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Introduction: For the first time since 1971, new regulations were introduced for cervical cancer screening as an organized cancer screening guideline (oKFE-RL) starting 1 January 2020. From the age of 20, a cytological smear test is performed annually, and from the age of 35, so-called co-testing (cytology and test for high-risk HPVs) is performed every three years. In case of abnormalities, the algorithm is used as the basis for investigation. According to this diagnostic algorithm, even so-called low-risk groups receive early colposcopic evaluation. This approach has been heavily debated and serves as the basis for this registry study. Methods: All patients who presented to the centers for a colposcopy as part of the diagnostic algorithm were included after signing an informed consent form. The following findings were obtained: Medical history, colposcopy, histology, and cytology findings, as well as possible therapies and their findings. The aim was to evaluate the frequency of the target lesions cervical intraepithelial neoplasia (CIN) 2+/CIN 3+ in the respective groups. Result: A total of 4763 patients were enrolled in the study from July 2020 to October 2022. As a referral diagnosis, HPV persistence (HPV: human papillomavirus) with group I was determined in 23.9% (1139), HPV persistence with group II-a in 2.1% (100), II-p (ASC-US) in 11.2% (535), and II-g (AGC endocervical NOS) in 1.3% (64). III-p (ASC-H) and III-g (AGC endocervical favor neoplastic) were found in 9.4% (447) and 2.2% (107), respectively, IIID1 (LSIL) in 19% (906), IIID2 (HSIL, moderate dysplasia) in 18.9% (898), IVa-p (HSIL, severe dysplasia) in 10.7% (508), IVa-g (AIS) in 0.7% (31), IVb-p (HSIL with features suspicious for invasion) and IVb-g (AIS with features suspicious for invasion) in 0.3% (15), 0.1% (6), and 7 with suspected invasion V-p (squamous cell carcinoma)/V-g (endocervical adenocarcinoma) (0.1%). In the IVa-p group (HSIL, severe dysplasia), 67.7% had CIN 2+ and 56.5% had CIN 3+, adenocarcinoma in situ (AIS), and adenocarcinoma. If the histology of the excised tissue specifically based on the colposcope findings was also evaluated, CIN 2+ was found in 79.7% of cases, and CIN 3+ in 67.3% of cases. In IIID2 (HSIL, moderate dysplasia), CIN 2+ was detected in 50.9%, and CIN 3+/AIS in 28.3%. After evaluating patients who underwent surgery immediately, this increased to 53.0% for CIN 2+ and 29.3% for CIN 3+/AIS. In IIID1 (LSIL), CIN 2+ was detected in 27.4% and CIN 3+/AIS in 11.7%, and in II-p (ASC-US), CIN 2+ was detected in 23.4% and CIN 3+ and AIS in 10.8%, and in II-g (AGC endocervical NOS), CIN 2+ was detected in 34.4% and CIN 3+ in 23.4%. In the HPV persistence/II-a and I group, 21% showed CIN 2+, and 12.1% showed CIN 3+ and AIS, and 13% showed CIN 2+ and 5.9% showed CIN 3+ and AIS. In patients who were HPV-negative and had further diagnostics performed on the basis of cytologic smear alone, 27.9% had CIN 2+, and 14.1% had CIN 3 and AIS. Discussion: In a synopsis of the present findings of our initial data of the registry study on the new cervical cancer screening, according to the organized early cancer screening guideline (oKFE-RL), we could show that the target lesion CIN 3+ and AIS is detected unexpectedly frequently in a not insignificant proportion, especially in the cytological low-risk group. Currently, we cannot answer whether this can reduce the incidence and mortality of cervical carcinoma, but this could be an initial indication of this and will be reviewed in further long-term evaluations.
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Human papillomavirus (HPV) infection is a necessary but not sufficient condition for the development of cervical cancer. The dysbiotic shift in the cervicovaginal microbiome appears to be a major co-factor in carcinogenesis. New analytical methods, such as next-generation sequencing (NGS), can be used to detect all of the vaginal microorganisms present and therefore identify individual therapeutic options. The relationship of bacterial vaginosis and carcinogenesis, as well as possible indications for the use of microbiome analysis, will be discussed.
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Aim This is an update of the interdisciplinary S3-guideline on the Diagnosis, Therapy and Follow-up of Cervical Cancer (AWMF Registry No. 032/033OL), published in March 2021. The work on the updated guideline was funded by German Cancer Aid (Deutsche Krebshilfe) as part of the German Guideline Program in Oncology. The guideline was coordinated by the German Society of Gynecology and Obstetrics ( Deutsche Gesellschaft für Gynäkologie und Geburtshilfe , DGGG) and the Working Group on Gynecological Oncology ( Arbeitsgemeinschaft Gynäkologische Onkologie , AGO) of the German Cancer Society ( Deutsche Krebsgesellschaft , DKG). Method The process used to update the 2014 S3-guideline was based on an appraisal of the available evidence using the criteria of evidence-based medicine, adaptations of existing evidence-based national and international guidelines or - if evidence was lacking - on the consensus of the specialists involved in compiling the update. After an initial review of the current literature was carried out according to a prescribed algorithm, several areas were identified which, in contrast to the predecessor version from September 2014, required new recommendations or statements which would take account of more recently published literature and the recent appraisal of new evidence. Recommendations The short version of this guideline consists of recommendations and statements on palliative therapy and follow-up of patients with cervical cancer. The most important aspects included in this updated guideline are the new FIGO classification published in 2018, the radical open surgery approach used to treat cervical cancer up to FIGO stage IB1, and the use of the sentinel lymph node technique for tumors ≤ 2 cm. Other changes include the use of PET-CT, new options in radiotherapy (e.g., intensity-modulated radiotherapy, image-guided adaptive brachytherapy), and drug therapies to treat recurrence or metastasis.
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Aim This update of the interdisciplinary S3 guideline on the Diagnosis, Therapy and Follow-up of Cervical Cancer (AWMF Registry No. 032/033OL) was published in March 2021. This updated guideline was funded by German Cancer Aid (Deutsche Krebshilfe) as part of the German Guideline Program in Oncology. The guideline was coordinated by the German Society of Gynecology and Obstetrics ( Deutsche Gesellschaft für Gynäkologie und Geburtshilfe , DGGG) and the Working Group on Gynecological Oncology ( Arbeitsgemeinschaft Gynäkologische Onkologie , AGO) of the German Cancer Society ( Deutsche Krebsgesellschaft , DKG). Method The process of updating the S3 guideline dating from 2014 was based on an appraisal of the available evidence using the criteria of evidence-based medicine, adaptations of existing evidence-based national and international guidelines or - if evidence was lacking - on a consensus of the specialists involved in compiling the update. After an initial review of the current literature was carried out according to a prescribed algorithm, several areas were identified which, in contrast to the predecessor version from September 2014, required new recommendations or statements which took account of more recently published literature and the appraisal of the new evidence. Recommendations The short version of this guideline consists of recommendations and statements on the epidemiology, screening, diagnostic workup and therapy of patients with cervical cancer. The most important new aspects included in this updated guideline include the newly published FIGO classification of 2018, the radical open surgery approach for cervical cancers up to FIGO stage IB1, and use of the sentinel lymph node technique for tumors ≤ 2 cm. Other changes include the use of PET-CT, new options in radiotherapy (e.g., intensity-modulated radiotherapy, image-guided adaptive brachytherapy), and drug therapies to treat recurrence or metastasis.
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The new guideline on organized cancer screening programs has been in force in Germany since January 1st, 2020. The guideline has amended earlier recommendations on cytological examinations, which were previously carried out annually during screening. The guidelines-based recommendations on the appropriate follow-up for preinvasive and invasive lesions of the uterine cervix and endometrium are briefly outlined and differentiated from screening cytology and Pap/HPV co-testing as described in the guideline on organized cancer screening programs (oKFE-RL).
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Inadequate hygiene, aggressive cleansing, and chafing skin folds, as well as urine, feces, and sweat may trigger irritative contact dermatitis in the anogenital area. Serious recommendations for protection of the skin toward irritants include hygienic aspects and the use of appropriate skin care. Furthermore, preventing an accumulation of irritants on unprotected skin is mandatory. An intraindividual comparison study with 30 participants (17 female, 13 male; age: 44.2±8.3 years) was performed to evaluate the properties of a newly developed water-in-oil (W/O) balm on artificial sodium dodecyl sulfate-damaged epidermal barrier. The balm was applied 14 days twice daily, and transepidermal water loss and erythema were investigated. A significant improvement of both parameters after 12 days and even after 21 days could be confirmed. Two major clinical trials were performed to evaluate the safety and efficacy regarding protective and regenerative properties of the W/O balm on irritated skin in the anogenital area. Therefore, 29 children were enrolled (14 male, 15 female, age: 15.5±7.8 months) in an open-labeled 4-week clinical study. The balm was used in the area under disposable diapers at least after diaper change or if required. Furthermore, in a second open, multicenter study, 43 women (mean age: 46.2±16.9) with predisposition to skin irritation in the outer anogenital region were included. The product was applied for 4 weeks 1-2 times daily. In both studies, skin tolerability, applicability, scent, spreadability, and removability of the balm were evaluated by participants and practitioners predominantly as good or even very good, also skin hydration, protection, and regeneration were judged positively. The studies confirmed that the newly developed W/O balm exhibits excellent tolerability and is easy to remove. At the same time, excellent properties with respect to efficacy regarding regeneration and protection could be observed, without any undesired effects at any time.
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Persistent infection with human papillomaviruses (HPV) is a prerequisite for the development of cervical cancer. Vaccination with virus-like particles (VLP) has demonstrated efficacy in prophylaxis but lacks therapeutic potential. HPV16 L1E7 chimeric virus-like particles (CVLP) consist of a carboxy-terminally truncated HPV16L1 protein fused to the amino-terminal part of the HPV16 E7 protein and self-assemble by recombinant expression of the fusion protein. The CVLP are able to induce L1- and E7-specific cytotoxic T lymphocytes. We have performed a first clinical trial to gain information about the safety and to generate preliminary data on the therapeutic potential of the CVLP in humans. A randomized, double blind, placebo-controlled clinical trial has been conducted in 39 HPV16 mono-infected high grade cervical intraepithelial neoplasia (CIN) patients (CIN 2/3). Two doses (75 mug or 250 mug) of CVLP were applied. The duration of the study was 24 weeks with 2 optional visits after another 12 and 24 weeks. The vaccine showed a very good safety profile with only minor adverse events attributable to the immunization. Antibodies with high titers against HPV16 L1 and low titers against HPV16 E7 as well as cellular immune responses against both proteins were induced. Responses were equivalent for both vaccine concentrations. A trend for histological improvement to CIN 1 or normal was seen in 39% of the patients receiving the vaccine and only 25% of the placebo recipients. Fifty-six percent of the responders were also HPV16 DNA-negative by the end of the study. Therefore, we demonstrated evidence for safety and a nonsignificant trend for the clinical efficacy of the HPV16 L1E7 CVLP vaccine.