دورية أكاديمية
Effect of Screening With Primary Cervical HPV Testing vs Cytology Testing on High-grade Cervical Intraepithelial Neoplasia at 48 Months: The HPV FOCAL Randomized Clinical Trial.
| العنوان: | Effect of Screening With Primary Cervical HPV Testing vs Cytology Testing on High-grade Cervical Intraepithelial Neoplasia at 48 Months: The HPV FOCAL Randomized Clinical Trial. |
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| المؤلفون: | Ogilvie GS; Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.; British Columbia Centre for Disease Control, Vancouver, British Columbia, Canada., van Niekerk D; Lower Mainland Laboratories, Vancouver, British Columbia, Canada.; Cervical Cancer Screening Program, British Columbia Cancer, Vancouver, British Columbia, Canada., Krajden M; Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.; British Columbia Centre for Disease Control, Vancouver, British Columbia, Canada., Smith LW; Cervical Cancer Screening Program, British Columbia Cancer, Vancouver, British Columbia, Canada., Cook D; British Columbia Centre for Disease Control, Vancouver, British Columbia, Canada.; Cervical Cancer Screening Program, British Columbia Cancer, Vancouver, British Columbia, Canada., Gondara L; Cervical Cancer Screening Program, British Columbia Cancer, Vancouver, British Columbia, Canada., Ceballos K; Cervical Cancer Screening Program, British Columbia Cancer, Vancouver, British Columbia, Canada., Quinlan D; Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada., Lee M; Cervical Cancer Screening Program, British Columbia Cancer, Vancouver, British Columbia, Canada., Martin RE; Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada., Gentile L; Cervical Cancer Screening Program, British Columbia Cancer, Vancouver, British Columbia, Canada., Peacock S; Cancer Control Research, BC Cancer, British Columbia, Canada.; Canadian Centre for Applied Research in Cancer Control, Vancouver, British Columbia, Canada.; Faculty of Health Sciences, Simon Fraser University, Burnaby, British Columbia, Canada., Stuart GCE; Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada., Franco EL; Departments of Oncology and Epidemiology & Biostatistics, McGill University, Montreal, Quebec, Canada., Coldman AJ; Cervical Cancer Screening Program, British Columbia Cancer, Vancouver, British Columbia, Canada. |
| المصدر: | JAMA [JAMA] 2018 Jul 03; Vol. 320 (1), pp. 43-52. |
| نوع المنشور: | Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: American Medical Association Country of Publication: United States NLM ID: 7501160 Publication Model: Print Cited Medium: Internet ISSN: 1538-3598 (Electronic) Linking ISSN: 00987484 NLM ISO Abbreviation: JAMA Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Chicago : American Medical Association, 1960- |
| مواضيع طبية MeSH: | Papanicolaou Test* , Vaginal Smears*, Early Detection of Cancer/*methods , Papillomaviridae/*isolation & purification , Papillomavirus Infections/*diagnosis , Uterine Cervical Neoplasms/*diagnosis , Uterine Cervical Dysplasia/*diagnosis, Adult ; Aged ; Cervix Uteri/pathology ; Cervix Uteri/virology ; Female ; Humans ; Incidence ; Middle Aged ; Neoplasm Grading ; Uterine Cervical Neoplasms/prevention & control ; Uterine Cervical Dysplasia/prevention & control |
| مستخلص: | Importance: There is limited information about the relative effectiveness of cervical cancer screening with primary human papillomavirus (HPV) testing alone compared with cytology in North American populations. Objective: To evaluate histologically confirmed cumulative incident cervical intraepithelial neoplasia (CIN) grade 3 or worse (CIN3+) detected up to and including 48 months by primary HPV testing alone (intervention) or liquid-based cytology (control). Design, Setting, and Participants: Randomized clinical trial conducted in an organized Cervical Cancer Screening Program in Canada. Participants were recruited through 224 collaborating clinicians from January 2008 to May 2012, with follow-up through December 2016. Women aged 25 to 65 years with no history of CIN2+ in the past 5 years, no history of invasive cervical cancer, or no history of hysterectomy; who have not received a Papanicolaou test within the past 12 months; and who were not receiving immunosuppressive therapy were eligible. Interventions: A total of 19 009 women were randomized to the intervention (n = 9552) and control (n = 9457) groups. Women in the intervention group received HPV testing; those whose results were negative returned at 48 months. Women in the control group received liquid-based cytology (LBC) testing; those whose results were negative returned at 24 months for LBC. Women in the control group who were negative at 24 months returned at 48 months. At 48-month exit, both groups received HPV and LBC co-testing. Main Outcomes and Measures: The primary outcome was the cumulative incidence of CIN3+ 48 months following randomization. The cumulative incidence of CIN2+ was a secondary outcome. Results: Among 19 009 women who were randomized (mean age, 45 years [10th-90th percentile, 30-59]), 16 374 (8296 [86.9%] in the intervention group and 8078 [85.4%] in the control group) completed the study. At 48 months, significantly fewer CIN3+ and CIN2+ were detected in the intervention vs control group. The CIN3+ incidence rate was 2.3/1000 (95% CI, 1.5-3.5) in the intervention group and 5.5/1000 (95% CI, 4.2-7.2) in the control group. The CIN3+ risk ratio was 0.42 (95% CI, 0.25-0.69). The CIN2+ incidence rate at 48 months was 5.0/1000 (95% CI, 3.8-6.7) in the intervention group and 10.6/1000 (95% CI, 8.7-12.9) in the control group. The CIN2+ risk ratio was 0.47 (95% CI, 0.34-0.67). Baseline HPV-negative women had a significantly lower cumulative incidence of CIN3+ at 48 months than cytology-negative women (CIN3+ incidence rate, 1.4/1000 [95% CI, 0.8-2.4]; CIN3+ risk ratio, 0.25 [95% CI, 0.13-0.48]). Conclusions and Relevance: Among women undergoing cervical cancer screening, the use of primary HPV testing compared with cytology testing resulted in a significantly lower likelihood of CIN3+ at 48 months. Further research is needed to understand long-term clinical outcomes as well as cost-effectiveness. Trial Registration: isrctn.org Identifier: ISRCTN79347302. |
| التعليقات: | Comment in: JAMA. 2018 Jul 3;320(1):35-37. (PMID: 29971379) Comment in: Cancer Discov. 2018 Sep;8(9):OF6. (PMID: 30054288) Erratum in: JAMA. 2018 Dec 4;320(21):2273. (PMID: 30512084) Comment in: Cancer. 2018 Dec 1;124(23):4430-4431. (PMID: 30536585) Comment in: Am J Clin Pathol. 2019 Jul 5;152(2):253. (PMID: 31227830) |
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| معلومات مُعتمدة: | Canada CIHR |
| تواريخ الأحداث: | Date Created: 20180705 Date Completed: 20180712 Latest Revision: 20221207 |
| رمز التحديث: | 20221213 |
| مُعرف محوري في PubMed: | PMC6583046 |
| DOI: | 10.1001/jama.2018.7464 |
| PMID: | 29971397 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 1538-3598 |
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| DOI: | 10.1001/jama.2018.7464 |