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Cremer M, Alfaro K, Garai J, et al. Evaluation of two alternative ablation treatments for cervical pre-cancer against standard gas-based cryotherapy: a randomized non-inferiority study. Int J Gynecol Cancer. 2019;doi: 10.1136/ijgc-2018-000148.
Cremer, M., Alfaro, K., Garai, J., Salinas, M., Maza, M., Zevallos, A., Taxa, L., Diaz, A. C., Castle, P., Alonzo, T. A., Masch, R., Soler, M., Conzuelo-Rodriguez, G., Gage, J. C., & Felix, J. C. (2019). Evaluation of two alternative ablation treatments for cervical pre-cancer against standard gas-based cryotherapy: a randomized non-inferiority study. International journal of gynecological cancer : official journal of the International Gynecological Cancer Society, . https://doi.org/10.1136/ijgc-2018-000148
Cremer, Miriam, et al. "Evaluation of two alternative ablation treatments for cervical pre-cancer against standard gas-based cryotherapy: a randomized non-inferiority study." International journal of gynecological cancer : official journal of the International Gynecological Cancer Society vol. (2019). doi: https://doi.org/10.1136/ijgc-2018-000148
Cremer M, Alfaro K, Garai J, Salinas M, Maza M, Zevallos A, Taxa L, Diaz AC, Castle P, Alonzo TA, Masch R, Soler M, Conzuelo-Rodriguez G, Gage JC, Felix JC. Evaluation of two alternative ablation treatments for cervical pre-cancer against standard gas-based cryotherapy: a randomized non-inferiority study. Int J Gynecol Cancer. 2019 May 03; doi: 10.1136/ijgc-2018-000148. Epub 2019 May 03. PMID: 31055452.
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Int J Gynecol Cancer. 2019 May 03; doi: 10.1136/ijgc-2018-000148. Epub 2019 May 03.

Evaluation of two alternative ablation treatments for cervical pre-cancer against standard gas-based cryotherapy: a randomized non-inferiority study.

International journal of gynecological cancer : official journal of the International Gynecological Cancer Society

Miriam Cremer, Karla Alfaro, Jillian Garai, Manuel Salinas, Mauricio Maza, Alberto Zevallos, Luis Taxa, Ana C Diaz, Philip Castle, Todd A Alonzo, Rachel Masch, Montserrat Soler, Gabriel Conzuelo-Rodriguez, Julia C Gage, Juan C Felix

Affiliations

  1. OB/GYN and Women's Health Institute, Cleveland Clinic, Cleveland, Ohio, USA.
  2. Basic Health International, San Salvador, El Salvador.
  3. Basic Health International, New York City, New York, USA.
  4. Instituto Salvadoreño del Seguro Social, San Salvador, El Salvador.
  5. Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru.
  6. Yeshiva University Albert Einstein College of Medicine, Bronx, New York, USA.
  7. University of Southern California, Los Angeles, California, USA.
  8. OB/GYN and Women's Health Institute, Cleveland Clinic, Cleveland, Ohio, USA [email protected].
  9. National Cancer Institute, Bethesda, Maryland, USA.
  10. Medical College of Wisconsin, Milwaukee, Wisconsin, USA.

PMID: 31055452 DOI: 10.1136/ijgc-2018-000148

Abstract

INTRODUCTION: Gas-based cryotherapy is the conventional ablative treatment for cervical pre-cancer in low-income settings, but the use of gas poses significant challenges. We compared the depth of necrosis induced by gas-based cryotherapy with two gas-free alternatives: cryotherapy using CryoPen,and thermoablation.

METHODS: We conducted a five-arm randomized non-inferiority trial: double-freeze carbon dioxide (CO

RESULTS: A total of 133 patients were enrolled in the study. The slides from three women were deemed unreadable. One patient was excluded because her hysterectomy was postponed for reasons unrelated to the study, and two patients were excluded because treatment application did not follow the established protocol. For the remaining 127 women, mean depth of necrosis for double-freeze CO

DISCUSSION: Compared with the referent, non-inferiority could not be concluded for other methods. Mean pain scores were low for all treatments. Depth of necrosis is a surrogate for treatment efficacy, but a randomized clinical trial is necessary to establish true cure rates.

© IGCS and ESGO 2019. No commercial re-use. See rights and permissions. Published by BMJ.

Keywords: cervix uteri; genitalia, female; gynecology

Conflict of interest statement

Competing interests: MC is president/founder of Basic Health International, a trainer for Nexplanon, and a speaker for Merck. PEC has received cervical screening tests and diagnostics at a reduced or

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