Background: Assessing the axillary response to neoadjuvant chemotherapy (NACT) in patients with initially node-positive breast cancer is crucial to determine the most appropriate surgical approach. While axillary ultrasound (AUS) is a well-established tool in the upfront surgery setting, its performance after NACT is still questioned. Here, we assess the reliability of AUS in predicting the pathological axillary status after NACT using data from the large prospective multicenter AXSANA trial. 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.
Diagnostic performance of axillary ultrasound after neoadjuvant chemotherapy in initially node-positive breast cancer patients – Results from the prospective AXSANA registry trial / Di Micco, R.; Hartmann, S.; Banys-Paluchowski, M.; De Boniface, J.; Schmidt, E.; Ditsch, N.; Stickeler, E.; Schroth, J.; Karadeniz Cakmak, G.; Hahn, M.; Thill, M.; Lux, M. P.; Kolberg, H. -C.; Rubio, I. T.; Gasparri, M. L.; Kontos, M.; Bonci, E. -A.; Niinikoski, L.; Murawa, D.; Pinto, D.; Peintinger, F.; Schlichting, E.; Nina, H.; Valiyeva Qanimat, H.; Vanhoeij, M.; Rebaza, L.; Kadayaprath, G.; Porpiglia, M.; Gentilini, O. D.; Kuhn, T.. - In: EUROPEAN JOURNAL OF CANCER. - ISSN 0959-8049. - 226:(2025). [10.1016/j.ejca.2025.115607]
Diagnostic performance of axillary ultrasound after neoadjuvant chemotherapy in initially node-positive breast cancer patients – Results from the prospective AXSANA registry trial
Gentilini O. D.Co-ultimo
;
2025-01-01
Abstract
Background: Assessing the axillary response to neoadjuvant chemotherapy (NACT) in patients with initially node-positive breast cancer is crucial to determine the most appropriate surgical approach. While axillary ultrasound (AUS) is a well-established tool in the upfront surgery setting, its performance after NACT is still questioned. Here, we assess the reliability of AUS in predicting the pathological axillary status after NACT using data from the large prospective multicenter AXSANA trial. 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.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
