Le Dang, Linghua Kong, Yuqian Zhao, Yi Dai, Li Ma, Lihui Wei, Shulan Zhang, Jihong Liu, Mingrong Xi, Long Chen, Xianzhi Duan, Qing Xiao, Guzhalinuer Abulizi, Guonan Zhang, Ying Hong, Qi Zhou, Xing Xie, Li Li, Mayinuer Niyazi, Zhifen Zhang, Jiyu Tuo, Yiling Ding, Youlin Qiao, Jinghe Lang
{"title":"评价宫颈癌筛查中高危人乳头瘤病毒阳性妇女的分诊策略:中国不同资源环境下的一项多中心随机对照试验","authors":"Le Dang, Linghua Kong, Yuqian Zhao, Yi Dai, Li Ma, Lihui Wei, Shulan Zhang, Jihong Liu, Mingrong Xi, Long Chen, Xianzhi Duan, Qing Xiao, Guzhalinuer Abulizi, Guonan Zhang, Ying Hong, Qi Zhou, Xing Xie, Li Li, Mayinuer Niyazi, Zhifen Zhang, Jiyu Tuo, Yiling Ding, Youlin Qiao, Jinghe Lang","doi":"10.21147/j.issn.1000-9604.2022.05.09","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>We aimed to evaluate the effectiveness of different triage strategies for high-risk human papillomavirus (hrHPV)-positive women in primary healthcare settings in China.</p><p><strong>Methods: </strong>This study was undertaken in 11 rural and 9 urban sites. Women aged 35-64 years old were enrolled. HrHPV-positive women were randomly allocated to liquid-based cytology (LBC), visual inspection with acetic acid and Lugol's iodine (VIA/VILI) (rural only) triage, or directly referred to colposcopy (direct COLP). At 24 months, hrHPV testing, LBC and VIA/VILI were conducted for combined screening.</p><p><strong>Results: </strong>In rural sites, 1,949 hrHPV-positive women were analyzed. A total of 852, 218 and 480 women were randomly assigned to direct COLP, LBC and VIA/VILI. At baseline, colposcopy referral rates of LBC or VIA/VILI triage could be reduced by 70%-80%. LBC (n=3 and n=7) or VIA/VILI (n=8 and n=26) could significantly decrease the number of colposcopies needed to detect one cervical intraepithelial neoplasia (CIN) 2 or worse and CIN3+ compared with direct COLP (n=14 and n=23). For the 24-month cumulative detection rate of CIN2+, VIA/VILI triage was 0.50-fold compared with LBC triage and 0.46-fold with the direct COLP. When stratified by age, baseline LBC triage+ performed best (P<0.001), peaking among women aged 35-44 years (P<sub>trend</sub>=0.002). In urban sites, 1,728 women were hrHPV genotyping test positive. A total of 408, 571 and 568 women were randomly assigned to direct COLP for HPV16/18+, direct COLP for other hrHPV subtypes+, and LBC triage for other hrHPV subtypes+. LBC (n=12 and n=31) significantly decreased the number of colposcopies needed to detect one CIN2+ and CIN3+ compared with direct COLP (n=14 and n=44). HPV16/18+ increased the 24-month cumulative detection rate of CIN2+ (17.89%, P<0.001).</p><p><strong>Conclusions: </strong>LBC triage for hrHPV-positive women in rural settings and direct COLP for HPV16/18+ women and LBC triage for other hrHPV subtype+ women in urban settings might be feasible strategies.</p>","PeriodicalId":9830,"journal":{"name":"Chinese journal of cancer research = Chung-kuo yen cheng yen chiu","volume":" ","pages":"496-509"},"PeriodicalIF":0.0000,"publicationDate":"2022-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9646459/pdf/cjcr-34-5-496.pdf","citationCount":"0","resultStr":"{\"title\":\"Evaluation of triage strategies for high-risk human papillomavirus-positive women in cervical cancer screening: A multicenter randomized controlled trial in different resource settings in China.\",\"authors\":\"Le Dang, Linghua Kong, Yuqian Zhao, Yi Dai, Li Ma, Lihui Wei, Shulan Zhang, Jihong Liu, Mingrong Xi, Long Chen, Xianzhi Duan, Qing Xiao, Guzhalinuer Abulizi, Guonan Zhang, Ying Hong, Qi Zhou, Xing Xie, Li Li, Mayinuer Niyazi, Zhifen Zhang, Jiyu Tuo, Yiling Ding, Youlin Qiao, Jinghe Lang\",\"doi\":\"10.21147/j.issn.1000-9604.2022.05.09\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>We aimed to evaluate the effectiveness of different triage strategies for high-risk human papillomavirus (hrHPV)-positive women in primary healthcare settings in China.</p><p><strong>Methods: </strong>This study was undertaken in 11 rural and 9 urban sites. Women aged 35-64 years old were enrolled. HrHPV-positive women were randomly allocated to liquid-based cytology (LBC), visual inspection with acetic acid and Lugol's iodine (VIA/VILI) (rural only) triage, or directly referred to colposcopy (direct COLP). At 24 months, hrHPV testing, LBC and VIA/VILI were conducted for combined screening.</p><p><strong>Results: </strong>In rural sites, 1,949 hrHPV-positive women were analyzed. A total of 852, 218 and 480 women were randomly assigned to direct COLP, LBC and VIA/VILI. At baseline, colposcopy referral rates of LBC or VIA/VILI triage could be reduced by 70%-80%. LBC (n=3 and n=7) or VIA/VILI (n=8 and n=26) could significantly decrease the number of colposcopies needed to detect one cervical intraepithelial neoplasia (CIN) 2 or worse and CIN3+ compared with direct COLP (n=14 and n=23). For the 24-month cumulative detection rate of CIN2+, VIA/VILI triage was 0.50-fold compared with LBC triage and 0.46-fold with the direct COLP. When stratified by age, baseline LBC triage+ performed best (P<0.001), peaking among women aged 35-44 years (P<sub>trend</sub>=0.002). In urban sites, 1,728 women were hrHPV genotyping test positive. A total of 408, 571 and 568 women were randomly assigned to direct COLP for HPV16/18+, direct COLP for other hrHPV subtypes+, and LBC triage for other hrHPV subtypes+. LBC (n=12 and n=31) significantly decreased the number of colposcopies needed to detect one CIN2+ and CIN3+ compared with direct COLP (n=14 and n=44). HPV16/18+ increased the 24-month cumulative detection rate of CIN2+ (17.89%, P<0.001).</p><p><strong>Conclusions: </strong>LBC triage for hrHPV-positive women in rural settings and direct COLP for HPV16/18+ women and LBC triage for other hrHPV subtype+ women in urban settings might be feasible strategies.</p>\",\"PeriodicalId\":9830,\"journal\":{\"name\":\"Chinese journal of cancer research = Chung-kuo yen cheng yen chiu\",\"volume\":\" \",\"pages\":\"496-509\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2022-10-30\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9646459/pdf/cjcr-34-5-496.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Chinese journal of cancer research = Chung-kuo yen cheng yen chiu\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.21147/j.issn.1000-9604.2022.05.09\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Chinese journal of cancer research = Chung-kuo yen cheng yen chiu","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.21147/j.issn.1000-9604.2022.05.09","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Evaluation of triage strategies for high-risk human papillomavirus-positive women in cervical cancer screening: A multicenter randomized controlled trial in different resource settings in China.
Objective: We aimed to evaluate the effectiveness of different triage strategies for high-risk human papillomavirus (hrHPV)-positive women in primary healthcare settings in China.
Methods: This study was undertaken in 11 rural and 9 urban sites. Women aged 35-64 years old were enrolled. HrHPV-positive women were randomly allocated to liquid-based cytology (LBC), visual inspection with acetic acid and Lugol's iodine (VIA/VILI) (rural only) triage, or directly referred to colposcopy (direct COLP). At 24 months, hrHPV testing, LBC and VIA/VILI were conducted for combined screening.
Results: In rural sites, 1,949 hrHPV-positive women were analyzed. A total of 852, 218 and 480 women were randomly assigned to direct COLP, LBC and VIA/VILI. At baseline, colposcopy referral rates of LBC or VIA/VILI triage could be reduced by 70%-80%. LBC (n=3 and n=7) or VIA/VILI (n=8 and n=26) could significantly decrease the number of colposcopies needed to detect one cervical intraepithelial neoplasia (CIN) 2 or worse and CIN3+ compared with direct COLP (n=14 and n=23). For the 24-month cumulative detection rate of CIN2+, VIA/VILI triage was 0.50-fold compared with LBC triage and 0.46-fold with the direct COLP. When stratified by age, baseline LBC triage+ performed best (P<0.001), peaking among women aged 35-44 years (Ptrend=0.002). In urban sites, 1,728 women were hrHPV genotyping test positive. A total of 408, 571 and 568 women were randomly assigned to direct COLP for HPV16/18+, direct COLP for other hrHPV subtypes+, and LBC triage for other hrHPV subtypes+. LBC (n=12 and n=31) significantly decreased the number of colposcopies needed to detect one CIN2+ and CIN3+ compared with direct COLP (n=14 and n=44). HPV16/18+ increased the 24-month cumulative detection rate of CIN2+ (17.89%, P<0.001).
Conclusions: LBC triage for hrHPV-positive women in rural settings and direct COLP for HPV16/18+ women and LBC triage for other hrHPV subtype+ women in urban settings might be feasible strategies.
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