Kathleen N Moore, Mansoor R Mirza, Charlie Gourley, Sandro Pignata, Domenica Lorusso, Bradley J Monk, Jalid Sehouli, Jeanne M Schilder, Nathalie D'Esquermes, Antonio González-Martín
{"title":"Physician-reported patient involvement and treatment decisions in first-line ovarian cancer in the USA and Europe.","authors":"Kathleen N Moore, Mansoor R Mirza, Charlie Gourley, Sandro Pignata, Domenica Lorusso, Bradley J Monk, Jalid Sehouli, Jeanne M Schilder, Nathalie D'Esquermes, Antonio González-Martín","doi":"10.1136/ijgc-2024-005405","DOIUrl":"10.1136/ijgc-2024-005405","url":null,"abstract":"<p><strong>Objectives: </strong>Real-world data evaluating how approvals of novel treatment regimens for ovarian cancer have impacted the treatment paradigm, including first-line maintenance, are lacking. This analysis aimed to describe treatment patterns for advanced epithelial ovarian cancer in Europe and the USA in the first-line maintenance setting. Patient characteristics, biomarker testing rates, and drivers of treatment choice were also evaluated.</p><p><strong>Methods: </strong>A retrospective chart review study of electronic medical records in Europe and the USA was conducted for patients diagnosed with epithelial ovarian cancer (June 1, 2017-May 31, 2020), in line with Healthcare Market Research guidelines. Eligible physicians extracted data from electronic medical records by completing standardized patient record forms, including questions on patient involvement in treatment decisions. Patients with advanced (stage III/IV) disease were stratified by country and diagnosis date to provide information on treatment patterns.</p><p><strong>Results: </strong>Patient record forms for 7072 patients with epithelial ovarian cancer were completed by 416 physicians; 5386 patients had stage III/IV ovarian cancer. Over time, the percentage of patients who were tested for <i>BRCA</i> mutations or homologous recombination deficiency increased. Patient preference was documented as a reason for treatment selection in approximately one-sixth of cases in the first-line adjuvant and first-line maintenance settings. The use of first-line maintenance poly(ADP-ribose) polymerase inhibitor monotherapy increased over time, while the use of vascular endothelial growth factor inhibitor monotherapy decreased.</p><p><strong>Conclusions: </strong>This real-world study showed that treatment patterns for advanced epithelial ovarian cancer varied by country. Rates of physician-reported patient involvement in treatment decisions in the first-line adjuvant and maintenance treatment settings for ovarian cancer were low, highlighting an unmet need for initiatives to improve patient involvement in shared decision-making regarding maintenance therapy selection.</p>","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":" ","pages":"1753-1760"},"PeriodicalIF":4.1,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142008709","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Neha Bakshi, Rahul D Modi, Mala Srivastava, Sonia Badwal
{"title":"Mixed neuroendocrine and endometrioid carcinoma of the endometrium: a rare aggressive malignancy.","authors":"Neha Bakshi, Rahul D Modi, Mala Srivastava, Sonia Badwal","doi":"10.1136/ijgc-2023-004929","DOIUrl":"10.1136/ijgc-2023-004929","url":null,"abstract":"","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":" ","pages":"1828-1830"},"PeriodicalIF":4.1,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139106109","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Correspondence on 'An international worldwide retrospective cohort observational study comparing primary cytoreductive surgery with neoadjuvant chemotherapy and interval cytoreductive surgery in patients with carcinoma of the ovary, fallopian tubes, and peritoneum (SUROVA trial)' by Chiva et al.","authors":"Mauro Signorelli, Roldano Fossati","doi":"10.1136/ijgc-2024-006035","DOIUrl":"10.1136/ijgc-2024-006035","url":null,"abstract":"","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":" ","pages":"1840"},"PeriodicalIF":4.1,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142390426","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Mapping the path: round ligament metastasis in ovarian cancer.","authors":"Aarthi S Jayraj, Seema Singhal","doi":"10.1136/ijgc-2024-005520","DOIUrl":"https://doi.org/10.1136/ijgc-2024-005520","url":null,"abstract":"","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":"34 11","pages":"1831-1832"},"PeriodicalIF":4.1,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142575801","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Maria Kfoury, Clément Bonnet, Nicolas Delanoy, Karen Howarth, Christophe Marzac, Etienne Rouleau, Jean-Baptiste Micol, Alexandra Leary
{"title":"Dynamic changes in <i>TP53</i> mutated circulating tumor DNA predicts outcome of patients with high-grade ovarian carcinomas.","authors":"Maria Kfoury, Clément Bonnet, Nicolas Delanoy, Karen Howarth, Christophe Marzac, Etienne Rouleau, Jean-Baptiste Micol, Alexandra Leary","doi":"10.1136/ijgc-2024-005581","DOIUrl":"10.1136/ijgc-2024-005581","url":null,"abstract":"<p><p>There is a lack of biomarkers to predict outcome following initial treatment in patients with high-grade ovarian cancer. We hypothesized that monitoring <i>TP53</i> mutation (<i>TP53m</i>) in circulating tumor DNA (ctDNA) could be a tumor-specific biomarker. Patients enrolled in a prospective study (NCT03010124) consented to analysis of biological samples through the disease course. ctDNA was extracted and analyzed to detect the presence of <i>TP53m</i> Next-generation sequencing was performed on tumor tissue to detect <i>TP53m</i> and on whole blood to detect clonal hematopoiesis of indeterminate potential (CHIP).A total of 102 samples were sequentially collected from 26 patients. ctDNA was detected in all patients at diagnosis. The same <i>TP53m</i> was found in ctDNA and tumor tissue in 77% of patients. <i>TP53m</i> in ctDNA was not CHIP related. During neoadjuvant chemotherapy, increasing ctDNA was associated with failure to achieve complete interval cytoreductive surgery in 60% of patients. Rising ctDNA or de novo <i>TP53m</i> seemed to be associated with a trend for worst survival compared with decrease or complete clearance: progression-free survival 10 versus 26.5 months, HR 3.2. Despite macroscopically complete surgery, 30% of patients had detectable ctDNA post-operatively and had worse survival than those with undetectable ctDNA. Monitoring TP53m in ctDNA during chemotherapy or after surgery could help guide the best adjuvant therapy.</p>","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":" ","pages":"1836-1839"},"PeriodicalIF":4.1,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142307740","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sarah Huepenbecker, Larissa A Meyer, Miranda Craft, John K Chan, Christopher Craggs, Peter Lambert, Yvonne G Lin
{"title":"Real-world use of immune checkpoint inhibitors in advanced or recurrent endometrial cancer.","authors":"Sarah Huepenbecker, Larissa A Meyer, Miranda Craft, John K Chan, Christopher Craggs, Peter Lambert, Yvonne G Lin","doi":"10.1136/ijgc-2024-005541","DOIUrl":"10.1136/ijgc-2024-005541","url":null,"abstract":"<p><strong>Objective: </strong>The aim of this study was to describe real-world use of immune checkpoint inhibitors for women with advanced or recurrent endometrial cancer.</p><p><strong>Methods: </strong>Adult women with advanced or recurrent endometrial cancer who received at least one line of systemic treatment between January 1, 2014 and November 1, 2020, then followed to May 31, 2021 in a nationwide electronic health record-derived de-identified database. Chi-Squared test or Welch's 2-sample t-tests were used to compare patient and clinical factors associated with immune checkpoint inhibitor treatment. Time to next treatment analyses were performed based on the treatment line of the immune checkpoint inhibitor. Sankey plots depicted patient-level temporal systemic treatment.</p><p><strong>Results: </strong>During our study period, 326 women received their first immune checkpoint inhibitor treatment, increasing from 12 patients in 2016 to 148 in 2020. Factors associated with ever receiving immune checkpoint inhibitors included disease stage (p=0.002), mismatch repair (MMR)/microsatellite instability (MSI) status (p<0.001), performance status (p=0.001), and prior radiation receipt (p<0.001) and modality (p=0.003). The most common immune checkpoint inhibitor regimen was pembrolizumab (47.9%) followed by pembrolizumab and lenvatinib (34.7%). Immune checkpoint inhibitors were given as first, second, and third or greater lines of therapy in 24.5%, 41.7%, and 46.1% of evaluable patients. The median time to next treatment was significantly longer if given as an earlier line of treatment (p=0.008). There were significant differences in treatment line of immune checkpoint inhibitor by region (p=0.004), stage (p<0.001), and prior radiation receipt (p=0.014) and modality (p=0.009). Among 326 patients who received immune checkpoint inhibitors, 114 (34.9%) received subsequent treatment including chemotherapy (43.9%), additional immune checkpoint inhibitors (29.8%), and other (26.3%) with no differences in demographic or clinical characteristics based on the type of post-immune checkpoint inhibitor treatment.</p><p><strong>Conclusion: </strong>In an observational retrospective real-world database study, immune checkpoint inhibitors were used in 14.7% of patients with advanced or recurrent endometrial cancer across multiple lines of treatment, including after initial immune checkpoint inhibitor treatment.</p>","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":" ","pages":"1719-1728"},"PeriodicalIF":4.1,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141476588","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ramon Rovira, Liliana Mereu, François Planchamp, Henrik Falconer, Ahmed El-Balat, Marc Barahona, Anna Fagotti, Denis Querleu, Cagatay Taskiran
{"title":"ESGE/ESGO/SERGS consensus statement on surgical steps in minimally invasive surgery in gynecologic oncology: transperitoneal and extraperitioneal approach for paraaortic lymphadenectomy.","authors":"Ramon Rovira, Liliana Mereu, François Planchamp, Henrik Falconer, Ahmed El-Balat, Marc Barahona, Anna Fagotti, Denis Querleu, Cagatay Taskiran","doi":"10.1136/ijgc-2024-005796","DOIUrl":"10.1136/ijgc-2024-005796","url":null,"abstract":"<p><strong>Introduction: </strong>Assessment of retroperitoneal nodes is an important part of the surgical staging of gynecologic cancers. Although pelvic and paraaortic lymphadenectomy have been widely described by different authors, there is little consensus on the description of the different surgical steps for each procedure. An Intergroup Committee on Onco-Gyn Minimally Invasive Surgery has been established with members of the European Society for Gynecological Endoscopy (ESGE), European Society of Gynaecological Oncology (ESGO) and the Society of European Robotic Gynaecological Surgery (SERGS). The Intergroup Committee has various objectives: writing down a surgical description of the technique, which will be assessed by a group of experts following a formal consensus method and developing a specific Objective Structured Assessment of Technical Skills (OSATS) scale for each procedure.</p><p><strong>Methods: </strong>A hierarchical task analysis was conducted by a working group of eight experts from the three societies in order to identify the surgical steps of transperitoneal and extraperitoneal approach in paraaortic lymphadenectomy. The selection of the definitive surgical steps was confirmed by a group of 19 experts from the different societies, following a formal consensus method. Two rounds of Delphi panel rating were considered necessary for achieving an agreement. The consensus agreement identified 29 surgical steps in transperitoneal and 17 surgical steps in extraperitoneal approach to complete a paraaortic lymphadenectomy. Once the description of the procedure and the consensus were established, an Objective specific Scale for the Assessment of Technical Skills for Paraaortic lymphadenectomy (PA-OSATS) in the transperitoneal and extraperitoneal approach was developed.</p><p><strong>Results: </strong>In the first round of rating we found that 28 steps out of 29 in the transperitoneal approach and 13 out of 17 in the extraperitoneal approach did not reach a strong degree of agreement. They were reformulated based on comments made by the experts, and submitted to a second round of rating and this finally achieved an agreement.</p><p><strong>Conclusion: </strong>We defined a list of surgical steps in transperitoneal and extraperitoneal approach in paraaortic lymphadenectomy and a specific PA-OSATS scale for these procedures. This tool will be useful for teaching, assessing and standardizing this surgical procedure.</p>","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":" ","pages":"1673-1676"},"PeriodicalIF":4.1,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142346242","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Patriciu Achimas-Cadariu, Paul Milan Kubelac, Andrei Pasca, Vlad Alexandru Gata, Bogdan Fetica, Ovidiu Balacescu, Eva Fischer-Fodor, Monica Focsan, Simion Astilean, Catalin Ioan Vlad
{"title":"Intraoperative imaging of residual ovarian cancer after neoadjuvant chemotherapy using indocyanine green.","authors":"Patriciu Achimas-Cadariu, Paul Milan Kubelac, Andrei Pasca, Vlad Alexandru Gata, Bogdan Fetica, Ovidiu Balacescu, Eva Fischer-Fodor, Monica Focsan, Simion Astilean, Catalin Ioan Vlad","doi":"10.1136/ijgc-2024-005568","DOIUrl":"https://doi.org/10.1136/ijgc-2024-005568","url":null,"abstract":"<p><strong>Objectives: </strong>Interval debulking surgery has similar outcomes and less morbidity compared with primary debulking in advanced ovarian cancer. However, there is controversy regarding the selection of chemotherapy-resistant clones. Complete resection is an essential prerequisite, and near-infrared surgery combined with various techniques for highlighting malignant foci strives to achieve actual complete resection. This study investigated the role of indocyanine green (ICG) in identifying additional residual malignant foci during interval debulking of apparently intact peritoneum not deemed clinically suspicious under white light inspection.</p><p><strong>Methods: </strong>Patients diagnosed with stage III or IV high-grade serous ovarian carcinoma, older than 18 years of age, with satisfactory hepatic and renal functions who underwent neoadjuvant chemotherapy according to the institutional protocol and were scheduled to undergo interval debulking surgery between 2020 and 2022 were deemed suitable for inclusion after agreeing to the study protocol and acknowledging no contraindications for the administration of the ICG product. After laparotomy and white light inspection, using bolus administration of ICG, additional suspect peritoneal samples in near infrared (defined by clinical hyper- or hypointensity areas compared with surrounding ICG fluorescence using the Zeiss Opmi Pentero 800 surgical microscope, that were not deemed clinically suspicious under white light) were excised. Descriptive statistics were inferred and the chi-square test was used for the comparison of excised areas. The Kaplan-Meier method was deployed for computing the overall survival and progression-free survival of the cohort. All statistical analyses were performed using IBM SPSS Statistics software.</p><p><strong>Results: </strong>Fifteen patients with a median age of 56 years were included. Most cases (n=10, 66.7%) were International Federation of Gynecology and Obstetrics (FIGO) stage III, and all patients received four to seven cycles of neoadjuvant platinum chemotherapy, with 40% of regimens using bevacizumab. The mean interval between neoadjuvant treatment and surgery was 39 (median 42, range 20-78) days. A total of 39 suspect additional peritoneal samples were analyzed, with 41% confirming malignant foci. The positive predictive value (PPV) for malignant foci was 30% in ICG hyperintense areas and 46% in ICG hypointense areas. Germline BRCA1/2 mutant patients and using neoadjuvant bevacizumab led to a higher PPV for ICG hypointense areas (60% and 72.7%, respectively). Overall, the number of additionally resected pathologically confirmed malignant lesions through ICG fluorescence increased by 25%.</p><p><strong>Conclusions: </strong>The use of ICG was associated with an increase in the resection of samples with residual malignant foci. Overall, hypointense areas had a higher positive PPV for malignant foci in comparison with hyperintense ICG areas (46% vs","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":" ","pages":""},"PeriodicalIF":4.1,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142575889","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Hyun-Woong Cho, Hee-Seung Kim, Jeong-Yeol Park, Yoo Young Lee, Myong Cheol Lim, Sung-Jong Lee, Kyung-Jin Min, Kyung Jin Eoh, Kwang Beom Lee, Min Kyu Kim, Jae Yun Song, Seung-Hyuk Shim, Yong Il Ji, Yong-Joong Song, Suk-Joon Chang, Mi Kyung Kim, Akiko Abe, Yusuke Kobayashi, Hiroaki Kajiyama, Muneaki Shimada, Aikou Okamoto, Joseph S Ng, Jung-Yun Lee
{"title":"A randomized phase II study of secondary cytoreductive surgery in patients with relapsed ovarian cancer who have progressed on a PARP inhibitor as first-line maintenance therapy: the SOCCER-P study (KGOG 3067/JGOG 3036/APGOT-OV11).","authors":"Hyun-Woong Cho, Hee-Seung Kim, Jeong-Yeol Park, Yoo Young Lee, Myong Cheol Lim, Sung-Jong Lee, Kyung-Jin Min, Kyung Jin Eoh, Kwang Beom Lee, Min Kyu Kim, Jae Yun Song, Seung-Hyuk Shim, Yong Il Ji, Yong-Joong Song, Suk-Joon Chang, Mi Kyung Kim, Akiko Abe, Yusuke Kobayashi, Hiroaki Kajiyama, Muneaki Shimada, Aikou Okamoto, Joseph S Ng, Jung-Yun Lee","doi":"10.1136/ijgc-2024-005838","DOIUrl":"10.1136/ijgc-2024-005838","url":null,"abstract":"<p><strong>Background: </strong>Although two recent phase III randomized controlled trials showed survival benefits of undergoing secondary cytoreductive surgery for an initial relapse of ovarian cancer, patients who received a poly-ADP ribose polymerase inhibitor (PARPi) as the first-line maintenance treatment, which is currently the standard treatment for advanced ovarian cancer, were not included in those trials. Therefore, determining an optimal treatment strategy, including secondary cytoreductive surgery, in patients whose cancer progresses even with PARPi treatment, is needed.</p><p><strong>Primary objective: </strong>To determine whether secondary cytoreductive surgery is beneficial in patients who have progressed on PARPi maintenance treatment.</p><p><strong>Study hypothesis: </strong>Secondary cytoreductive surgery followed by chemotherapy is superior to chemotherapy alone for patients who have progressed on PARPi maintenance treatment.</p><p><strong>Trial design: </strong>The SOCCER-P study is a multicenter randomized phase II clinical trial. Patients who meet the eligibility criteria will be randomized to either undergo secondary cytoreductive surgery and subsequent platinum-based chemotherapy plus or minus bevacizumab, or to receive platinum-based chemotherapy plus or minus bevacizumab alone. Patients randomly allocated to the surgery group will undergo secondary cytoreductive surgery followed by six cycles of a physician's choice of platinum-based chemotherapy once they have recovered from surgery.</p><p><strong>Major inclusion/exclusion criteria: </strong>The major inclusion criteria are as follows: first recurrence of disease with treatment-free interval from last platinum dose (TFIp) ≥6 months and progression during PARPi maintenance or treatment-free interval from last PARPi therapy (TFI<sub>PARPi</sub>) <3 months. The major exclusion criteria are as follows: >1 line of prior chemotherapy, TFIp <6 months, and radiological signs suggesting metastases not accessible to surgical removal (complete resection is deemed not possible).</p><p><strong>Primary endpoint: </strong>Progression-free survival.</p><p><strong>Sample size: </strong>124 patients.</p><p><strong>Estimated dates for completing accrual and presenting results: </strong>Accrual completion approximately the end of 2026 and the results are expected after 2 years of follow-up in 2029.</p><p><strong>Trial registration: </strong>NCT05704621.</p>","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":" ","pages":"1809-1812"},"PeriodicalIF":4.1,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142008708","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Comparing visual inspection with acetic acid, with and without Lugol's Iodine for triage of HPV self-sample positive women in Ethiopia: a randomized controlled trial.","authors":"Selamawit Fisseha Mekuria, Habtamu Biazin, Tamrat Abebe, Christer Borgfeldt, Nahom Assegid, Adane Mihret, Reta Obsi Nemomsa, Ola Forslund, Mats Jerkeman","doi":"10.1136/ijgc-2024-005694","DOIUrl":"10.1136/ijgc-2024-005694","url":null,"abstract":"<p><strong>Background: </strong>Most women who are high-risk human papilloma virus (hrHPV) positive in a cervical cancer screening test will spontaneously heal from their infection. Visual inspection with acetic acid (VIA) is recommended by the World Health Organization as a triage test for cervical screening, however its accuracy as a triage test has been questioned. In this study, we aimed to examine the sensitivity and specificity of VIA with and without Lugol's iodine as a triage test to detect cervical intraepithelial neoplasia (CIN2+) among women who tested positive for hrHPV after self-sampling.</p><p><strong>Method: </strong>This two-armed randomized controlled trial (RCT) took place in Adama, Ethiopia. The women who tested positive for vaginal hrHPV (Anyplex ΙΙ, Seegene) after self-sampling were randomized to VIA with or without iodine and appointed to a midwife-led clinic. The result of the triage test was categorized as positive, negative, suspicion of cancer or inconclusive, and treated accordingly. Cervical biopsies were collected from women who were hrHPV positive to serve as a gold standard.</p><p><strong>Results: </strong>22.4% (197/878) of women tested hrHPV positive. Sensitivity and specificity for VIA to detect CIN2+was 25.0% (95% CI 0.6 to 80.0) and 82.7% (95% CI 69.7 to 91.8), respectively. For VIA with iodine, the sensitivity was 50.0% (95% CI 0.7 to 93.2) and the specificity 86.3% (95% CI 71.4 to 93.0). The difference between the two methods was not statistically significant, p=0.5. The odds of detecting CIN2+ was 5.4 times higher if positive for VIA with iodine compared with a negative result. For VIA without iodine, the odds of detecting CIN2+ was 1.6 compared with a negative result. The odds of detecting CIN2+ was 6.4 times higher if the women were HIV positive than for those who were HIV negative.</p><p><strong>Conclusion: </strong>VIA with iodine improved detection of CIN2+ in women who were hrHPV DNA positive but was not significantly better than VIA alone.</p><p><strong>Trial registration number: </strong>NCT05125380.</p>","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":" ","pages":"1691-1697"},"PeriodicalIF":4.1,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142371809","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}