title: RTOG 95-17, a Phase II trial to evaluate brachytherapy as the sole method of radiation therapy for Stage I and II breast carcinoma--year-5 toxicity and cosmesis.
abstract: OBJECTIVE
  Radiation Therapy Oncology Group (RTOG) 95-17, a Phase II trial to evaluate multicatheter brachytherapy (mCathBrachy) as the sole method of radiation therapy for Stage I-II breast cancer (BrCa), was the first cooperative group trial in North America to evaluate accelerated partial breast irradiation (APBI) and include patient-reported outcomes (PROs). This report presents the year-5 toxicity and cosmesis data.
  
  
  METHODS
  After lumpectomy and axillary dissection for invasive BrCa (tumor size <3cm with zero to three positive lymph nodes), 100 patients (pts), 98 evaluable, were treated (txed) with mCathBrachy from 1997 to 2000 with 34Gy administered twice daily in 10 high-dose-rate fractions or 45Gy in 3.5-6 days as a low-dose-rate implant to 1-2cm beyond the lumpectomy bed. The PROs and physician-reported outcomes of toxicity, cosmesis, and tx satisfaction at year-5 are reported here, defined as data submitted 54-78 months after tx.
  
  
  RESULTS
  Grade (G) 1-2 skin toxicity developed in 78% of the pts and G3 in 13% (no G4). The tx effects included skin dimpling/indentation (37%), fibrosis (45%), telangiectasias (45%), skin catheter marks (54%), and symptomatic fat necrosis (15%). Breast asymmetry was reported in 73%. Rates of excellent-to-good cosmesis were similar between PROs (66%) and radiation oncologists (68%). The PROs of tx satisfaction at year-5 was 75%.
  
  
  CONCLUSIONS
  RTOG 95-17 documents the year-5 skin toxicity and tx effects of mCathBrachy APBI, which are associated with PROs of good-to-excellent cosmesis and high tx satisfaction. This emphasizes the importance of PROs when assessing BrCa tx. National Surgical Adjuvant Breast and Bowel Project B39/RTOG 0413 will allow for definitive comparisons between APBI and whole breast radiation therapy.
authors.affiliation: Department of Radiation Oncology, University of Colorado Hospital, Aurora, CO. Electronic address: rachel.rabinovitch@ucdenver.edu.
authors.forename: Rachel
authors.initials: R
authors.lastname: Rabinovitch
authors.affiliation: Department of Statistics, Radiation Therapy Oncology Group, Philadelphia, PA.
authors.forename: Kathryn
authors.initials: K
authors.lastname: Winter
authors.affiliation: Department of Radiation Oncology, AZ Oncology Services, Scottsdale, AZ; Radiation Oncology, Arizona Breast Cancer Specialists, Scottsdale, AZ.
authors.forename: Robert
authors.initials: R
authors.lastname: Kuske
authors.affiliation: Department of Surgery, Ochsner Clinic, New Orleans, LA.
authors.forename: John
authors.initials: J
authors.lastname: Bolton
authors.affiliation: Department of Radiation Oncology, Medical College of Virginia, Richmond, VA.
authors.forename: Doug
authors.initials: D
authors.lastname: Arthur
authors.affiliation: Department of Radiation Oncology, Ochsner Baptist Medical Center, New Orleans, LA.
authors.forename: Troy
authors.initials: T
authors.lastname: Scroggins
authors.affiliation: Department of Radiation Oncology, William Beaumont Hospital, Royal Oak, MI; Radiation Oncology, Michigan HealthCare Professionals/21st Century Oncology, Farmington Hills, MI.
authors.forename: Frank
authors.initials: F
authors.lastname: Vicini
authors.affiliation: Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center, New York, NY.
authors.forename: Beryl
authors.initials: B
authors.lastname: McCormick
authors.affiliation: Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee, WI; Department of Radiation Oncology, Ohio State University Medical Center, Columbus, OH.
authors.forename: Julia
authors.initials: J
authors.lastname: White
mesh_terms: D005260:Female; D006801:Humans; D001918:Brachytherapy / Q000379:methods; D001940:Breast / Q000473:pathology / Q000528:radiation effects / Q000601:surgery; D001943:Breast Neoplasms / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy; D005500:Follow-Up Studies; D016462:Mammaplasty / Q000379:methods; D009367:Neoplasm Staging; D017060:Patient Satisfaction; D011879:Radiotherapy Dosage; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
keywords: Brachytherapy; Breast cancer; Cosmesis; Partial breast irradiation; Patient-reported outcomes; Toxicity
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