A Phase I clinical trial of carbon ion radiotherapy for Stage I breast cancer: clinical and pathological evaluation.


Journal

Journal of radiation research
ISSN: 1349-9157
Titre abrégé: J Radiat Res
Pays: England
ID NLM: 0376611

Informations de publication

Date de publication:
01 May 2019
Historique:
received: 16 08 2018
revised: 21 12 2018
pubmed: 26 2 2019
medline: 23 11 2019
entrez: 27 2 2019
Statut: ppublish

Résumé

Even with its high RBE and >20 years history, there had been no breast cancer clinical trial using carbon-ion radiotherapy. We started a Phase I trial of carbon ion radiotherapy for Stage I breast cancer in 2013. This article describes the clinical and pathological evaluation of this study. Patients with low-risk Stage I breast cancer were eligible. A dose escalation study was designed, with dose levels of 48.0, 52.8 or 60.0 Gy relative biological effectiveness (RBE) administered in four fractions within 1 week. Three months after radiotherapy, the patients underwent tumor excision for pathological evaluation. Between April 2013 and December 2014, three cases receiving 48 Gy (RBE), three cases receiving 52.8 Gy (RBE) and one case receiving 60 Gy (RBE) underwent this protocol. No adverse effects were observed except for Grade 1 acute skin reaction in four cases. Pathological evaluation revealed that all four cases with doses of 52.8 Gy (RBE) and 60.0 Gy (RBE) achieved Grade 2b or more, but only two cases reached Grade 3. At the end of 2017, all cases were alive without recurrence or late had not caused any late adverse reaction. Carbon ion radiotherapy for Stage I breast cancer seems to be safe, and we found that it did not reach enough treatment effect 3 months after the treatment.

Identifiants

pubmed: 30805611
pii: 5364867
doi: 10.1093/jrr/rry113
pmc: PMC6530622
doi:

Types de publication

Clinical Trial, Phase I Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

342-347

Informations de copyright

© The Author(s) 2019. Published by Oxford University Press on behalf of The Japan Radiation Research Society and Japanese Society for Radiation Oncology.

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Auteurs

Kumiko Karasawa (K)

National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Science and Technology, 4-9-1, Anagawa, Inage-ku, Chiba-city, Japan.
Department of Radiation Oncology, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan.

Tokuhiki Omatsu (T)

National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Science and Technology, 4-9-1, Anagawa, Inage-ku, Chiba-city, Japan.

Atsushi Arakawa (A)

Department of Pathology, Juntendo University, 2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan.

Naohito Yamamoto (N)

Department of Breast Surgery, Chiba Cancer Center,666-2, Nitonacho, Chuo-ku, Chiba-city, Japan.

Takashi Ishikawa (T)

Department of Breast Surgery, Tokyo Medical University, 6-1-1, Shinjuku, Shinjuku-ku, Tokyo, Japan.

Mitsue Saito (M)

Department of Breast Surgery, Juntendo University, 2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan.

Shigekazu Fukuda (S)

National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Science and Technology, 4-9-1, Anagawa, Inage-ku, Chiba-city, Japan.

Tadashi Kamada (T)

National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Science and Technology, 4-9-1, Anagawa, Inage-ku, Chiba-city, Japan.

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