Section snippets

Patients and methods

Randomisation was carried out using the minimisation technique, stratifying patients according to their institution, stage and menopausal status[17]. Randomisation was performed centrally at the EORTC Data Center in Brussels. In the first two years, randomisation was done using a 1:2 ratio as it was planned to share the control arm (MRM) with another European study. After 1982 the study plans had to be modified and the randomisation ratio was changed to adjust further randomisation. The main

Results

Between May 1980 and May 1986, 902 patients were entered into EORTC trial 10801, 436 patients were randomised into the MRM arm and 466 into the BCT arm (local excision + axillary dissection with external irradiation and iridium implant). 29 patients were considered to be ineligible on review (equally distributed between both treatment arms), the main reasons being a too advanced tumour situation or an incorrect diagnosis. For 1 other patient we received no onstudy form.

In total, 278 patients (127

Discussion

In this paper we have reported the results of a QoL investigation carried out as part of a large, multicentre, randomised trial comparing BCT with MRM in the treatment of early-stage breast cancer. Specific QoL domains assessed included body image, fear of disease recurrence and overall treatment satisfaction. Additionally, ratings of the cosmetic results of BCT were elicited from both patients and clinicians. The low compliance rate of 33% observed for the QoL evaluation in this trial reflects

Acknowledgements

The EORTC Data Center is grateful to the Parthenon Trust which provided support for this research.

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