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Background <p>At present, no clinical guidelines have been established regarding the use of radiofrequency ablation (RFA) for early stage breast cancer. The Radiofrequency Ablation Therapy for Early Breast Cancer as Local Therapy (RAFAELO) study aimed to assess the efficacy and safety of RFA as an alternative to partial mastectomy in patients with early stage breast cancer.</p> Patients and Methods <p>This study was a multicenter, single-arm, phase 3 study. Female patients with a single breast cancer classified as Tis–T1 (tumor size ≤&#xa0;1.5 cm), N0M0 Stage 0–I underwent treatment RFA. All patients then received radiation therapy totaling 45–60 Gy. The primary endpoint was the 5-year ipsilateral breast tumor recurrence-free survival (IBTRFS) rate. The threshold for a clinically unacceptable 5-year IBTRFS rate was set at 90% with a one-sided alpha of 5%.</p> Results <p>A total of 370 patients underwent RFA and 353 patients (median [IQR] age, 55 [47–65] years) completed the 5-year follow-up. For the primary endpoint, the IBTRFS rate at 5 years was 98.6% (90% CI 97.1–99.3%, 95% CI 96.6–99.4%). The lower limit of the 90% CI was greater than the threshold of 90%, suggesting the noninferiority of RFA to historical control partial mastectomy. During the study, two recurrences were observed in the ipsilateral breast. Skin ulceration grade ≥&#xa0;3 was observed in just one of the 370 patients.</p> Conclusions <p>RFA was shown to be a safe and minimally invasive treatment for early stage breast cancer, comparable in efficacy to partial mastectomy.</p>

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Radiofrequency Ablation for Early Stage Breast Cancer as a Potential Alternative to Partial Mastectomy: 5-Year Results from the Multiple-Center, Single-Arm, Phase 3 RAFAELO Study (NCCH1409)

  • 期刊论文

  • 发表日期：

    2026年2月18日

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  • Takayuki Kinoshita,
  • Shin Takayama,
  • Tomomi Fujisawa,
  • Kenichi Watanabe,
  • Naohito Yamamoto,
  • Tadahiko Shien,
  • Mitsuya Ito,
  • Mina Takahashi,
  • Manabu Futamura,
  • Tatsuya Onishi,
  • Masayuki Yoshida,
  • Masato Takahashi,
  • Hiroyoshi Doihara,
  • Eiko Yorikane,
  • Keiko Ohata,
  • Ryunosuke Machida,
  • Hitoshi Tsuda,
  • Takayuki Kinoshita,
  • Shin Takayama,
  • Tomomi Fujisawa,
  • Kenichi Watanabe,
  • Naohito Yamamoto,
  • Tadahiko Shien,
  • Mitsuya Ito,
  • Mina Takahashi,
  • Manabu Futamura,
  • Tatsuya Onishi,
  • Hitoshi Tsuda

摘要

Background

At present, no clinical guidelines have been established regarding the use of radiofrequency ablation (RFA) for early stage breast cancer. The Radiofrequency Ablation Therapy for Early Breast Cancer as Local Therapy (RAFAELO) study aimed to assess the efficacy and safety of RFA as an alternative to partial mastectomy in patients with early stage breast cancer.

Patients and Methods

This study was a multicenter, single-arm, phase 3 study. Female patients with a single breast cancer classified as Tis–T1 (tumor size ≤ 1.5 cm), N0M0 Stage 0–I underwent treatment RFA. All patients then received radiation therapy totaling 45–60 Gy. The primary endpoint was the 5-year ipsilateral breast tumor recurrence-free survival (IBTRFS) rate. The threshold for a clinically unacceptable 5-year IBTRFS rate was set at 90% with a one-sided alpha of 5%.

Results

A total of 370 patients underwent RFA and 353 patients (median [IQR] age, 55 [47–65] years) completed the 5-year follow-up. For the primary endpoint, the IBTRFS rate at 5 years was 98.6% (90% CI 97.1–99.3%, 95% CI 96.6–99.4%). The lower limit of the 90% CI was greater than the threshold of 90%, suggesting the noninferiority of RFA to historical control partial mastectomy. During the study, two recurrences were observed in the ipsilateral breast. Skin ulceration grade ≥ 3 was observed in just one of the 370 patients.

Conclusions

RFA was shown to be a safe and minimally invasive treatment for early stage breast cancer, comparable in efficacy to partial mastectomy.