title: Radiation-related quality of life parameters after targeted intraoperative radiotherapy versus whole breast radiotherapy in patients with breast cancer: results from the randomized phase III trial TARGIT-A.
abstract: BACKGROUND
  Intraoperative radiotherapy (IORT) is a new treatment approach for early stage breast cancer. This study reports on the effects of IORT on radiation-related quality of life (QoL) parameters.
  
  
  METHODS
  Two hundred and thirty women with stage I-III breast cancer (age, 31 to 84 years) were entered into the study. A single-center subgroup of 87 women from the two arms of the randomized phase III trial TARGIT-A (TARGeted Intra-operative radioTherapy versus whole breast radiotherapy for breast cancer) was analyzed. Furthermore, results were compared to non-randomized control groups: n = 90 receiving IORT as a tumor bed boost followed by external beam whole breast radiotherapy (EBRT) outside of TARGIT-A (IORT-boost), and n = 53 treated with EBRT followed by an external-beam boost (EBRT-boost). QoL was collected using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires C30 (QLQ-C30) and BR23 (QLQ-BR23). The mean follow-up period in the TARGIT-A groups was 32 versus 39 months in the non-randomized control groups.
  
  
  RESULTS
  Patients receiving IORT alone reported less general pain (21.3 points), breast (7.0 points) and arm (15.1 points) symptoms, and better role functioning (78.7 points) as patients receiving EBRT (40.9; 19.0; 32.8; and 60.5 points, respectively, P < 0.01). Patients receiving IORT alone also had fewer breast symptoms than TARGIT-A patients receiving IORT followed by EBRT for high risk features on final pathology (IORT-EBRT; 7.0 versus 29.7 points, P < 0.01). There were no significant differences between TARGIT-A patients receiving IORT-EBRT compared to non-randomized IORT-boost or EBRT-boost patients and patients receiving EBRT without a boost.
  
  
  CONCLUSIONS
  In the randomized setting, important radiation-related QoL parameters after IORT were superior to EBRT. Non-randomized comparisons showed equivalent parameters in the IORT-EBRT group and the control groups.
authors.affiliation: Department of Radiation Oncology, University Medical Centre Mannheim, University of Heidelberg, Mannheim, 68167, Germany. grit.welzel@umm.de.
authors.forename: Grit
authors.initials: G
authors.lastname: Welzel
authors.forename: Angela
authors.initials: A
authors.lastname: Boch
authors.forename: Elena
authors.initials: E
authors.lastname: Sperk
authors.forename: Frank
authors.initials: F
authors.lastname: Hofmann
authors.forename: Uta
authors.initials: U
authors.lastname: Kraus-Tiefenbacher
authors.forename: Axel
authors.initials: A
authors.lastname: Gerhardt
authors.forename: Marc
authors.initials: M
authors.lastname: Suetterlin
authors.forename: Frederik
authors.initials: F
authors.lastname: Wenz
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001943:Breast Neoplasms / Q000532:radiotherapy*; D003430:Cross-Sectional Studies; D005260:Female; D006801:Humans; D008875:Middle Aged; D011788:Quality of Life; D011878:Radiotherapy / Q000009:adverse effects* / Q000379:methods*