title: A Phase II Trial Exploring the Success of Cryoablation Therapy in the Treatment of Invasive Breast Carcinoma: Results from ACOSOG (Alliance) Z1072.
abstract: 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.
authors.affiliation: 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.
authors.forename: Rache M
authors.initials: RM
authors.lastname: Simmons
authors.affiliation: Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.
authors.forename: Karla V
authors.initials: KV
authors.lastname: Ballman
authors.affiliation: Department of Surgery, University of South Florida, Tampa, FL, USA.
authors.forename: Charles
authors.initials: C
authors.lastname: Cox
authors.affiliation: Department of Surgery, Lankenau Medical Center, Wynnewood, PA, USA.
authors.forename: Ned
authors.initials: N
authors.lastname: Carp
authors.affiliation: Department of Surgery, Lankenau Medical Center, Wynnewood, PA, USA.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Sabol
authors.affiliation: Department of Breast Surgical Oncology, MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: Rosa F
authors.initials: RF
authors.lastname: Hwang
authors.affiliation: Department of Surgery, Providence Saint Joseph Medical Center, Burbank, CA, USA.
authors.forename: Deanna
authors.initials: D
authors.lastname: Attai
authors.affiliation: Department of Surgery, University of Michigan Hospital, Ann Arbor, MI, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Sabel
authors.affiliation: Department of Surgery, Henry Ford Hospital, Detroit, MI, USA.
authors.forename: David
authors.initials: D
authors.lastname: Nathanson
authors.affiliation: Department of Surgery, Bridgeport Hospital, Bridgeport, CT, USA.
authors.forename: Andrew
authors.initials: A
authors.lastname: Kenler
authors.affiliation: Department of Surgery, Genesys Regional Medical Center, Grand Blanc, MI, USA.
authors.forename: Linsey
authors.initials: L
authors.lastname: Gold
authors.affiliation: Department of Surgery, Bellingham Breast Center, Bellingham, WA, USA.
authors.forename: Cary
authors.initials: C
authors.lastname: Kaufman
authors.affiliation: Department of Surgery, Indiana University Hospital, Indianapolis, IN, USA.
authors.forename: Linda
authors.initials: L
authors.lastname: Han
authors.affiliation: Department of Surgery, Lehigh Valley Hospital, Allentown, PA, USA.
authors.forename: Aaron
authors.initials: A
authors.lastname: Bleznak
authors.affiliation: Department of Surgery, Penn State Milton S. Hershey Medical Center, Hershey, PA, USA.
authors.forename: J
authors.initials: J
authors.lastname: Stanley Smith
authors.affiliation: Department of Surgery, University of Southern California, Los Angeles, CA, USA.
authors.forename: Dennis
authors.initials: D
authors.lastname: Holmes
authors.affiliation: Department of Diagnostic Radiology, MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: Bruno
authors.initials: B
authors.lastname: Fornage
authors.affiliation: Department of Diagnostic Radiology, MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: Carisa
authors.initials: C
authors.lastname: Le-Petross
authors.affiliation: Department of Pathology, Weill Cornell Medical College, New York, NY, USA.
authors.forename: Syed
authors.initials: S
authors.lastname: Hoda
authors.affiliation: Alliance Statistics and Data Center, Duke University, Durham, NC, USA.
authors.forename: Linda
authors.initials: L
authors.lastname: McCall
authors.affiliation: Department of Breast Surgical Oncology, MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: Kelly K
authors.initials: KK
authors.lastname: Hunt
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001943:Breast Neoplasms / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery*; D018270:Carcinoma, Ductal, Breast / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery*; D003452:Cryosurgery / Q000379:methods*; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D011237:Predictive Value of Tests; D016896:Treatment Outcome