title: Toxicity at three years with and without irradiation of the internal mammary and medial supraclavicular lymph node chain in stage I to III breast cancer (EORTC trial 22922/10925).
abstract: BACKGROUND
  The EORTC 22922/10925 trial investigated the potential survival benefit and toxicity of elective irradiation of the internal mammary and medial supraclavicular (IM-MS) nodes Accrual completed in January 2004 and first results are expected in 2012. We present the toxicity reported until year 3 after treatment.
  
  
  METHODS
  At each visit, toxicity was reported but severity was not graded routinely. Toxicity rates and performance status (PS) changes at three years were compared by chi(2) tests and logistic regression models in all the 3,866 of 4,004 patients eligible to the trial who received the allocated treatment.
  
  
  RESULTS
  Only lung (fibrosis; dyspnoea; pneumonitis; any lung toxicities) (4.3% vs. 1.3%; p < 0.0001) but not cardiac toxicity (0.3% vs. 0.4%; p = 0.55) significantly increased with IM-MS treatment. No significant worsening of the PS was observed (p = 0.79), suggesting that treatment-related toxicity does not impair patient's daily activities.
  
  
  CONCLUSIONS
  IM-MS irradiation seems well tolerated and does not significantly impair WHO PS at three years. A follow-up period of at least 10 years is needed to determine whether cardiac toxicity is increased after radiotherapy.
authors.affiliation: European Organisation for Research and Treatment of Cancer (EORTC), Headquarters, Brussels, Belgium. Oscar.Matzinger@chuv.ch
authors.forename: Oscar
authors.initials: O
authors.lastname: Matzinger
authors.forename: Irma
authors.initials: I
authors.lastname: Heimsoth
authors.forename: Philip
authors.initials: P
authors.lastname: Poortmans
authors.forename: Laurence
authors.initials: L
authors.lastname: Collette
authors.forename: Henk
authors.initials: H
authors.lastname: Struikmans
authors.forename: Walter
authors.initials: W
authors.lastname: Van Den Bogaert
authors.forename: Alain
authors.initials: A
authors.lastname: Fourquet
authors.forename: Harry
authors.initials: H
authors.lastname: Bartelink
authors.forename: Fatma
authors.initials: F
authors.lastname: Ataman
authors.forename: Akos
authors.initials: A
authors.lastname: Gulyban
authors.forename: Marianne
authors.initials: M
authors.lastname: Pierart
authors.forename: Geertjan
authors.initials: G
authors.lastname: Van Tienhoven
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D003131:Combined Modality Therapy; D005260:Female; D006321:Heart / Q000528:radiation effects; D006801:Humans; D008207:Lymphatic Metastasis / Q000532:radiotherapy*; D008408:Mastectomy; D008875:Middle Aged; D009367:Neoplasm Staging; D011658:Pulmonary Fibrosis / Q000209:etiology; D011878:Radiotherapy / Q000009:adverse effects*; D012720:Severity of Illness Index