Page 91 - Strategies for non-invasive managementof high-grade cervical intraepithelial neoplasia - prognostic biomarkers and immunotherapy Margot Maria Koeneman

predictive properties of 3q26/hTERC gain in histologically confirmed high-grade lesions is scarce (n=5). This prompted us to perform a pilot study evaluating the predictive properties of 3q26/ hTERC gain in histologically confirmed high-grade lesions.
Pilot study: results
Patient characteristics
A total of 19 women were included in our study. The mean age was 31 years (range 25-41). The 4 mean interval between the initial colposcopy and the follow-up colposcopy with LEEP was 115
days (91-154 days). Nine women (47%) showed disease regression during this follow-up period
and ten did not (53%). The mean age and biopsy-LEEP interval did not differ significantly between
women who showed spontaneous regression and those who did not (mean age 32 vs 31 years, mean biopsy-LEEP interval 115 vs 114 days respectively).
Lesions characteristics: CIN grade, lesions size, HPV genotyping and p16 staining
Sixteen patients were diagnosed with a CIN3 lesion and three with a CIN2 lesion. Of the patients with a CIN2 lesion, two showed regression and one showed disease persistence (22% vs 10%, p=0.5). In the original study, lesions were classified according to size in two categories: larger than 2.5mm or equal to or smaller than 2.5mm. There was no difference between these two categories in terms of the number of women with and without regression: a lesion larger than 2.5mm was found in 5/9 (56%) women with disease regression and in 7/10 (70%) women with disease persistence (p=0.54). All women carried high-risk HPV. HPV16 was found in 5/9 (56%) women with disease regression and 7/10 (70%) women with disease persistence (p=0.54). The biopsy material of all cases was p16 positive, confirming HPV infection.
FISH results
Results of the 3q26 analysis are shown in table 3. Figure 1 shows typical examples of the FISH analysis. Four patients showed no 3q26 gain, all of their lesions regressed spontaneously. Of interest, all CIN2 lesions showed 3q26 gain. The test performance of 3q26 gain in the prediction of natural prognosis of high-grade CIN in the study population is shown in table 4. When the analysis was restricted to only CIN3 lesions, the positive predictive value increased to 75%, while the negative predictive value remained 100%.
3q26 as a prognostic biomarker
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