Background
Mortality associated with cervical cancer is a public health concern for women, particularly
in HIV–seropositive women in resource-limited countries. HIV-seropositive women are
at a higher risk of high-grade cervical precancer, which can eventually progress to
invasive carcinoma as compared to HIV-seronegative women. It is imperative to identify
effective treatment methods for high-grade cervical precursors among HIV-seropositive
women.
Objective
Randomized controlled trial data are needed comparing cryotherapy vs loop electrosurgical
excision procedure treatment efficacy in HIV-seropositive women. Our primary aim was
to compare the difference in the efficacy of loop electrosurgical excision procedure
vs cryotherapy for the treatment of high-grade cervical intraepithelial neoplasia
(grade ≥2) among HIV-seropositive women by conducting a randomized clinical trial.
Study Design
HIV-seropositive women (n = 166) aged 18-65 years with histology-proven cervical intraepithelial
neoplasia grade ≥2 were randomized (1:1) to cryotherapy or loop electrosurgical excision
procedure treatment at a government hospital in Johannesburg. Treatment efficacy was
compared using 6- and 12-month cumulative incidence posttreatment of: (1) cervical
intraepithelial neoplasia grade ≥2; (2) secondary endpoints of histologic cervical
intraepithelial neoplasia grade ≥3 and grade ≥1; and (3) high-grade and low-grade
cervical cytology. The study was registered (ClinicalTrials.gov NCT01723956).
Results
From January 2010 through August 2014, 166 participants were randomized (86 loop electrosurgical
excision procedure; 80 cryotherapy). Cumulative cervical intraepithelial neoplasia
grade ≥2 incidence was higher for cryotherapy (24.3%; 95% confidence interval, 16.1–35.8)
than loop electrosurgical excision procedure at 6 months (10.8%; 95% confidence interval,
5.7–19.8) (P = .02), although by 12 months, the difference was not significant (27.2%; 95% confidence
interval, 18.5–38.9 vs 18.5%; 95% confidence interval, 11.6–28.8, P = .21). Cumulative cervical intraepithelial neoplasia grade ≥1 incidence for cryotherapy
(89.2%; 95% confidence interval, 80.9–94.9) did not differ from loop electrosurgical
excision procedure (78.3%; 95% confidence interval, 68.9–86.4) at 6 months (P = .06); cumulative cervical intraepithelial neoplasia grade ≥1 incidence by 12 months
was higher for cryotherapy (98.5%; 95% confidence interval, 92.7–99.8) than loop electrosurgical
excision procedure (89.8%; 95% confidence interval, 82.1–95.2) (P = .02). Cumulative high-grade cytology incidence was higher for cryotherapy (41.9%)
than loop electrosurgical excision procedure at 6 months (18.1%, P < .01) and 12 months (44.8% vs 19.4%, P < .001). Cumulative incidence of low-grade cytology or greater in cryotherapy (90.5%)
did not differ from loop electrosurgical excision procedure at 6 months (80.7%, P = .08); by 12 months, cumulative incidence of low-grade cytology or greater was higher
in cryotherapy (100%) than loop electrosurgical excision procedure (94.8%, P = .03). No serious adverse effects were recorded.
Conclusion
Although rates of cumulative cervical intraepithelial neoplasia grade ≥2 were lower
after loop electrosurgical excision procedure than cryotherapy treatment at 6 months,
both treatments appeared effective in reducing cervical intraepithelial neoplasia
grade ≥2 by >70% by 12 months. The difference in cumulative cervical intraepithelial
neoplasia grade ≥2 incidence between the 2 treatment methods by 12 months was not
statistically significant. Relatively high cervical intraepithelial neoplasia grade
≥2 recurrence rates, indicating treatment failure, were observed in both treatment
arms by 12 months. A different treatment protocol should be considered to optimally
treat cervical intraepithelial neoplasia grade ≥2 in HIV-seropositive women.
Key words
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Article info
Publication history
Published online: March 30, 2017
Accepted:
March 23,
2017
Received in revised form:
March 19,
2017
Received:
January 12,
2017
Footnotes
Funded by the University of North Carolina Center for AIDS Research (P30-AI50410), United States Agency for International Development President's Emergency Plan For AIDS Relief (674-A-00-08-00007-00), USAID PHE ZA.09.0265, and South African Research Chairs Initiative of the Department of Science and Technology. Ms Sanusi was funded under a Schlumberger Foundation Faculty for the Future fellowship. President's Emergency Plan For AIDS Relief, the study sponsor, gave comments on the trial study protocol, and had no role in the data collection, analysis, interpretation, or writing of this manuscript. No other funders had a role in the research.
The authors report no conflict of interest.
Cite this article as: Smith JS, Sanusi B, Swarts A, et al. A randomized clinical trial comparing cervical dysplasia treatment with cryotherapy vs loop electrosurgical excision procedure in HIV-seropositive women from Johannesburg, South Africa. Am J Obstet Gynecol 2017;217:183.e1-11.
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Access this article on ScienceDirectLinked Article
- Recurrence of CIN 2 and 3 after treatment in HIV positive patientsAmerican Journal of Obstetrics & GynecologyVol. 219Issue 2
- PreviewA randomized controlled trial of 166 HIV-positive patients comparing treatment for cervical intraepithelial neoplasia (CIN) 2 and 3 by loop electrosurgical excision (LEEP) (n = 86) and cryotherapy (n = 80) in a tertiary government hospital in South Africa, published in the August edition of this journal,1 highlights the high recurrence rates after treatment.
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