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Fertility tracking devices offer women direct-to-user information about their fertility. The objective of this study is to understand how a fertility tracking device algorithm adjusts to changes of the individual menstrual cycle and under different conditions.A retrospective analysis was conducted on a cohort of women who were using the device between January 2004 and November 2014. Available temperature and menstruation inputs were processed through the Daysy 1.0.7 firmware to determine fertility outputs. Sensitivity analyses on temperature noise, skipped measurements, and various characteristics were conducted.A cohort of 5328 women from Germany and Switzerland contributed 107,020 cycles. Mean age of the sample was 30.77 [SD 5.1] years, with a BMI of 22.07 kg/m^2 [SD 2.4]. The mean cycle length reported was 29.54 [SD 3.0] days. The majority of women were using the device 80-100% of the time during the cycle (53.1%). For this subset of women, the fertility device identified on average 41.4% [SD 6.4] possibly fertile (red) days, 42.4% [SD 8.7] infertile (green) days and 15.9% [SD 7.3] yellow days. The number of infertile (green) days decreases proportionally to the number of measured days, whereas the number of undefined (yellow) days increases.Overall, these results showed that the fertility tracker algorithm was able to distinguish biphasic cycles and provide personalised fertility statuses for users based on daily basal body temperature readings and menstruation data. We identified a direct linear relationship between the number of measurements and output of the fertility tracker.

Purpose Colposcopy-guided punch biopsy is a cornerstone method for diagnosing vulvar diseases. The aim of this study was to evaluate the concordance rate of clinical findings in vulvar diseases during examinations, in comparison with colposcopy-directed punch biopsy. We also developed a new classification to simplify the categorization of vulvoscopic findings. Methods The concordance rate of the clinical findings was compared with the final histology results from punch biopsies. The data were collected between January 2014 and May 2017 at the Erlangen University Hospital. Results A total of 482 colposcopy-directed punch biopsies of the vulva were obtained in 420 women. The overall concordance rate of the clinical findings in comparison with the histological vulvar punch-biopsy findings was 53.9% for all entities — benign lesions, lichen, low- and high-grade squamous intraepithelial lesions (LSIL/HSILs), and vulvar carcinoma. The concordance rate for detecting LSILs was 64.3% (45/70). The concordance rate for detecting HSILs was 62.3% and for Vulvar carcinoma 65.2%. Conclusions Punch biopsy of suspicious lesions continues to be a cornerstone in diagnosing HSILs and carcinoma of the vulva. Careful work-up of the vulva is recommended when patients have symptoms such as pruritus or pain. The new classification is more specific for diagnosing lesions in the vulva.

Die Operation stellt die Therapie der Wahl beim fruhen Zervixkarzinom (FIGO IA1 bis FIGO IIa; gemas Federation Internationale de Gynecologie et d’Obstetrique) dar. Abhangig vom Alter der Patientin und der Tumorausbreitung ist das Ausmas der operativen Therapie fur die Patientin, insbesondere bei Wunsch nach Fertilitatserhalt, festzulegen. In letzter Zeit rucken zur Senkung der Mortalitat und Morbiditat zunehmend weniger radikale operative Verfahren und Konzepte zur Sentinellymphonodektomie in den Fokus. Kontroversen ergeben sich aktuell im Rahmen neuer Studien bezuglich der Wahl des operativen Zugangswegs. Der Beitrag stellt eine Ubersichtsarbeit zur operativen Therapie des Zervixkarzinoms dar. Es wird eine Ubersicht uber die aktuelle Studienlage und Literatur gegeben unter Einbeziehung der aktuell geltenden deutschen S3-Leitlinie zum Zervixkarzinom. Bei der Behandlung des lokal begrenzten Zervixkarzinoms (≤FIGO IIa) steht die operative Therapie im Vordergrund. In aktuellen Studien wie SHAPE wird untersucht, ob weniger radikale operative Verfahren ausreichend onkologische Sicherheit bieten konnen. Ein fertilitatserhaltendes Vorgehen ist je nach Vorliegen von Risikofaktoren bis zum Stadium IB1 moglich. Nach Veroffentlichung der Ergebnisse der LACC-Studie mit erhohter Rezidiv- und Mortalitatsrate beim laparoskopischen Vorgehen gegenuber der Laparotomie ist ein minimal-invasives Vorgehen mit den Patientinnen im Vorfeld unter Hinweis auf die Datenlage kritisch zu diskutieren. Die Therapie des Zervixkarzinoms sollte stadiengerecht erfolgen. Dabei ist die operative Therapie die Domane beim fruhen Zervixkarzinom. Auch weniger radikale Verfahren scheinen zunehmend ausreichend onkologische Sicherheit zu bieten.

ZusammenfassungIn den letzten Jahren haben sich Diagnostik und Therapie im Bereich der gynäkologischen Onkologie und Senologie stetig weiterentwickelt. Dennoch ist das Versterben an einer Krebserkrankung in den hoch entwickelten Ländern eine der häufigsten Todesursachen der Frau 1. Maßnahmen zur Primärprävention sind daher von hoher Bedeutung, um die Morbidität und Mortalität von Krebserkrankungen zu senken.

Bei vielen Organentitaten ist das neoadjuvante Konzept mittlerweile etablierter Bestandteil der Therapie. Die neoadjuvante Therapie scheint auch in speziellen Situationen fur Zervixkarzinompatientinnen interessant. Dieser Artikel soll einen Uberblick uber die aktuell diskutierten Einsatzgebiete in der Neoadjuvanz beim Zervixkarzinom darlegen, die verschiedenen Optionen werden besprochen. Als Grundlage fur diesen Artikel dient die S3-Leitlinie Diagnostik, Therapie und Nachsorge der Patientin mit Zervixkarzinom AWMF(Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften)-Registernummer 032/033OL in der Version von 2014. Diese wurde durch die Literatur zur Update-Recherche der Neufassung der Leitlinie erweitert. Die NACT(neoadjuvante Chemotherapie)-Ansprechrate liegt bei 84 %, das progressionsfreie Uberleben (PFS) uber 5 Jahre und das Gesamtuberleben (OS) betragen 61,9 und 72,8 %. Das Ansprechen auf eine NACT korreliert mit einem besseren Langzeituberleben. In einer Cochrane-Analyse von 2012 wurde gezeigt, dass eine neoadjuvante Chemotherapie vor geplanter Operation zu einer Verbesserung des PFS (HR [Hazard Ratio] 0,75, 95 %-KI [Konfidenzintervall] 0,61–0,93, p = 0,008) und des Gesamtuberlebens (HR 0,77, 95 %-KI 0,62–0,96, p = 0,02) fuhrt. Unter Berucksichtigung des Random-Effekt-Modells war der Effekt aber nicht mehr signifikant (OR [Odds Ratio] 0,60, 95 %-KI 0,32–1,12, p = 0,11). Bei makroinvasiven Karzinomen in der Schwangerschaft vor einer moglichen Entbindung ist die NACT fester Bestandteil der Therapie. Die Datenlage zum Einsatz der neoadjuvanten Therapie beim Zervixkarzinom ist unklar. Die neoadjuvante Therapie ist aktuell kein Standard in der Behandlung des Zervixkarzinoms. Ungeklart ist auch die Rolle des operativen Stagings und positiver Lymphknoten nach der neoadjuvanten Therapie. In verschiedenen Metaanalysen konnte gezeigt werden, dass die neoadjuvante Therapie das PFS und das OS verbessert. Dies gilt insbesondere fur Frauen, die auf die neoadjuvante Therapie angesprochen haben.

Purpose This is an official guideline, published and coordinated by the Gynecological Oncology Working Group (AGO) of the German Cancer Society (DKG) and the German Society for Gynecology and Obstetrics (DGGG). Vaginal cancers are rare tumors, which is why there is very little evidence on these tumors. Knowledge about the optimal clinical management is limited. This first German S2k guideline on vaginal cancer has aimed to compile the most current expert knowledge and offer new recommendations on the appropriate treatment as well as providing pointers about individually adapted therapies with lower morbidity rates than were previously generally available. The purpose of this guideline is also to set up a register to record data on treatment data and the course of disease as a means of obtaining evidence in future. Methods The present S2k guideline was developed by members of the Vulvar und Vaginal Tumors Commission of the AGO in an independently moderated, structured, formal consensus process and the contents were agreed with the mandate holders of the participating scientific societies and organizations. Recommendations To optimize the daily care of patients with vaginal cancer: 1. Monitor the spread pattern; 2. Follow the step-by-step diagnostic workup based on initial stage at detection; 3. As part of individualized clinical therapeutic management of vaginal cancer, follow the sentinel lymph node protocol described here, where possible; 4. Participate in the register study on vaginal cancer.

Malignancies of the vagina are rare, but colposcopy-directed biopsies play a major role in detecting vaginal intraepithelial lesions. Data of accuracy in detecting neoplasia of the vagina are very rare compared to accuracy in detecting cervical neoplasia. The aim of this study was to evaluate the accuracy of colposcopy-directed biopsy in comparison with clinical findings of the examiner. The accuracy of colposcopy-directed biopsy was compared with the clinical finding in relation to the patient’s age and the examiner’s level of training. This was done in combination with PAP-smear, HPV-test results, and the history of other malignancies of the lower genital tract. The data were collected between January 2014 and February 2018 at the certified Dysplasia Unit of the University Hospital Erlangen. In total, 253 biopsies from 253 women from the vagina were obtained. The overall accuracy of biopsy in comparison with clinical finding was 52.17% for all entities—benign lesions, low-grade squamous intraepithelial lesions (LSILs), high-grade squamous intraepithelial lesions (HSILs), and vaginal carcinoma. The accuracy for detecting HSIL was 82.46% (47/57), with an underdiagnosis rate of 15.79% and an overdiagnosis rate of 1.79%. With a sensitivity of over 80%, colposcopy-directed biopsy plays an important role in detecting vaginal–HSIL. A highly experienced practitioner is increasing the sensitivity in detecting vaginal–HSIL. Careful examination is required in women with a history of HSIL of the lower genital tract or with simultaneous neoplasia because they are of greater risk of developing vaginal malignancies. The combination of careful clinical work up, PAP-smear, HPV-testing, and colposcopy-guided biopsy is crucial in detecting vaginal–HSIL.

A novel histopathological grading system based on tumour budding and cell nest size has recently been shown to outperform conventional (WHO-based) grading algorithms in several tumour entities such as lung, oral, and oesophageal squamous cell carcinoma (SCC) in terms of prognostic patient stratification. Here, we tested the prognostic value of this innovative grading approach in two completely independent cohorts of SCC of the uterine cervix. To improve morphology-based grading, we investigated tumour budding activity and cell nest size as well as several other histomorphological factors (e.g., keratinization, nuclear size, mitotic activity) in a test cohort (n = 125) and an independent validation cohort (n = 122) of cervical SCC. All parameters were correlated with clinicopathological factors and patient outcome. Small cell nest size and high tumour budding activity were strongly associated with a dismal patient prognosis (p < 0.001 for overall survival [OS], disease-specific survival, and disease-free survival; test cohort) in both cohorts of cervical SCC. A novel grading algorithm combining these two parameters proved to be a highly effective, stage-independent prognosticator in both cohorts (OS: p < 0.001, test cohort; p = 0.001, validation cohort). In the test cohort, multivariate statistical analysis of the novel grade revealed that the hazard ratio (HR) for OS was 2.3 for G2 and 5.1 for G3 tumours compared to G1 neoplasms (p = 0.010). In the validation cohort, HR for OS was 3.0 for G2 and 7.2 for G3 tumours (p = 0.012). In conclusion, our novel grading algorithm incorporating cell nest size and tumour budding allows strongly prognostic histopathological grading of cervical SCC superior to WHO-based grading. Therefore, our data can be regarded as a cross-organ validation of previous results demonstrated for oesophageal, lung, and oral SCC. We suggest this grading algorithm as an additional morphology-based parameter for the routine diagnostic assessment of this tumour entity.

Die Heterogenitat der Diagnostik und der Therapie des Zervixkarzinoms bei kaum sinkender Morbiditat und Mortalitat machte ein Upgrade der bestehenden S2k-Leitlinie von 2008 auf S3-Niveau notwendig. Dies fuhrte zur seit 2014 gultigen S3-Leitlinie „Diagnostik, Therapie und Nachsorge der Patientin mit Zervixkarzinom“ (AWMF-Registernummer: 032-033OL). Die vorliegende Ubersichtsarbeit stellt den aktuellen Therapiestandard des Zervixkarzinoms dar und geht dabei im Speziellen auf die medikamentose Therapie ein. Es wird auserdem Stellung zur Diagnostik genommen, die letztlich zur Therapieentscheidung fuhrt. Auf Basis der aufwendigen Evidenzaufarbeitung und der Empfehlungen der S3-Leitlinie werden die aktuellen Therapiealgorithmen dargelegt und diskutiert. Die Therapie des Zervixkarzinoms erfolgt in den fruhen Stadien zumeist operativ. Ab Stadium FIGO IIB besteht die Indikation zur simultanen cisplatinhaltigen Radiochemotherapie. Beim nichtoperablen Rezidiv oder in der metastasierten Situation gibt es palliative Chemotherapieoptionen. Seit 2014 ist auch erstmals die Hinzunahme eines zielgerichteten Therapiekonzepts mit Bevacizumab moglich. Die Behandlung von Zervixkarzinomen hat sich in den letzten Jahren deutlich weiterentwickelt. Die Therapieoptionen sind vielfaltig, sie werden individuell und stadienadaptiert eingesetzt. Die Entscheidung uber die Therapiemodalitat erfolgt interdisziplinar in der Tumorkonferenz. Sie ist individuell angepasst und sollte gemeinsam mit der Patientin getroffen werden. Berucksichtigt werden mussen der Allgemeinzustand und die Lebenssituation der Patientin sowie Erkrankungsstadium, Risikofaktoren und das unterschiedliche Nebenwirkungsprofil der Therapien. Ziel ist eine moglichst geringe Beeinflussung der Lebensqualitat bei maximalem Uberleben.

Colposcopy-directed biopsy is a cornerstone method for diagnosing cervical intraepithelial neoplasia. The aim of this study was to evaluate the accuracy of colposcopy-directed biopsy in comparison with definitive surgery. The accuracy of colposcopy-directed biopsy was compared with the final histology in relation to different types of transformation zone (TZ), the patient’s age, and the examiner’s level of training. The overall accuracy of biopsy in comparison with definitive surgery was 71.9% for all entities—benign lesions, low-grade squamous intraepithelial lesions, high-grade squamous intraepithelial lesions (HSILs), and cervical carcinoma—with an underdiagnosis rate of 11.8% and an overdiagnosis rate of 16.5%. The accuracy for detecting HSIL was 88% (401/455), with an underdiagnosis rate of 10.5% and overdiagnosis rate of 1.3%. The accuracy rates for detecting HSIL in women with TZ 1, TZ 2, or TZ 3 were 92.2, 90.5, and 76.5%, respectively. The accuracy rates for detecting HSIL in the different age groups were 93.1% (age 0–34), 83.6% (age 34–55), and 80% (age 55 or older). A combination of the colposcopic findings, cytology, human papillomavirus testing, and colposcopy-directed biopsy is necessary for the correct diagnosis of HSIL. The accuracy rate depends on the TZ and the patient’s age. The examiner’s level of training does not have any substantial influence on the accuracy.

Purpose: This is an official guideline, published and coordinated by the Arbeitsgemeinschaft Gynakologische Onkologie (AGO, Study Group for Gynecologic Oncology) of the Deutsche Krebsgesellschaft (DKG, German Cancer Society) and the Deutsche Gesellschaft fur Gynakologie und Geburtshilfe (DGGG, German Society for Gynecology and Obstetrics). The number of cases with vulvar cancer is on the rise, but because of the former rarity of this condition and the resulting lack of literature with a high level of evidence, in many areas knowledge of the optimal clinical management still lags behind what would be required. This updated guideline aims to disseminate the most recent recommendations, which are much clearer and more individualized, and is intended to create a basis for the assessment and improvement of quality care in hospitals. Methods: This S2k guideline was drafted by members of the AGO Committee on Vulvar and Vaginal Tumors; it was developed and formally completed in accordance with the structured consensus process of the Association of Scientific Medical Societies in Germany (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften, AWMF). Recommendations: 1. The incidence of disease must be taken into consideration. 2. The diagnostic pathway, which is determined by the initial findings, must be followed. 3. The clinical and therapeutic management of vulvar cancer must be done on an individual basis and depends on the stage of disease. 4. The indications for sentinel lymph node biopsy must be evaluated very carefully. 5. Follow-up and treatment for recurrence must be adapted to the individual case.