What is the evidence for using cryoablation (cryotherapy ablation) in breast cancer treatment?

Evidence for Cryoablation in Breast Cancer Treatment

Cryoablation is an evolving minimally invasive therapy for early-stage breast cancer that shows promise primarily for small invasive ductal carcinomas ≤1.5 cm with minimal DCIS component, but it is not yet established as a standard treatment option for breast cancer.

Current Evidence Base

The evidence for cryoablation in breast cancer is primarily based on small studies and early-phase clinical trials. The most recent meta-analysis from 2025 reported encouraging results:

• Pooled local recurrence rate of only 1.1% (95% CI 0.42-3.03%) in patients treated with cryoablation alone 1
• Pooled residual tumor rate of 8.2% (95% CI 3.84-16.68%) in patients treated with cryoablation followed by surgery 1

Patient Selection Criteria

Cryoablation appears most effective for:

• Tumors <1.0 cm (100% success rate) 2
• Tumors between 1.0-1.5 cm in patients with invasive ductal carcinoma without significant DCIS component 2
• Ultrasound-visible tumors 2

Limitations and Contraindications

Cryoablation is not reliable for:

• Tumors >1.5 cm 2
• Tumors with significant DCIS component (>25% in core biopsy) 2
• Non-calcified DCIS (major cause of cryoablation failures) 2

Procedural Considerations

Cryoablation is performed as an office-based procedure under local anesthesia using an argon gas-based system with a double freeze/thaw cycle 2. Key advantages include:

• Minimally invasive approach
• Well-tolerated with minimal post-procedural pain
• No reported need for narcotic pain medications
• Preservation of breast aesthetics 3

Comparison to Standard Treatments

While surgical excision remains the standard of care for breast cancer, cryoablation offers potential advantages:

• Avoids risks associated with surgery
• Outpatient procedure under local anesthesia
• Comparable oncological outcomes to traditional treatments in carefully selected patients 3
• Potential immunological effects that may help prevent tumor recurrence 4

Future Directions

Several aspects of cryoablation for breast cancer require further investigation:

• Optimal technical parameters
• Long-term efficacy data
• Standardized imaging follow-up protocols
• Potential synergistic effects when combined with immunotherapy 5

Clinical Implications

For clinicians considering cryoablation for breast cancer patients:

1. Limit application to patients with invasive ductal carcinoma ≤1.5 cm with <25% DCIS in core biopsy 2
2. Ensure tumors are well-visualized on ultrasound
3. Consider cryoablation as an alternative for patients with significant comorbidities that preclude surgical treatment 5
4. Recognize that while early results are promising, larger comparative studies are needed before widespread adoption

It's worth noting that while the NCCN guidelines mention cryoablation as an evolving therapy for prostate cancer 6, current breast cancer guidelines do not yet include specific recommendations for cryoablation in breast cancer management 6, highlighting its investigational status for this indication.