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The presented study investigated the relevance of mutations in 17 cancer genes and response to neoadjuvant chemotherapy in two clinical cohorts of HER2+ breast cancer. 364 samples from HER2+ tumors of the neoadjuvant studies GeparTrio (no anti-HER2 treatment, n = 71) and GeparSepto (dual HER2 blockade and randomization for paclitaxel vs. nab-paclitaxel, n = 293) were analyzed by targeted next generation sequencing of hot spot regions of 17 genes. Mutations in TP53 (47.3%) and PIK3CA (23.9%) were most prevalent. EGFR, KRAS, NRAS, HRAS were combined to the MAPK module with 2.5% harboring mutations. In GeparSepto, the pCR rate was significantly lower in PIK3CA-mutant vs wild-type (wt) tumors (47.7% vs. 66.7%; p = 0.009). In patients treated with nab-paclitaxel, pCR rates were significantly lower in PIK3CA-mutated tumors compared to wt-tumors (38.7% vs. 72.0%; p = 0.001). In the GeparTrio cohort without neoadjuvant anti-HER2 therapy the pCR rate was 27.3% in the mutant cohort compared to 16.3% in the PIK3CA-wt cohort (p = 0.339). In HER2+ breast cancer, PIK3CA mutations were significantly associated with reduced response to dual HER2 blockade with pertuzumab+trastuzumab as well as reduced response to nab-paclitaxel. This reduction was not observed in GeparTrio without anti-HER2 therapy.
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.
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.
This case report describes the prenatal diagnosis of the extremely rare Blepharo-Cheilo-Dontic syndrome. After sonographic diagnosis of the bilateral cleft lip and palate and the persistent open eyelids, amniocentesis with subsequent molecular genetics confirmed the sonographically presumed de-novo mutation of the CDH1 gene and the Blepharo-Cheilo-Dontic Syndrome. After multidisciplinary counseling the patients termined the pregnancy.
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The DestinyBreast (DB)04 and DB06 trials have shown clinical activity of trastuzumab-deruxtecan (T-DXd) in HER2-low and HER2-ultralow metastatic breast cancer. The identification of HER2-low and HER2-ultralow breast cancer is therefore essential for personalized therapy with T-DXd. We evaluated 723 residual tumors from the Penelope-B trial (NCT01864746) and correlated different levels of HER2 protein expression with prognosis and messenger RNA (mRNA) profiles, including HER2 transcripts. In Penelope-B, 57.68% (n = 417) of 723 residual tumors were HER2 low. The HER2-ultralow category was assigned to 109 (15.08%) tumors, and 197 (27.25%) tumors were completely HER2 negative (HER2 0). In Kaplan-Meier analysis, there were no survival differences among these 3 subgroups. There was no significant difference in HER2 mRNA expression between HER2-0 and HER2-ultralow tumors (P = .08). In contrast, there was a highly significant difference in HER2 mRNA expression between HER2-ultralow and HER2-low tumors (P < .0001) and between HER2-low and HER2-positive tumors (P < .0001). The extracellular protease cathepsin L, which has been suggested as a biomarker for extracellular cleavage of T-DXd, was detectable in all HER2-related subgroups and was a negative prognostic factor for invasive disease-free survival and overall survival (P = .0001) in preneoadjuvant core biopsies. In our study, we were able to characterize HER2 low as a clinically relevant and molecular defined tumor group with significantly increased HER2 expression. In contrast, for HER2 ultralow, we did not observe a defined molecular phenotype, despite the clinically relevant regulatory approval of T-DXd also in the ultralow subgroup. Additional investigations are needed to identify biomarkers beyond HER2 for T-DXd response as a basis for refined criteria for treatment eligibility.
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.
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.
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.
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.
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.
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.
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).
[This corrects the article DOI: 10.1055/a-2612-3790.].
Progressive multifocal leukoencephalopathy (PML) is a life-threatening demyelinating disease caused by reactivation of the JC virus (JCV) in immunocompromised patients. While immune checkpoint inhibitors (ICIs) show therapeutic potential, responses vary and predictive biomarkers are lacking. To determine whether pretreatment JCV- and/or BK virus-specific T cells in the blood are associated with treatment efficacy. This retrospective cohort study included 111 patients with PML who were treated with ICIs stratified by peripheral virus-specific T cell presence (ELISpot/flow cytometry) between August 2021 and May 2024, with a median (IQR) follow-up of 7 (1-13) months. Of 112 patients with definite PML across 39 centers, 1 patient refused participation; 111 patients were included. Patients received pembrolizumab (n = 81), nivolumab (n = 28), or atezolizumab (n = 2) per availability and prescribing practices at participating centers. Clinical outcomes, diagnostic parameters, and immune-related adverse events were compared; association of virus-specific T-cell responses with survival was analyzed using the Kaplan-Meier method. The study cohort consisted of 111 patients (median [IQR] age, 61 [50-70] years; 74 male [66.6%]). Twenty-one patients had detectable virus-specific T cells prior to therapy, 22 were T cell-negative and 68 had an unknown T-cell status. T cell-positive patients showed significantly higher response rates and improved survival compared to both T cell-negative patients (18/21 [86%] vs 5/22 [23%]; P < .001; median survival time, none [95% CI, undefined] vs 136.5 days [95% CI, 19 to ∞]; P = .002) and those with unknown T-cell status (18/21 [86%] vs 29/68 [43%]; P = .001; median survival time, none vs 162 days [95% CI, 66 to ∞]; P = .004). They achieved better functional outcomes (median [IQR] modified Rankin Scale score, 3 [2-4] vs 4 [3-6]; P = .009) and lower JC viral load in cerebrospinal fluid (median [IQR], 0 copies/mL [0-502.5] vs 2500 copies/mL [0-6900]; P = .01) during follow-up compared to T cell-negative patients. Immune-related adverse events were most frequent in T cell-negative patients (10/20 [50%]), including the most severe events, and least frequent in T cell-positive patients (2/20 [10%]) (P = .02). Preexisting functional virus-specific T cells were associated with better clinical response, longer survival, and lower toxicity in PML. These findings suggest the likely importance of preexisting antiviral immunity for successful ICI therapy.
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.
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.
To report updated patient-reported (PRO) health-related quality of life (HRQOL) findings and evaluate the effect of disease progression on HRQOL using data from the final analysis of the PRIMA/ENGOT-OV26/GOG-3012 trial. Patients were randomized 2:1 to niraparib first-line maintenance or placebo. Longitudinal HRQOL was a prespecified secondary endpoint assessed via European Organisation for Research and Treatment of Cancer QOL-Core Questionnaire (EORTC QLQ-C30) and -Ovarian Cancer module (EORTC QLQ-OV28), Functional Assessment of Cancer Therapy Ovarian Cancer Symptom Index (FOSI), and EuroQol 5-dimension 5-level questionnaire with visual analog scale (EQ-VAS). Post hoc analyses evaluated least-squares mean change from baseline or last on-treatment visit before disease progression (clinical cutoff: April 8, 2024). Questionnaire completion rates exceeded 89% through cycle 24 and were 80% at end of treatment. Early differences in gastrointestinal symptom scores between arms resolved over time, and no differences in overall HRQOL were observed. Disease progression reduced overall HRQOL across arms, with marked reductions in EORTC QLQ-C30 overall HRQOL, FOSI, and EQ-VAS scores that never recovered to pre-progression levels. Progression also resulted in sustained deterioration across all EORTC QLQ-C30 and QLQ-OV28 functional scales and worsening symptom scores, particularly for fatigue, dyspnea, pain, and appetite loss. Similar results were observed when patients were evaluated by homologous recombination deficiency status. In the final PRIMA PRO analysis, results confirmed that niraparib first-line maintenance did not negatively affect HRQOL versus placebo. Disease progression caused sustained HRQOL deterioration across arms, emphasizing the clinical importance of extending progression-free survival to preserve patient HRQOL. NCT02655016.
Physicians interested in endometriosis and infertility as well as medical teams in reproductive medicine and endometriosis centers. A practical guide for clinical decision-making. This guide was compiled by the working group at the 2025 Weissensee Workshop of the Scientific Endometriosis Foundation. The contents are based on the available evidence regarding fertility and endometriosis and, where this was lacking, on the authors' clinical experience. It is intended as a guide for persons responsible for caring and treating patients with this condition in everyday clinical practice. This work is explicitly not intended to be a guideline as the authors were not commissioned to draft a guideline. Rather, its aim is to provide quality care in clinical practice, avoid unnecessary or potentially harmful measures, and establish the optimal therapy for individual patients.
The treatment landscape for metastatic triple-negative breast cancer (mTNBC) has evolved. However, data on implementation of novel treatment approaches in clinical routine and current real-world outcomes are limited. Patients with mTNBC who initiated first-line (1L) treatment between January 2018 and August 2023 were prospectively observed within the OPAL registry. Treatment patterns, median real-world overall survival (rwOS), and progression-free survival (rwPFS) were analyzed by programmed death-ligand 1 (PD-L1) status. Among 368 patients included in this analysis, 31.8% were PD-L1 positive, 35.9% PD-L1 negative, and 32.3% PD-L1 unknown. Median age was 62.0 years, 10.6% had an Eastern Cooperative Oncology Group performance status ≥2, and 37.8% had de novo metastatic disease. Of patients with PD-L1-positive tumors, 81.2% received 1L PD-(L)1 inhibitors ± chemotherapy. Mono-chemotherapy was the most common treatment strategy for patients with PD-L1-negative and unknown status. At database cut, 25.8% of patients died before start of second line (2L). In the total cohort, rwOS was 17.6 months [95% confidence interval (CI) 15.6-19.7 months] and rwPFS was 6.8 months (95% CI 5.9-7.6 months). For patients with PD-L1-positive tumors treated with PD-(L)1 inhibitors, rwOS was 23.2 months (95% CI 17.5-28.2 months) and rwPFS was 7.2 months (95% CI 6.5-9.1 months). In patients with PD-L1-negative tumors receiving chemotherapy, rwOS was 16.0 months (95% CI 13.9-20.7 months) and rwPFS was 6.3 months (95% CI 4.9-7.6 months). Although new treatment options have been rapidly integrated into clinical routine, chemotherapy remains standard for most patients in 1L. Survival remains poor, with at least one-quarter dying without reaching 2L. This highlights the need for novel therapies to improve mTNBC outcomes.