Br J Cancer：原发宫颈癌普查中HPV DNA检查较液基细胞学检查有优越性

人乳头状瘤病毒(HPV) FOCAL研究是一项三臂、随机试验(Three-arm study)，旨在评估HPV DNA检查作为宫颈癌原发筛查程序的效果。其首轮数据显示，对于相继检查结果或者为hrHPV阳性/细胞学阴性或者为ASC-US阳性/HPV阴性的女性，与随机进入细胞学检查臂组的女性相比，随机进入HPV检查臂组的女性CIN2+检出率会更高。论文发表于BJC杂志最新一期在线版上。第一作者为加拿大英属哥伦比亚大学GS Ogilvie博士。

试验中的三臂分别为：对照臂—由hrHPV检查分检得到的未见显着性的不典型鳞状上皮细胞(ASC-US)行液基细胞学检查；介入臂—hrHPV介入液基细胞学检查(LBC)，且hrHPV显示阳性，4年后退出；安全校验组—hrHPV介入液基细胞学检查(LBC)，且hrHPV显示阳性，2年后退出。

结果显示，总共6154例女性随机接受对照臂检查，12494例患者接受HPV臂介入（介入和可靠性校验）。HPV臂组中，研究人员发现基线子宫颈上皮细胞瘤形成(CIN)2+ 和CIN3+率分别为9.2/1000 (95%CI; 7.4, 10.9)和4.8/1000 (95%CI; 3.6, 6.1)，检查结果为HPV-DNA阳性/细胞学检查阴性的女性(CIN)2+ 和CIN3+发生率分别增长为16.1/1000 (95%CI 13.2, 18.9)和8.0/1000 (95%CI; 5.9, 10.0)。试验观察到，对照臂组ASC-US阳性/ hrHPV DNA阴性检查结果的女性检出率未见改变，其(CIN)2+ 和CIN3+发生率分别为11.0/1000和5.0/1000。

研究人员由此得出结论，对于相继检查结果或者为hrHPV阳性/细胞学阴性或者为ASC-US阳性/HPV阴性的女性，与随机进入细胞学检查臂组的女性相比，随机进入HPV检查臂组的女性CIN2+检出率会更高。

与宫颈癌相关的拓展阅读：

• 我国宫颈癌发病呈年轻化趋势
• J Natl Cancer Inst：Self-HPV检查有助宫颈癌的预防
• 罗氏cobas 4800 HPV检测开启宫颈癌预防新境界
• Journal of Clinical Oncology：单次HPV DNA检测可预测18年宫颈癌风险
• 合理筛查，对宫颈癌说“不”
更多信息请点击：有关宫颈癌更多资讯

doi: 10.1038/bjc.2012.489
PMC:
PMID:

Primary cervical cancer screening with HPV testing compared with liquid-based cytology: results of round 1 of a randomised controlled trial - the HPV FOCAL Study.

Ogilvie GS, Krajden M, van Niekerk DJ, Martin RE, Ehlen TG, Ceballos K, Smith LW, Kan L, Cook DA, Peacock S, Stuart GC, Franco EL, Coldman AJ.

Background:Round 1 data of human papillomavirus (HPV) FOCAL, a three-arm, randomised trial, which aims to establish the efficacy of HPV DNA testing as a primary screen for cervical cancer, are presented.Methods:The three arms are: Control arm - liquid based cytology with atypical squamous cells of unknown significance (ASC-US) triage with hrHPV testing; Intervention Arm - hrHPV at entry with liquid-based cytology (LBC) triage of hrHPV positives, with exit screen at 4 years; Safety check arm - hrHPV at entry with LBC triage of hrHPV positives with exit screen at 2 years.Results:A total of 6154 women were randomised to the control arm and 12 494 to the HPV arms (intervention and safety check). In the HPV arm, the baseline cervical intraepithelial neoplasia (CIN)2+ and CIN3+ rate was 9.2/1000 (95%CI; 7.4, 10.9) and 4.8/1000 (95%CI; 3.6, 6.1), which increased to 16.1/1000 (95%CI 13.2, 18.9) for CIN2+ and to 8.0/1000 (95%CI; 5.9, 10.0) for CIN3+ after subsequent screening of HPV-DNA-positive/cytology-negative women. Detection rate in the control arm remained unchanged after subsequent screening of ASC-US-positive/hrHPV DNA-negative women at 11.0/1000 for CIN2+ and 5.0/1000 for CIN3+.Conclusion:After subsequent screening of women who were either hrHPV positive/cytology negative or ASC-US positive/HPV negative, women randomised to the HPV arms had increased CIN2+ detection compared with women randomised to the cytology arm.

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