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Ann Surg Oncol. 2016 Aug;23(8):2438-45. doi: 10.1245/s10434-016-5275-3. Epub 2016 May 24.

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

Author information

1
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.
2
Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.
3
Department of Surgery, University of South Florida, Tampa, FL, USA.
4
Department of Surgery, Lankenau Medical Center, Wynnewood, PA, USA.
5
Department of Breast Surgical Oncology, MD Anderson Cancer Center, Houston, TX, USA.
6
Department of Surgery, Providence Saint Joseph Medical Center, Burbank, CA, USA.
7
Department of Surgery, University of Michigan Hospital, Ann Arbor, MI, USA.
8
Department of Surgery, Henry Ford Hospital, Detroit, MI, USA.
9
Department of Surgery, Bridgeport Hospital, Bridgeport, CT, USA.
10
Department of Surgery, Genesys Regional Medical Center, Grand Blanc, MI, USA.
11
Department of Surgery, Bellingham Breast Center, Bellingham, WA, USA.
12
Department of Surgery, Indiana University Hospital, Indianapolis, IN, USA.
13
Department of Surgery, Lehigh Valley Hospital, Allentown, PA, USA.
14
Department of Surgery, Penn State Milton S. Hershey Medical Center, Hershey, PA, USA.
15
Department of Surgery, University of Southern California, Los Angeles, CA, USA.
16
Department of Diagnostic Radiology, MD Anderson Cancer Center, Houston, TX, USA.
17
Department of Pathology, Weill Cornell Medical College, New York, NY, USA.
18
Alliance Statistics and Data Center, Duke University, Durham, NC, USA.

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.

PMID:
27221361
PMCID:
PMC5433250
DOI:
10.1245/s10434-016-5275-3
[Indexed for MEDLINE]
Free PMC Article

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