Margaret West Comprehensive Breast Center, West Cancer Center and Research Institute, Germantown, TN, USA.
CentraState Medical Center, Freehold, NJ, USA.
Ann Surg Oncol. 2024 Oct;31(11):7273-7283. doi: 10.1245/s10434-024-16181-0. Epub 2024 Sep 16.
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.
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。
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