Introduction: This is a prospective single arm clinical trial on cryosurgery for early
breast cancers, to evaluate the expanded criteria to tumors larger than 1.5cm and
non-luminal breast cancers.
Methods: Inclusion criteria include Solitary T1 breast cancers of any immunohistotypes.
Cryosurgery was performed using the IceCure ProSense Cryoablation™ System. Lumpectomy
of the cryoablated tumor was then performed 8 weeks after cryosurgery.
Results: 15 patients underwent cryosurgery followed by lumpectomy (BCS). Median age
was 53 years old 5 (33.3%) patients had ductal carcinoma in situ (DCIS), while 10
(66.7%) patients had invasive ductal carcinoma (IDC), of which 5 (50%) patients had
luminal type cancers of which 3 (60%) were luminal A and 2 (40%) luminal B, 3 (30%)
patients had HER2 enriched invasive carcinoma and 2 (20%) patients had triple negative
IDC. Median tumor size was 13mm (Range 8.6 – 18mm).
7 (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 histopathology, immunochemistry and TUNEL assay for evaluation of cell
viability. 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.
Conclusion: Residual cancer occurs at the periphery of the cryoablation site, careful
pre-operative planning and intra-operative monitoring is crucial to ensure complete
Micro-abstract: Residual cancer was found in 46.7% of patients with cryosurgery performed. All residual
cancers were found at the periphery, of the cryoablation zone. Complete breast cancer
ablation is achieved at the center of the cryozone, irrespective of tumor biology.
Careful pre-operative planning and intra-operative monitoring is crucial to ensure