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早期乳腺癌的冷冻消融而非切除术:ICE3 试验同侧乳腺肿瘤复发 5 年随访结果。

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

机构信息

Margaret West Comprehensive Breast Center, West Cancer Center and Research Institute, Germantown, TN, USA.

CentraState Medical Center, Freehold, NJ, USA.

出版信息

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


DOI:10.1245/s10434-024-16181-0
PMID:39283572
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11452421/
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.

摘要

背景:ICE3 试验评估了冷冻消融在年龄≥60 岁、患有低危早期乳腺癌的女性中的安全性和有效性,旨在提供一种非手术治疗选择,并避免潜在的手术风险。本研究报告了 5 年随访试验结果。

方法:ICE3 试验是一项机构审查委员会批准的、前瞻性的、多中心的、非随机试验,纳入了年龄≥60 岁、单发、超声可见、浸润性导管癌≤1.5cm 大小、组织学分级 1-2 级、激素受体(HR)阳性和人表皮生长因子受体 2(HER2)阴性的女性。5 年同侧乳房肿瘤复发(IBTR)的主要研究终点根据 Kaplan-Meier 估计进行评估。

结果:共有 194 名符合入选标准的患者按方案接受了成功的冷冻消融治疗,并纳入分析。平均年龄为 74.9 岁(55-94 岁),平均肿瘤大小为 7.4mm 横径(2.8-14.0mm)和 8.1mm 矢状径(2.5-14.9mm)。中位随访时间为 54.16 个月,5 年时的 IBTR 率为 4.3%,乳腺癌生存率为 96.7%。在 124 名仅接受内分泌治疗的患者中,IBTR 为 3.7%。无严重与器械相关的不良事件报告。轻微(88.2%)和中度(9.6%)不良事件的严重程度较轻,无残留影响。生活质量评分显示,与基线相比,6 个月时的痛苦显著改善(p<0.001)。

结论:在选择的患者中,乳腺冷冻消融术为手术提供了一种有前途的替代方案,具有微创程序和最小风险的优势。鼓励进一步研究以确认冷冻消融术作为低危患者手术切除的可行替代方案。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/553c/11452421/4aa2dbb5cfeb/10434_2024_16181_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/553c/11452421/1057509f40a5/10434_2024_16181_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/553c/11452421/4aa2dbb5cfeb/10434_2024_16181_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/553c/11452421/1057509f40a5/10434_2024_16181_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/553c/11452421/4aa2dbb5cfeb/10434_2024_16181_Fig2_HTML.jpg

相似文献

[1]
Cryoablation Without Excision for Early-Stage Breast Cancer: ICE3 Trial 5-Year Follow-Up on Ipsilateral Breast Tumor Recurrence.

Ann Surg Oncol. 2024-10

[2]
Cryoablation Without Excision for Low-Risk Early-Stage Breast Cancer: 3-Year Interim Analysis of Ipsilateral Breast Tumor Recurrence in the ICE3 Trial.

Ann Surg Oncol. 2021-10

[3]
Pre-surgical cryoablation in ≤ 2 cm ER + /HER2-tumors. Prognostic factors for the presence of residual invasive carcinoma.

Breast Cancer Res Treat. 2024-8

[4]
Comparison of ipsilateral breast tumor recurrence after breast-conserving surgery between ductal carcinoma in situ and invasive breast cancer.

World J Surg Oncol. 2016-4-27

[5]
Cryoablation of Primary Breast Cancer in Patients Ineligible for Clinical Trials: A Multiinstitutional Study.

AJR Am J Roentgenol. 2024-9

[6]
Cryoablation: A promising non-operative therapy for low-risk breast cancer.

Am J Surg. 2021-1

[7]
Reply to: Comment on: Cryoablation Without Excision for Low-Risk Early-Stage Breast Cancer: 3-Year Interim Analysis of Ipsilateral Breast Tumor Recurrence in the ICE3 Trial.

Ann Surg Oncol. 2024-8

[8]
The Value of Ipsilateral Breast Tumor Recurrence as a Quality Indicator: Hospital Variation in the Netherlands.

Ann Surg Oncol. 2015-12

[9]
Cryoablation of early-stage breast cancer: work-in-progress report of a multi-institutional trial.

Ann Surg Oncol. 2004-5

[10]
Long-term primary results of accelerated partial breast irradiation after breast-conserving surgery for early-stage breast cancer: a randomised, phase 3, equivalence trial.

Lancet. 2019-12-5

引用本文的文献

[1]
Cryoablation and Intratumoral Immunotherapy for Breast Cancer: A Future Path to Cost-Effective De-Escalation for Larger Tumors, Lymph Nodes and Metastatic Disease.

Cancers (Basel). 2025-6-9

[2]
Cryoablation in the treatment of early breast cancer: a comprehensive analysis.

Front Oncol. 2025-5-20

[3]
Cryoablation for breast cancer: a narrative review of advances, clinical applications, and future challenges.

Transl Cancer Res. 2025-2-28

[4]
The Role of Molecular Profiling in De-Escalation of Toxic Therapy in Breast Cancer.

Int J Mol Sci. 2025-2-4

[5]
Cryoablation of primary breast cancer tumors induces a systemic abscopal effect altering TIME (Tumor Immune Microenvironment) in distant tumors.

Front Immunol. 2024-12-2

[6]
ESR Bridges: image-guided breast cancer treatment de-escalation-a multidisciplinary view.

Eur Radiol. 2025-5

[7]
Cryotherapy in the Treatment of Early-Stage Breast Cancer.

World J Oncol. 2024-10

本文引用的文献

[1]
Percutaneous ultrasound-guided cryoablation for early-stage primary breast cancer: a follow-up study in Japan.

Breast Cancer. 2024-7

[2]
Safety and Efficacy of Ultrasound-Guided Cryoablation for Benign Breast Fibroepithelial Lesions.

J Breast Imaging. 2019-12-5

[3]
Cryoablation Therapy for Early-Stage Breast Cancer: Evidence and Rationale.

J Breast Imaging. 2023-11-30

[4]
Cryoablation Allows the Ultimate De-escalation of Surgical Therapy for Select Breast Cancer Patients.

Ann Surg Oncol. 2023-12

[5]
Cryoablation for the Treatment of Breast Cancer: A Review of the Current Landscape and Future Possibilities.

Acad Radiol. 2023-12

[6]
Survival outcomes and quality of life after percutaneous cryoablation for liver metastasis: A systematic review and meta-analysis.

PLoS One. 2023

[7]
Cryoablation is superior to radiofrequency ablation for the treatment of non-small cell lung cancer: A meta-analysis.

Cryobiology. 2023-9

[8]
Breast Cancer Cryoablation Fundamentals Past and Present: Technique Optimization and Imaging Pearls.

Acad Radiol. 2023-10

[9]
Ablative Therapies for Breast Cancer: State of Art.

Technol Cancer Res Treat. 2023

[10]
The Role of Cryoablation in Breast Cancer Beyond the Oncologic Control: COST and Breast-Q Patient-Reported Outcomes.

Ann Surg Oncol. 2023-2

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