Phase 2 Open-Label Trial Investigating Percutaneous Laser Ablation for Treatment of Early-Stage Breast Cancer: MRI, Pathology, and Outcome Correlations

Barbara Schwartzberg, John Lewin, Osama Abdelatif, Jacqueline Bernard, Hanadi Bu-Ali, Simon Cawthorn, Margaret Chen-Seetoo, Sheldon Feldman, Sasirekha Govindarajulu, Lyn Jones, Arne Juette, Sanjay Kavia, Robert Maganini, Simon Pain, Mike Shere, Craig Shriver, Simon Smith, Alexandra Valencia, Eric Whitacre, Roger Whitney

Research output: Contribution to journalArticle

4 Scopus citations

Abstract

Background: An institutional review board-approved, multicenter clinical trial was designed to determine the efficacy and outcome of percutaneous laser ablation (PLA) in the treatment of invasive ductal breast carcinoma (IDC). Post-ablation magnetic resonance imaging (MRI) was compared with surgical pathology in evaluation of residual post-ablation IDC and ductal carcinoma in situ. Methods: Patients with a single focus of IDC 20 mm or smaller by pre-ablation MRI were treated with PLA. The patients underwent a 28-day post-ablation MRI, followed by surgical resection. Cell viability criteria were applied to pre- and post-ablation pathology specimens, which evaluated hematoxylin–eosin (H&E), cytokeratin (CK) 8/18, estrogen receptor, and Ki67 staining patterns. Results: In this study, 61 patients were reported as the intention-to-treat cohort for determination of PLA efficacy. Of these 61 patients, 51 (84%) had complete tumor ablation confirmed by pathology analysis. One subject’s MRI imaging was not performed per protocol, which left 60 subjects evaluable for MRI pathology correlation. Five patients (8.3%) had residual IDC shown by both MRI and pathology. Post-ablation discordance was noted between MRI and pathology, with four patients (6.7%) false-positive and four patients (6.7%) false-negative. The negative predictive value (NPV) of MRI for all the patients was 92.2% (95% confidence interval [CI], 71.9–91.9%). Of the 47 patients (97.9%) with tumors 15 mm or smaller, 46 were completely ablated, with an MRI NPV of 97.7% (95% CI, 86.2–99.9%). Conclusions: Percutaneous laser ablation is a potential alternative to surgery for treatment of early-stage IDC. Strong correlations exist between post-ablation MRI and pathologic alterations in CK8/18, ER, and Ki67 staining.

Original languageEnglish (US)
Pages (from-to)2958-2964
Number of pages7
JournalAnnals of Surgical Oncology
Volume25
Issue number10
DOIs
StatePublished - Oct 1 2018

ASJC Scopus subject areas

  • Surgery
  • Oncology

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    Schwartzberg, B., Lewin, J., Abdelatif, O., Bernard, J., Bu-Ali, H., Cawthorn, S., Chen-Seetoo, M., Feldman, S., Govindarajulu, S., Jones, L., Juette, A., Kavia, S., Maganini, R., Pain, S., Shere, M., Shriver, C., Smith, S., Valencia, A., Whitacre, E., & Whitney, R. (2018). Phase 2 Open-Label Trial Investigating Percutaneous Laser Ablation for Treatment of Early-Stage Breast Cancer: MRI, Pathology, and Outcome Correlations. Annals of Surgical Oncology, 25(10), 2958-2964. https://doi.org/10.1245/s10434-018-6623-2