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09.07.2018 | Breast Oncology | Ausgabe 10/2018 Open Access

Annals of Surgical Oncology 10/2018

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

Zeitschrift:
Annals of Surgical Oncology > Ausgabe 10/2018
Autoren:
MD Barbara Schwartzberg, MD John Lewin, MD Osama Abdelatif, MD Jacqueline Bernard, MD Hanadi Bu-Ali, Mr Simon Cawthorn, MD Margaret Chen-Seetoo, MD Sheldon Feldman, Miss Sasirekha Govindarajulu, MD Lyn Jones, MD Arne Juette, MD Sanjay Kavia, MD Robert Maganini, Mr Simon Pain, MD Mike Shere, MD Craig Shriver, Mr Simon Smith, MD Alexandra Valencia, MD Eric Whitacre, MD Roger Whitney
Wichtige Hinweise
The original version of this article was revised due to a retrospective Open Access order.
A correction to this article is available online at https://​doi.​org/​10.​1245/​s10434-018-6861-3.

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.

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