New 5-Year Evidence Supporting Radiofrequency Ablation (RFA) in Early-Stage Breast Cancer

New 5-Year Evidence Supporting Radiofrequency Ablation (RFA) in Early-Stage Breast Cancer

I’m pleased to share results from the RAFAELO Phase 3 multicenter trial — published online in Annals of Surgical Oncology (Feb 18, 2026) — assessing radiofrequency ablation (RFA) as a minimally invasive alternative to partial mastectomy in early-stage breast cancer. 

🔍 Study Overview

• Design: Multicenter, single-arm, Phase 3 clinical study.

• Population: 370 women with solitary Tis–T1 (≤1.5 cm), N0M0 breast carcinomas.

• Intervention: Percutaneous RFA followed by whole-breast radiation (45–60 Gy).

• Primary Endpoint: 5-year ipsilateral breast tumor recurrence-free survival (IBTRFS). 

📈 Key Findings

✔ At 5 years, IBTRFS was 98.6% (90% CI 97.1–99.3%), exceeding the pre-specified noninferiority margin of 90%.

✔ Only 2 ipsilateral recurrences were observed at 5 years.

✔ Grade ≥3 skin ulceration was rare (1/370 patients), underscoring a favorable safety profile.

✔ These results suggest that RFA with adjuvant radiation may be comparable to partial mastectomy in appropriately selected early-stage patients. 

🏷 Clinical Significance

This large prospective trial provides the most robust long-term evidence to date that RFA — a less invasive approach — may be a viable local-control strategy in small, node-negative breast cancers. These findings reinforce ongoing interest in expanding treatment options that balance oncologic safety with patient-centred care (e.g., cosmesis, procedural morbidity). 

Optional Add-Ons for Engagement

🔹 Thanks to the RAFAELO Study Group and contributing centers for advancing patient-centred oncology. 

🔹 Looking forward to longer follow-up, quality-of-life data, and comparative trials against standard surgery

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