Patients Offer Radiofrequency Ablation Therapy for Early Breast Cancer as Local Therapy (PO-RAFAELO) Study under the Patient-proposed Health Services

Shin Takayama; Takayuki Kinoshita; Sho Shiino; Kenjiro Jimbo; Ken-Ichi Watanabe; Tomomi Fujisawa; Naohito Yamamoto; Tatsuya Onishi; Tadahiko Shien; Mitsuya Ito; Mina Takahashi; Manabu Futamura; Tomoyuki Aruga; Koji Kaneko; Akihiko Suto

doi:10.31662/jmaj.2023-0047

Patients Offer Radiofrequency Ablation Therapy for Early Breast Cancer as Local Therapy (PO-RAFAELO) Study under the Patient-proposed Health Services

JMA J. 2023 Oct 16;6(4):505-512. doi: 10.31662/jmaj.2023-0047. Epub 2023 Oct 2.

Authors

Affiliations

¹ Department of Breast Surgery, National Cancer Center Hospital, Tokyo, Japan.
² Department of Breast Surgery, National Hospital Organization Tokyo Medical Center, Tokyo, Japan.
³ Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Hokkaido, Japan.
⁴ Department of Breast Oncology, Gunma Prefectural Cancer Center, Gunma, Japan.
⁵ Division of Breast Surgery, Chiba Cancer Center, Chiba, Japan.
⁶ Department of Breast Surgery, National Cancer Center Hospital East, Chiba, Japan.
⁷ Department of Breast and Endocrine Surgery, Okayama University Hospital, Okayama, Japan.
⁸ Division of Breast Surgery, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan.
⁹ Department of Breast Oncology, National Hospital Organization Shikoku Cancer Center, Ehime, Japan.
¹⁰ Department of Breast Surgery, Gifu University Hospital, Gifu, Japan.
¹¹ Department of Breast Surgery, Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital, Tokyo, Japan.
¹² Department of Breast Oncology, Niigata Cancer Center Hospital, Niigata, Japan.

Abstract

Introduction: Due to the increase in the number of early-stage breast cancer patients, there is growing interest in minimally invasive local therapies for breast cancer. Radiofrequency ablation (RFA) therapy is one of the most promising minimally invasive treatments. The Radiofrequency Ablation Therapy for Early Breast Cancer as Local Therapy (RAFAELO) study, a multicenter collaborative study that aims to validate the efficacy and safety of RFA and to standardize its use for early-stage breast cancer, was conducted under the Advanced Medical Care B system in 2013. This study enrolled the expected number of patients in November 2017; moreover, it is currently in the follow-up period. Some patients with early-stage breast cancer who are eligible for RFA could not receive the RFA treatment, as it is still not covered by insurance. Therefore, the Patients Offer Radiofrequency Ablation Therapy for Early Breast Cancer as Local Therapy (PO-RAFAELO) study under the Patient-proposed Health Services (PPHS) was proposed and approved in March 2019.

Methods: The PPHS is a system that allows patients to receive prompt access to advanced medical care at a medical facility close to them, starting with their request. This system is considered a part of the specific and special medical coverage. The PO-RAFAELO study is the only study in the surgical field utilizing the PPHS, aiming to help in achieving regulatory approval and insurance coverage of RFA for breast cancer.

Results: As of January 2023, 120 patients have undergone RFA using the PPHS and no grade 3 or higher early adverse events have occurred.

Conclusions: A certain number of patients with early-stage breast cancer prefer nonsurgical treatment, and it is important to provide information regarding the availability of RFA for early-stage breast cancer under the PPHS.Trial registration: registered with Japan Registry of Clinical Trial on March 06, 2019 (Trial ID: jRCTs032180187).

Keywords: Patient-proposed Health Services; breast cancer; nonsurgical ablation; radiofrequency ablation therapy.

Publication types

Clinical Trial