ArticlesBreast conserving therapy versus mastectomy for stage I–II breast cancer: 20 year follow-up of the EORTC 10801 phase 3 randomised trial
Introduction
Breast-cancer surgery has improved substantially over the past decades. Up to the 1980s radical mastectomy, usually the Halsted mastectomy, or modified radical mastectomy (MRM) such as the Patey or Madden procedure, was the standard treatment for most patients regardless of the stage of their disease. Gradually, the question arose as to whether the breast could be preserved, especially for small tumours, without compromising survival. The success of moderate-dose radiotherapy for elimination of subclinical foci of disease in the ipsilateral breast allowed the concept of breast-preserving therapy to move forward. Since the 1980s several randomised trials have shown that breast-conserving surgery followed by radiotherapy (or breast-conserving therapy [BCT]), is as effective as mastectomy for the treatment of breast tumours up to 5 cm.1, 2, 3, 4, 5, 6
During the past decade, long-term updates of these trials have been published, assessing the continued effectiveness of BCT. In 2002, Fisher and colleagues and Veronesi and colleagues published the long-term results of the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-06 trial7 and the Milan Cancer Institute trial,8 respectively, comparing BCT and mastectomy. Both studies showed that women with early breast cancer, who were treated with BCT and postoperative radiotherapy to the ipsilateral breast, had higher rates of local recurrence but similar long-term survival when compared with those undergoing radical mastectomy. Of note, the NSABP B-06 and the Milan trials had substantial differences in the patient population (tumour size up to 2 cm or up to 4 cm), breast-conserving operation (quadrantectomy or lumpectomy), and supplemental radiotherapy (boost or no boost delivered).
The European Organisation for Research and Treatment of Cancer (EORTC) 10801 trial was one of the largest randomised trials to compare BCT followed by radiotherapy with MRM for patients with clinical stages I and II operable breast cancer. The study differed from the NSABP B-06 and the Milan trials by treating patients with more advanced disease—696 (80%) patients had tumour sized 2·1–5·0 cm and 357 (41%) patients had positive lymph nodes. Furthermore, microscopic margin involvement was reported in 217 (48%) patients in the BCT group.
The initial results and a long-term update based on a median follow-up of 13·4 years were reported in 19925 and 2000.9 van Dongen and colleagues9 reported that the 10-year locoregional recurrence rate was significantly higher for patients assigned to BCT (20%) than for those after MRM (12%; p=0·0097). This significant difference remained, even after adjustment for important clinicopathological factors such as tumour size, pathological node status, and age. However, no significant difference between the treatment groups was reported for time to distant metastases or overall survival. The unclear trend for these two endpoints towards the end of the follow-up period prompted us to update the follow-up data and undertake an additional long-term analysis with a median follow-up of 22·1 years. As only very few locoregional events were reported in the 9 years follow-up since the previous analysis, we focused on the effect of the higher locoregional recurrence rate in the BCT group on the occurrence of distant metastases and overall survival.
Section snippets
Patients
The EORTC 10801 trial was open for accrual between 1980 and 1986 in eight centres in the UK, the Netherlands, Belgium, and South Africa. The main inclusion criteria were histologically proven invasive breast carcinoma, stage I or II disease,10 which includes tumours 5 cm or smaller and axillary node negative or positive disease (N0=no palpable homolateral axillary lymph nodes; N1A=movable homolateral axillary lymph nodes, not containing growth; N1B=movable homolateral axillary lymph nodes,
Results
902 patients were entered in the trial. As in the previous analysis 34 patients were excluded from this analysis because they were ineligible after a medical review (figure 1). Of the remaining 868 eligible patients, 420 (48%) had been randomly assigned to mastectomy and 448 (52%) to BCT. Adjuvant parasternal-lymph-node radiation was given to 167 (40%) patients in the mastectomy group and 202 (45%) in the BCT group (table 1). Postoperative irradiation of the chest wall after mastectomy was
Discussion
Our update of the EORTC 10801 trial showed no significant difference in either the occurrence of distant metastases or overall survival between BCT plus radiotherapy and mastectomy after a median of 22·1 years, despite the fact that a significant proportion of patients had microscopically incomplete resection in the BCT group.9 Although our study included more patients with a higher tumour stage than the NSABP B-067 and Milan8 trials, our conclusions are in line with the long-term results
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