Accuracy of magnetic resonance imaging-guided biopsy to verify breast cancer pathologic complete response after neoadjuvant chemotherapy: A nonrandomized controlled trial Journal Article
| Authors: | Sutton, E. J.; Braunstein, L. Z.; El-Tamer, M. B.; Brogi, E.; Hughes, M.; Bryce, Y.; Gluskin, J. S.; Powell, S.; Woosley, A.; Tadros, A.; Sevilimedu, V.; Martinez, D. F.; Toni, L.; Smelianskaia, O.; Nyman, C. G.; Razavi, P.; Norton, L.; Fung, M. M.; Sedorovich, J. D.; Sacchini, V.; Morris, E. A. |
| Article Title: | Accuracy of magnetic resonance imaging-guided biopsy to verify breast cancer pathologic complete response after neoadjuvant chemotherapy: A nonrandomized controlled trial |
| Abstract: | Importance: After 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. Objective: To 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 Participants: Single-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. Interventions: Post-NAC MRI-guided biopsy without the use of intravenous contrast of the tumor bed before definitive surgery. Main Outcomes and Measures: The 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. Results: Twenty 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 Relevance: This 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 Registration: ClinicalTrials.gov Identifier: NCT03289195. |
| Journal Title: | JAMA Network Open |
| Volume: | 4 |
| Issue: | 1 |
| ISSN: | 2574-3805 |
| Publisher: | American Medical Association |
| Date Published: | 2021-01-01 |
| Start Page: | e2034045 |
| Language: | English |
| DOI: | 10.1001/jamanetworkopen.2020.34045 |
| PUBMED: | 33449096 |
| PROVIDER: | scopus |
| PMCID: | PMC7811182 |
| DOI/URL: | |
| Notes: | Article -- Export Date: 1 March 2021 -- Source: Scopus |
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