title: Mexican Cervical Cancer Screening Study II: 6-month and 2-year follow-up of HR-HPV women treated with cryotherapy in a low-resource setting.
abstract: OBJECTIVE
  To determine the efficacy and tolerance of cryotherapy in a visual inspection with acetic acid (VIA) triage protocol after primary human papillomavirus (HPV) screening in a low-resource setting.
  
  
  METHODS
  This continuous series conducted over 2 years enrolled nonpregnant, high-risk HPV (HR-HPV)-positive women between the ages of 30 and 50 years, who resided in the state of Michoacán, Mexico, and had a history of no Pap smear screening or knowledge of Pap smear results within the last 3 years. These women were initially enrolled in the Mexican Cervical Cancer Screening Study II (MECCS II) trial and were treated with cryotherapy after VIA triage. They subsequently followed up at 6 months and 2 years for repeat VIA, colposcopy, and biopsy.
  
  
  RESULTS
  A total of 291 women were treated with cryotherapy, of whom 226 (78%) followed up at 6 months. Of these 226 women, 153 (68%) were HR-HPV-negative; there were no findings of cervical intraepithelial neoplasia grade 2 (CIN2) or worse. The remaining 73 women (32%) were HR-HPV-positive; of these women, 2 had CIN2 and 3 had CIN3. Only 137 women followed up at 2 years. Of these 137 women, 116 were HR-HPV-negative and 21 were HR-HPV-positive. Of the 21 women positive for HR-HPV, 9 had negative biopsy results, 11 had CIN1, and 1 had no biopsy. The clearance rate of HR-HPV was 83% (95% confidence interval: 0.78-0.87). There were no biopsy findings of CIN2 or worse at 2 years. Before cryotherapy, of the 226 women, 15 (6.6%) were positive for endocervical curettage (ECC) and 5 (2.2%) were referred for surgical management. Of these 15 ECC-positive women, 10 (67%) followed up at 6 months and it was shown that no patient was ECC positive at that time point. Moreover, of the 15 ECC-positive women, 11 (73%) followed up at 2 years and it was shown that no patient was ECC positive at that time point. In our study, VIA had a false-positive rate of 5%.
  
  
  CONCLUSIONS
  Cryotherapy was an effective, acceptable, and well-tolerated means of treating cervical dysplasia in a low-resource setting.
authors: 1Cleveland Clinic Women's Health Institute, Cleveland, OH; 2Prueba Para La Vida A.C., Morelia, Mexico; 3Preventive Oncology International Inc., Cleveland Heights, OH; 4Department of Pathology, Cleveland Clinic, Cleveland, OH; 5Department of Pathology, Hospital de la Mujer; and 6Department of Pathology, Hospital Civil, Morelia, Mexico.
authors: David
authors: D
authors: Starks
authors: Lucybeth Nieves
authors: LN
authors: Arriba
authors: Christine L
authors: CL
authors: Enerson
authors: Jennifer
authors: J
authors: Brainard
authors: Norma
authors: N
authors: Nagore
authors: Andres
authors: A
authors: Chiesa-Vottero
authors: Jesús Villagran
authors: JV
authors: Uribe
authors: Jerome
authors: J
authors: Belinson
mesh_terms: D000328:Adult; D001706:Biopsy; D003127:Colposcopy; D017679:Cryotherapy / Q000009:adverse effects / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006651:Histocytochemistry; D006801:Humans; D008800:Mexico; D008875:Middle Aged; D030361:Papillomavirus Infections / Q000150:complications*; D016896:Treatment Outcome; D002583:Uterine Cervical Neoplasms / Q000628:therapy*