The "International Consensus Conference for Advanced Breast Cancer" was initiated with the rationale to standardize treatment of advanced breast cancer (ABC) based on available evidence. The aim was to ensure that all ABC patients worldwide receive adequate treatment and get access to new diagnostic, therapeutic, and supportive options. Since the beginning ABC Consensus Conference has been organized in Lisbon/Portugal. The 8th International Consensus Conference for ABC (ABC8) took place there from November 4th to 8th, 2025, and focused not only on metastatic disease but also on locally advanced and inflammatory breast cancer (BC). Special topics were new drugs and new therapies with promising results in randomized clinical trials. Not all of them are currently approved by FDA (Food and Drug Administration) or EMA (European Medicines Agency) for the indication in which the study was conducted. As in previous years, patient advocates from around the world were integrated into the ABC Conference and contributed substantially to the consensus. A German BC expert panel comments on the voting results of the ABC8 panelists regarding their relevance for routine clinical practice in Germany. As with previous meetings, the ABC8 votes focused on modified or new statements. Statements not modified for the ABC8 consensus remain valid. The German comments are always based on the current recommendations of the "Breast Committee" of the Gynecological Oncology Working Group (Arbeitsgemeinschaft Gynäkologische Onkologie, AGO Mamma).
We analyzed health-related quality of life (HRQoL) and time until definitive HRQoL deterioration (TUDD) for patients with newly diagnosed advanced ovarian cancer receiving olaparib plus bevacizumab or placebo plus bevacizumab in PAOLA-1. HRQoL and TUDD, prespecified secondary endpoints, were assessed by EORTC Core Quality of Life Questionnaire (QLQ-C30) and Ovarian Cancer module (QLQ-OV28) at baseline and then every 12 weeks for 2 years. HRQoL and TUDD by homologous recombination deficiency (HRD) status and effect of progression on HRQoL were post hoc analyses. 806 patients were randomized (olaparib plus bevacizumab n = 537; placebo plus bevacizumab n = 269). There were no clinically meaningful between-group differences in adjusted mean global change from baseline in QLQ-C30 or QLQ-OV28 domains overall (between-group difference in QLQ-C30 Global Heath Status (GHS) score [95% CI] 1.65 [-0.27, 3.56]) or in the HRD-positive subgroup (1.23 [-1.25, 3.71]). TUDD estimates of QLQ-C30 GHS scores did not differ between treatment arms in the modified intention-to-treat population (hazard ratio [HR]=0.88; 95% CI = 0.72, 1.07) and favored olaparib plus bevacizumab vs placebo plus bevacizumab in the HRD-positive subgroup (HR = 0.70; 95% CI = 0.52, 0.93). Analyses of patients (103/465 [22.2%]) following disease progression showed clinically meaningful deterioration in QLQ-C30 emotional and social scores. Adding maintenance olaparib to bevacizumab showed no clinically meaningful detrimental effect on global HRQoL either overall or in the HRD-positive subgroup. ClinicalTrials.gov ID: NCT02477644.
Biomarkers are integral to modern breast cancer management by providing essential information for prognosis and treatment selection. This review presents the 2026 update of the recommendations of the Arbeitsgemeinschaft Gynäkologische Onkologie (German Gynecological Oncology Group, AGO) on therapy-relevant prognostic and predictive biomarkers. The recommendations are based on a structured evaluation of the most recent and clinically relevant evidence using the AGO grading system to support decision-making in routine clinical practice.
Cancer patients prone to toxicities might benefit from dose reduction over fixed-dose recommendations. We develop a predictive index to identify patients with increased probability of dose reduction, intolerable toxicities, or therapy discontinuation (hereafter: dose reduction) in metastatic breast cancer (MBC) and compare real-world effectiveness of reduced (RSD) versus full starting dose (FSD) using this index. This analysis included 618 patients with HR-positive, HER2-negative MBC from the prospective, observational, multicenter registry OPAL (NCT03417115), receiving first-line palbociclib (n = 386) or ribociclib (n = 232) plus endocrine therapy. A logistic regression model was employed to derive the predictive index. Inverse probability of treatment weighting was used to emulate a head-to-head comparison of RSD and FSD by analyzing progression-free (PFS) and overall survival (OS). Within 6 months, 215 patients (35%) underwent dose reduction, including 109 (51%) with RSD. Predictors for dose reduction were age ≥65 years and Charlson comorbidity index (CCI) ≥1. Among patients with increased probability of dose reduction (index ≥1: ≥65 years and/or CCI ≥ 1), median PFS and OS were 30.1 [21.7, 54.0] and 57.6 [40.0, NA] months with RSD vs. 29.3 [24.9, 32.0] and 43.1 [38.8, 50.3] months with FSD. For low-probability patients (index = 0: <65 years and CCI = 0), median PFS and OS were 17.6 [9.1, 29.8] and 32.9 [23.1, 40.9] months with RSD vs. 24.5 [19.8, 32.0] and 54.2 [48.8, NA] months with FSD. In this real-world MBC setting, patients ≥65 years and/or with CCI ≥ 1 had an increased probability of dose reduction and may benefit from RSD, as this yielded outcomes comparable to FSD. Younger, fitter patients may require full dosing. Future studies, ideally randomized controlled trials, should aim to confirm these findings.
Goal The aim of this official guideline, which was coordinated by the German Society of Gynaecology and Obstetrics (DGGG) together with the German Society of Urology (DGU) and the German Society of Reproductive Medicine (DGRM), is to provide consensus-based recommendations for counselling and the use of fertility preservation measures in prepuscent girls and boys and for patients of reproductive age by evaluating the relevant literature. Methods This S2k guideline was developed by a structured consensus of representative members of various professional associations on behalf of the guideline commission of the DGGG, DGU and DGRM. Recommendations Recommendations for counselling and the use of fertility-preserving measures in patients are presented, taking into account their life circumstances, the planned oncological therapy and the individual risk profile, as well as the procedure for selected tumour entities.
Malignant ovarian germ cell tumours (MOGCT) are rare tumours that disproportionally affect younger women. The Arbeitsgemeinschaft fuer Gynaekologische Onkologie (AGO) study group has established a clinico-pathological database (Current Ovarian geRm cell and SEx cord stromal Tumour Treatment strategies, CORSETT) to provide an overview of the current treatment strategies and survival of MOGCT patients. Twenty German centres provided mixed retro- and prospective data of patients with tumour specimens treated between 2001 and 2014. A second opinion pathology board reviewed the tumour specimens. Descriptive analyses of the treatment strategies and fertility outcomes were conducted. Kaplan-Meier curves were plotted for disease-free and overall survival data. Seventy-seven MOGCT patients were included, 36 malignant dysgerminoma (MD), 21 malignant teratoma (MT) and 20 mixed MOGCT (MM) patients. Patients had a median age of 28 (MD), 38 (MT) and 33 (MM) years and fertility-sparing surgery (FSS) was offered in most (83% MD, 81% MT and 75% MM) patients. Final FIGO stage I disease was diagnosed in 78% (MD), 81% (MT) and 60% (MM) and adjuvant systemic treatment was given to 56% (MD), 53% (MT) and 70% (MM) patients. After a median observation time of 78.2 months, 5% (MD), 14% (MT) and 45% (MM) experienced disease recurrence. Overall survival was excellent in all groups (100% MD, 100% MT and 95% MM). In this descriptive analysis, FSS was the surgical method of choice for patients with MOGCT in AGO centres without negative impact on OS. MOGCTs appeared however as a heterogeneous group of tumours with particularly high recurrence rates for patients with MM.
Objective The objective of this revised official guideline, published by the German Society for Gynecology and Obstetrics (DGGG) and coordinated in the joint guidelines program of the DGGG, the Austrian Society for Gynecology and Obstetrics (OEGGG), and the Swiss Society for Gynecology and Obstetrics (SGGG), is to provide evidence-based and consensus-based recommendations for the diagnosis, treatment, care, and support of girls and women with confirmed or suspected endometriosis. Methods This S2k guideline was developed through a structured consensus process involving representative members of various professions (37 professional associations, organizations, and self-help groups) and includes 25 statements and 73 recommendations which are based on a systematic literature review (2019 - 2023) and expert consensus. Recommendations For the first time, the revised guideline has placed a greater focus on individualized, symptom-oriented diagnosis and treatment that combines hormonal, surgical, and multimodal approaches. A significant innovation is the use of transvaginal ultrasound as the central diagnostic procedure for detecting endometriosis. Therapeutically, primary hormone treatment is now recommended as the first choice approach, with surgical interventions and multimodal approaches supplemented on an individual and symptom-oriented basis.
Ovarian cancer (OC) is frequently diagnosed at a late, advanced stage, resulting in poor survival outcomes. PARP inhibitors like niraparib have shown significant efficacy in high-grade OC, particularly in tumors with homologous recombination deficiency, including BRCA mutations. This study aimed to evaluate dose modifications, safety, tolerability, and the impact on quality of life associated with niraparib in real-world clinical practice. This non-interventional, register-based study included patients with platinum-sensitive recurrent OC who received niraparib as part of the compassionate-use program (CUP) in Germany. Clinical baseline characteristics, treatment data, adverse events (AEs), and quality-of-life measures were collected both prospectively and retrospectively across 14 centers. Data analysis was performed using descriptive statistical methods. Overall, 68 female patients were enrolled in the CUP register. Most patients had good performance status, with no significant comorbidities or concomitant medications. The most frequently reported AEs associated with niraparib were thrombocytopenia, fatigue, and nausea. Approximately half of patients required dose adjustments. AEs were less common in patients with normal physical examination findings, better ECOG performance status, and absence of comorbidities. Prior use of PARP inhibitors or previous treatment-related side effects increased the likelihood of AEs during niraparib therapy. The median treatment duration was 182 days, with disease progression being the most common reason for discontinuation. Niraparib treatment within the German CUP demonstrated favorable safety and tolerability profiles, supporting its effectiveness in a real-world setting for patients with recurrent OC. These findings are consistent with results from clinical trials, further reinforcing the role of niraparib in this patient population.
This study aimed to assess the association of CA125 levels at pre-defined clinical time points with survival outcomes and to evaluate its role in recurrence detection in low-grade serous ovarian cancer. In this retrospective multi-center cohort study, patients with low-grade serous ovarian cancer of all International Federation of Gynecology and Obstetrics stages treated between 2007 and 2023 at 9 tertiary centers in Germany and Austria were included. Clinical data and serial CA125 measurements were extracted from medical records at pre-defined time points: diagnosis, after debulking surgery, during adjuvant therapy, follow-up, and recurrence. Associations with progression-free survival and overall survival were analyzed using Kaplan-Meier estimates and Cox regression. Sensitivity of CA125 for recurrence detection was assessed. A total of 368 patients were included; 84.2% had International Federation of Gynecology and Obstetrics stage IIB to IV disease. Median baseline CA125 was 113 U/mL, declining to 16 U/mL after primary treatment and remaining below 35 U/mL during follow-up. A 10-fold increase in baseline CA125 was associated with worse overall survival (hazard ratio 2.24, 95% confidence interval 1.37 to 3.67), remaining significant after adjustment for International Federation of Gynecology and Obstetrics stage, residual disease, age, and ascites (hazard ratio 1.90; 95% confidence interval 1.13 to 3.19). Elevated post-operative CA125 was associated with shorter progression-free survival. Persistently elevated CA125 after 6 cycles of adjuvant chemotherapy was associated with a higher hazard of progression or death (hazard ratio 5.54; 95% confidence interval 2.21 to 13.9). At recurrence, CA125 detected most relapses; however, 15.7% occurred despite normal marker levels, corresponding to a sensitivity of 84% (95% CI 74.0 to 90.4). CA125 in low-grade serous ovarian cancer correlates with disease stage, reflects treatment response, and shows prognostic relevance for progression-free survival at pre-defined clinical time points. It may support recurrence detection but should not be used as a stand-alone marker.
To map the risk profile of drug classes at the population level by identifying associations between newly prescribed reimbursed drugs and sudden cardiac arrest (SCA), thereby providing a systematic basis for assessing individual drug effects. Population-based, matched case-control study. Greater Vienna area, Austria, using linked data from the Austrian Healthcare Reimbursement Database and the Vienna Ambulance Service between 2013 and 2020. A total of 31 330 insured individuals were included from an estimated 14 448 612 person-years at risk. Cases (n=6266) were patients with SCA, each matched 1:4 to controls (n=25 064) without SCA by age, sex and event date. The estimated absolute case risk equals 43.4 per 100 000 person-years. Newly prescribed reimbursed drugs within 4 weeks before the SCA event, classified according to four-digit Anatomical Therapeutic Chemical (ATC) codes. Associations between newly prescribed drug classes and SCA, estimated using conditional logistic regression and expressed as ORs with 95% CIs, adjusted for comorbidities and concomitant medications prescribed 120-29 days before the event. Among 322 relevant ATC drug classes, 245 were newly prescribed within 28 days prior to the SCA event. Of these, 57 (23%) were significantly associated with SCA. Eight drug classes demonstrated a markedly elevated risk (OR≥10), including oripavine derivatives (OR 64, 95% CI 8 to 486), other cardiac preparations (OR 22, 95% CI 2 to 204), plain antiandrogens (OR 18, 95% CI 1.2 to 275) and phenylpiperidine derivatives (OR 16, 95% CI 7 to 38). The most frequently prescribed associated drug classes were penicillins with beta-lactamase inhibitors (179 cases; OR 2.17, 95% CI 1.8 to 2.7), pyrazolones (167 cases; OR 2.14, 95% CI 1.7 to 2.7) and adrenergics combined with anticholinergics (130 cases; OR 2.94, 95% CI 2.2 to 3.9). Numerous outpatient-prescribed drug classes were associated with SCA. This exploratory, population-based analysis provides a systematic map of potential safety signals to inform more detailed pharmaco-epidemiological investigations, in which confounding and causality can be examined more rigorously.
Epithelial ovarian cancer frequently recurs and becomes resistant to platinum chemotherapy. We investigated whether adding pembrolizumab to weekly paclitaxel, with or without bevacizumab, improves progression-free survival and overall survival compared with weekly paclitaxel, with or without bevacizumab, in participants with platinum-resistant recurrent ovarian cancer who had received one to two previous systemic regimens. ENGOT-ov65/KEYNOTE-B96 is a randomised, double-blind, phase 3 study conducted at 187 gynaecologic oncology centres in 25 countries in the Americas, Asia, Europe, and Oceania. Adults (≥18 years) with histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, who received one to two previous systemic therapies including at least one platinum regimen and who progressed 6 months or less after the last platinum regimen, were eligible. Participants were randomly assigned 1:1 to intravenous pembrolizumab 400 mg every 6 weeks for up to 18 cycles plus open-label intravenous paclitaxel 80 mg/m2 on days 1, 8, and 15 of each 21-day cycle or intravenous placebo (saline solution) every 6 weeks for up to 18 cycles plus open-label intravenous paclitaxel 80 mg/m2 on days 1, 8, and 15 of each 21-day cycle; intravenous bevacizumab 10 mg/kg every 2 weeks was permitted per investigator. Randomisation was stratified by planned bevacizumab use, region, and PD-L1 combined positive score (CPS). The primary endpoint was investigator-assessed progression-free survival per RECIST version 1.1; the key secondary endpoint was overall survival. Results from two interim analyses and the final analysis are included in this Article. This study is registered with ClinicalTrials.gov, NCT05116189, and is now completed. Between Dec 13, 2021, and July 3, 2023, 643 female participants were randomly assigned; 322 to pembrolizumab plus paclitaxel and 321 to placebo plus paclitaxel. At the first interim analysis, pembrolizumab plus paclitaxel significantly improved progression-free survival versus placebo plus paclitaxel in both the PD-L1 CPS 1 or higher (median 8·3 months vs 7·2 months; hazard ratio [HR] 0·72; 95% CI 0·58-0·89; p=0·0014 α=0·012]) and overall populations (median 8·3 months vs 6·4 months; HR 0·70, 95% CI 0·58-0·84; p<0·0001, [α=0·0023]), meeting the prespecified criteria for confirmatory efficacy. At the second interim analysis, overall survival was significantly improved in the PD-L1 CPS 1 or higher population (median 18·2 months vs 14·0 months; HR 0·76, 95% CI 0·61-0·94; p=0·0053, [α=0·0083]). At the final analysis, overall survival was significantly improved in the overall population (median 17·7 months vs 14·0 months; HR 0·82, 95% CI 0·69-0·97; p=0·011 [α=0·024]). Grade 3 or worse treatment-related adverse events occurred in 217 (68%) of 320 participants in the pembrolizumab plus paclitaxel group versus 176 (55%) of 318 participants in the placebo plus paclitaxel group. The most common treatment-related adverse events (any grade) included anaemia, peripheral neuropathy, alopecia, fatigue, and nausea. Treatment-related adverse events resulted in death in four participants (1%) in the pembrolizumab plus paclitaxel group (colitis, interstitial lung disease, acute myeloid leukaemia, and intestinal perforation) and in five participants (2%) in the placebo plus paclitaxel group (cardiac failure, intestinal perforation [in two participants], and large-intestine perforation [in two participants]). Pembrolizumab plus weekly paclitaxel, with or without bevacizumab, significantly improved progression-free survival and overall survival in participants with platinum-resistant recurrent ovarian cancer who had received one to two previous systemic regimens, supporting this regimen as a new treatment option for this population. Funded by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ, USA.
What is this summary about?This is a plain language summary of the results of a survey of women who have HER2 positive (HER2+) breast cancer. HER2 is a protein found on the surface of some cells and helps control how they grow and divide. In HER2+ breast cancer, cancer cells have more HER2 proteins than normal. This means the cells grow and divide faster, which can make the cancer more aggressive. Thanks to advances in cancer treatments and emergence of special medicines that can target and block the HER2 protein, the vast majority of patients with HER2+ breast cancer are still alive many years after their diagnosis. But there is still a risk that the cancer can come back, known as ’risk of recurrence’. The risk of recurrence is different for everybody and can determine what treatment is best for different people.What did the survey ask?This research aimed to better understand the major fears and concerns of women with HER2+ breast cancer and how these concerns can affect their health behaviours. It also aimed to explore what their interactions with healthcare professionals were like, including their worries or fears concerning their cancer, their treatment options, and their risk of recurrence. The survey also asked participants how much they want to be proactively involved in making decisions about their treatment and if they would consider additional options, such as lifestyle changes, to reduce the risk of recurrence.What do the results mean?The survey results showed that it is important for healthcare professionals to involve women with HER2+ breast cancer in decisions about their treatment. A shared decision-making approach is important for all women at different stages of their cancer treatment plan, but especially at early stage of the disease to create and build trust between patients and healthcare professionals.
Background: High-grade serous ovarian carcinoma (HGSOC) can be subdivided into four prognostic molecular subtypes based on gene expression: C1/Mesenchymal (C1.MES), C2/Immunoreactive (C2.IMM), C4/Differentiated (C4.DIF) and C5/Proliferative (C5.PRO), each representing distinct biological characteristics with immune and stromal microenvironments. PrOTYPE enables prognosis and treatment guidance from biopsy material. Metastatic biopsies are often more accessible than primary adnexal sampling; their utility assumes stable tumor-intrinsic properties relative to the primary. Metastases may diverge due to microenvironmental pressure as well as the site-specific subtype dynamics. Methods: Treatment-naïve HGSOC specimens from 138 patients were profiled using the 55-gene nanostring PrOTYPE assay at adnexal, contralateral adnexal, and/or metastatic sites. Results: Adnexal PrOTYPE yielded expected distributions (21% C1.MES, 31% C2.IMM, 23% C4.DIF, 25% C5.PRO) with moderate reproducibility (κ = 0.49). Same-site replicate analysis showed substantial reproducibility (κ = 0.7). Non-adnexal sites were enriched for immune/mesenchymal subtypes (C1.MES/C2.IMM, 36/63 cases), most prominently at the omentum (24/32 C1.MES). C5.PRO was distinctly underrepresented at non-adnexal sites. Subtype shifts from adnexal to extra-adnexal sites were enriched for the second-place adnexal type prediction (p < 0.001). Detailed 55-gene analysis showed POSTN/CTSK were most commonly upregulated across metastatic sites. EMT pathway enrichment increased with metastatic distance (from adnexa to omentum, adj p < 0.05), paralleling-but independent of-C1.MES predominance. Conclusions: Adnexal PrOTYPE showed good stability. However, non-random subtype shifts and EMT enrichment at metastatic sites suggest dissemination selects pre-existing transcriptional plasticity rather than acquiring states de novo as HGSOC adapts to new microenvironments. Microenvironment changes may help predict metastatic potential and should be considered for precision medicine targeting.
For spaying in older female dogs, ovariohysterectomy (OHE) is often preferred over ovariectomy (OE) in practice due to possible uterine diseases in advanced age. The aim of this retrospective study was to evaluate patient data in order to assess OE as a surgical method for the prevention of uterine diseases in older female dogs without uterine abnormalities. In addition, complications and long-term effects after spaying were determined in the patient population and compared with regard to the surgical technique. The evaluation was based on patient data in the patient management system, questionnaires and internal follow-up checks. In addition, an ultrasound examination of the uterus was performed in female dogs>3 years of age at the time of OE. Patients who underwent major regional surgery under the same anesthesia or with an anesthesia time of>150 minutes were excluded. Complications were classified as minor or major, with major complications requiring surgical treatment or intensive inpatient care. 486 bitches were included in the evaluation (OE: 267; OHE: 219). A total of 19 ultrasound examinations after OE revealed no abnormalities, and none of the questionnaires reported uterine disease after OE in any patient with a follow-up of up to 9 years. Intraoperatively only minor complications occurred in 35/486 (7.2%) bitches. For postoperative complications, 315 cases were evaluated, with complications occurring in 18 (5.7%) bitches. These included wound healing disorders (12/315; 3.8%), reoperation due to abdominal bleeding (3/315; 1.0%) and the occurrence of sepsis (3/315; 1.0%). These included 9 (2.9%) major complications. Long-term effects were examined in 205 patients: urinary dribbling was reported in 19 (9.3%), coat changes in 50 (24.4%) and weight gain in 65 (31.7%) of the bitches. No difference was found between OE and OHE. Age had no significant influence. The results of the study suggest that OE can also be recommended for older bitches without macroscopically detectable uterine abnormalities. The complications that occurred were comparable overall for OE and OHE. Bei der Kastration älterer Hündinnen wird aufgrund möglicher Uteruserkrankungen im fortgeschrittenen Alter in der Praxis häufig die Ovariohysterektomie (OHE) der Ovariektomie (OE) vorgezogen. Ziel dieser retrospektiven Studie war die Auswertung von Patientendaten, um die OE als Operationsmethode zur Prävention von Uteruserkrankungen bei älteren Hündinnen ohne uterine Veränderungen zu bewerten. Zudem wurden Komplikationen sowie Spätfolgen nach der Kastration untersucht und hinsichtlich der Operationstechniken verglichen.Die Auswertung basierte auf Daten im Patientenverwaltungssystem, Fragebogen und klinikinternen Nachkontrollen. Bei Hündinnen>3 Jahre zum Zeitpunkt der OE wurde zusätzlich eine Ultraschalluntersuchung des Uterus durchgeführt. Ausgeschlossen wurden Patienten mit größeren regionalen Eingriffen in gleicher Narkose oder einer Anästhesiedauer von>150min. Die Komplikationen wurden in Minor und Major klassifiziert, letztere erforderten eine chirurgische Versorgung oder intensivmedizinische stationäre Therapie.486 Hündinnen wurden in die Auswertung miteinbezogen (OE: 267; OHE: 219). Bei insgesamt 19 Ultraschalluntersuchungen nach OE zeigten sich keine Auffälligkeiten und in den Fragebögen wurde bei keinem Patienten eine Uteruserkrankung nach OE angegeben (Follow-Up bis zu 9 Jahre). Intraoperativ traten ausschließlich Minor-Komplikationen bei 35/486 (7,2%) Hündinnen auf. Postoperative Komplikationen wurden in 315 Fällen ausgewertet und bei insgesamt 18 (5,7%) Hündinnen festgestellt, darunter Wundheilungsstörungen (12/315; 3,8%), Reoperationen nach abdominaler Blutung (3/315; 1,0%) und Sepsis (3/315; 1,0%). Hiervon stellten 9 (2,9%) Major-Komplikationen dar. Spätfolgen wurden bei 205 Patienten ausgewertet: Harnträufeln wurde bei 19 (9,3%), Fellveränderungen bei 50 (24,4%) und eine Gewichtszunahme bei 65 (31,7%) der Hündinnen angegeben. Zwischen OE und OHE konnte kein Unterschied festgestellt werden. Das Alter hatte keinen signifikanten Einfluss.Die Ergebnisse der Studie lassen den Schluss zu, dass die OE auch bei älteren Hündinnen ohne makroskopische uterine Veränderungen empfohlen werden kann. Die Komplikationsrate war bei OE und OHE insgesamt vergleichbar.
Paclitaxel is a standard therapy in platinum-resistant ovarian cancer, but nab-paclitaxel, a solvent-free formulation with a favorable toxicity profile approved in other tumors, has not been evaluated against solvent-based paclitaxel (sb-paclitaxel) in this setting. This study compares efficacy and safety of nab-paclitaxel to sb-paclitaxel monotherapy in platinum-resistant ovarian cancer to inform clinical decision-making and guidelines. A mixed-methods approach combined a systematic literature review with expert discussions. Study selection followed 2 sample frames: (1) randomized controlled trials for sb-paclitaxel monotherapy published after the Cochrane review (2022), and (2) randomized and observational studies for nab-paclitaxel monotherapy, identified through searches of major databases through October 2024. Findings were discussed in 2 inter disciplinary, patient-centered workshops. These workshops integrated trial data with real-world experience and expert judgment to evaluate treatment outcomes, safety, and research gaps. The review identified no randomized head-to-head trials comparing nab-paclitaxel and sb-paclitaxel in platinum-resistant ovarian cancer. No new randomized trials of sb-paclitaxel were published since the Cochrane review. However, a related trial was identified comparing weekly with 3-weekly sb-paclitaxel. It reported improved survival and reduced hematologic toxicity with weekly dosing, although quality-of-life data were limited. Existing studies on nab-paclitaxel are limited to single-arm and combination trials with heterogeneous populations and treatment regimens. The experts agree that indirect evidence from other tumors (breast/gastric cancer), demonstrates comparable efficacy between the 2 formulations, with nab-paclitaxel showing a favorable safety profile by avoiding Cremophor® EL-related toxicities. The consensus was that nab-paclitaxel's tolerability allows higher dosing and may enhance quality of life. Regulatory and reimbursement challenges persist without approval for nab-paclitaxel monotherapy in platinum-resistant ovarian cancer. Despite the absence of direct trials, experts considered evidence sufficient to support nab-paclitaxel as a viable alternative to sb-paclitaxel in platinum-resistant ovarian cancer with comparable efficacy, safety, and fewer hypersensitivity reactions. Additional randomized trials were not deemed necessary.
Secondary cytoreductive surgery is considered for selected patients with recurrent ovarian cancer. Although evidence supports its impact on progression-free survival, its effect on overall survival remains controversial. This study aims to identify patient sub-groups that benefit most from secondary cytoreductive surgery. A systematic review and trial-level meta-analysis of randomized controlled trials published through March 2025 was conducted. The primary end points were pooled hazard ratio (HR) for overall survival and progression-free survival comparing secondary cytoreductive surgery plus chemotherapy versus chemotherapy alone. Sub-group analyses were performed based on histology, platinum-free interval, number of recurrent lesions, individualized model or Arbeitsgemeinschaft Gynäkologische Onkologie score, and residual disease status. Three randomized controlled trials involving 1249 patients were included in this meta-analysis. Patients with favorable validated selection scores (positive Arbeitsgemeinschaft Gynäkologische Onkologie or individualized model ≤4.7) showed significantly improved overall survival (HR 0.79, 95% confidence interval [CI] 0.66 to 0.96). Complete resection was associated with significantly better overall survival (HR 0.53, 95% CI 0.43 to 0.64) and progression-free survival (HR 0.51, 95% CI 0.42 to 0.61) than patients who had residual disease. A progression-free survival benefit was also observed in the non-high-grade serous histology (HR 0.52, 95% CI 0.38 to 0.72). In patients with a platinum-free interval of 6 to 12 months (SOC-1, 6-16 months), there was a significant trend toward improved overall survival (HR 0.70, 95% CI 0.55 to 0.91). Secondary cytoreductive surgery significantly improves progression-free survival and provides an overall survival benefit in carefully selected patients, particularly, those with a high likelihood of complete resection, favorable surgical selection scores, and a shorter platinum-free interval (<16 months). These findings highlight the critical role of patient selection and surgical completeness in optimizing outcomes for recurrent ovarian cancer.
Despite treatment advances in newly diagnosed advanced-stage ovarian cancer (aOC), improved outcomes are needed. DUO-O (NCT03737643), a phase III placebo-controlled trial, enrolled patients with newly diagnosed aOC. Following one cycle of carboplatin/paclitaxel ± bevacizumab, patients without a tumor BRCA mutation (non-tBRCAm) were randomly assigned (1 : 1 : 1) at cycle 2 to carboplatin/paclitaxel plus bevacizumab followed by bevacizumab (control); carboplatin/paclitaxel, bevacizumab plus durvalumab followed by bevacizumab plus durvalumab (durvalumab arm); or carboplatin/paclitaxel, bevacizumab plus durvalumab followed by bevacizumab, durvalumab plus olaparib (durvalumab + olaparib arm). Investigator-assessed progression-free survival (PFS; primary endpoint) was tested for the durvalumab + olaparib arm versus control in the non-tBRCAm homologous recombination deficiency (HRD)-positive and non-tBRCAm intention-to-treat (ITT) populations. One thousand one hundred and thirty patients were randomly allocated to the study. The prespecified interim PFS analysis [data cut-off (DCO): 5 December 2022] qualified as the primary analysis; PFS hazard ratio (HR) for the durvalumab + olaparib arm versus control was 0.49 [95% confidence interval (CI) 0.34-0.69, P < 0.0001; median (m) PFS 37.3 versus 23.0 months] in the non-tBRCAm HRD-positive and 0.63 (95% CI 0.52-0.76, P < 0.0001; mPFS 24.2 versus 19.3 months) in the non-tBRCAm ITT population. For the durvalumab arm versus control, PFS HR was 0.87 (95% CI 0.73-1.04, P = 0.13; mPFS 20.6 versus 19.3 months) in the non-tBRCAm ITT population. At final PFS and interim overall survival (OS) analysis (DCO: 18 September 2023), PFS results were consistent with primary analysis; interim OS HR for the durvalumab + olaparib arm versus control was 0.95 (95% CI 0.76-1.20, P = 0.68; 39.0% maturity) in the non-tBRCAm ITT population. Safety was generally consistent with the profiles of the individual agents. DUO-O met its primary PFS endpoints for first-line durvalumab plus carboplatin/paclitaxel and bevacizumab followed by durvalumab, bevacizumab plus olaparib maintenance versus carboplatin/paclitaxel and bevacizumab followed by bevacizumab in the non-tBRCAm HRD-positive and non-tBRCAm ITT populations. Further insight into long-term benefit is anticipated with additional follow-up.
The German Guideline Committee (AGO: Working Group on Gynecologic Cancers) updated its yearly recommendations on the diagnosis and treatment of breast cancer in March 2026. Chapters on oncological and oncoplastic-reconstructive surgery are coordinated with the Working Group for Plastic, Aesthetic, and Reconstructive Surgery in Gynecology (AWOgyn). The most important changes include the ommission of sentinel lymph node biopsy (SLNB) and preffered axillary staging in patients with node-positive breast cancer undergoing neoadjuvant chemotherapy (NACT). Targeted axillary dissection (TAD) is endorsed as the method of choice [AGO ++] in patients converting from cN + to ycN0 status, and other de-escalated techniques (SLNB, target lymph node biopsy [TLNB]) are also possible options [AGO +]. Following NACT, ALND is indicated only when macrometastatic disease is detected in the sentinel and/or in the target lymph node.
Standard therapy for advanced ovarian cancer consists of primary surgical debulking followed by 6 cycles of platinum-based chemotherapy and maintenance therapy with bevacizumab and/or poly-ADP ribose polymerase (PARP) inhibitors (PARPi). While homologous recombination deficiency (HRD)-positive patients derive meaningful benefit from PARPi maintenance; HRD-negative patients derive limited benefit, and the toxicity associated with 6 cycles of chemotherapy may negatively affect patients' quality of life, raising the question whether reducing chemotherapy cycles could decrease morbidity without compromising efficacy. To compare recurrence-free survival and overall survival in patients with International Federation of Gynecology and Obstetrics stage III to IV, HRD-positive ovarian cancer who achieve complete debulking, treated with either 3 or 6 cycles of platinum-based chemotherapy, both followed by maintenance therapy with the PARP inhibitor niraparib. We hypothesize that recurrence-free survival in patients receiving 3 cycles of chemotherapy followed by niraparib is non-inferior (defined as a hazard ratio [HR] ≤1.3) to 6 cycles of chemotherapy followed by niraparib, as assessed by a multi-variable Cox regression model. This is a multicenter, randomized, open-label Phase II non-inferiority study. Participants will be randomized 1:1 to either 3 (Arm A) or 6 (Arm B) cycles of platinum-based chemotherapy, both followed by niraparib maintenance for 3 years, at a starting dose of 200 mg once daily or 300 mg once daily depending on patient factors (eg, body weight, platelet count), after complete surgical debulking. The study is currently open for recruitment in all participating countries in Europe, further details can be found under at Clinicaltrials.gov ID: NCT05460000. Eligible patients include women with International Federation of Gynecology and Obstetrics stage III to IV high-grade ovarian cancer, confirmed HRD positivity (including pathogenic BRCA mutations) after centralized testing, and no residual disease following primary tumor debulking. The HRD test will be conducted centrally using the validated North-Eastern-German Society of Gynaecologic Oncology-Genomic Instability Score Assay. The primary endpoint is recurrence-free survival. Overall survival, Quality of life, Toxicity, detailed list under "outcomes." 640 patients. Accrual completion is expected in 2032, with results presentation anticipated in 2033. NCT05460000. This trial aims to provide high-quality evidence on whether a reduced number of chemotherapy cycles in the era of niraparib maintenance for 3 years can safely maintain efficacy while minimizing treatment-related toxicity and improving patients' quality of life.
Objective This guideline aims to improve and standardize medical care, support, and evidence collection for female victims of sexual violence in Germany. Method In accordance with the requirements for S1 guidelines, the contents were formally discussed and agreed upon in numerous online meetings by a representative interdisciplinary group of experts well versed in the guideline topic. The German Society for Gynecology and Obstetrics (DGGG) led the discussion. Recommendations Empathy, experience, and expertise, as well as respect and objectivity on the part of the medical personnel involved, are crucial for the care of women after sexual violence. The guideline provides 130 recommendations for the care and examination of women affected by sexual violence, including requirements for examination, the collection of evidence and documentation of injuries, testing for sexually transmitted infections, post-exposure prophylaxis and infectious disease follow-up examinations, as well as aspects of psychological and psychosocial care and psychological aftercare.