A Phase II Trial Exploring the Success of Cryoablation Therapy in the Treatment of Invasive Breast Carcinoma: Results from ACOSOG (Alliance) Z1072
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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.
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.
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.
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.
KeywordsSentinel Node Biopsy Invasive Breast Cancer Breast Magnetic Resonance Imaging Bilateral Breast Cancer Successful Ablation
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.
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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