Kliniken Essen-Mitte

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Fibroblast activation protein (FAP)-targeted tracers have emerged as promising agents for breast cancer imaging, with recent studies demonstrating PET performance comparable to or surpassing, that of [18F]FDG. Nevertheless, data comparing [68Ga]Ga-FAPI-46 and [18F]FDG uptake in hormone receptor and/or HER2-positive breast cancer (luminal-like vs HER2-positive) remain scarce. Aim of this study was to investigate the diagnostic performance of [68Ga]Ga-FAPI-46 versus [18F]FDG PET/CT in patients with hormone-receptor and/or HER2-positive breast cancer, and to evaluate the uptake of both tracers stratified by molecular subtypes (luminal-like vs HER2-positive). A sub-analysis of a prospective observational trial (NCT04571086) was conducted. Patients with histologically confirmed, hormone receptor- and/or HER2-positive breast cancer who underwent whole-body [68Ga]Ga-FAPI-46 and [18F]FDG PET/CT in the same week for initial staging or follow-up were included. [68Ga]Ga-FAPI-46 or [18F]FDG PET-positive lesions were defined as visually increased lesion uptake compared to adjacent organ background. Semi-automatic segmentation was performed to determine SUVmax, SUVpeak, TLRpeak, total number of lesions, total tumour volume, and total tumour SUV mean. Data were compared between molecular subtypes (luminal-like vs HER2-positive). Thirteen patients were included. Overall, the detection performance was comparable between [68Ga]Ga-FAPI-46 and [18F]FDG PET. The semi-quantitative analysis showed comparable mean uptake values in breast cancer lesions on [68Ga]Ga-FAPI-46 and [18F]FDG PET/CT (SUVmax: 13.4 vs. 12.9; TLRpeak: 5.6 vs. 4.5) and revealed no significant differences in the median lesion count (4.5 vs. 5), mean total tumour volume (71.5 vs. 73.2 mL), or mean total tumour SUVmean (5.4 vs. 5.4). No substantial differences between molecular subtypes (luminal-like vs. HER2-positive) were observed. In this small exploratory cohort, comparable uptake patterns in [68Ga]Ga-FAPI-46- and [18F]FDG-positive breast cancer lesions were observed across subtypes, underscoring the potential of [68Ga]Ga-FAPI-46 as a versatile imaging tool. Future studies in larger cohorts are warranted to explore the potential of FAP-targeted theranostics in different breast cancer subtypes. 68-Ga-FAPI-PET for Tumor Detection: A Prospective Observational Trial, NCT04571086, 09-15-2020, https://clinicaltrials.gov/study/NCT04571086 .

Abstract Background: In the KEYNOTE-522 study (NCT03036488), neoadjuvant pembrolizumab (pembro) plus chemotherapy (chemo) followed by adjuvant pembro plus chemo significantly improved pathological complete response (pCR), event-free survival, and OS compared with placebo (pbo) plus chemo in participants (pts) with early-stage TNBC. Following neoadjuvant therapy, the estimated treatment difference in pCR for pembro plus chemo vs pbo plus chemo was 13.6% (95% CI, 5.4%‒21.8%; P < 0.001) at the first interim analysis (N=602). Although pCR provides a definitive indicator of neoadjuvant treatment success, other measures, such as RECIST v1.1 and functional tumor volume (FTV), may offer an earlier signal of therapeutic activity. This prespecified exploratory analysis evaluated associations of pCR with ORR at different time points per MRI by RECIST v1.1 and FTV by blinded independent central review. Methods: Pts with previously untreated TNBC (stage T1c N1-N2 or T2-T4 N0-N2) were randomized 2:1 to neoadjuvant pembro 200 mg Q3W or pbo, each with 4 cycles of paclitaxel plus carboplatin (treatment 1) then with 4 cycles of doxorubicin or epirubicin plus cyclophosphamide (treatment 2). After definitive surgery, pts received adjuvant pembro or pbo for 9 cycles or until recurrence/unacceptable toxicity. Breast MRI was performed for consenting pts at screening and after neoadjuvant treatments 1 and 2. Responders were defined as pts who achieved CR or PR per RECIST v1.1 by blinded independent central radiology review. The subgroup analyses population included the randomized pts who signed MRI consent and had baseline values by central radiology review. Results: At data cutoff (March 23, 2021), MRI subgroup analyses included 162 pts (pembro plus chemo, n = 97; pbo plus chemo, n = 65). After treatment 1, ORR per RECIST v1.1 was 91.8% for pembro plus chemo vs 84.6% for pbo plus chemo, while ORR per MRI FTV was 96.9% vs 93.8%. After treatment 2, ORR per RECIST v1.1 was 82.5% vs 90.8%, and ORR per MRI FTV was 84.5% vs 92.3% for pembro plus chemo and pbo plus chemo, respectively. In the post hoc exploratory analyses for pCR in the MRI subgroup, pCR rate (ypT0/Tis ypN0; 95% CI) was 62.9% (52.5%-72.5%) with pembro plus chemo vs 52.3% (39.5%-64.9%) with pbo plus chemo. Odds ratios (OR) for achieving pCR among pts with ORR per RECIST v1.1 or FTV across all patients (pembro plus chemo and pbo plus chemo combined) are shown in the Table. Conclusions: Across all pts (ie, for pembro plus chemo and pbo plus chemo combined), the odds of achieving pCR were higher among pts who had an objective response per either RECIST v1.1 or FTV. Citation Format: J. Cortés, R. Dent, H. McArthur, L. Pusztai, S. Kümmel, C. Denkert, J. O’Shaughnessy, P. A. Fasching, M. Untch, R. Tarnawaski, M. Mouret-Reynier, S. M. Stemmer, T. Foukakis, J. Boileau, C. Chung, M. Fernandez, J. A. Mejia, F. Beca, S. Hou, P. Schmid. Phase 3 study of neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab for early-stage TNBC: KEYNOTE-522 magnetic resonance imaging (MRI) subgroup analysis [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2025; 2025 Dec 9-12; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2026;32(4 Suppl):Abstract nr PS4-07-24.

Background: Patients with inflammatory rheumatic diseases (IRD) are susceptible to influenza infections and their complications. However, they may avoid vaccination for fear of exacerbating their IRD. This study evaluates the 2023/24 influenza vaccine in IRD patients, aiming to provide recommendations for this group in the upcoming season. Methods: In this prospective, longitudinal study, we assessed the self-reported impact of influenza vaccination on patients with IRD. Participants were recruited nationwide between October and December 2023 and completed an online questionnaire after vaccination as well as at three and six months of follow-up. Results: Among 633 patients, 87.5% were female, with a median age of 50.4 (18-84) years. Post-vaccination, 50% experienced injection site pain; 41% reported no side effects. IRD flares occurred in 5%, with 1% requiring changes to immunomodulation. Among 428 patients with follow-up, influenza infections were reported in 38 patients (8.9%), including 10 (2.3%) with reinfections. No severe cases requiring hospitalization were reported. Spondyloarthritis patients had higher susceptibility to influenza (p = 0.002), accounting for 55.3% of infections. IRD flare-ups in the 12 months before vaccination predicted infections (p = 0.002). Conclusions: The 2023/24 vaccine was well tolerated by IRD patients, with no impact on the course of the disease in 95% of cases. Only 9% of patients reported influenza infections, none of which were severe. In light of these findings, physicians are advised to recommend vaccination to eligible IRD patients prior to or in the respective season.

Uro-oncological diseases have negative long-term consequences for physical, functional, psychological, and socioeconomic well-being. Acommon focus of palliative and integrative medicine is improving quality of life by alleviating symptoms. What treatment options are available for frequently occurring symptoms in uro-oncology patients? Based on current literature and international guideline recommendations, an overview of palliative and integrative medical therapies and their significance in the management of advanced uro-oncological tumors is given. Palliative care treatment options combined with complementary medicine can effectively contribute to symptom relief. The foundation of tumor pain therapy is medication, which can be effectively supplemented with acupuncture, for example. Medication and relaxation exercises can also have synergistic effects on sleep disorders. Amultiprofessional and interdisciplinary approach is also beneficial for the treatment of anxiety and depression, combining medication, psycho-oncological support, physiotherapy, social services, nutritional therapy, mindfulness exercises, meditative movement exercises, and so on. It is important that palliative and integrative medical support be offered early in the course of the illness. This support includes not only optimizing symptom relief but also communication with patients and their families and caregivers. Palliative medicine and integrative medicine offer the chance to improve the quality of life and symptom management in advanced uro-oncological cancer.

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.

Amyloidosen sind Erkrankungen, bei denen sich unlsliche Proteinfibrillen extrazellulr in Organsystemen ablagern.tiologien, Manifestationsmuster und Therapieoptionen unterscheiden sich erheblich (Tab.1).Das Nervensystem kann frh und schwer betroffen sein. Welche wichtigen behandelbaren Amyloidosen gibt es?Die AL-Amyloidose ist eine Plasmazellerkrankung (v.a. monoklonale Gammopathie, seltener multiples Myelom oder B-Zell-Lymphom), bei der monoklonale Leichtketten das Amyloid bilden [1].Charakteristisch ist eine direkte Kardiotoxizitt der zirkulierenden freien Leichtketten als Hauptschdigungsmechanismus [2].Die kardiale Manifestation (75-80 %) ist prognosebestimmend [3].Zudem bestehen oft eine renale (65 %, Niereninsuffizienz, Proteinurie, Albuminurie) sowie seltener hepatische Beteiligung (ca.10-15 %), Weichteil-(z.B. periorbitale

We performed multiomic factor analysis of biomarkers potentially associated with pathologic complete response (pCR) after a chemotherapy-free combination of immunotherapy and dual ERBB2 (HER2) blockade. Forty-eight patients with HER2 2+ (ISH+) or 3+ early breast cancer, stage I to III, and HER2-enriched subtype received pembrolizumab, trastuzumab biosimilar, and pertuzumab. The primary outcome was pCR (ypT0/is ypN0). Multiomic factors representing combined markers from pooling different translational research marker data were identified based on the eigenvalue >1 criteria. Additionally, logistic regressions with elastic net regularization were performed using all single markers, multiomic factors, and clinical characteristics to evaluate their association with pCR. The multiomic factor involving genes related to immune response and tumorigenesis, multiplexed IHC markers related to immune response and HER2 in the stroma, and stromal tumor-infiltrating lymphocytes were associated with pCR. pCR rates were 66.7% and 28.6% in the high (>median) and low (≤median) factor score groups, respectively (unadjusted OR, 5.00; 95% confidence interval, 1.35-18.56; nominal P = 0.016). In the analysis using standardized values for all individual markers from gene expression analysis, multiplexed IHC analysis in the stroma, and stromal tumor-infiltrating lymphocytes, markers with the greatest impact on pCR were the genes FNBP1, CD36, MYCN, and SIX1 (OR between 1.43 and 1.62), and progesterone receptor status (OR, 0.65), which surpassed grade (OR, 1.22) and nodal status (OR, 0.90). Our multiomic analysis uncovered mechanisms of tumor response to immunotherapy combined with dual HER2 blockade. These results could inform the design of larger trials investigating chemotherapy-free regimens in selected patients with HER2+ early breast cancer.