Diagnostic performance of axillary ultrasound after neoadjuvant chemotherapy in initially node-positive breast cancer patients - Results from the prospective AXSANA registry trial.
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Di Micco Rosa, Hartmann Steffi, Banys-Paluchowski Maggie, de Boniface Jana, Schmidt Esther, Ditsch Nina, Stickeler Elmar, Schroth Jennifer, Karadeniz Cakmak Guldeniz, Hahn Markus, Thill Marc, Lux Michael Patrick, Kolberg Hans-Christian, Rubio Isabel T, Gasparri Maria Luisa, Kontos Michalis, Bonci Eduard-Alexandru, Niinikoski Laura, Murawa Dawid, Pinto David, Peintinger Florentia, Schlichting Ellen, Nina Helidon, Valiyeva Qanimat Hagigat, Vanhoeij Marian, Rebaza Lia, Kadayaprath Geeta, Porpiglia Mauro, Gentilini Oreste Davide, Kühn Thorsten, AXSANA Study Group
Аннотация
METHODS: Between June 1, 2020, and May 31, 2024, 5.559 patients were enrolled in the AXSANA trial. For this analysis, patients with clinically node-positive breast cancer who underwent AUS after NACT were eligible. AUS`s sensitivity, specificity, positive (PPV) and negative predictive value (NPV) were analyzed using surgical staging as reference.
FINDINGS: 3840 patients were eligible for this analysis. Of these, 3428(89.3 %) patients underwent preoperative AUS after NACT, classified as unclear in 168(4.9 %), positive in 1060(30.9 %) and negative in 2200 (64.2 %). An axillary pathological complete response (pCR) was achieved in 1793(55.0 %). Nodal metastases were detected in 786 of 2200 patients (35.7 %) with an negative AUS, while 379(35.8 %) of 1060 patients with a positive AUS achieved an axillary pCR. AUS sensitivity was 46.4 %(95 % CI 43.8 %-49.0 %), specificity 78.9 %(76.9 %-80.7 %), PPV 64.2 %(61.3 %-67.1 %), and NPV 64.3 %(62.2 %-66.3 %). PPV was highest for HR+ /HER2- tumors (81.9 %, 78.9 %-85.2 %), NPV for HR-/HER2 + tumors (88.3 %, 84.2 %-91.7 %). Triple negative and HER2 + subtypes were significantly less frequently associated with false-negative AUS results than an HR+ /HER2- cancer.
INTERPRETATION: AUS alone does not reliably predict pathological nodal status. Axillary lymph node dissection based on positive AUS findings after NACT results in surgical overtreatment. Surgical axillary staging after NACT remains essential for the accurate assessment of axillary lymph node status in patients with initially node-positive breast cancer.