title: Postoperative vaginal cuff irradiation using high dose rate remote afterloading: a phase II clinical protocol.
abstract: OBJECTIVE
  In September 1989, a postoperative Phase II high dose rate (HDR) brachytherapy protocol was started for International Federation of Gynecology and Obstetrics (FIGO) Stage I endometrial adenocarcinoma. This review reports the overall survival, local control, and complication rates for the initial 63 patients treated in this Phase II study.
  
  
  METHODS
  High dose rate brachytherapy was delivered using an Iridium-192 HDR remote afterloader. Sixty-three patients were entered into the Phase II protocol, each receiving two vaginal cuff treatments 1 week apart (range 4-12 days) with vaginal ovoids (diameter 2.0-3.0 cm). No patient received adjuvant external beam radiation. A dose of 32.4 Gy in two fractions was prescribed to the ovoid surface in 63 patients. The first three patients treated at our institution received 15, 16.2, and 29 Gy, respectively, to determine acute effects.
  
  
  RESULTS
  At a median follow-up of 1.6 years (range 0.75-4.3 years) no patient has developed a vaginal cuff recurrence. One regional recurrence (1.6%) occurred at 1.2 years at the pelvic side wall. This patient is alive and without evidence of disease 7 months after completion of salvage irradiation, which resulted in the only vaginal stenosis (1.6%). Fourteen patients (22%) experienced vaginal apex fibrosis by physical exam, which was clinically symptomatic in four patients. Two patients reported stress incontinence; however, these symptoms were noted prior to their HDR therapy. One patient died 2.4 years after HDR therapy due to cardiovascular disease without evidence of cancer at autopsy.
  
  
  CONCLUSIONS
  Preliminary results of our phase II HDR vaginal cuff protocol for postoperative FIGO Stage IA, Grade 3 or Stage IB, Grade 1-2 patients demonstrate that 32.4 Gy in two fractions is well tolerated by the vaginal cuff mucosa. Local control appears comparable to our prior experience and others with low dose rate (LDR) brachytherapy. Additional patient accrual and further follow-up will better determine the late morbidity, local control, and overall survival of these patients.
authors.affiliation: Department of Human Oncology, University of Wisconsin Medical School, Madison 53792, USA.
authors.forename: W R
authors.initials: WR
authors.lastname: Noyes
authors.forename: K
authors.initials: K
authors.lastname: Bastin
authors.forename: S A
authors.initials: SA
authors.lastname: Edwards
authors.forename: D A
authors.initials: DA
authors.lastname: Buchler
authors.forename: J A
authors.initials: JA
authors.lastname: Stitt
authors.forename: B R
authors.initials: BR
authors.lastname: Thomadsen
authors.forename: J F
authors.initials: JF
authors.lastname: Fowler
authors.forename: T J
authors.initials: TJ
authors.lastname: Kinsella
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001918:Brachytherapy / Q000009:adverse effects* / Q000379:methods*; D005260:Female; D006801:Humans; D007496:Iridium Radioisotopes / Q000627:therapeutic use; D008875:Middle Aged; D009336:Necrosis; D009367:Neoplasm Staging; D011832:Radiation Injuries / Q000453:epidemiology / Q000209:etiology; D012007:Rectum / Q000528:radiation effects; D015996:Survival Rate; D001743:Urinary Bladder / Q000528:radiation effects; D014594:Uterine Neoplasms / Q000473:pathology / Q000532:radiotherapy*; D014621:Vagina / Q000528:radiation effects; D014626:Vaginal Smears
chemical_list: D007496:Iridium Radioisotopes