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 M. 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

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)1-7
Number of pages7
JournalAnnals of Surgical Oncology
DOIs
StateAccepted/In press - Jul 9 2018

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Laser Therapy
Magnetic Resonance Imaging
Pathology
Breast Neoplasms
Carcinoma, Ductal, Breast
Therapeutics
Confidence Intervals
Keratin-8
Staining and Labeling
Keratin-18
Surgical Pathology
Carcinoma, Intraductal, Noninfiltrating
Research Ethics Committees
Estrogen Receptors
Multicenter Studies
Neoplasms
Cell Survival
Clinical Trials

ASJC Scopus subject areas

  • Surgery
  • Oncology

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Phase 2 Open-Label Trial Investigating Percutaneous Laser Ablation for Treatment of Early-Stage Breast Cancer : MRI, Pathology, and Outcome Correlations. / Schwartzberg, Barbara; Lewin, John; Abdelatif, Osama; Bernard, Jacqueline; Bu-Ali, Hanadi; Cawthorn, Simon; Chen-Seetoo, Margaret; Feldman, Sheldon M.; Govindarajulu, Sasirekha; Jones, Lyn; Juette, Arne; Kavia, Sanjay; Maganini, Robert; Pain, Simon; Shere, Mike; Shriver, Craig; Smith, Simon; Valencia, Alexandra; Whitacre, Eric; Whitney, Roger.

In: Annals of Surgical Oncology, 09.07.2018, p. 1-7.

Research output: Contribution to journalArticle

Schwartzberg, B, Lewin, J, Abdelatif, O, Bernard, J, Bu-Ali, H, Cawthorn, S, Chen-Seetoo, M, Feldman, SM, 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, pp. 1-7. https://doi.org/10.1245/s10434-018-6623-2
Schwartzberg, Barbara ; Lewin, John ; Abdelatif, Osama ; Bernard, Jacqueline ; Bu-Ali, Hanadi ; Cawthorn, Simon ; Chen-Seetoo, Margaret ; Feldman, Sheldon M. ; Govindarajulu, Sasirekha ; Jones, Lyn ; Juette, Arne ; Kavia, Sanjay ; Maganini, Robert ; Pain, Simon ; Shere, Mike ; Shriver, Craig ; Smith, Simon ; Valencia, Alexandra ; Whitacre, Eric ; Whitney, Roger. / Phase 2 Open-Label Trial Investigating Percutaneous Laser Ablation for Treatment of Early-Stage Breast Cancer : MRI, Pathology, and Outcome Correlations. In: Annals of Surgical Oncology. 2018 ; pp. 1-7.
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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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T1 - Phase 2 Open-Label Trial Investigating Percutaneous Laser Ablation for Treatment of Early-Stage Breast Cancer

T2 - MRI, Pathology, and Outcome Correlations

AU - Schwartzberg, Barbara

AU - Lewin, John

AU - Abdelatif, Osama

AU - Bernard, Jacqueline

AU - Bu-Ali, Hanadi

AU - Cawthorn, Simon

AU - Chen-Seetoo, Margaret

AU - Feldman, Sheldon M.

AU - Govindarajulu, Sasirekha

AU - Jones, Lyn

AU - Juette, Arne

AU - Kavia, Sanjay

AU - Maganini, Robert

AU - Pain, Simon

AU - Shere, Mike

AU - Shriver, Craig

AU - Smith, Simon

AU - Valencia, Alexandra

AU - Whitacre, Eric

AU - Whitney, Roger

PY - 2018/7/9

Y1 - 2018/7/9

N2 - 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.

AB - 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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