27 Citations (Scopus)

Abstract

Objective: To 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 Data: Pathologic 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. Methods: Forty 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. Results: Median initial clinical tumor size was 3.3cm (range, 1.2-7.0cm); 16 patients (40%) had biopsy-proven nodal metastases. After NST, median clinical tumor size was 1.1cm (range, 0-4.2cm). 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). Conclusions: After 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.

Original languageEnglish (US)
Pages (from-to)946-951
Number of pages6
JournalAnnals of surgery
Volume267
Issue number5
DOIs
StatePublished - May 1 2018

Fingerprint

Neoadjuvant Therapy
Vacuum
Fine Needle Biopsy
Clinical Trials
Breast Neoplasms
Biopsy
Breast
Residual Neoplasm
Image-Guided Biopsy
Neoplasms
Breast Diseases
Carcinoma in Situ
Mammography
Neoplasm Metastasis

Keywords

  • breast cancer
  • breast imaging
  • neoadjuvant
  • prospective clinical trial
  • surgery

ASJC Scopus subject areas

  • Surgery

Cite this

@article{b381ffd831c5459098adfec0e1502784,
title = "A Clinical Feasibility Trial for Identification of Exceptional Responders in Whom Breast Cancer Surgery Can Be Eliminated Following Neoadjuvant Systemic Therapy",
abstract = "Objective: To 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 Data: Pathologic 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. Methods: Forty 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. Results: Median initial clinical tumor size was 3.3cm (range, 1.2-7.0cm); 16 patients (40{\%}) had biopsy-proven nodal metastases. After NST, median clinical tumor size was 1.1cm (range, 0-4.2cm). 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). Conclusions: After 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.",
keywords = "breast cancer, breast imaging, neoadjuvant, prospective clinical trial, surgery",
author = "Kuerer, {Henry M.} and Rauch, {Gaiane M.} and Savitri Krishnamurthy and Adrada, {Beatriz E.} and Caudle, {Abigail S.} and Desnyder, {Sarah M.} and Black, {Dalliah M.} and Lumarie Santiago and Hobbs, {Brian P.} and Anthony Lucci and Michael Gilcrease and Hwang, {Rosa F.} and Candelaria, {Rosalind P.} and Mariana Chavez-Macgregor and Smith, {Benjamin D.} and Elsa Arribas and Tanya Moseley and Mediget Teshome and Miggins, {Makesha V.} and Vicente Valero and Hunt, {Kelly K.} and Yang, {Wei T.}",
year = "2018",
month = "5",
day = "1",
doi = "10.1097/SLA.0000000000002313",
language = "English (US)",
volume = "267",
pages = "946--951",
journal = "Annals of Surgery",
issn = "0003-4932",
publisher = "Lippincott Williams and Wilkins",
number = "5",

}

TY - JOUR

T1 - A Clinical Feasibility Trial for Identification of Exceptional Responders in Whom Breast Cancer Surgery Can Be Eliminated Following Neoadjuvant Systemic Therapy

AU - Kuerer, Henry M.

AU - Rauch, Gaiane M.

AU - Krishnamurthy, Savitri

AU - Adrada, Beatriz E.

AU - Caudle, Abigail S.

AU - Desnyder, Sarah M.

AU - Black, Dalliah M.

AU - Santiago, Lumarie

AU - Hobbs, Brian P.

AU - Lucci, Anthony

AU - Gilcrease, Michael

AU - Hwang, Rosa F.

AU - Candelaria, Rosalind P.

AU - Chavez-Macgregor, Mariana

AU - Smith, Benjamin D.

AU - Arribas, Elsa

AU - Moseley, Tanya

AU - Teshome, Mediget

AU - Miggins, Makesha V.

AU - Valero, Vicente

AU - Hunt, Kelly K.

AU - Yang, Wei T.

PY - 2018/5/1

Y1 - 2018/5/1

N2 - Objective: To 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 Data: Pathologic 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. Methods: Forty 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. Results: Median initial clinical tumor size was 3.3cm (range, 1.2-7.0cm); 16 patients (40%) had biopsy-proven nodal metastases. After NST, median clinical tumor size was 1.1cm (range, 0-4.2cm). 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). Conclusions: After 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.

AB - Objective: To 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 Data: Pathologic 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. Methods: Forty 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. Results: Median initial clinical tumor size was 3.3cm (range, 1.2-7.0cm); 16 patients (40%) had biopsy-proven nodal metastases. After NST, median clinical tumor size was 1.1cm (range, 0-4.2cm). 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). Conclusions: After 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.

KW - breast cancer

KW - breast imaging

KW - neoadjuvant

KW - prospective clinical trial

KW - surgery

UR - http://www.scopus.com/inward/record.url?scp=85019718572&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85019718572&partnerID=8YFLogxK

U2 - 10.1097/SLA.0000000000002313

DO - 10.1097/SLA.0000000000002313

M3 - Article

C2 - 28549010

AN - SCOPUS:85019718572

VL - 267

SP - 946

EP - 951

JO - Annals of Surgery

JF - Annals of Surgery

SN - 0003-4932

IS - 5

ER -