{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,4]],"date-time":"2026-06-04T13:04:04Z","timestamp":1780578244764,"version":"3.54.1"},"reference-count":53,"publisher":"MDPI AG","issue":"11","license":[{"start":{"date-parts":[[2026,6,4]],"date-time":"2026-06-04T00:00:00Z","timestamp":1780531200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancers"],"abstract":"<jats:p>Background: Cryoablation is a minimally invasive technique that is being investigated as an alternative to surgery for early-stage breast cancer. Its potential advantages include outpatient treatment under local anaesthesia, favourable cosmetic outcomes, and possible immunologic synergy. However, its oncologic efficacy and long-term effectiveness are yet to be determined. Methods: We conducted a systematic review in accordance with PRISMA 2020 and the Cochrane Handbook, registered on PROSPERO (CRD420251137549). Databases searched were PubMed\/MEDLINE, Scopus, and CENTRAL, from inception to August 2025. Eligible studies included women with unifocal, node-negative invasive ductal carcinoma \u2264 2 cm treated with percutaneous cryoablation. Outcomes of interest were residual disease, ipsilateral breast tumour recurrence, procedural and late complications, and cosmetic or patient-reported outcomes. Results: From 1074 records, 15 unique studies (17 reports) were included, comprising cryoablation-only studies (n = 7), treat-and-resect studies (n = 6), and comparative studies versus surgery (n = 2). Studies containing overlapping pathology validation and comparative components were classified within a single category to avoid duplication. Across treat-and-resect cohorts, complete tumour necrosis was reported in 88\u201395% of cases, with residual invasive carcinoma (RIC) ranging from 5% to 12%. In cryoablation-only cohorts, IBTR rates ranged from 0% to 4.3%, with follow-up durations spanning 2 months to 8 years. The largest study (ICE3, n = 194) reported a 5-year recurrence rate of 4.3%. Procedural complications were infrequent and self-limiting, most commonly bruising, oedema, or superficial frostbite. No major adverse events were reported. Validated quality-of-life instruments reported high patient satisfaction, with favourable results in selected comparative domains. Most included studies were of moderate methodological quality. Conclusions: Cryoablation appears technically feasible, safe, and cosmetically favourable in well-selected low-risk early-stage breast cancers. Oncologic outcomes are encouraging, with reported local recurrence rates in carefully selected low-risk populations being low, although direct comparison with breast-conserving surgery remains limited by the small number of comparative studies and substantial heterogeneity across the evidence base. Rigorous multicentre randomised trials with long-term follow-up and validated patient-reported outcomes are needed before cryoablation can be considered for routine clinical adoption.<\/jats:p>","DOI":"10.3390\/cancers18111842","type":"journal-article","created":{"date-parts":[[2026,6,4]],"date-time":"2026-06-04T11:52:30Z","timestamp":1780573950000},"page":"1842","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Cryoablation in Early-Stage Breast Cancer: A Systematic Review of Efficacy, Safety and Oncologic Outcomes"],"prefix":"10.3390","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4640-2983","authenticated-orcid":false,"given":"Sandra Maria","family":"Tsoti","sequence":"first","affiliation":[{"name":"School of Medicine, National and Kapodistrian University of Athens, 115 27 Athens, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9856-8152","authenticated-orcid":false,"given":"Vasileios","family":"Kalles","sequence":"additional","affiliation":[{"name":"Mediterraneo Hospital, 166 75 Athens, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aristotelis","family":"Nikitaras","sequence":"additional","affiliation":[{"name":"Euroclinic, 115 21 Athens, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9723-5054","authenticated-orcid":false,"given":"Ioannis","family":"Papapanagiotou","sequence":"additional","affiliation":[{"name":"Mediterraneo Hospital, 166 75 Athens, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nikolaos","family":"Michalopoulos","sequence":"additional","affiliation":[{"name":"School of Medicine, National and Kapodistrian University of Athens, 115 27 Athens, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,6,4]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"628","DOI":"10.1001\/jamasurg.2021.1438","article-title":"Survival After Breast Conservation vs Mastectomy Adjusted for Comorbidity and Socioeconomic Status","volume":"156","author":"Szulkin","year":"2021","journal-title":"JAMA Surg."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"1158","DOI":"10.1016\/S1470-2045(16)30067-5","article-title":"10 year survival after breast-conserving surgery plus radiotherapy compared with mastectomy in early breast cancer in the Netherlands: A population-based study","volume":"17","author":"Jobsen","year":"2016","journal-title":"Lancet Oncol."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"737","DOI":"10.14740\/wjon1909","article-title":"Cryotherapy in the Treatment of Early-Stage Breast Cancer","volume":"15","author":"Ciambella","year":"2024","journal-title":"World J. 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