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

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 Ther...

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Autores principales: Takayama, Shin, Kinoshita, Takayuki, Shiino, Sho, Jimbo, Kenjiro, Watanabe, Ken-ichi, Fujisawa, Tomomi, Yamamoto, Naohito, Onishi, Tatsuya, Shien, Tadahiko, Ito, Mitsuya, Takahashi, Mina, Futamura, Manabu, Aruga, Tomoyuki, Kaneko, Koji, Suto, Akihiko
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Japan Medical Association 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10628329/
https://www.ncbi.nlm.nih.gov/pubmed/37941717
http://dx.doi.org/10.31662/jmaj.2023-0047
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author Takayama, Shin
Kinoshita, Takayuki
Shiino, Sho
Jimbo, Kenjiro
Watanabe, Ken-ichi
Fujisawa, Tomomi
Yamamoto, Naohito
Onishi, Tatsuya
Shien, Tadahiko
Ito, Mitsuya
Takahashi, Mina
Futamura, Manabu
Aruga, Tomoyuki
Kaneko, Koji
Suto, Akihiko
author_facet Takayama, Shin
Kinoshita, Takayuki
Shiino, Sho
Jimbo, Kenjiro
Watanabe, Ken-ichi
Fujisawa, Tomomi
Yamamoto, Naohito
Onishi, Tatsuya
Shien, Tadahiko
Ito, Mitsuya
Takahashi, Mina
Futamura, Manabu
Aruga, Tomoyuki
Kaneko, Koji
Suto, Akihiko
author_sort Takayama, Shin
collection PubMed
description 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).
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spelling pubmed-106283292023-11-08 Patients Offer Radiofrequency Ablation Therapy for Early Breast Cancer as Local Therapy (PO-RAFAELO) Study under the Patient-proposed Health Services Takayama, Shin Kinoshita, Takayuki Shiino, Sho Jimbo, Kenjiro Watanabe, Ken-ichi Fujisawa, Tomomi Yamamoto, Naohito Onishi, Tatsuya Shien, Tadahiko Ito, Mitsuya Takahashi, Mina Futamura, Manabu Aruga, Tomoyuki Kaneko, Koji Suto, Akihiko JMA J Clinical Trial 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). Japan Medical Association 2023-10-02 2023-10-16 /pmc/articles/PMC10628329/ /pubmed/37941717 http://dx.doi.org/10.31662/jmaj.2023-0047 Text en Copyright © Japan Medical Association https://creativecommons.org/licenses/by/4.0/JMA Journal is an Open Access journal distributed under the Creative Commons Attribution 4.0 International License. To view the details of this license, please visit (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Clinical Trial
Takayama, Shin
Kinoshita, Takayuki
Shiino, Sho
Jimbo, Kenjiro
Watanabe, Ken-ichi
Fujisawa, Tomomi
Yamamoto, Naohito
Onishi, Tatsuya
Shien, Tadahiko
Ito, Mitsuya
Takahashi, Mina
Futamura, Manabu
Aruga, Tomoyuki
Kaneko, Koji
Suto, Akihiko
Patients Offer Radiofrequency Ablation Therapy for Early Breast Cancer as Local Therapy (PO-RAFAELO) Study under the Patient-proposed Health Services
title Patients Offer Radiofrequency Ablation Therapy for Early Breast Cancer as Local Therapy (PO-RAFAELO) Study under the Patient-proposed Health Services
title_full Patients Offer Radiofrequency Ablation Therapy for Early Breast Cancer as Local Therapy (PO-RAFAELO) Study under the Patient-proposed Health Services
title_fullStr Patients Offer Radiofrequency Ablation Therapy for Early Breast Cancer as Local Therapy (PO-RAFAELO) Study under the Patient-proposed Health Services
title_full_unstemmed Patients Offer Radiofrequency Ablation Therapy for Early Breast Cancer as Local Therapy (PO-RAFAELO) Study under the Patient-proposed Health Services
title_short Patients Offer Radiofrequency Ablation Therapy for Early Breast Cancer as Local Therapy (PO-RAFAELO) Study under the Patient-proposed Health Services
title_sort patients offer radiofrequency ablation therapy for early breast cancer as local therapy (po-rafaelo) study under the patient-proposed health services
topic Clinical Trial
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10628329/
https://www.ncbi.nlm.nih.gov/pubmed/37941717
http://dx.doi.org/10.31662/jmaj.2023-0047
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