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Annals of Surgical Oncology

, Volume 25, Issue 10, pp 2958–2964 | Cite as

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
Breast Oncology

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.

Notes

Acknowledgement

This research received a Grant from Novian Health.

Disclosure

Dr. Schwartzberg is a consultant for Novian Health and the principal investigator in this trial.

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Copyright information

© The Author(s) 2018
Corrected publication October/2018

Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits use, duplication, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license and indicate if changes were made.

Authors and Affiliations

  • Barbara Schwartzberg
    • 1
  • John Lewin
    • 2
  • Osama Abdelatif
    • 3
  • Jacqueline Bernard
    • 4
  • Hanadi Bu-Ali
    • 5
  • Simon Cawthorn
    • 6
  • Margaret Chen-Seetoo
    • 7
  • Sheldon Feldman
    • 8
  • Sasirekha Govindarajulu
    • 6
  • Lyn Jones
    • 6
  • Arne Juette
    • 9
  • Sanjay Kavia
    • 10
  • Robert Maganini
    • 11
  • Simon Pain
    • 9
  • Mike Shere
    • 6
  • Craig Shriver
    • 4
  • Simon Smith
    • 10
  • Alexandra Valencia
    • 6
  • Eric Whitacre
    • 12
  • Roger Whitney
    • 10
  1. 1.Sarah Cannon Research Institute at Rose Medical CenterDenverUSA
  2. 2.Women’s Imaging CenterDenverUSA
  3. 3.Tucson Pathology AssociatesTucsonUSA
  4. 4.Walter Reed National Military Medical CenterBethesdaUSA
  5. 5.Virginia Piper Cancer InstituteSt. PaulUSA
  6. 6.Southmead HospitalBristolUK
  7. 7.Herbert Irving Pavilion, Columbia UniversityNew YorkUSA
  8. 8.Montefiore Einstein Center for Cancer CareBronxUSA
  9. 9.Norfolk and Norwich University HospitalNorwichUK
  10. 10.Broomfield HospitalChelmsfordUK
  11. 11.St. Alexius Breast Care CenterBartlettUSA
  12. 12.Breast Center of Southern ArizonaTucsonUSA

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