Histology Findings after Two Years of Cytology/HPV Co-Testing in Germany.

Introduction: Since 1 January 2020, diagnostic confirmation of abnormalities detected in the context of cytology/HPV co-testing in cervical cancer screening under the statutory health insurance scheme in women aged 35 and over has been performed according to predefined algorithms. A colposcopy is indicated even in the case of borderline/low-grade cytological changes and/or HPV persistence. In this article we compare the histology findings after primary screening examinations in 2020/21 with those from 2018/19, thus also comparing the results of two different screening approaches.

An audit of 1632 routinely collected cervical cancer screening smears from 398 women in Germany: Results from the TeQaZ Study.

Objective: There is evidence in Germany that half of the cervical cancer (CC) cases had undergone screening frequently in the decade preceding their diagnosis, signaling cytology quality issues. This study investigates routine smear assessment accuracy in Germany.

Methods: Within a population-based case-control study in 9 German states, we recruited cases (women with a histologically confirmed diagnosis of CC) and population controls (women with no history of CC or hysterectomy).

Comparison of the Hologic Genius Digital Diagnostics System with the ThinPrep Imaging System-A retrospective assessment.

Background: Digital cytology (DC) with artificial intelligence (AI) is a new approach. The authors compared DC with liquid-based cytology (LBC) using computer assistance (CAS) in a retrospective, noninterventional study.

Methods: In total, 1994 ThinPrep LBC slides (Hologic), which were previously analyzed in 2020 using an imaging system with CAS in routine cotesting for cytology/human papillomavirus, were reviewed in a blinded mode using the Genius Digital Diagnostics System (Hologic).

Two Years of Cytology and HPV Co-Testing in Germany: Initial Experience.

On 1 January 2020 the screening programme for the prevention of cervical cancer in women from the age of 35 years of the Statutory Health Insurance (GKV) in Germany changed from an annual cytology examination to cytological and HPV co-testing carried out every three years. A large standard diagnostics laboratory has been using liquid-based cytology (LBC) with computer-assisted screening (CAS) since 1 January 2020 to assess the samples. The cytological and HPV results for all cases examined with co-testing from 01.

Colposcopy non-attendance following an abnormal cervical cancer screening result: a prospective population-based cohort study.

Background: A considerable proportion of cervical cancer diagnoses in high-income countries are due to lack of timely follow-up of an abnormal screening result. We estimated colposcopy non-attendance, examined the potential factors associated and described non-attendance reasons in a population-based screening study.

Methods: Data from the MARZY prospective cohort study were analysed.

German evidence and consensus-based (S3) guideline: Vaccination recommendations for the prevention of HPV-associated lesions.

Anogenital and oropharyngeal infections with human papilloma viruses (HPV) are common. Clinically manifest disease may significantly impact quality of life; the treatment of HPV-associated lesions is associated with a high rate of recurrence and invasive neoplasms, such as cervical, anal, vulvar, penile, and oropharyngeal cancers, which are characterized by significant morbidity and mortality. Vaccination against HPV is an effective and safe measure for the primary prevention of HPV-associated lesions, but immunization rates are still low in Germany.

Cervical Cancer Screening: Comparison of Conventional Pap Smear Test, Liquid-Based Cytology, and Human Papillomavirus Testing as Stand-alone or Cotesting Strategies.

Background: Some countries have implemented stand-alone human papillomavirus (HPV) testing while others consider cotesting for cervical cancer screening. We compared both strategies within a population-based study.

Methods: The MARZY cohort study was conducted in Germany.

Triage of hrHPV-positive women: comparison of two commercial methylation-specific PCR assays.

Aim: High-risk human papillomavirus (hrHPV)-based screening is becoming increasingly important, either by supplementing or replacing the traditional cytology-based cervical Pap smear. However, hrHPV screening lacks specificity, because it cannot differentiate between transient virus infection and clinically relevant hrHPV-induced disease. Therefore, reliable triage methods are needed for the identification of HPV-positive women with cervical intraepithelial neoplasia (CIN) in need of treatment.

Prevention of Cervical Cancer: Guideline of the DGGG and the DKG (S3 Level, AWMF Register Number 015/027OL, December 2017) - Part 2 on Triage, Treatment and Follow-up.

Annual opportunistic screening for cervical carcinoma has been done in Germany since 1971. The creation of this S3 guideline meets an important need, outlined in the National Cancer Plan, with regard to screening for cervical cancer, as this guideline aims to provide important information and support for planned organized screening for cervical cancer in Germany. With the financial support of German Cancer Aid, 21 professional societies developed evidence-based statements and recommendations (classified using the GRADE system) for the screening, management and treatment of precancerous conditions of the cervix.

Prevention of Cervical Cancer: Guideline of the DGGG and the DKG (S3 Level, AWMF Register Number 015/027OL, December 2017) - Part 1 with Introduction, Screening and the Pathology of Cervical Dysplasia.

Annual opportunistic screening for cervical carcinoma has been carried out in Germany since 1971. The creation of this S3 guideline meets an important need, outlined in the National Cancer Plan, with regard to screening for cervical cancer, as the guideline aims to provide important information and support for planned organized screening for cervical cancer in Germany. With the financial support of German Cancer Aid, 21 professional societies developed evidence-based statements and recommendations (classified using the GRADE system) for the screening, management and treatment of precancerous conditions of the cervix.

Performance of a DNA methylation marker panel using liquid-based cervical scrapes to detect cervical cancer and its precancerous stages.

Background: A change of cervical cancer screening algorithms to an HPV-based screening setting is discussed in many countries, due to higher sensitivity of HPV testing compared to cytology. Reliable triage methods are, however, an essential prerequisite in such a setting to avoid overtreatment and higher screening costs.

Results: In this study, a series of cervical scrapes collected in PreservCyt liquid-based cytology (LBC) medium from women with cervical cancer (n = 5), cervical intraepithelial neoplasia grade 1-3 (n = 74), and normal cytology (n = 201; further n = 352 collected in SureThin®) were assessed for methylation of the marker regions ASTN1, DLX1, ITGA4, RXFP3, SOX17, and ZNF671 using the GynTect assay and compared to cobas® HPV and CINtec Plus® biomarker results.

Prospective evaluation of p16/Ki-67 dual-stained cytology for managing women with abnormal Papanicolaou cytology: PALMS study results.

Background: Testing for the presence of the human papillomavirus (HPV) is widely accepted for triaging Papanicolaou cytology results categorized as atypical squamous cells of undetermined significance (ASC-US). In contrast, HPV testing has limited use in triaging cytological low-grade squamous intraepithelial lesions (LSILs) due to prevalence rates of typically >80%. In the current study, the authors assessed the diagnostic performance of p16/Ki-67 dual-stained cytology in triaging ASC-US and LSIL cases within the prospective, multicentric Primary ASC-US LSIL Marker Study (PALMS).

Laboratory diagnosis of human papillomavirus infection.

Human papillomaviruses (HPVs) are associated with numerous cutaneous or mucosal benign and malignant neoplasms. The majority of available data on routine HPV diagnostics has been centered on evaluating the cervix. Consequently, there is limited data on the utility and efficacy of HPV diagnostics in cutaneous lesions.

Screening for cervical cancer precursors with p16/Ki-67 dual-stained cytology: results of the PALMS study.

Background: Pap cytology is known to be more specific but less sensitive than testing for human papillomavirus (HPV) for the detection of high-grade cervical intraepithelial neoplasia (CIN2+). We assessed whether p16/Ki-67 dual-stained cytology, a biomarker combination indicative of transforming HPV infections, can provide high sensitivity for CIN2+ in screening while maintaining high specificity. Results were compared with Pap cytology and HPV testing.

A randomized trial comparing conventional cytology to liquid-based cytology and computer assistance.

Liquid-based cytology (LBC) has replaced conventional cytology (CC) for cervical cancer screening in some countries. However, it remains unclear whether LBC is superior to CC. A randomized controlled trial was conducted between August 2007 and March 2009 in Germany to compare LBC, alone and in combination with computer-assisted imaging technology (CAS), to CC in the detection of histologically confirmed cervical intraepithelial neoplasia (CIN).

MALDI imaging as a specific diagnostic tool for routine cervical cytology specimens.

Cervical squamous cell carcinoma (SCC) is among the most common malignancies in women worldwide. In developed countries routine cytology screening has dramatically reduced SCC mortality within the last three decades. High risk (HR) human papilloma virus (HPV) infection is the main causal factor in nearly 100% of invasive SCCs, in most cases of low grade squamous intraepithelial lesion (LSIL) and in nearly all cases of high grade squamous intraepithelial lesion (HSIL).

Vaccination trial with HPV16 L1E7 chimeric virus-like particles in women suffering from high grade cervical intraepithelial neoplasia (CIN 2/3).

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.

An economic analysis of human papillomavirus triage for the management of women with atypical and abnormal Pap smear results in Germany.

We developed decision-analytic models to determine the cost effectiveness of incorporating human papillomavirus (HPV) testing into the management of atypical and abnormal Pap smear results in Germany. The models compare three management strategies: (1) repeat Pap smear, (2) triage with HPV DNA testing, or (3) immediate treatment. The primary outcome measure is incremental cost per case of cervical intraepithelial neoplasia (CIN) 2+ detected and treated.

Morphologic characteristics of p16INK4a-positive cells in cervical cytology samples.

Objective: Overexpression of p16INK4a has been proposed as a biomarker helpful for the identification of dysplastic cervical epithelial cells on histologic slides as well as in cervical smears. Since a few nontransformed cells in the genital tract in some instances may also express p16INK4a, we evaluated whether applying established morphologic criteria for cervical dysplasia allows a distinction of dysplastic from nondysplastic p16INK4a-stained cells in cytologic samples.

Study Design: Liquid-based cytology samples were obtained from a screening population (n=50), and from patients attending a dysplasia clinic (n=40).

Blood hemoglobin level and treatment outcome of early breast cancer.

Background And Purpose: To determine whether the blood hemoglobin concentration correlates with the prognosis of patients with early breast cancer and, if so, whether this is restricted to treatment modality.

Patients And Methods: Data were collected retrospectively from patients with early breast cancer (T1,2 N0-2 M0) who underwent either breast-conserving surgery followed by adjuvant radiotherapy (BCS-RT; n=96) or a modified radical mastectomy (MRM; n=194). The effect of preoperative blood hemoglobin level, nodal status, histological grading and hormone receptor status on disease-free survival was determined for both treatment modalities using a Cox regression model and visualized by Kaplan-Meier plots.