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Annals of Surgical Oncology

, Volume 23, Issue 8, pp 2438–2445 | Cite as

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

  • Rache M. Simmons
  • Karla V. Ballman
  • Charles Cox
  • Ned Carp
  • Jennifer Sabol
  • Rosa F. Hwang
  • Deanna Attai
  • Michael Sabel
  • David Nathanson
  • Andrew Kenler
  • Linsey Gold
  • Cary Kaufman
  • Linda Han
  • Aaron Bleznak
  • J. Stanley Smith
  • Dennis Holmes
  • Bruno Fornage
  • Carisa Le-Petross
  • Syed Hoda
  • Linda McCall
  • Kelly K. Hunt
  • on behalf of the ACOSOG investigators
Breast 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.

Keywords

Sentinel Node Biopsy Invasive Breast Cancer Breast Magnetic Resonance Imaging Bilateral Breast Cancer Successful Ablation 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgments

The authors are grateful to Wendy Lindeman for study coordination, and Bettye Green, Patient Advocate, for her steadfast support.

ACOSoG Investigators The following additional ACOSOG investigators and the following institutions participated in this study: Lorraine Tafra, MD, Anne Arundel Medical Center, Annapolis, MD, USA. Bellingham Breast Center, Bellingham, WA, USA. Marla Dudek, MD, Bethesda Memorial Hospital, Boynton Beach, FL, USA. Susan Weinberg, MD, Bethesda North Hospital, Cincinnati, OH, USA. Bridgeport Hospital, Bridgeport, CT, USA. Center for Breast Care Inc., Burbank, CA, USA. Genesys Regional Medical Center, Grand Blanc, MI, USA. Henry Ford Hospital, Detroit, MI, USA. Indiana University Hospital/Melvin and Bren Simon Cancer Center, Indianapolis, IN, USA. Lankenau Medical Center, Wynnewood, PA, USA. Lehigh Valley Hospital, Allentown, PA, USA. Janice N. Cormier, MD, MPH, MD Anderson Cancer Center, Houston, TX, USA. Thomas A. Buchholz, MD, MD Anderson Cancer Center, Houston, TX, USA. Michael Kinney, MD, Northwest Community Hospital, Arlington Heights, IL, USA. Penn State Milton S. Hershey Medical Center, Hershey, PA, USA. Providence Saint Joseph Medical Center/Disney Family Cancer Center, Burbank, CA, USA. University Community Hospital, Tampa, FL, USA. University of Michigan Health System–Cancer Center, Ann Arbor, MI, USA.

Support

Research reported in this publication was supported by the National Cancer Institute of the National Institutes of Health under award numbers U10CA180821 and U10CA180882 to the Alliance for Clinical Trials in Oncology, and CA076001 to the ACOSOG. The cryoablation probes were supplied by Sanarus Technologies, Pleasanton, CA, USA. The content of this manuscript is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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Copyright information

© Society of Surgical Oncology 2016

Authors and Affiliations

  • Rache M. Simmons
    • 1
  • Karla V. Ballman
    • 2
  • Charles Cox
    • 3
  • Ned Carp
    • 4
  • Jennifer Sabol
    • 4
  • Rosa F. Hwang
    • 5
  • Deanna Attai
    • 6
  • Michael Sabel
    • 7
  • David Nathanson
    • 8
  • Andrew Kenler
    • 9
  • Linsey Gold
    • 10
  • Cary Kaufman
    • 11
  • Linda Han
    • 12
  • Aaron Bleznak
    • 13
  • J. Stanley Smith
    • 14
  • Dennis Holmes
    • 15
  • Bruno Fornage
    • 16
  • Carisa Le-Petross
    • 16
  • Syed Hoda
    • 17
  • Linda McCall
    • 18
  • Kelly K. Hunt
    • 5
  • on behalf of the ACOSOG investigators
  1. 1.Department of Surgery, Iris Cantor Women’s Health Center, The New York Presbyterian HospitalJoan and Sanford Weill Medical College of Cornell UniversityNew YorkUSA
  2. 2.Alliance Statistics and Data CenterMayo ClinicRochesterUSA
  3. 3.Department of SurgeryUniversity of South FloridaTampaUSA
  4. 4.Department of SurgeryLankenau Medical CenterWynnewoodUSA
  5. 5.Department of Breast Surgical OncologyMD Anderson Cancer CenterHoustonUSA
  6. 6.Department of SurgeryProvidence Saint Joseph Medical CenterBurbankUSA
  7. 7.Department of SurgeryUniversity of Michigan HospitalAnn ArborUSA
  8. 8.Department of SurgeryHenry Ford HospitalDetroitUSA
  9. 9.Department of SurgeryBridgeport HospitalBridgeportUSA
  10. 10.Department of SurgeryGenesys Regional Medical CenterGrand BlancUSA
  11. 11.Department of SurgeryBellingham Breast CenterBellinghamUSA
  12. 12.Department of SurgeryIndiana University HospitalIndianapolisUSA
  13. 13.Department of SurgeryLehigh Valley HospitalAllentownUSA
  14. 14.Department of SurgeryPenn State Milton S. Hershey Medical CenterHersheyUSA
  15. 15.Department of SurgeryUniversity of Southern CaliforniaLos AngelesUSA
  16. 16.Department of Diagnostic RadiologyMD Anderson Cancer CenterHoustonUSA
  17. 17.Department of PathologyWeill Cornell Medical CollegeNew YorkUSA
  18. 18.Alliance Statistics and Data CenterDuke UniversityDurhamUSA

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