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

Abstract
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.
AuthorsKumiko Karasawa, Tokuhiki Omatsu, Atsushi Arakawa, Naohito Yamamoto, Takashi Ishikawa, Mitsue Saito, Shigekazu Fukuda, Tadashi Kamada, Working Group for Breast Cancer
JournalJournal of radiation research (J Radiat Res) Vol. 60 Issue 3 Pg. 342-347 (May 01 2019) ISSN: 1349-9157 [Electronic] England
PMID30805611 (Publication Type: Clinical Trial, Phase I, Journal Article)
Copyright© The Author(s) 2019. Published by Oxford University Press on behalf of The Japan Radiation Research Society and Japanese Society for Radiation Oncology.
Topics
  • Aged
  • Aged, 80 and over
  • Breast Neoplasms (pathology, radiotherapy)
  • Dose-Response Relationship, Radiation
  • Female
  • Heavy Ion Radiotherapy
  • Humans
  • Magnetic Resonance Imaging
  • Middle Aged
  • Neoplasm Staging

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