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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

Starks, David MD, MPH1; Arriba, Lucybeth Nieves MD, MPH1; Enerson, Christine L. MD2,3; Brainard, Jennifer MD4; Nagore, Norma MD5; Chiesa-Vottero, Andres MD4; Uribe, Jesús Villagran MD6; Belinson, Jerome MD1,3

Journal of Lower Genital Tract Disease: October 2014 - Volume 18 - Issue 4 - p 333–337
doi: 10.1097/LGT.0000000000000029
Original Articles

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.

Materials and 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.

Cryotherapy is an effective, acceptable, and well-tolerated treatment modality for cervical dysplasia in a low-resource setting.

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

Reprint requests to: David Starks, MD, MPH, Avera McKennan Hospital, 1000 E 23rd St, Suite 350, Sioux Falls, SD 57105. E-mail: David.Starks@Avera.org

This study was supported by Preventive Oncology International, Inc., Gen-Probe Inc., and The Secretary of Health, State of Michoacán, México.

The authors have declared they have no conflicts of interest.

Copyright © 2014 by the American Society for Colposcopy and Cervical Pathology