Quality of life in breast cancer patients aged over 70 years, participating in the EORTC 10850 randomised clinical trial

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Abstract

Mastectomy and breast-conserving treatment have proven equally effective in terms of survival in early breast cancer, but studies continue to provide evidence that patients undergoing breast-conserving procedures have a better quality of life (QOL). Age is not considered to be a contraindication for breast-conserving treatment, but retrospective studies have indicated that elderly patients are less likely to be treated conservatively. In the present study, survival, QOL and treatment preference have been investigated in a multicentre, randomised clinical trial of elderly patients with early breast cancer undergoing mastectomy or tumour excision plus tamoxifen. Eligible patients were aged 70 years or more and had histologically- or cytologically-confirmed operable breast cancer. A QOL questionnaire consisting of 36 items was constructed covering 9 scales assessing different QOL domains. Patients completed their assessment between 2 and 12 months after randomisation. 136 patients (65 in the mastectomy arm and 71 in the local excision arm) from six centres filled out a QOL form during the first year of follow-up. No significant difference in the duration of survival between the two treatment arms was observed when including patients included in the QOL sub-study (P=0.33). Patients undergoing tumour excision and tamoxifen did not differ from those undergoing mastectomy in terms of fatigue, emotional functioning, fear of recurrence, social support, physical functioning and leisure time activities. However, conservatively treated patients reported fewer arm problems (P=0.04) and a shift, although borderline significant, in the direction of a benefit in body image (P=0.06). As QOL seems to be better after conservative treatment, such treatment is to be preferred in both elderly and younger patients.

Introduction

The choice of surgical treatment for breast cancer continues to interest both surgeons and patients. Mastectomy and breast-conserving treatment have proven equally effective in terms of survival, even after loco-regional recurrence of breast cancer [1]. At the same time, studies continue to provide evidence showing that patients undergoing breast-conserving procedures have a better quality of life (QOL), especially in terms of body image, in the short- as well as the long-term 2, 3, 4.

Age alone need not be a factor that modifies a cancer treatment plan 5, 6. Even though age is not considered to be a contraindication for breast-conserving treatment [7], several retrospective studies have indicated that elderly patients are less likely to be treated conservatively 8, 9, 10, 11. It is unclear why this is the case. Surgical treatment may be selected for elderly patients for arbitrary reasons rather than based on empirical evidence [12]. This might occur because little empirical evidence supporting treatment policy in these patients is available: they are generally excluded from clinical trials [13] and few trials have specifically addressed the effectiveness of cancer treatments among elderly patients.

In the present study, survival, QOL and treatment preference have been investigated in a multicentre, randomised clinical trial of elderly patients with early breast cancer undergoing mastectomy or tumour excision plus tamoxifen. The results of the trial may support evidence-based decision-making in the surgical treatment of elderly breast cancer patients.

Section snippets

Study design

This multicentre, randomised study comparing mastectomy and tumour excision plus tamoxifen in breast cancer patients over 70 years was conducted by the European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Cooperative Group (10850). The endpoints of the study were survival, QOL and treatment preference. Randomisation was by the minimisation technique [14], stratifying patients according to their institution and TNM stage.

Eligible patients were aged 70 years or more

Patients

Between September 1985 and October 1991, 236 patients from 11 centres were entered into EORTC trial 10850; 120 patients were randomised into the radical mastectomy arm and 116 into the local excision+tamoxifen arm. For 5 patients, no on-study form or any follow-up data were received (4 in the mastectomy arm and 1 in the local excision+tamoxifen arm). In total, 136 patients (65 in the mastectomy arm and 71 in the local excision arm) from six centres that collected QOL data, filled out at least

Conclusions

Few clinical trials have been undertaken to establish the level of effectiveness of treatment in elderly breast cancer patients. As a result, these patients may be treated for arbitrary reasons. In the present trial, the effect of conservative breast cancer surgery and radical mastectomy was compared and it was found that survival was similar after the two procedures. QOL thus becomes the main endpoint to support decision-making. As QOL seems to be better after conservative treatment, on the

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