284 - Population‑Level Eligibility for Minimally Invasive Breast Tumor Cryoablation in the United States: SEER 2016–2022 and Historical Treatment Patterns

Purpose: Breast cryoablation is an emerging minimally invasive alternative to surgery for carefully selected early‑stage cancers, yet the size of the eligible U.S. population and how these patients are currently treated is unclear. We quantified national eligibility and modeled near‑term growth to inform planning, equity, and guidelines discussions.

Materials and Methods: We performed a retrospective, population-based analysis of SEER registry data (2016–2022). Eligibility criteria aligned with published prospective trials: female sex, invasive ductal/papillary carcinoma, grade I–II, localized stage, estrogen/progesterone receptor–positive, HER2-negative, and tumor size ≤15 mm (primary cohort), with secondary analysis at ≤20 mm. Surgical treatment was categorized as lumpectomy/partial mastectomy, mastectomy, or no surgery. Strict unmet need was defined as eligible patients not undergoing any breast operation during the index episode. The high-opportunity group comprised patients who underwent breast-conserving surgery (BCS). A log-linear regression model incorporating a COVID-19 indicator was applied to generate projections through 2030 with 95% confidence intervals (CI).

Results: From 2016–2022, 125,335 cases met ≤15 mm criteria and 149,186 met ≤20 mm criteria, averaging 17,905 and 21,312 annually, respectively. Among ≤20 mm, strict unmet need patients receiving no surgery was rare (0.2%), while the high-opportunity group comprised 75.2% (132,042 cases). An additional 23.8% underwent mastectomy. The combined opportunity population (strict unmet need plus BCS) totaled 132,474 patients (75.4%), averaging 18,925 annually. Refined-eligibility counts increased 3.5% annually, with projections reaching 279,024 eligible cases by 2030 (95% CI: 251,122–306,926).

Conclusion: This study provides the first comprehensive, population-level assessment of breast cryoablation eligibility in the United States, revealing a substantial candidate population of 149,186 patients over seven years. Our findings establish essential national benchmarks for systematic program development, payer policy, and multidisciplinary interventional oncology integration.