Screen-and-Treat Approaches for Cervical Cancer Prevention in Low-Resource Settings

Department of Epidemiology, Columbia University, New York, New York, United States
JAMA The Journal of the American Medical Association (Impact Factor: 35.29). 12/2005; 294(17):2173-81. DOI: 10.1001/jama.294.17.2173
Source: PubMed


Non-cytology-based screen-and-treat approaches for cervical cancer prevention have been developed for low-resource settings, but few have directly addressed efficacy.
To determine the safety and efficacy of 2 screen-and-treat approaches for cervical cancer prevention that were designed to be more resource-appropriate than conventional cytology-based screening programs.Design, Setting, and
Randomized clinical trial of 6555 nonpregnant women, aged 35 to 65 years, recruited through community outreach and conducted between June 2000 and December 2002 at ambulatory women's health clinics in Khayelitsha, South Africa.
All patients were screened using human papillomavirus (HPV) DNA testing and visual inspection with acetic acid (VIA). Women were subsequently randomized to 1 of 3 groups: cryotherapy if she had a positive HPV DNA test result; cryotherapy if she had a positive VIA test result; or to delayed evaluation.
Biopsy-confirmed high-grade cervical cancer precursor lesions and cancer at 6 and 12 months in the HPV DNA and VIA groups compared with the delayed evaluation (control) group; complications after cryotherapy.
The prevalence of high-grade cervical intraepithelial neoplasia and cancer (CIN 2+) was significantly lower in the 2 screen-and-treat groups at 6 months after randomization than in the delayed evaluation group. At 6 months, CIN 2+ was diagnosed in 0.80% (95% confidence interval [CI], 0.40%-1.20%) of the women in the HPV DNA group and 2.23% (95% CI, 1.57%-2.89%) in the VIA group compared with 3.55% (95% CI, 2.71%-4.39%) in the delayed evaluation group (P<.001 and P = .02 for the HPV DNA and VIA groups, respectively). A subset of women underwent a second colposcopy 12 months after enrollment. At 12 months the cumulative detection of CIN 2+ among women in the HPV DNA group was 1.42% (95% CI, 0.88%-1.97%), 2.91% (95% CI, 2.12%-3.69%) in the VIA group, and 5.41% (95% CI, 4.32%-6.50%) in the delayed evaluation group. Although minor complaints, such as discharge and bleeding, were common after cryotherapy, major complications were rare.
Both screen-and-treat approaches are safe and result in a lower prevalence of high-grade cervical cancer precursor lesions compared with delayed evaluation at both 6 and 12 months. Trial Registration Identifier: NCT00233727.

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    • "Although Pap smear is the most commonly used cervical screening modality in the developed world, it requires substantial medical infrastructure, training, and financial resources to implement, and therefore is not feasible for widespread application in most developing countries [2]. A simpler, more cost-effective [2] screening method is visual inspection with acetic acid (VIA), which has been shown to be accurate for detection of precancerous and cancerous cervical lesions [3] and effective for cancer prevention in large, randomized studies conducted in developing countries [4, 5]. "
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    ABSTRACT: Visual inspection with acetic acid (VIA) to identify and treat pre-cancerous lesions is effective for cervical cancer prevention. Screening programs also facilitate screening and diagnosis of invasive cancers that must be referred for radiation therapy or chemotherapy. This study compared characteristics of women diagnosed with invasive cervical cancer by a VIA screening program who did and did not follow up for treatment and who did and did not complete treatment at the Ocean Road Cancer Institute (ORCI), Dar es Salaam, Tanzania. We conducted a retrospective cohort study of ORCI screening referrals from the period November 2002 to June 2011. Women referred for treatment of invasive disease (n = 980) were identified from an existing database of all women attending the screening clinic during this period (n = 20,131) and matched to a dataset of all cervical cancer patients attending ORCI in this period (n = 8,240). Treatment information was abstracted from patient records of women who followed up. Records of a random sample (n = 333) of unscreened patients were reviewed for disease stage. Of the 980 women referred women, 829 (84.6%) sought treatment. Most of those women (82.8%) completed their prescribed radiation. Lower disease stage, having a skilled occupation, residence in Dar es Salaam, and younger age were independently associated with loss to follow-up. Higher disease stage, residence in Dar es Salaam, older age, and later year of first treatment appointment were independently associated with incomplete treatment among those who followed up. Significantly more screened women had stage 1 disease (14.0%) than unscreened women (7.8%). Most women referred from the screening clinic completed treatment for their cancer at ORCI. Some of those lost to follow-up may have sought treatment elsewhere. In most cases, the screening clinic appears to facilitate diagnosis and treatment, rather than screening, for women with invasive cervical cancer.
    Full-text · Article · Sep 2014 · BMC Public Health
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    • "The findings of a randomized trial of cryotherapy based on VIA or HPV-DNA testing in South Africa has prompted the Alliance for Cervical Cancer Prevention to recommend that primary screening in low-resource settings should be based on either VIA or HPV-DNA testing89. Amongst young women in China, 3.4% were diagnosed with lesions of CIN grade 2 or worse and 17.1% tested positive for HPV DNA10. The International Agency for Research on Cancer has published several systematic reviews and is now recommending that HPV-DNA testing be used for primary screening, as an alternative to cytology2. "
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    ABSTRACT: This study assessed the clinical accuracy of the correlation between the careHPV test and the HC2 test, as well as the correlation between the careHPV test and the HPV-PCR test. From September 21 to December 31, 2009, 419 cervical specimens from women, 30-49 years, were collected. All women were assessed by Digene HC2 High-Risk HPV DNA Test (HC2), careHPV test, and HPV-PCR. The concordance rate between careHPV and HC2 was 93.81% and between careHPV and HPV-PCR 88.12%. The sensitivity and specificity of the careHPV test to detect cancers of equal or greater severity than CIN 2 were 85.71% and 83.15% respectively. Results from careHPV, HC2, and HPV-PCR were highly consistent. The careHPV test has good sensitivity and specificity for the detection of HPV infection and is a promising primary screening method for cervical cancer in low-resource regions.
    Full-text · Article · Apr 2014 · Scientific Reports
    • "The additional benefit will be that because of the high negative predictive value of HC2, the VIA-positive but HC2-negative women will require less frequent follow-ups. A strategy of ‘screen and treat’ has been proved to reduce the burden of high-grade cervical cancer precursors and the effect is much more pronounced if HC2 test is used to screen.[10] VIA followed by triaging with HC2 for cryotherapy will significantly reduce the number of over-treatment in such a scenario. "
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    ABSTRACT: VIA is a simple, inexpensive test widely advocated for resource-limited settings. Major limitation of VIA is its low specificity. HPV DNA testing can be used to triage VIA-positive women if the facilities are available. The major concern for such strategy would be whether sample collection after acetic acid wash will alter HPV test characteristics. This study aimed to evaluate whether samples for HPV testing by Hybrid Capture 2 (HC2) technology can be collected immediately after VIA without altering test performance. Total 204 VIA-positive women were recruited. Cervical samples were collected for HC2 test before and after VIA at the same sitting by the same provider. The paired samples were analyzed at the same laboratory by the same technician in the same batch of testing. Agreement in HC2 results between pre-VIA and post-VIA samples was estimated using kappa statistics. All women had colposcopy and biopsies were obtained if colposcopy was suspicious of neoplasia. Sensitivity and specificity of HC2 test in detecting CIN2+ lesions were calculated using negative colposcopy or biopsy as the gold standard and were compared between the pre and post VIA samples. Almost perfect agreement in HC2 results (kappa=0.85) and RLU/Cut off ratios (correlation coefficient=0.92) was observed between samples collected before and after VIA. The sensitivity and specificity to detect CIN2+ lesions remained unaltered even when cervical samples were collected after VIA. This confirmed that acetic acid wash did not alter HC2 performance. Collection of samples for HC2 test is feasible immediately after VIA.
    No preview · Article · Feb 2014 · International journal of preventive medicine
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