title: A multicenter investigation of late adverse events in Japanese women treated with breast-conserving surgery plus conventional fractionated whole-breast radiation therapy.
abstract: OBJECTIVE
  To investigate late adverse events in Japanese women treated with breast-conserving surgery plus conventional fractionated radiation therapy in 24 hospitals.
  
  
  METHODS
  This is a prospective investigation into patients who have been followed for 3 years or more after the completion of radiation therapy. The women visited hospitals for routine medical follow-up between 1 March and 31 May 2008. All patients underwent interviews and visual/palpating examinations. Their clinical chart, past chest X-rays and laboratory findings were reviewed. Evaluation criteria for late adverse events and breast cosmetic outcome were based on the Common Terminology Criteria for Adverse Events v.3 and the European Organization for Research and Treatment of Cancer Global Cosmetic Rating System.
  
  
  RESULTS
  Seven hundred and three women, including 448 treated with whole-breast irradiation and 255 treated with whole-breast and boost irradiation, were examined by radiation oncologists in 24 hospitals. The frequent adverse events were breast pain (Grade 1, 115; Grade 2, 2), breast fibrosis (Grade 1, 72; Grade 2, 8), chest wall pain (Grade 1, 67; Grade 2, 3), telangiectasia (Grade 1, 29; Grade 2, 5) and pneumonitis (Grade 1, 20; Grade 2, 6; Grade 3, 3). Adverse events of Grade 2 or 3 were found in 27 patients (3.8%); 3 presented with radiation pneumonitis of Grade 3. The percentage of patients with an excellent or good cosmetic outcome was 69.1%.
  
  
  CONCLUSIONS
  In the first multicenter investigation for Japanese women after breast-conserving therapy, the evaluation of late adverse events and breast cosmetic outcome was similar to several other reports from clinical trials in North America and Europe.
authors.affiliation: Department of Radiology, Dokkyo Medical University Koshigaya Hospital, 2-1-50 Minami-Koshigaya, Koshigaya-Shi, Saitama, Japan. miwako@dokkyomed.ac.jp
authors.forename: Miwako
authors.initials: M
authors.lastname: Nozaki
authors.forename: Yoshikazu
authors.initials: Y
authors.lastname: Kagami
authors.forename: Michihide
authors.initials: M
authors.lastname: Mitsumori
authors.forename: Masahiro
authors.initials: M
authors.lastname: Hiraoka
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D044466:Asian People / Q000706:statistics & numerical data*; D001943:Breast Neoplasms / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery*; D019583:Dose Fractionation, Radiation; D005260:Female; D005500:Follow-Up Studies; D006321:Heart / Q000528:radiation effects*; D006801:Humans; D007564:Japan / Q000453:epidemiology; D008168:Lung / Q000528:radiation effects*; D015412:Mastectomy, Segmental; D059373:Mastodynia / Q000453:epidemiology* / Q000209:etiology; D008875:Middle Aged; D009367:Neoplasm Staging; D011446:Prospective Studies; D017564:Radiation Pneumonitis / Q000453:epidemiology* / Q000209:etiology; D018714:Radiotherapy, Adjuvant / Q000009:adverse effects; D012867:Skin / Q000528:radiation effects*; D013997:Time Factors