title: Interstitial brachytherapy alone after breast conserving surgery: interim results of a German-Austrian multicenter phase II trial.
abstract: OBJECTIVE
  To evaluate the value of interstitial brachytherapy (iBT) alone in the treatment of low-risk breast cancer patients with regard to local control, side effects, and cosmesis.
  
  
  METHODS
  From November 2000 to January 2004, 176 patients with low-risk breast cancer were treated with iBT only. Patients were eligible for entering the study if: the tumor size was <3 cm; resection margins were clear by at least 2 mm; there were no lymph node metastases or only one micrometastasis (pNo, pNmi); age was >35 years; steroid hormone receptor was positive; and histologic grade was 1 or 2. Seventy-five percent of patients received pulsed-dose-rate brachytherapy (D(ref) = 50 Gy); 25% of patients received high-dose-rate brachytherapy (D(ref) = 32.0 Gy). An interim analysis is presented for all patients after an interim follow-up of 12 months, and for half the patient population with an interim follow-up of 21 months.
  
  
  RESULTS
  All patients remained disease-free on the date of analysis. A perioperative complication breast infection was recorded for 1/176 (0.6%) patients. Late toxicity i.e., hypersensation, hyperpigmentation, fibrosis, or teleangiectasia was observed in 1-12% of all patients. Grade I Fibrosis was registered in 7.6% (13/172) and grade II in 7.0% (12/172) of evaluable patients. Similarly, grade I teleangiectasia was observed in 4.7% (8/172), grade II in 0.6% (1/172), and grade III also in 0.6% (1/172) of evaluable patients. Excellent or good cosmetic results have been observed in 92-95% of patients.
  
  
  CONCLUSIONS
  Brachytherapy as monotherapy in low-risk breast cancer patients after breast-conserving surgery is an effective, precise treatment modality without perioperative morbidity, low acute, mild late toxicity, and yields good to excellent cosmetic results.
authors.affiliation: Department of Radiation Oncology, Erlangen-Nürnberg University, Universitätstr. 27, 91052 Erlangen, Germany. vstrnad@strahlen.med.uni-erlangen.de
authors.forename: Vratislav
authors.initials: V
authors.lastname: Strnad
authors.forename: Oliver
authors.initials: O
authors.lastname: Ott
authors.forename: Richard
authors.initials: R
authors.lastname: Pötter
authors.forename: Guido
authors.initials: G
authors.lastname: Hildebrandt
authors.forename: Josef
authors.initials: J
authors.lastname: Hammer
authors.forename: Alexandra
authors.initials: A
authors.lastname: Resch
authors.forename: Michael
authors.initials: M
authors.lastname: Lotter
authors.forename: Sven
authors.initials: S
authors.lastname: Ackermann
authors.forename: Matthias W
authors.initials: MW
authors.lastname: Beckmann
authors.forename: Rolf
authors.initials: R
authors.lastname: Sauer
mesh_terms: D001317:Austria; D001918:Brachytherapy / Q000379:methods; D001943:Breast Neoplasms / Q000532:radiotherapy* / Q000601:surgery; D003131:Combined Modality Therapy; D005260:Female; D005858:Germany; D006801:Humans; D008875:Middle Aged; D011446:Prospective Studies