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A swab culture of the periprosthetic space – the space between the prosthesis and the breast wall – as well as a definitive mycobacterial culture of the unidentified pathogen isolated from the prosthesis in the initial laboratory were sent to the National Reference Center on Mycobacteria of Pitié-Salpêtrière Pitié-Salpêtrière, France.
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Metastatic disease was defined as recurrence of breast cancer occurring beyond the confines of the ipsilateral breast, chest wall and regional lymph nodes.
The primary end point of the trial was DFS, defined as the time from randomization to the earliest recurrence of the primary disease (in the breast, chest wall, or nodal or distant metastatic sites) or the development of a new primary breast cancer in the contralateral breast.
The primary end point of the trial was disease-free survival (DFS), defined as the time from randomization to first occurrence of: invasive recurrence in ipsilateral breast, chest wall, regional site (internal mammary/axilla), or distant site (including ipsilateral supraclavicular); contralateral breast cancer (invasive); second malignancy (non-breast); or death without prior cancer event.
Local recurrence was defined as tumor arising in the treated breast, chest wall or axilla.
Locoregional recurrences were defined as of the ipsilateral breast, chest wall, axilla or supraclavicular fossa.
All patients received adjuvant radiotherapy to the breast, chest wall and axillary nodes.
Breast, chest wall or lymph node irradiation should be performed with caution, with the aim of limiting the irradiation of healthy tissue, while satisfying quality assurance criteria (standard).
It is suggested that diethylstilboestrol is a useful treatment in patients with soft tissue disease (breast, chest wall and/or lymph nodes).
We previously demonstrated that IMRT provides excellent treatment target coverage while generally reducing the volume of ipsilateral breast, chest wall, lung, and heart exposed to high doses [ 36], and that increased pain correlated with larger chest wall and overall volumes receiving >75%% of the prescribed dose [ 37].
Second, tissue acquisition of breast, chest wall, or axillary disease (two thirds of patients in the current study) as part of therapeutic completion mastectomy and associated surgery may fit with routine clinical practice and be more readily achieved than biopsy of distant metastatic disease.
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