Prospective clinical trial on expanding indications for cryosurgery for early breast cancers

Abstract

<h3>Introduction</h3><p>This is a prospective single arm <a href="https://www.sciencedirect.com/topics/medicine-and-dentistry/clinical-trial" title="Learn more about clinical trial from ScienceDirect's AI-generated Topic Pages">clinical trial</a> on cryosurgery for early breast cancers, to evaluate the expanded criteria to tumors larger than 1.5 cm and non-luminal breast cancers.</p><h3>Methods</h3><p>Inclusion criteria include Solitary T1 breast cancers of any immunohistotypes. Cryosurgery was performed using the IceCure ProSense Cryoablation System. <a href="https://www.sciencedirect.com/topics/medicine-and-dentistry/lumpectomy" title="Learn more about Lumpectomy from ScienceDirect's AI-generated Topic Pages">Lumpectomy</a> of the cryoablated tumor was then performed 8 weeks after cryosurgery.</p><h3>Results</h3><p>Fifteen <a href="https://www.sciencedirect.com/topics/medicine-and-dentistry/patient" title="Learn more about patients from ScienceDirect's AI-generated Topic Pages">patients</a> underwent cryosurgery followed by lumpectomy (BCS). Median age was 53 years old 5 (33.3%) patients had <a href="https://www.sciencedirect.com/topics/medicine-and-dentistry/intraductal-carcinoma" title="Learn more about ductal carcinoma in situ from ScienceDirect's AI-generated Topic Pages">ductal carcinoma in situ</a> (DCIS), while 10 (66.7%) patients had <a href="https://www.sciencedirect.com/topics/medicine-and-dentistry/breast-carcinoma" title="Learn more about invasive ductal carcinoma from ScienceDirect's AI-generated Topic Pages">invasive ductal carcinoma</a> (IDC), of which 5 (50%) patients had luminal <a href="https://www.sciencedirect.com/topics/medicine-and-dentistry/cancer-types" title="Learn more about type cancers from ScienceDirect's AI-generated Topic Pages">type cancers</a> of which 3 (60%) were luminal A and 2 (40%) luminal B, 3 (30%) patients had HER2 enriched <a href="https://www.sciencedirect.com/topics/medicine-and-dentistry/invasive-carcinoma" title="Learn more about invasive carcinoma from ScienceDirect's AI-generated Topic Pages">invasive carcinoma</a> and 2 (20%) patients had triple negative IDC. Median tumor size was 13mm (Range 8.6-18mm). Seven (46.7%) patients were found to have residual cancer in the post-cryosurgery lumpectomy specimen. All residual cancers were found at the periphery of the cryoablated breast tissue. All breast cancers were otherwise completely ablated centrally as confirmed by routine <a href="https://www.sciencedirect.com/topics/medicine-and-dentistry/histopathology" title="Learn more about histopathology from ScienceDirect's AI-generated Topic Pages">histopathology</a>, <a href="https://www.sciencedirect.com/topics/medicine-and-dentistry/immunochemistry" title="Learn more about immunochemistry from ScienceDirect's AI-generated Topic Pages">immunochemistry</a> and <a href="https://www.sciencedirect.com/topics/medicine-and-dentistry/tunel-assay" title="Learn more about TUNEL assay from ScienceDirect's AI-generated Topic Pages">TUNEL assay</a> for evaluation of <a href="https://www.sciencedirect.com/topics/medicine-and-dentistry/cell-viability" title="Learn more about cell viability from ScienceDirect's AI-generated Topic Pages">cell viability</a>. None of the tumor factors such as tumor biology, as well as surgical factors such as ablation time and iceball size, were associated with risk of residual cancer. None of the 15 patients developed post-operative complications.</p><h3>Conclusion</h3><p>Residual cancer occurs at the periphery of the cryoablation site, careful pre-operative planning and intra-operative monitoring is crucial to ensure complete cryoablation.</p>