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Top Line : Do patients with sentinel lymph node positive breast cancer benefit from regional nodal irradiation? The Study : Sure, there are a number of trials addressing this topic, but many were plagued by lower than planned accrual. Here’s another to add to the list. OPTIMAL was a randomized, phase 3 trial from Spain and Portugal designed to test the non-inferiority of whole breast radiation alone in patients with clinically occult node-positive disease after breast conservation surgery and sentinel lymph node biopsy (SLNB). Eligible patients had cT1-2N0 invasive ductal carcinoma and occult lymph node metastasis after breast conservation surgery and SLNB. Most (95%) had ER+ disease. Here’s where the trial took a small detour. Instead of quantifying SLNB nodal burden by counting the number of positive nodes, nodal burden was quantified by CK19 expression. One-step nucleic acid amplification (OSNA) measured the expression of CK19 and calculated a total tumor load (TTL), which is the

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