Cryoablation Without Excision for Low-Risk Early-Stage Breast Cancer: 3-Year Interim Analysis of Ipsilateral Breast Tumor Recurrence in the ICE3 Trial.

Autor: Fine RE; Margaret West Comprehensive Breast Center, West Cancer Center and Research Institute, Germantown, TN, USA. rfine@westclinic.com., Gilmore RC; Margaret West Comprehensive Breast Center, West Cancer Center and Research Institute, Germantown, TN, USA., Dietz JR; Allegheny Health Network, Pittsburgh, PA, USA., Boolbol SK; Nuvance Health System, Poughkeepsie, NY, USA., Berry MP; Margaret West Comprehensive Breast Center, West Cancer Center and Research Institute, Germantown, TN, USA., Han LK; Parkview Health, Indianapolis, IN, USA., Kenler AS; Bridgeport Hospital, Bridgeport, CT, USA., Sabel M; The University of Michigan Health System, Ann Arbor, MI, USA., Tomkovich KR; CentraState Medical Center, Freehold, NJ, USA., VanderWalde NA; Margaret West Comprehensive Breast Center, West Cancer Center and Research Institute, Germantown, TN, USA., Chen M; Columbia University Medical Center, New York, NY, USA., Columbus KS; Cincinnati Breast Surgeons Inc, Cincinnati, OH, USA., Curcio LD; BreastLink, Laguna Hills, CA, USA., Feldman SM; Montefiore-Einstein Center for Cancer Care, New York, NY, USA., Gold L; Comprehensive Breast Care, Troy, MI, USA., Hernandez L; Cincinnati Breast Surgeons Inc, Cincinnati, OH, USA., Manahan ER; Dalton Surgical Group, Dalton, GA, USA., Seedman SA; Presbyterian Cancer Center, Rio Rancho, NM, USA., Vaidya RP; Ironwood Cancer and Research Centers, Glendale, AZ, USA., Sevrukov AB; Thomas Jefferson University Hospital, Philadelphia, PA, USA., Aoun HD; Karmanos Cancer Institute, Detroit, MI, USA., Hicks RD; Regional Medical Imaging, Flint, MI, USA., Simmons RM; Weill Cornell Weill Medical College, Cornell University, New York, NY, USA.
Jazyk: angličtina
Zdroj: Annals of surgical oncology [Ann Surg Oncol] 2021 Oct; Vol. 28 (10), pp. 5525-5534. Date of Electronic Publication: 2021 Aug 15.
DOI: 10.1245/s10434-021-10501-4
Abstrakt: Background: The ICE3 trial is designed to evaluate the safety and efficacy of breast cryoablation, enabling women older than 60 years with low-risk early-stage breast cancers to benefit from a nonsurgical treatment and to avoid the associated surgical risks.
Methods: The ICE3 trial is a prospective, multi-center, single-arm, non-randomized trial including women age 60 years or older with unifocal, ultrasound-visible invasive ductal carcinoma size 1.5 cm or smaller and classified as low to intermediate grade, hormone receptor (HR)-positive, and human epidermal growth factor receptor 2 (HER2)-negative. Ipsilateral breast tumor recurrence (IBTR) at 5 years was the primary outcome. A 3-year interim analysis of IBTR was performed, and the IBTR probability was estimated using the Kaplan-Meier method.
Results: Full eligibility for the study was met by 194 patients, who received successful cryoablation per protocol. The mean age was 75 years (range, 55-94 years). The mean tumor length was 8.1 mm (range, 8-14.9 mm), and the mean tumor width was 7.4 mm (range, 2.8-14 mm). During a mean follow-up period of 34.83 months, the IBTR rate was 2.06% (4/194 patients). Device-related adverse events were reported as mild in 18.4% and moderate in 2.4% of the patients. No severe device-related adverse events were reported. More than 95% of the patients and 98% of the physicians reported satisfaction with the cosmetic results at the clinical follow-up evaluation.
Conclusions: Breast cryoablation presents a promising alternative to surgery while offering the benefits of a minimally invasive procedure with minimal risks. Further study within a clinical trial or registry is needed to confirm cryoablation as a viable alternative to surgical excision for appropriately selected low-risk patients.
(© 2021. Society of Surgical Oncology.)
Databáze: MEDLINE
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