Abstract
Simple SummaryWomen diagnosed with cervical intraepithelial neoplasia grade 2 or worse (CIN2+) and treated by excisional procedures remain at high risk for recurrence over time. “Treatment failure” has been reported in up to 23% of women within two years after treatment. The aim of this study was to investigate the impact of HPV same genotype persistence on CIN2+ recurrence. Our findings confirm that HPV same genotype persistence has 30-fold increased odds of developing CIN2+ recurrence (p < 0.001), whereas histological grade, glandular crypt involvement, and margin status are not significantly related with treatment failure. Persistence of multiple genotypes and of HPV 16/18 with or without other HR genotypes show a significant impact on relapse free survival. HPV genotyping as “test-of-cure” enables a personalized risk-based management, by identifying women at higher risk of relapse who need intensive follow-up and avoiding risk of over-treatment in women with new HPV genotype infection after surgery.To evaluate the significance of HPV persistence as a predictor for the development of CIN2+ recurrence and the impact of multiple genotypes and of HPV 16/18 on recurrence risk. A prospective cohort observational study was carried out at the European Institute of Oncology, Milan, Italy, from December 2006 to December 2014. A total of 408 women surgically treated by excisional procedure for pre-neoplastic and neoplastic cervical lesions were enrolled. HPV test was performed at baseline and at first follow-up visit planned at 6 ± 3 months after treatment. Two-year cumulative incidences for relapse were estimated and compared by the Gray’s test. Overall, 96 (23.5%) patients were persistent for at least one genotype at three to nine months from baseline and 21 (5.1%) patients relapsed. The two-year cumulative relapse incidence was higher in HPV persistent patients compared to not-persistent (CIF = 27.6%, 95% CI: 16.2–40.2% versus CIF = 1.7%, 95% CI: 0.3–5.8%, p < 0.001), in women with persistent multiple infections (CIF = 27.2%, 95% CI: 7.3–52.3%, p < 0.001), and with the persistence of at least one genotype between 16 and 18, irrespective of the presence of other HR genotypes (CIF = 32.7%, 95% CI: 17.9–48.3%, p < 0.001), but not significantly different from women positive for single infections or any other HR genotype, but not for 16 and 18. The risk of CIN2+ recurrence should not be underestimated when same HPV genotype infection persists after treatment.
Highlights
Women diagnosed with cervical intraepithelial neoplasia (CIN) or invasive cervical carcinoma (ICC) and conservatively treated by excisional procedures remain at high risk for persistence or recurrence of CIN grade 2 or worse (CIN2+) over time
It has been widely proven that persistent Human Papillomavirus (HPV) infection, in particular of High-Risk (HR) genotypes, is the main risk factor for the development of pre-cancerous and cancerous cervical lesions [6,7]
Patients were included if the following criteria were met: (a) age at diagnosis of 18 years or older; (b) conservative surgical treatment, including loop electrosurgical excision procedure (LEEP) and laser conization, for the removal of persistent CIN1 or CIN2+; (c) histological confirmation of any grade of CIN, adenocarcinoma in situ (AIS), and ICC, including squamous carcinomas and adenocarcinomas; (d) known HPV status and (e) expressed willingness to undergo follow-up visits at the European Institute of Oncology, Milan
Summary
Women diagnosed with cervical intraepithelial neoplasia (CIN) or invasive cervical carcinoma (ICC) and conservatively treated by excisional procedures remain at high risk for persistence or recurrence of CIN grade 2 or worse (CIN2+) over time. Persistent or recurrent CIN2+, known as “treatment failure”, have been reported in up to 23%. A careful post-treatment surveillance is mandatory for at least 25 years, to early detect women at high risk of relapse and to avoid anxiety and overtreatment in patients at low risk. Several risk factors for “treatment failure” have been identified and include patients’. It has been widely proven that persistent Human Papillomavirus (HPV) infection, in particular of High-Risk (HR) genotypes, is the main risk factor for the development of pre-cancerous and cancerous cervical lesions [6,7]. The post-treatment persistence of the same HR HPV genotype responsible for original cervical lesion occur in about one-third of women and may promote disease recurrence during the follow-up period. Surgical treatment ensures removal of the lesion, but not necessarily viral clearance [8,9]
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