Safety and Acceptability of Three Ablation Treatments for High-Grade Cervical Precancer: Early Data From a Randomized Noninferiority Clinical Trial.

Autor: Soler M; Ob/Gyn and Women's Health Institute, Cleveland Clinic, Cleveland, OH.; Basic Health International, Pittsburgh, PA; San Salvador, El Salvador., Alfaro K; Basic Health International, Pittsburgh, PA; San Salvador, El Salvador., Masch RJ; Basic Health International, Pittsburgh, PA; San Salvador, El Salvador., Conzuelo Rodriguez G; Basic Health International, Pittsburgh, PA; San Salvador, El Salvador., Qu X; Basic Health International, Pittsburgh, PA; San Salvador, El Salvador., Wu S; Department of Obstetrics and Gynecology, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Third Hospital of Shanxi Medical University, Taiyuan, Shanxi Province, China., Sun J; Department of Obstetrics and Gynecology, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Third Hospital of Shanxi Medical University, Taiyuan, Shanxi Province, China., Hernández Jovel DM; Ginecología y Obstetricia, Hospital Primero de Mayo, Instituto Salvadoreño del Seguro Social, San Salvador, El Salvador., Bonilla J; Centro Javeriano de Oncología, Hospital Universitario San Ignacio, Bogotá, Colombia., Puentes LO; Centro Javeriano de Oncología, Hospital Universitario San Ignacio, Bogotá, Colombia., Murillo R; Centro Javeriano de Oncología, Hospital Universitario San Ignacio, Bogotá, Colombia., Alonzo TA; Department of Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles, CA., Felix JC; Department of Pathology, Medical College of Wisconsin, Milwaukee, WI., Castle P; Divisions of Cancer Prevention and Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, MD., Cremer M; Ob/Gyn and Women's Health Institute, Cleveland Clinic, Cleveland, OH.; Basic Health International, Pittsburgh, PA; San Salvador, El Salvador.
Jazyk: angličtina
Zdroj: JCO global oncology [JCO Glob Oncol] 2022 Dec; Vol. 8, pp. e2200112.
DOI: 10.1200/GO.22.00112
Abstrakt: Purpose: This ongoing trial is comparing the efficacy and safety of three ablation treatments for cervical intraepithelial neoplasia grade 2 or higher. Here, we present early data regarding pain, side effects, and acceptability of CO 2 gas-based cryotherapy (CO 2 ), nongas cryotherapy, and thermal ablation (TA). Efficacy results are expected to become available in late 2023.
Materials and Methods: This noninferiority randomized trial is taking place in El Salvador, China, and Colombia. Patients are 1,152 eligible women with biopsy-confirmed cervical intraepithelial neoplasia grade 2 or higher who will receive one of three ablation treatments. Pain is measured before, during, and after treatment with a visual analog scale (1-10). Side effects and acceptability are assessed at 6 weeks.
Results: To date, 1,024 of 1,152 (89%) women were randomly assigned to treatment. The median pain level was higher during TA (4, IQR = 4) than CO 2 (2, IQR = 4) or nongas cryotherapy (2, IQR = 4) ( P < .01, range: 0-10). The most common post-treatment symptom was watery discharge, reported by 97.9% of women, and it lasted longer in the CO 2 group than the other two treatments (in days, median [IQR]: CO 2 = 20[20], nongas cryotherapy = 15[10], TA = 18[15], P < . 01). Bleeding was reported more frequently in women treated with TA (27.6%) than CO 2 (17.5) or nongas cryotherapy (18.7%) ( P < .01). The majority of patients reported being very satisfied with the treatment they received at 6 weeks (91%) and again at 12 months post-treatment (97%).
Conclusion: Despite differences in pain and side effects across ablation treatments, all were safe and highly acceptable to patients. In addition to efficacy, considerations such as cost and portability may be more significant in choosing a treatment method.
Databáze: MEDLINE
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