Title |
Phase 2 Open-Label Trial Investigating Percutaneous Laser Ablation for Treatment of Early-Stage Breast Cancer: MRI, Pathology, and Outcome Correlations
|
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Published in |
Annals of Surgical Oncology, July 2018
|
DOI | 10.1245/s10434-018-6623-2 |
Pubmed ID | |
Authors |
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 |
Abstract |
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. 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. 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%). 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. |
X Demographics
Geographical breakdown
Country | Count | As % |
---|---|---|
United States | 3 | 25% |
Sweden | 1 | 8% |
Mexico | 1 | 8% |
Switzerland | 1 | 8% |
Unknown | 6 | 50% |
Demographic breakdown
Type | Count | As % |
---|---|---|
Members of the public | 6 | 50% |
Science communicators (journalists, bloggers, editors) | 2 | 17% |
Practitioners (doctors, other healthcare professionals) | 2 | 17% |
Scientists | 2 | 17% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 55 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Student > Master | 9 | 16% |
Student > Bachelor | 5 | 9% |
Other | 3 | 5% |
Student > Ph. D. Student | 3 | 5% |
Lecturer | 2 | 4% |
Other | 10 | 18% |
Unknown | 23 | 42% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 13 | 24% |
Nursing and Health Professions | 8 | 15% |
Biochemistry, Genetics and Molecular Biology | 2 | 4% |
Engineering | 2 | 4% |
Sports and Recreations | 1 | 2% |
Other | 3 | 5% |
Unknown | 26 | 47% |