Sentinelnode invasion: Is it necessary to perform axillary lymph node dissection? Randomized trial SERC [Ganglion sentinelle envahi: Faut-il faire le curage ou pas? Essai randomisé SERC]

摘要

Contribution of axillary lymph node dissection (ALND) is questioned for positive sentinel node (SN), micro-metastasis and isolated tumor cells but also for macro-metastasis. The aim of this work is to precise why a prospective randomized trial is necessary and the design of this trial. Why? For positive SN, the scientific level evidence appears insufficient for validation of ALND omission as a new standard. Rational is presented with non-sentinel node involved rate and number of NSL involved at complementary ALND, axillary recurrence rate, disease free survival rate and adjuvant treatment decision impact. How? The proposed Sentinelle Envahi et Randomisation du Curage (SERC) trial will randomly assign to observation only or complementary ALND with positive SN. The aim is to demonstrate the non-inferiority of ALND omission versus ALND.