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Accuracy of core biopsy in predicting pathologic complete response in the breast in patients with complete/near complete clinical and radiological response (Complete Responders in the Breast - CRBr) - Trial design and conduct.

ABSTRACT: Introduction:With the advent of taxanes and targeted agents in neoadjuvant chemotherapy (NACT) for breast cancer, the rates of pathologic complete response (pCR) have been steadily increasing. One of the roles of surgery in these women is to serve as a biopsy to confirm or negate a pCR. Design:This is a prospective validation study. All newly diagnosed non-metastatic breast cancers, of any luminal subtype, planned for neoadjuvant chemotherapy (NACT) with a titanium clip placed in the tumor, will be screened. Eligible patients who have a complete/near complete response to NACT as seen on a mammogram and ultrasound of the breast, will undergo multiple core biopsies of the tumor bed under ultrasound guidance as an outpatient procedure. A minimum of four core biopsy specimens will be mandatory. An MRI will also be done for these patients for documentation and analysis. The core biopsy will be compared to the final histopathology report after definitive surgery. Objectives:The objective is to study the false negative rate and accuracy of ultrasound guided core biopsies of the tumor bed in predicting pCR. Additionally, the correlation of pCR in the breast with axillary response and the incremental benefit of an MRI in predicting pCR will be evaluated. Discussion:The concept of using image guided core biopsies to predict pCR could be useful in designing future studies aimed at avoiding redundant surgery in women with a complete response to NACT. This study is registered with Clinical Trials Registry of India (CTRI/2018/01/011122).

SUBMITTER: Hariharan N

PROVIDER: S-EPMC6921145 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Accuracy of core biopsy in predicting pathologic complete response in the breast in patients with complete/near complete clinical and radiological response (Complete Responders in the Breast - CRBr) - Trial design and conduct.

Hariharan N N Rao T S TS Rajappa S S Naidu C C K CCK Raju K V V N KVVN Koppula V V Murthy S S Kodandapani S S

International journal of surgery protocols 20190525

<h4>Introduction</h4>With the advent of taxanes and targeted agents in neoadjuvant chemotherapy (NACT) for breast cancer, the rates of pathologic complete response (pCR) have been steadily increasing. One of the roles of surgery in these women is to serve as a biopsy to confirm or negate a pCR.<h4>Design</h4>This is a prospective validation study. All newly diagnosed non-metastatic breast cancers, of any luminal subtype, planned for neoadjuvant chemotherapy (NACT) with a titanium clip placed in ...[more]

PMID: 31897442

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Project description:BackgroundTo investigate the association of axillary pathologic complete response (pCR) rate among breast cancer patients with pCR after neoadjuvant chemotherapy (NCT).MethodsThe retrospective clinical data of 1,903 patients who were treated with NCT between March, 2010 and December, 2018, were collected from one Chinese database and analyzed. The correlations between clinicopathological characteristics and breast pCR with axillary pCR were calculated by χ2 test. Binary logistic regression analysis was used for multivariate analysis. The relative risk of positive axillary nodes after NCT in patients with and without breast pCR was analyzed using a Cochran-Mantel-Haenszel (CMH) test stratified by initial N stage and tumor subtype.ResultsThe rate of axillary pCR was increased in the cases with initial cN0, Ki67 high expression, HR+HER2+/HR-HER2+/TN subtypes, and breast pCR. After NCT, the relative risk of nodal disease burden was 4.81 in patients without breast pCR compared with patients with breast pCR. The relative risk of positive nodal status in patients with cN0, cN1, cN2, and cN3 disease without vs. with breast pCR was 6.45, 4.88, 5.69 and 6.24, respectively. The relative risk of positive nodal status in patients with HR+HER2-, HR+HER2+, HR-HER2+, and TN disease was 4.02, 4.50, 3.82 and 4.18, respectively. Of cN0 patients with breast pCR, only 4 out of 44 (9%) with HER2-positive disease had 1 or 2 axillary lymph node metastases at final surgical pathology compared to 30 out of 98 (31%) of those without breast pCR. There was no evidence of positive nodal residue among all 21 patients (100%) with TN disease compared to 65% (36 of 55) of patients without breast pCR.ConclusionsNodal status is strongly correlated with breast pCR after NCT. Patients with initial cN0/1 TN/HER2 positive disease who achieve breast pCR at surgery have a low risk of nodal metastasis. These results suggest that the failure rate of missing positive lymph nodes among those patients was very low and that it is safe for such patients to undergo sentinel lymph node biopsy (SLNB) after NCT. This study also provides a theoretical basis for clinical trials focused on the avoidance of axillary surgery in selected patients.

Project description:ImportanceAfter neoadjuvant chemotherapy (NAC), pathologic complete response (pCR) is an optimal outcome and a surrogate end point for improved disease-free and overall survival. To date, surgical resection remains the only reliable method for diagnosing pCR.ObjectiveTo evaluate the accuracy of magnetic resonance imaging (MRI)-guided biopsy for diagnosing a pCR after NAC compared with reference-standard surgical resection.Design, setting, and participantsSingle-arm, phase 1, nonrandomized controlled trial in a single tertiary care cancer center from September 26, 2017, to July 29, 2019. The median follow-up was 1.26 years (interquartile range, 0.85-1.59 years). Data analysis was performed in November 2019. Eligible patients had (1) stage IA to IIIC biopsy-proven operable invasive breast cancer; (2) standard-of-care NAC; (3) MRI before and after NAC, with imaging complete response defined as no residual enhancement on post-NAC MRI; and (4) definitive surgery. Patients were excluded if they were younger than 18 years, had a medical reason precluding study participation, or had a prior history of breast cancer.InterventionsPost-NAC MRI-guided biopsy without the use of intravenous contrast of the tumor bed before definitive surgery.Main outcomes and measuresThe primary end point was the negative predictive value of MRI-guided biopsy, with true-negative defined as negative results of the biopsy (ie, no residual cancer) corresponding to a surgical pCR. Accuracy, sensitivity, positive predictive value, and specificity were also calculated. Two clinical definitions of pCR were independently evaluated: definition 1 was no residual invasive cancer; definition 2, no residual invasive or in situ cancer.ResultsTwenty of 23 patients (87%) had evaluable data (median [interquartile range] age, 51.5 [39.0-57.5] years; 20 women [100%]; 13 White patients [65%]). Of the 20 patients, pre-NAC median tumor size on MRI was 3.0 cm (interquartile range, 2.0-5.0 cm). Nineteen of 20 patients (95%) had invasive ductal carcinoma; 15 of 20 (75%) had stage II cancer; 11 of 20 (55%) had ERBB2 (formerly HER2 or HER2/neu)-positive cancer; and 6 of 20 (30%) had triple-negative cancer. Surgical pathology demonstrated a pCR in 13 of 20 (65%) patients and no pCR in 7 of 20 patients (35%) when pCR definition 1 was used. Results of MRI-guided biopsy had a negative predictive value of 92.8% (95% CI, 66.2%-99.8%), with accuracy of 95% (95% CI, 75.1%-99.9%), sensitivity of 85.8% (95% CI, 42.0%-99.6%), positive predictive value of 100%, and specificity of 100% for pCR definition 1. Only 1 patient had a false-negative MRI-guided biopsy result (surgical pathology showed <0.02 cm of residual invasive cancer).Conclusions and relevanceThis study's results suggest that the accuracy of MRI-guided biopsy to diagnose a post-NAC pCR approaches that of reference-standard surgical resection. MRI-guided biopsy may be a viable alternative to surgical resection for this population after NAC, which supports the need for further investigation.Trial registrationClinicalTrials.gov Identifier: NCT03289195.

Dataset Information

Accuracy of core biopsy in predicting pathologic complete response in the breast in patients with complete/near complete clinical and radiological response (Complete Responders in the Breast - CRBr) - Trial design and conduct.

Publications

Accuracy of core biopsy in predicting pathologic complete response in the breast in patients with complete/near complete clinical and radiological response (Complete Responders in the Breast - CRBr) - Trial design and conduct.

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