A Phase II Trial Exploring the Success of Cryoablation Therapy in the Treatment of Invasive Breast Carcinoma: Results from ACOSOG (Alliance) Z1072

Authors

Rache M. Simmons, Department of Surgery, Iris Cantor Women's Health Center, The New York Presbyterian Hospital, Joan and Sanford Weill Medical College of Cornell University, New York, NY, USA. rms2002@med.cornell.edu.
Karla V. Ballman, Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.
Charles Cox, Department of Surgery, University of South Florida, Tampa, FL, USA.
Ned Carp, Department of Surgery, Lankenau Medical Center, Wynnewood, PA, USA.
Jennifer Sabol, Department of Surgery, Lankenau Medical Center, Wynnewood, PA, USA.
Rosa F. Hwang, Department of Breast Surgical Oncology, MD Anderson Cancer Center, Houston, TX, USA.
Deanna Attai, Department of Surgery, Providence Saint Joseph Medical Center, Burbank, CA, USA.
Michael Sabel, Department of Surgery, University of Michigan Hospital, Ann Arbor, MI, USA.
David Nathanson, Department of Surgery, Henry Ford Hospital, Detroit, MI, USA.
Andrew Kenler, Department of Surgery, Bridgeport Hospital, Bridgeport, CT, USA.
Linsey Gold, Department of Surgery, Genesys Regional Medical Center, Grand Blanc, MI, USA.
Cary Kaufman, Department of Surgery, Bellingham Breast Center, Bellingham, WA, USA.
Linda Han, Department of Surgery, Indiana University Hospital, Indianapolis, IN, USA.
Aaron Bleznak, Department of Surgery, Lehigh Valley Hospital, Allentown, PA, USA.
J Stanley Smith, Department of Surgery, Penn State Milton S. Hershey Medical Center, Hershey, PA, USA.
Dennis Holmes, Department of Surgery, University of Southern California, Los Angeles, CA, USA.
Bruno Fornage, Department of Diagnostic Radiology, MD Anderson Cancer Center, Houston, TX, USA.
Carisa Le-Petross, Department of Diagnostic Radiology, MD Anderson Cancer Center, Houston, TX, USA.
Syed Hoda, Department of Pathology, Weill Cornell Medical College, New York, NY, USA.
Linda McCall, Alliance Statistics and Data Center, Duke University, Durham, NC, USA.
Kelly K. Hunt, Department of Breast Surgical Oncology, MD Anderson Cancer Center, Houston, TX, USA.

Document Type

Article

Publication Title

Annals of surgical oncology

Abstract

BACKGROUND: Cryoablation is a well-established technique to treat fibroadenomas. Pilot studies suggest this could be an effective non-surgical treatment for breast cancer. American College of Surgeons Oncology Group Z1072 is a phase II trial exploring the effectiveness of cryoablation in the treatment of breast cancers. METHODS: The primary endpoint of Z1072 was the rate of complete tumor ablation, defined as no remaining invasive breast cancer (IBC) or ductal carcinoma in situ (DCIS) on pathologic examination of the targeted lesion. A secondary objective was to evaluate the negative predictive value of magnetic resonance imaging (MRI) to determine residual IBC or DCIS. Eligible patients included those with unifocal invasive ductal breast cancer ≤2 cm, with <25 % intraductal component and tumor enhancement on MRI. A total of 19 centers contributed 99 patients, of which 86 patients (87 breast cancers) were evaluable for data analysis. RESULTS: Final pathology results, regardless of whether residual IBC/DCIS was in the targeted ablation zone or elsewhere in the breast, showed successful ablation in 66/87 (75.9 %) cancers. The 90 % confidence interval for the estimate of successful cryoablation was 67.1-83.2, with the one-sided lower-sided 90 % CI of 69.0. The negative predictive value of MRI was 81.2 % (90 % CI 71.4-88.8). When multifocal disease outside of the targeted cryoablation zone was not defined as an ablation failure, 80/87 (92 %) of the treated cancers had a successful cryoablation. CONCLUSION: Further studies with modifications on the Z1072 protocol could be considered to evaluate the role for cryoablation as a non-surgical treatment of early-stage breast cancer.

First Page

2438

Last Page

45

DOI

10.1245/s10434-016-5275-3

Publication Date

8-1-2016

Recommended Citation

Simmons, Rache M.; Ballman, Karla V.; Cox, Charles; Carp, Ned; Sabol, Jennifer; Hwang, Rosa F.; Attai, Deanna; Sabel, Michael; Nathanson, David; Kenler, Andrew; Gold, Linsey; Kaufman, Cary; Han, Linda; Bleznak, Aaron; Stanley Smith, J; Holmes, Dennis; Fornage, Bruno; Le-Petross, Carisa; Hoda, Syed; McCall, Linda; and Hunt, Kelly K., "A Phase II Trial Exploring the Success of Cryoablation Therapy in the Treatment of Invasive Breast Carcinoma: Results from ACOSOG (Alliance) Z1072" (2016). Surgery. 106.
https://scholar.bridgeporthospital.org/surgery/106

Identifier

27221361 (pubmed); NIHMS851426 (mid); PMC5433250 (pmc); 10.1245/s10434-016-5275-3 (doi); 10.1245/s10434-016-5275-3 (pii)