2020
DOI: 10.1016/s0959-8049(20)30616-x
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Do clinical trials truly mirror their target population? An external validity analysis of national register versus trial data from the Swedish prospective SENOMIC trial on sentinel node micrometastases in breast cancer

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“…28 Unfortunately, the BOOG trial had to be shut down due to insufficient inclusion. SENOMIC trial 29 was dedicated to patients with SN micro-metastasis, treated by BCS or mastectomy, without cALND. Axillary radiotherapy could be performed for patients without cALND, but AMAROS trial failed to demonstrate non-inferiority of axillary radiotherapy in comparison to cALND due to an insufficient number of patients 30 as reported by authors, and the aim for these patients is to avoid axillary dedicated treatment and morbidity of this therapy.…”
Section: Discussionmentioning
confidence: 99%
“…28 Unfortunately, the BOOG trial had to be shut down due to insufficient inclusion. SENOMIC trial 29 was dedicated to patients with SN micro-metastasis, treated by BCS or mastectomy, without cALND. Axillary radiotherapy could be performed for patients without cALND, but AMAROS trial failed to demonstrate non-inferiority of axillary radiotherapy in comparison to cALND due to an insufficient number of patients 30 as reported by authors, and the aim for these patients is to avoid axillary dedicated treatment and morbidity of this therapy.…”
Section: Discussionmentioning
confidence: 99%