• Annals of surgery · May 2018

    Clinical Trial

    A Clinical Feasibility Trial for Identification of Exceptional Responders in Whom Breast Cancer Surgery Can Be Eliminated Following Neoadjuvant Systemic Therapy.

    • Henry M Kuerer, Gaiane M Rauch, Savitri Krishnamurthy, Beatriz E Adrada, Abigail S Caudle, Sarah M DeSnyder, Dalliah M Black, Lumarie Santiago, Brian P Hobbs, Anthony Lucci, Michael Gilcrease, Rosa F Hwang, Rosalind P Candelaria, Mariana Chavez-MacGregor, Benjamin D Smith, Elsa Arribas, Tanya Moseley, Mediget Teshome, Makesha V Miggins, Vicente Valero, Kelly K Hunt, and Wei T Yang.
    • Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
    • Ann. Surg. 2018 May 1; 267 (5): 946-951.

    ObjectiveTo determine the accuracy of fine-needle aspiration (FNA) and vacuum-assisted core biopsy (VACB) in assessing the presence of residual cancer in the breast after neoadjuvant systemic therapy (NST).Summary Background DataPathologic complete response (pCR) rates after NST have improved dramatically, suggesting that surgery might be avoided in some patients. Safe avoidance of surgery would require accurate confirmation of no residual invasive/in situ carcinoma.MethodsForty patients with T1-3N0-3 triple-negative or HER2-positive cancer receiving NST were enrolled in this single-center prospective trial. Patients underwent ultrasound-guided or mammography-guided FNA and VACB of the initial breast tumor region before surgery. Findings were compared with findings on pathologic evaluation of surgical specimens to determine the performance of biopsy in predicting residual breast disease after NST.ResultsMedian initial clinical tumor size was 3.3 cm (range, 1.2-7.0 cm); 16 patients (40%) had biopsy-proven nodal metastases. After NST, median clinical tumor size was 1.1 cm (range, 0-4.2 cm). Nineteen patients (47.5%) had a breast pCR and were concordant with pathologic nodal status in 97.5%. Combined FNA/VACB demonstrated an accuracy of 98% (95% CI, 87%-100%), false-negative rate of 5% (95% CI, 0%-24%), and negative predictive value of 95% (95% CI, 75%-100%) in predicting residual breast cancer. VACB alone was more accurate than FNA alone (P = 0.011).ConclusionsAfter NST, image-guided FNA/VACB can accurately identify patients with a breast pCR. Based on these results, a prospective clinical trial has commenced in which breast surgery is omitted in patients with a breast pCR after NST according to image-guided biopsy.

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