TY - JOUR
T1 - Minimally Invasive Complete Response Assessment of the Breast After Neoadjuvant Systemic Therapy for Early Breast Cancer (MICRA trial): Interim Analysis of a Multicenter Observational Cohort Study
AU - van Loevezijn, Ariane A.
AU - van der Noordaa, Marieke E. M.
AU - van Werkhoven, Erik D.
AU - Loo, Claudette E.
AU - Winter-Warnars, Gonneke A. O.
AU - Wiersma, Terry
AU - van de Vijver, Koen K.
AU - Groen, Emilie J.
AU - Blanken-Peeters, Charlotte F. J. M.
AU - Zonneveld, Bas J. G. L.
AU - Sonke, Gabe S.
AU - van Duijnhoven, Frederieke H.
AU - Vrancken Peeters, Marie-Jeanne T. F. D.
N1 - Funding Information:
This work was supported by research grants from the Dutch Cancer Society (KWF, project NKI 2016-8210, Pink Ribbon 2016-206) and the Dutch Innovation Fund Health insurers (IFZ, project 3.642). GS received institutional research support from AstraZeneca, Merck, Novartis, and Roche. All other authors declare no competing interests.
Funding Information:
The authors thank all patients participating in the MICRA trial, all staff in the participating centers, breast radiologists, and members of the IDMC for their efforts. The authors acknowledge Pink Ribbon, the Dutch Cancer Society and the IFZ for funding the trial. The funders of the study had no role in study design, data collection and analysis, data interpretation, or writing of the report.
Funding Information:
The authors thank all patients participating in the MICRA trial, all staff in the participating centers, breast radiologists, and members of the IDMC for their efforts. The authors acknowledge Pink Ribbon, the Dutch Cancer Society and the IFZ for funding the trial. The funders of the study had no role in study design, data collection and analysis, data interpretation, or writing of the report.
Publisher Copyright:
© 2020, The Author(s).
PY - 2021/6
Y1 - 2021/6
N2 - Background: The added value of surgery in breast cancer patients with pathological complete response (pCR) after neoadjuvant systemic therapy (NST) is uncertain. The accuracy of imaging identifying pCR for omission of surgery, however, is insufficient. We investigated the accuracy of ultrasound-guided biopsies identifying breast pCR (ypT0) after NST in patients with radiological partial (rPR) or complete response (rCR) on MRI. Methods: We performed a multicenter, prospective single-arm study in three Dutch hospitals. Patients with T1–4(N0 or N +) breast cancer with MRI rPR and enhancement ≤ 2.0 cm or MRI rCR after NST were enrolled. Eight ultrasound-guided 14-G core biopsies were obtained in the operating room before surgery close to the marker placed centrally in the tumor area at diagnosis (no attempt was made to remove the marker), and compared with the surgical specimen of the breast. Primary outcome was the false-negative rate (FNR). Results: Between April 2016 and June 2019, 202 patients fulfilled eligibility criteria. Pre-surgical biopsies were obtained in 167 patients, of whom 136 had rCR and 31 had rPR on MRI. Forty-three (26%) tumors were hormone receptor (HR)-positive/HER2-negative, 64 (38%) were HER2-positive, and 60 (36%) were triple-negative. Eighty-nine patients had pCR (53%; 95% CI 45–61) and 78 had residual disease. Biopsies were false-negative in 29 (37%; 95% CI 27–49) of 78 patients. The multivariable associated with false-negative biopsies was rCR (FNR 47%; OR 9.81, 95% CI 1.72–55.89; p = 0.01); a trend was observed for HR-negative tumors (FNR 71% in HER2-positive and 55% in triple-negative tumors; OR 4.55, 95% CI 0.95–21.73; p = 0.058) and smaller pathological lesions (6 mm vs 15 mm; OR 0.93, 95% CI 0.87–1.00; p = 0.051). Conclusion: The MICRA trial showed that ultrasound-guided core biopsies are not accurate enough to identify breast pCR in patients with good response on MRI after NST. Therefore, breast surgery cannot safely be omitted relying on the results of core biopsies in these patients.
AB - Background: The added value of surgery in breast cancer patients with pathological complete response (pCR) after neoadjuvant systemic therapy (NST) is uncertain. The accuracy of imaging identifying pCR for omission of surgery, however, is insufficient. We investigated the accuracy of ultrasound-guided biopsies identifying breast pCR (ypT0) after NST in patients with radiological partial (rPR) or complete response (rCR) on MRI. Methods: We performed a multicenter, prospective single-arm study in three Dutch hospitals. Patients with T1–4(N0 or N +) breast cancer with MRI rPR and enhancement ≤ 2.0 cm or MRI rCR after NST were enrolled. Eight ultrasound-guided 14-G core biopsies were obtained in the operating room before surgery close to the marker placed centrally in the tumor area at diagnosis (no attempt was made to remove the marker), and compared with the surgical specimen of the breast. Primary outcome was the false-negative rate (FNR). Results: Between April 2016 and June 2019, 202 patients fulfilled eligibility criteria. Pre-surgical biopsies were obtained in 167 patients, of whom 136 had rCR and 31 had rPR on MRI. Forty-three (26%) tumors were hormone receptor (HR)-positive/HER2-negative, 64 (38%) were HER2-positive, and 60 (36%) were triple-negative. Eighty-nine patients had pCR (53%; 95% CI 45–61) and 78 had residual disease. Biopsies were false-negative in 29 (37%; 95% CI 27–49) of 78 patients. The multivariable associated with false-negative biopsies was rCR (FNR 47%; OR 9.81, 95% CI 1.72–55.89; p = 0.01); a trend was observed for HR-negative tumors (FNR 71% in HER2-positive and 55% in triple-negative tumors; OR 4.55, 95% CI 0.95–21.73; p = 0.058) and smaller pathological lesions (6 mm vs 15 mm; OR 0.93, 95% CI 0.87–1.00; p = 0.051). Conclusion: The MICRA trial showed that ultrasound-guided core biopsies are not accurate enough to identify breast pCR in patients with good response on MRI after NST. Therefore, breast surgery cannot safely be omitted relying on the results of core biopsies in these patients.
UR - https://www.scopus.com/pages/publications/85097021169
U2 - 10.1245/s10434-020-09273-0
DO - 10.1245/s10434-020-09273-0
M3 - Article
C2 - 33263830
SN - 1068-9265
VL - 28
SP - 3243
EP - 3253
JO - Annals of surgical oncology
JF - Annals of surgical oncology
IS - 6
ER -
SDG 3 Good Health and Well-being