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Multicenter Study
. 2024 Oct;31(11):7273-7283.
doi: 10.1245/s10434-024-16181-0. Epub 2024 Sep 16.

Cryoablation Without Excision for Early-Stage Breast Cancer: ICE3 Trial 5-Year Follow-Up on Ipsilateral Breast Tumor Recurrence

Richard E Fine  1 , Richard C Gilmore  2 , Kenneth R Tomkovich  3 , Jill R Dietz  4   5 , Michael P Berry  2 , Lydia E Hernandez  6 , Karen S Columbus  6 , Susan A Seedman  7 , Carla S Fisher  8 , Linda K Han  8 , Eric R Manahan  9 , Randy D Hicks  10 , Rashmi P Vaidya  11 , Lisa D Curcio  12 , Alexander B Sevrukov  13 , Andrew S Kenler  14 , Bret Taback  15 , Margaret Chen  15 , Megan E Miller  4 , Linsey Gold  16 , Beth V Anglin  17 , Hussein D Aoun  18 , Rache M Simmons  19 , Sheldon M Feldman  20 , Susan K Boolbol  21   22
Affiliations
Multicenter Study

Cryoablation Without Excision for Early-Stage Breast Cancer: ICE3 Trial 5-Year Follow-Up on Ipsilateral Breast Tumor Recurrence

Richard E Fine et al. Ann Surg Oncol. 2024 Oct.

Abstract

Background: The ICE3 trial evaluated the safety and efficacy of cryoablation in women aged ≥60 years with low-risk, early-stage breast cancers, aiming to provide a non-operative treatment option and avoid potential surgical risks. This study presents 5-year follow-up trial results.

Methods: The ICE3 trial is an Institutional Review Board-approved, prospective, multicentered, non-randomized trial including women ≥ 60 years of age with unifocal, ultrasound visible, invasive ductal carcinoma ≤ 1.5 cm in size, histologic grade 1-2, hormone receptor (HR)-positive, and human epidermal growth factor receptor 2 (HER2)-negative. The primary study endpoint of 5-year ipsilateral breast tumor recurrence (IBTR) was evaluated based on Kaplan-Meier estimates.

Results: Overall, 194 patients meeting eligibility received successful cryoablation treatment per protocol and were included for analysis. The mean age was 74.9 years (55-94) with a mean tumor size of 7.4 mm transverse (2.8-14.0 mm) and 8.1 mm sagittal (2.5-14.9 mm). With a mean follow-up period of 54.16 months, the IBTR rate at 5 years was 4.3% and breast cancer survival was 96.7%. Of the 124 patients who received endocrine therapy only, the IBTR was 3.7%. No serious device-related adverse events were reported. Minor (88.2%) and moderate (9.6%) adverse events were mild in severity and resolved without residual effects. Quality-of-life score demonstrated statistically significant improvement (p < 0.001) in distress at 6 months as compared with baseline.

Conclusions: Breast cryoablation presents a promising alternative to surgery in selected patients, offering the benefits of a minimally invasive procedure with minimal risks. Further studies are encouraged to confirm cryoablation as a viable alternative to surgical excision low-risk patients.

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Conflict of interest statement

Andrew Kenler was the Medical Director of IceCure for approximately 5 years and during the time period of this study, and was paid for his time as Medical Director. That relationship ended approximately 1 year ago. Kenneth Tomkovich: Stipend received for data entry for patients enrolled in the trial to CentraState Medical Center by IceCure Medical. The probes and cryoablation unit were provided by IceCure Medical to conduct the trial. I received no personal funds for conducting the trial or for the preparation of this manuscript. Neither I nor my medical institution have any relevant conflicts of interest in conducting this research. Richard Fine: West Cancer Center and Research Institute (author’s institution) received financial support for conducting the clinical trial. Served on the original scientific advisory board that participated in the Ice3 trial protocol design. Expenses were reimbursed for travel to Chicago, IL, in 2014. Susan Seedman profited $280 from the prior purchase and sale of publicly traded stock. Richard C. Gilmore, Jill R. Dietz, Michael P. Berry, Lydia E. Hernandez, Karen S. Columbus, Carla S. Fisher, Linda K. Han, Eric R. Manahan, Randy D. Hicks, Rashmi P. Vaidya, Lisa D. Curcio, Alexander B. Sevrukov, Bret Taback, Margaret Chen, Megan E. Miller, Linsey Gold, Beth V. Anglin, Hussein D. Aoun, Rache M. Simmons, Sheldon M. Feldman, and Susan K. Boolbol have no conflict of interest to declare that may be relevant to the contents of this study.

Figures

Fig. 1
Fig. 1
Kaplan–Meier plot of IBTR probability curve. The survival analysis IBTR rate was 4.3%, with an exact 95% CI of 2.1–8.7%. For all 194 subjects, the mean follow-up time was 54.2 ± 13.1 months, and the mean time to recurrence was 46.7 ± 12.4. IBTR ipsilateral breast tumor recurrence, CI confidence interval
Fig. 2
Fig. 2
Subgroup Kaplan–Meier plot of IBTR probability curve. For the endocrine therapy only subgroup (n = 124), the survival analysis IBTR rate was 3.7%, with an exact 95% CI of 1.4–9.6%. The mean time to recurrence was 48.0 ± 11.2. IBTR ipsilateral breast tumor recurrence, CI confidence interval
See this image and copyright information in PMC

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