Abstract
Simple SummaryAfter the results of many trials, it is now accepted to omit axillary dissection in selected patients with limited axillary involvement. However, the external validity of these trials is questionable. Our study aimed to evaluate the accuracy of the real French population representativity in the SERC (Sentinelle Envahi et Randomisation du Curage) trial population for patients with breast cancer (BC) associated with sentinel node (SN) micro-metastasis and the differences between the studied population and the real French population. The secondary aim was to compare the French and the Swedish populations of patients with SN micro-metastasis. The findings of our study in addition to the previously demonstrated concordance between the SENOMIC (Sentinelle node Micrometastasis) trial and the Swedish National Breast Cancer Registry (NKBC) populations implied that the results of both the SERC and the SENOMIC trials can be applied to both the French and Swedish real populations.Many trials confirmed the safety of omitting axillary dissection in the selected patients treated for early breast cancer. The external validity of these trials is questionable. Our study aimed to evaluate the accuracy of the French population representativity in the SERC trial and the differences between these two populations as well as comparing the French and the Swedish populations (the SENOMIC trial population and the Swedish National Breast Cancer Registry (NKBC) cohort) of patients with sentinel node (SN) micro-metastasis. A higher rate of smaller tumors and grade 1 tumors was observed in the French cohort when compared to the SERC population. Our findings conclude that both French populations show similar characteristics. Positive non-sentinel node (NSN) rates at completion axillary lymph node dissection (ALND) were 10.28 % and 11.3 % in the SERC trial and French cohort, respectively (p = 0.5). The rate of grade 1 tumors was lower in the SENOMIC trial (16.2%) and in the NKBC cohort (17.4%) compared to the SERC trial population (27.3%) and the French cohort (34.4%). Our findings in addition to the previously demonstrated concordance between the SENOMIC trial and the NKBC populations imply that the results of both the SERC and the SENOMIC trials can be applied to both French and Swedish real populations.
Highlights
Modern medicine relies mainly on randomized controlled trials (RCTs) and systematic reviews to guide the treatment plan
Patients eligible to the criteria of the ACOSOG-Z011 trial were more prevalent in the French cohort (p < 0.001) and this is in accordance with the main objective of the trial aiming to evaluate the safety of omitting cALND in patients undergoing mastectomies and extra-capsular extension
After the results of both the ACOSOG Z0011 and the IBCG 23-01 trials, it is considered safe to omit axillary lymph node dissection (ALND) in SLN positive patients. This had a major impact on clinical practice in breast cancer management and ALND omission was generalized even to the populations of patients under represented in these trials [8,9,13]
Summary
Modern medicine relies mainly on randomized controlled trials (RCTs) and systematic reviews to guide the treatment plan. The results of the NSABP-B-32 trial showed that in patients with early BC and negative sentinel nodes, ALND can be omitted and SLNB (sentinel lymph node biopsy) can be safely performed with no impact on the overall and disease-free survival or regional control [6]. Following this trial, the ACOSOG-Z011 and the IBCSG-23-01 trials with their corresponding 10 year follow-up and 5 year follow-up, respectively, showed that it was safe to omit ALND in patients presenting early BC with one or two positive SNs without extra capsular extension treated conservatively
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